[Version 8, 0 5 /2012 7.3.2, 10/2011 ] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1
[Version 8 052012732 102011]
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substanceltsgt
ltAdjuvant(ltsgt)gt
ltExcipient(ltsgt)gt
For athe full list of excipients see section 61
3 PHARMACEUTICAL FORM
4 CLINICAL PARTICULARS
41 Target species
42 Indications for use specifying the target species
43 Contraindications
ltNonegtltDo not use in hellipgtltDo not use in case of hypersensitivity to the active substance(s) lt to the adjuvant(s)gt or to any of the excipient(s)gt
44 Special warnings ltfor each target speciesgt
ltNonegt
45 Special precautions for use
Special precautions for use in animals
ltNot applicablegt
ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccination During this time the contact of immunodepressed immunosuppressed and unvaccinated species with vaccinated species should be avoidedgt
ltThe vaccineal strain can spread to speciesSpecial precautions should be taken to avoid spreading of the vaccine strain to speciesgt
ltAppropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible speciesgt
ltSpecies and unvaccinated species in contact with vaccinated species may react to the vaccine strain presenting clinical signs such as hellipgt
2
Special precautions to be taken by the person administering the veterinary medicinal product to animals
ltNot applicablegt
ltIn case of accidental ltself-administrationgt ltself-injectiongt ltingestiongt ltspillage onto skingt seek medical advice immediately and show the package leaflet or the label to the physiciangt
ltPeople with known hypersensitivity to INN should ltavoid contact with the veterinary medicinal productgt ltadminister the veterinary medicinal product with cautiongtgt
ltPersonal protective equipment consisting of specify should be worn when handling the veterinary medicinal productgt
ltThe veterinary medicinal product should not be administered by pregnant womengt
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt can be pathogenic for humans Since this ltvaccinegt ltimmunological veterinary medicinal productgt has been prepared with live attenuated microorganisms appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the processgt
ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccinationgt
ltImmunocompromised persons are advised to avoid contact with the ltvaccinegt ltimmunological veterinary medicinal productgt and vaccinated animals during periodgt
ltThe vaccine strain can be found in the environment for up to x ltdaysgt ltweeksgt Personnel involved in attending vaccinated species should follow general hygiene principles (changing clothes wearing gloves cleaning and disinfection of boots) and take particular care in handling litter from recently vaccinated speciesgt
ltTo the userThis veterinary medicinal product contains mineral oil Accidental injectionself injectionself-injection may result in severe pain and swelling particularly if injected into a joint or finger and in rare cases could result in the loss of the affected finger if prompt medical attention is not given If you are accidentally injected with this veterinary medicinal product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you If pain persists for more than 12 hours after medical examination seek medical advice again
To the physicianThis veterinary medicinal product contains mineral oil Even if small amounts have been injected accidental injection with this product can cause intense swelling which may for example result in ischaemic necrosis and even the loss of a digit Expert PROMPT surgical attention is required and may necessitate early incision and irrigation of the injected area especially where there is involvement of finger pulp or tendongt
ltThe long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated Therefore it is advisable not to treat animals on the same pasture every seasongt
3
46 Adverse reactions (frequency and seriousness)
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals)- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports) gt
47 Use during pregnancy lactation or lay
ltThe safety of the veterinary medicinal product has not been established during ltpregnancygtltlactationgt ltlaygtgt
ltPregnancygtltCan be used during pregnancygtltThe use is not recommended (during the whole or part of the pregnancy)gtltDo not use (during the whole or part of the pregnancy)gtltThe use is not recommended during ltpregnancygt ltlactationgtgtltUse only accordingly to the benefit-risk assessment by the responsible veterinariangtltLaboratory studies in species have not produced any evidence of a ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgtltLaboratory studies in species have shown evidence of ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgt
ltLactationgtltNot applicablegt
ltLaying birdsgtltDo not use in ltbirds in laygt ltbreeding birdsgt ltandor within 4 weeks before the onset of the laying periodgtgt
ltFertilitygtltDo not use in breeding animalsgt
48 Interaction with other medicinal products and other forms of interaction
ltNone knowngtltNo data availablegt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered on the same day but not mixed with description of tested product(s)gt
ltThe ltveterinary medicinal productgt ltvaccinegt ltimmunological veterinary medicinal productgt should be given at different sitesgt
4
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt
49 Amounts to be administered and administration route
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt
410 Overdose (symptoms emergency procedures antidotes) if necessary
411 Withdrawal period(s)
ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt
ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt
5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES
Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)
lt51 Pharmacodynamic propertiesgt
lt52 Pharmacokinetic particularsgt
ltEnvironmental propertiesgt
6 PHARMACEUTICAL PARTICULARS
61 List of excipients
62 Incompatibilities
ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt
5
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substanceltsgt
ltAdjuvant(ltsgt)gt
ltExcipient(ltsgt)gt
For athe full list of excipients see section 61
3 PHARMACEUTICAL FORM
4 CLINICAL PARTICULARS
41 Target species
42 Indications for use specifying the target species
43 Contraindications
ltNonegtltDo not use in hellipgtltDo not use in case of hypersensitivity to the active substance(s) lt to the adjuvant(s)gt or to any of the excipient(s)gt
44 Special warnings ltfor each target speciesgt
ltNonegt
45 Special precautions for use
Special precautions for use in animals
ltNot applicablegt
ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccination During this time the contact of immunodepressed immunosuppressed and unvaccinated species with vaccinated species should be avoidedgt
ltThe vaccineal strain can spread to speciesSpecial precautions should be taken to avoid spreading of the vaccine strain to speciesgt
ltAppropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible speciesgt
ltSpecies and unvaccinated species in contact with vaccinated species may react to the vaccine strain presenting clinical signs such as hellipgt
2
Special precautions to be taken by the person administering the veterinary medicinal product to animals
ltNot applicablegt
ltIn case of accidental ltself-administrationgt ltself-injectiongt ltingestiongt ltspillage onto skingt seek medical advice immediately and show the package leaflet or the label to the physiciangt
ltPeople with known hypersensitivity to INN should ltavoid contact with the veterinary medicinal productgt ltadminister the veterinary medicinal product with cautiongtgt
ltPersonal protective equipment consisting of specify should be worn when handling the veterinary medicinal productgt
ltThe veterinary medicinal product should not be administered by pregnant womengt
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt can be pathogenic for humans Since this ltvaccinegt ltimmunological veterinary medicinal productgt has been prepared with live attenuated microorganisms appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the processgt
ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccinationgt
ltImmunocompromised persons are advised to avoid contact with the ltvaccinegt ltimmunological veterinary medicinal productgt and vaccinated animals during periodgt
ltThe vaccine strain can be found in the environment for up to x ltdaysgt ltweeksgt Personnel involved in attending vaccinated species should follow general hygiene principles (changing clothes wearing gloves cleaning and disinfection of boots) and take particular care in handling litter from recently vaccinated speciesgt
ltTo the userThis veterinary medicinal product contains mineral oil Accidental injectionself injectionself-injection may result in severe pain and swelling particularly if injected into a joint or finger and in rare cases could result in the loss of the affected finger if prompt medical attention is not given If you are accidentally injected with this veterinary medicinal product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you If pain persists for more than 12 hours after medical examination seek medical advice again
To the physicianThis veterinary medicinal product contains mineral oil Even if small amounts have been injected accidental injection with this product can cause intense swelling which may for example result in ischaemic necrosis and even the loss of a digit Expert PROMPT surgical attention is required and may necessitate early incision and irrigation of the injected area especially where there is involvement of finger pulp or tendongt
ltThe long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated Therefore it is advisable not to treat animals on the same pasture every seasongt
3
46 Adverse reactions (frequency and seriousness)
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals)- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports) gt
47 Use during pregnancy lactation or lay
ltThe safety of the veterinary medicinal product has not been established during ltpregnancygtltlactationgt ltlaygtgt
ltPregnancygtltCan be used during pregnancygtltThe use is not recommended (during the whole or part of the pregnancy)gtltDo not use (during the whole or part of the pregnancy)gtltThe use is not recommended during ltpregnancygt ltlactationgtgtltUse only accordingly to the benefit-risk assessment by the responsible veterinariangtltLaboratory studies in species have not produced any evidence of a ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgtltLaboratory studies in species have shown evidence of ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgt
ltLactationgtltNot applicablegt
ltLaying birdsgtltDo not use in ltbirds in laygt ltbreeding birdsgt ltandor within 4 weeks before the onset of the laying periodgtgt
ltFertilitygtltDo not use in breeding animalsgt
48 Interaction with other medicinal products and other forms of interaction
ltNone knowngtltNo data availablegt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered on the same day but not mixed with description of tested product(s)gt
ltThe ltveterinary medicinal productgt ltvaccinegt ltimmunological veterinary medicinal productgt should be given at different sitesgt
4
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt
49 Amounts to be administered and administration route
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt
410 Overdose (symptoms emergency procedures antidotes) if necessary
411 Withdrawal period(s)
ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt
ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt
5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES
Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)
lt51 Pharmacodynamic propertiesgt
lt52 Pharmacokinetic particularsgt
ltEnvironmental propertiesgt
6 PHARMACEUTICAL PARTICULARS
61 List of excipients
62 Incompatibilities
ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt
5
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
Special precautions to be taken by the person administering the veterinary medicinal product to animals
ltNot applicablegt
ltIn case of accidental ltself-administrationgt ltself-injectiongt ltingestiongt ltspillage onto skingt seek medical advice immediately and show the package leaflet or the label to the physiciangt
ltPeople with known hypersensitivity to INN should ltavoid contact with the veterinary medicinal productgt ltadminister the veterinary medicinal product with cautiongtgt
ltPersonal protective equipment consisting of specify should be worn when handling the veterinary medicinal productgt
ltThe veterinary medicinal product should not be administered by pregnant womengt
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt can be pathogenic for humans Since this ltvaccinegt ltimmunological veterinary medicinal productgt has been prepared with live attenuated microorganisms appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the processgt
ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccinationgt
ltImmunocompromised persons are advised to avoid contact with the ltvaccinegt ltimmunological veterinary medicinal productgt and vaccinated animals during periodgt
ltThe vaccine strain can be found in the environment for up to x ltdaysgt ltweeksgt Personnel involved in attending vaccinated species should follow general hygiene principles (changing clothes wearing gloves cleaning and disinfection of boots) and take particular care in handling litter from recently vaccinated speciesgt
ltTo the userThis veterinary medicinal product contains mineral oil Accidental injectionself injectionself-injection may result in severe pain and swelling particularly if injected into a joint or finger and in rare cases could result in the loss of the affected finger if prompt medical attention is not given If you are accidentally injected with this veterinary medicinal product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you If pain persists for more than 12 hours after medical examination seek medical advice again
To the physicianThis veterinary medicinal product contains mineral oil Even if small amounts have been injected accidental injection with this product can cause intense swelling which may for example result in ischaemic necrosis and even the loss of a digit Expert PROMPT surgical attention is required and may necessitate early incision and irrigation of the injected area especially where there is involvement of finger pulp or tendongt
ltThe long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated Therefore it is advisable not to treat animals on the same pasture every seasongt
3
46 Adverse reactions (frequency and seriousness)
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals)- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports) gt
47 Use during pregnancy lactation or lay
ltThe safety of the veterinary medicinal product has not been established during ltpregnancygtltlactationgt ltlaygtgt
ltPregnancygtltCan be used during pregnancygtltThe use is not recommended (during the whole or part of the pregnancy)gtltDo not use (during the whole or part of the pregnancy)gtltThe use is not recommended during ltpregnancygt ltlactationgtgtltUse only accordingly to the benefit-risk assessment by the responsible veterinariangtltLaboratory studies in species have not produced any evidence of a ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgtltLaboratory studies in species have shown evidence of ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgt
ltLactationgtltNot applicablegt
ltLaying birdsgtltDo not use in ltbirds in laygt ltbreeding birdsgt ltandor within 4 weeks before the onset of the laying periodgtgt
ltFertilitygtltDo not use in breeding animalsgt
48 Interaction with other medicinal products and other forms of interaction
ltNone knowngtltNo data availablegt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered on the same day but not mixed with description of tested product(s)gt
ltThe ltveterinary medicinal productgt ltvaccinegt ltimmunological veterinary medicinal productgt should be given at different sitesgt
4
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt
49 Amounts to be administered and administration route
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt
410 Overdose (symptoms emergency procedures antidotes) if necessary
411 Withdrawal period(s)
ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt
ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt
5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES
Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)
lt51 Pharmacodynamic propertiesgt
lt52 Pharmacokinetic particularsgt
ltEnvironmental propertiesgt
6 PHARMACEUTICAL PARTICULARS
61 List of excipients
62 Incompatibilities
ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt
5
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
46 Adverse reactions (frequency and seriousness)
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals)- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports) gt
47 Use during pregnancy lactation or lay
ltThe safety of the veterinary medicinal product has not been established during ltpregnancygtltlactationgt ltlaygtgt
ltPregnancygtltCan be used during pregnancygtltThe use is not recommended (during the whole or part of the pregnancy)gtltDo not use (during the whole or part of the pregnancy)gtltThe use is not recommended during ltpregnancygt ltlactationgtgtltUse only accordingly to the benefit-risk assessment by the responsible veterinariangtltLaboratory studies in species have not produced any evidence of a ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgtltLaboratory studies in species have shown evidence of ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgt
ltLactationgtltNot applicablegt
ltLaying birdsgtltDo not use in ltbirds in laygt ltbreeding birdsgt ltandor within 4 weeks before the onset of the laying periodgtgt
ltFertilitygtltDo not use in breeding animalsgt
48 Interaction with other medicinal products and other forms of interaction
ltNone knowngtltNo data availablegt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered on the same day but not mixed with description of tested product(s)gt
ltThe ltveterinary medicinal productgt ltvaccinegt ltimmunological veterinary medicinal productgt should be given at different sitesgt
4
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt
49 Amounts to be administered and administration route
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt
410 Overdose (symptoms emergency procedures antidotes) if necessary
411 Withdrawal period(s)
ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt
ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt
5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES
Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)
lt51 Pharmacodynamic propertiesgt
lt52 Pharmacokinetic particularsgt
ltEnvironmental propertiesgt
6 PHARMACEUTICAL PARTICULARS
61 List of excipients
62 Incompatibilities
ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt
5
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt
ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt
ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt
49 Amounts to be administered and administration route
ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt
410 Overdose (symptoms emergency procedures antidotes) if necessary
411 Withdrawal period(s)
ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt
ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt
5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES
Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)
lt51 Pharmacodynamic propertiesgt
lt52 Pharmacokinetic particularsgt
ltEnvironmental propertiesgt
6 PHARMACEUTICAL PARTICULARS
61 List of excipients
62 Incompatibilities
ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt
5
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt
ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt
ltNone knowngt
63 Shelf life
ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt
lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt
64 Special precautions for storage
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgt
ltThis veterinary medicinal product does not require any special temperature storage conditions gt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
6
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
65 Nature and composition of immediate packaging
ltNot all pack sizes may be marketedgt
66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt
ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt
7 MARKETING AUTHORISATION HOLDER
Name and addresslttTelgtltFfaxgtlteE-mailgt
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip
ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt
10 DATE OF REVISION OF THE TEXT
MMYYYY or ltmonth YYYYgt
ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt
PROHIBITION OF SALE SUPPLY ANDOR USE
ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
7
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ANNEX II
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C STATEMENT OF THE MRLs
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt
8
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE
ltName and address of the manufacturerltsgt of the biological active substanceltsgt
Name and addressgt
Name and address of the manufacturerltsgt responsible for batch release
Name and address
ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt
ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt
ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)
In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt
C STATEMENT OF THE MRLs
ltNot applicablegt
[For pharmaceutical products]
The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
9
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[In case of MRLs not been published yet]
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows
Pharmaco-logically active substance
Marker residue
Animal species MRLs Target
tissuesOther
provisionsTherapeutic classification
ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt
[For immunological products]
ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt
ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt
ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market
ltPSURsgt
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ltNot applicablegtltFor use by veterinary surgeons onlygt
ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt
ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures
10
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
Description Due date
gt
ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt
ltThe MAH shall complete within the stated timeframe the following measures
Description Due date
gt gt
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
A LABELLING
13
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES
3 PHARMACEUTICAL FORM
4 PACKAGE SIZE
5 TARGET SPECIES
6 INDICATION(S)
7 METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
8 WITHDRAWAL PERIOD
ltWithdrawal period gt
9 SPECIAL WARNING(S) IF NECESSARY
ltRead the package leaflet before usegt
ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt
10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt
14
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
11 SPECIAL STORAGE CONDITIONS
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY
ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt
13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE
For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt
ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt
ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt
14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo
Keep out of the sight and reach and sight of children
15
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Name and addressltTtelgtltFfaxgtlteE-mailgt
16 MARKETING AUTHORISATION NUMBER(S)
EU0200000000
17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
2 QUANTITY OF THE ACTIVE SUBSTANCE(S)
3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES
4 ROUTE(S) OF ADMINISTRATION
5 WITHDRAWAL PERIOD
ltWithdrawal period gt
6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
7 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt
8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURETYPE
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)
2 NAME OF THE MARKETING AUTHORISATION HOLDER
Name
3 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltEXP monthyeargt
4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]
ltBatchgt ltLotgt ltBNgt number
5 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo
For animal treatment only
18
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
B PACKAGE LEAFLET
19
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget
speciesgt
1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT
ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt
ltManufacturer responsible for the batch release gt
2 NAME OF THE VETERINARY MEDICINAL PRODUCT
(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)
3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4 INDICATION(S)
5 CONTRAINDICATIONS
6 ADVERSE REACTIONS
lt The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt
If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon
7 TARGET SPECIES
8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION
9 ADVICE ON CORRECT ADMINISTRATION
ltDo not use name of product if you notice description of the visible signs of deteriorationgt
10 WITHDRAWAL PERIOD
20
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach and sight of children
ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt
ltin order to protect from ltlightgt ltandgt ltmoisturegtgt
ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt
ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt
[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]
Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt
ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip
ltDo not use name if you notice description of the visible signs of deteriorationgt
12 SPECIAL WARNING(S)
ltNonegt
ltSpecial warnings lt for each target species gt
21
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
ltSpecial precautions for usegt
ltSpecial precautions for use in animalsgt
ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt
ltPregnancygt
ltLactationgt
ltLaygt
ltInteraction with other medicinal products and other forms of interactiongt
ltOverdose (symptoms emergency procedures antidotes ) gt
ltIncompatibilitiesgt
13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY
ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt
14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt
lt15 OTHER INFORMATIONgt
ltNot all pack sizes may be marketedgt
ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt
BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt
LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt
Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt
MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt
22
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt
MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt
DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt
NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt
DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt
NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt
Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt
OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt
ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt
EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt
PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt
FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt
RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt
IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt
SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt
23
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24
IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt
Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt
ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt
SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt
ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt
SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt
LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt
United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt
LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt
gt
24