08/01/2013 13:49 - VISTAlink folder 952511 - Page 1/2 Read this entire leaflet carefully before taking this medicine. •Keep this leaflet; you may need to read it again. •If you have any other questions, if you are unsure, ask your doctor or pharmacist for more information. •This medicine has been prescribed for you. Never give it to someone else; even if they have identical symptoms, it may harm them. •If any of the undesirable effects becomes severe or if you notice an undesirable effect not listed in this leaflet, talk to your doctor or pharmacist. Cardiovascular Risk The use of NSAIDs particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke.). Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. In this leaflet : 1.What is Profenid 1mg/ml syrup, and in which cases is it used? 2.What are the information to know before taking Profenid 1mg/ml syrup? 3.How to take Profenid 1mg/ml syrup? 4.What are the possible undesirable effects ? 5.How to store Profenid 1mg/ml syrup? 6.Additional information 1.What is Profenid 1mg/ml syrup and in which cases is it used ? Antipyretic. This medicine is indicated, in infants starting from 6 months and in children up to 11 years, in case of fever. 2.What are the information to know before taking Profenid 1mg/ml syrup? If your doctor has informed you about an intolerance to certain sugars, contact him before taking this medicine. Never use Profenid 1mg/ml syrup: •beyond 5 months of pregnancy (24 weeks of amenorrhea), •history of allergy to ketoprofen or to any of the constituents of this product, •history of asthma triggered by taking this drug (ketoprofen) or a related drug, especially other non-steroidal anti-inflammatory drugs (NSAID), or aspirin, •history of gastrointestinal bleeding or ulcers associated with previous treatments by NSAID, •in progress, or recurrent ulcer / bleeding of the stomach or intestine •gastrointestinal hemorrhage, cerebral hemorrhage or other ongoing hemorrhage, •severe heart disease, •severe kidney disease, •severe liver disease, •infants under 6 months. In case of doubt, it is essential to seek the advice of your doctor or pharmacist. Be careful with Profenid 1mg/ml syrup Special warnings: This medicine should not be taken unless under medical supervision. At high doses, this drug has anti-inflammatory properties and can cause inconveniences that are sometimes severe which are seen with anti-inflammatory drugs. Do not exceed the prescribed doses or the duration of treatment. In case of known heart problems, stroke or risk factors for this type of pathology (e.g. in case of high blood pressure, diabetes, high cholesterol levels), talk to your doctor or pharmacist. Precaution for use Because it may be necessary to adapt the treatment, it is important to inform your doctor before taking Profenid in the following cases: •history of asthma associated with chronic rhinitis, chronic sinusitis or nasal polyps. The administration of this medicine can cause difficulty of breathing, asthma, especially in certain subjects allergic to aspirin or other non-steroidal anti-inflammatory drugs (see section « Never use Profenid 1mg/ml syrup »). •coagulation disorders, taking concomitant anticoagulant treatment. This medicine may cause severe gastrointestinal manifestations, •heart diseases (hypertension and/or heart failure), liver or kidney diseases, as in case of water retention, •chronic inflammatory bowel disease (such as Crohn's disease or hemorrhagic rectocolitis), •history of gastrointestinal disorders (gastric or duodenal ulcer) •concomitant treatment with other drugs that increase the risk of peptic ulcer or hemorrhage, such as glucocorticoids, antidepressants (SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent formation of blood clots such as aspirin or anticoagulants such as warfarin. If you have any of these cases, consult your doctor before taking Profenid (see section « Taking or using other drugs »). •history of skin reaction when exposed to the sun or UV rays (tanning cabinet), •chickenpox. This drug is not recommended due to exceptionally severe skin infection. The use of this drug is not recommended in patients with fructose intolerance, a syndrome of malabsorption of glucose and galactose or a sucrase/isomaltase deficit (rare hereditary diseases). During treatment: •signs of infection or aggravation of symptoms, inform your doctor. Like any non-steroidal anti-inflammatory drugs , ketoprofen may mask the symptoms of an underlying infection (like fever) •in case of gastrointestinal hemorrhage, (discharge of blood through the mouth or stool, black coloration of stool), stop the treatment and immediately contact a doctor or a medical emergency service. •if suggestive signs of allergy to this drug, especially asthma, urticaria, or sudden swelling of the face and neck (see What are the possible undesirable effects ?), stop the treatment and immediately contact a doctor. This medication contains 0.6 g of sucrose per ml, which must be considered in case of low sugar diet or in case of diabetes. This medicine contains a non-steroidal anti-inflammatory drug : ketoprofen. Your child should not take together with Profenid other medications containing aspirin and/or non-steroidal anti-inflammatory drugs. Read carefully the leaflets of the other medications that your child takes to ensure the absence of aspirin and/or non-steroidal anti-inflammatory drugs. Taking or using other drugs: Tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including medicines obtained without a prescription, because there are certain medicines that should not be taken simultaneously and others that may require a modification of the dose when taken together. Always inform your doctor or pharmacist if your child uses or receives one of the following medications before taking Profenid : •acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs, •corticosteroids, •oral anticoagulants such as warfarin, injectable heparin, antiplatelet or other thrombolytic agents such as ticlopidine, •lithium, •methotrexate, •angiotensin converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists, •certain antidepressants (selective serotonin reuptake inhibitors), •deferasirox, •cyclosporin, tacrolimus. •Patients should be advised not to take concomitantly metronidazole and Profenid® Syrup, due to potential interaction of metronidazole with the excipient propylene glycol. Pregnancy and lactation Pregnancy: This drug is intended for infant and child. However, in exceptional circumstances when used in women of childbearing age, the following facts must be remembered: During the first trimester of pregnancy (12 weeks of amenorrhea or 12 weeks after the first day of your last period), your doctor may, if necessary, prescribe this medicine for you. From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medicine will not be used unless advised by your doctor and taken for a brief period. Prolonged use of this medication is strongly not advised. Beyond 5 months of pregnancy (beyond 24 weeks of amenorrhea), you should not under any circomstances take this medicine, because its effects on your child can have serious consequences especially at the cardiopulmonary and renal level, even with a single intake. If you have taken this medicine while you were pregnant for more than five months, talk to your obstetrician / gynecolo- gist so that you will be given appropriate supervision. Lactation: In case of lactation, the use of this drug should be avoided. Ask your doctor or pharmacist for advice before taking any medication. Effects on the ability to drive vehicles or operate machines In rare cases, taking this drug can cause dizziness, drowsiness, convulsions or visual disturbances. It is advisable not to drive or operate machinery if any of these symptoms occurs. Important information regarding certain components of Profenid 1mg/ml syrup This medicine contains sucrose. 3. How to take Profenid 1mg/ml syrup? Dosage: The dose depends on the weight of your child. If you do not know the weight of your child, weigh him to be able to give him the most appropriate dose. The usual dose is 0.5 mg/kg/intake, 3 to 4 times daily, without exceeding 2 mg/kg/day. Frequency of administration: The intakes must be spaced by a minimum interval of 4 hours. If you feel that the effect of Profenid is too strong or too weak, consult your doctor or pharmacist. Duration of treatment: Usually 2 to 3 days. If the fever persists for more than 3 days, or in case of insufficient efficacy or occurrence of any other signs, do not continue treatment without the advice of your doctor. Method and route of administration: Orally. Close the bottle after each use. If your child has a fever above 38.5°C: You can improve the efficacy of the drug treatment through the following measures: •uncover your child, •make him drink regularly, •do not leave your child in a place that is too hot, •and eventually, bathe him in water with a temperature that is 2°C lower than that of the child. If despite of the treatment, fever persists for more than 3 days, consult your doctor again. If you have used Profenid 1mg/ml syrup more than you should: Immediately consult your doctor or pharmacist. If you forget to take Profenid 1mg/ml syrup: Do not take a double dose to compensate for the single dose that you forgot to take. 4. What are the possible undesirable effects ? Like all medicines, Profenid 1mg/ml syrup is likely to cause undesirable effects, although not everyone is affected. Undesirable effects reported during clinical trials in infants and children: •allergic reactions: edema of the face, urticaria. You should immediately stop the treatment and notify your doctor. •digestive disorders: nausea, vomiting, abdominal pain, diarrhea. You should notify your doctor. Undesirable effects reported with ketoprofen in infants and children: •Exceptionally, severe infections of the skin were observed in case of chickenpox. Undesirable effects reported with ketoprofen in adults: •Allergic reactions can occur : - skin: skin eruption, itching, urticaria, aggravation of chronic urticaria, - respiratory: asthma, difficulty of breathing especially in subjects allergic to aspirin or to non-steroidal anti-inflammatory drugs, - general: very rarely, sudden swelling of the face and neck (Quincke's disease –angioneurotic edema), anaphylactic (allergic) shock •May also occur : - gastrointestinal hemorrhage (see warnings). This is more frequent when the dose used is high, - skin reaction when exposed to the sun or UV rays (tanning cabinet), - exceptionally, peeling of the skin which can rapidly spread in a severe way in the whole body. In all these cases, you must immediately stop the treatment and notify your doctor. •During treatment, it is also possible to occur: - digestive disorders: nausea, vomiting, diarrhea, constipation, stomach aches, gastrointestinal discomfort, more rarely, inflammation of the intestine, - headache, dizziness, drowsiness, exceptionally convulsions and mood disorders, tinnitus, disturbed vision, hypertension, loss of hair or body hair, edema. In all these cases, you must notify your doctor: •Cases of gastric ulcer or intestinal perforation, renal impairment and hepatitis were observed. •Some biological modifications may possibly require a control of blood and kidney profiles. If you notice any undesirable effects not listed in this leaflet, or if certain undesirable effects become severe, inform your doctor or pharmacist. 5. How to store Profenid 1mg /ml syrup? Keep out of reach and sight of children. Do not use Profenid after the expiry date mentioned on the bottle. The expiry date refers to the last day of the month. Store at a temperature not exceeding 30°C. Do not use Profenid if you see any visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste Ask your pharmacist about what should be done with unused medications. These measures will help protect the environment. 6. Additional information What does Profenid 1 mg/ml syrup contain ? The active substance is : Ketoprofen 1.00 mg per 1 ml of syrup. The other components are : Propylene glycol, glycerol, sucrose syrup, sodium citrate, caramel (E 150), mixed fruit aroma, sodium hydroxide solution (30%), purified water. What is Profenid 1 mg/ml syrup and content of the outer packaging? Syrup, bottle of 100 ml. KEEP ALL MEDICINES OUT OF REACH OF CHILDREN Produced by SANOFI Egypt s.a.e Under license of SANOFI / France This insert was last approved in September2012 S 2 Syrup 1mg /ml Brand name: Profenid syrup Artwork type: Leaflet Version number (Revision): S2 (A1) Bar code: 1206 SAP identification no.: E042714 Country: Egypt Date: 21.08.2012 Designer: Gamal Habib Dimensions: 400 x 200 mm Logo version: A1 Minimum point size of text: 7 Pt. Colors: Panton Reflex blue • • • • • • • • • • • • • • • • • • • • SSRI • • • • • • • • • • • • • • • – – " " • • • • • • • • • • • • E
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08/01/2013 13:49 - VISTAlink folder 952511 - Page 1/2
Read this entire lea�et carefully before taking this medicine. •Keep this leaflet; you may need to read it again. •If you have any other questions, if you are unsure, ask your doctor or pharmacist for more information. •This medicine has been prescribed for you. Never give it to someone else; even if they have identical symptoms, it may harm them. •If any of the undesirable effects becomes severe or if you notice an undesirable effect not listed in this leaflet, talk to your doctor or pharmacist. Cardiovascular Risk The use of NSAIDs particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke.). Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
In this lea�et :1.What is Profenid 1mg/ml syrup, and in which cases is it used?2.What are the information to know before taking Profenid 1mg/ml syrup?3.How to take Profenid 1mg/ml syrup?4.What are the possible undesirable effects ?5.How to store Profenid 1mg/ml syrup?6.Additional information1.What is Profenid 1mg/ml syrup and in which cases is it used ?Antipyretic. This medicine is indicated, in infants starting from 6 months and in children up to 11 years, in case of fever.2.What are the information to know before taking Profenid 1mg/ml syrup?If your doctor has informed you about an intolerance to certain sugars, contact him before taking this medicine.Never use Profenid 1mg/ml syrup:•beyond 5 months of pregnancy (24 weeks of amenorrhea),•history of allergy to ketoprofen or to any of the constituents of this product,•history of asthma triggered by taking this drug (ketoprofen) or a related drug, especially other non-steroidal anti-inflammatory drugs (NSAID), or aspirin,•history of gastrointestinal bleeding or ulcers associated with previous treatments by NSAID,•in progress, or recurrent ulcer / bleeding of the stomach or intestine •gastrointestinal hemorrhage, cerebral hemorrhage or other ongoing hemorrhage,•severe heart disease, •severe kidney disease,•severe liver disease,•infants under 6 months.In case of doubt, it is essential to seek the advice of your doctor or pharmacist.Be careful with Profenid 1mg/ml syrupSpecial warnings: This medicine should not be taken unless under medical supervision. At high doses, this drug has anti-inflammatory properties and can cause inconveniences that are sometimes severe which are seen with anti-inflammatory drugs. Do not exceed the prescribed doses or the duration of treatment. In case of known heart problems, stroke or risk factors for this type of pathology (e.g. in case of high blood pressure, diabetes, high cholesterol levels), talk to your doctor or pharmacist.Precaution for useBecause it may be necessary to adapt the treatment, it is important to inform your doctor before taking Profenid in the following cases:•history of asthma associated with chronic rhinitis, chronic sinusitis or nasal polyps. The administration of this medicine can cause difficulty of breathing, asthma, especially in certain subjects allergic to aspirin or other non-steroidal anti-inflammatory drugs (see section « Never use Profenid 1mg/ml syrup »).•coagulation disorders, taking concomitant anticoagulant treatment. This medicine may cause severe gastrointestinal manifestations,•heart diseases (hypertension and/or heart failure), liver or kidney diseases, as in case of water retention,•chronic inflammatory bowel disease (such as Crohn's disease or hemorrhagic rectocolitis),•history of gastrointestinal disorders (gastric or duodenal ulcer)•concomitant treatment with other drugs that increase the risk of peptic ulcer or hemorrhage, such as glucocorticoids, antidepressants (SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent formation of blood clots such as aspirin or anticoagulants such as warfarin. If you have any of these cases, consult your doctor before taking Profenid (see section « Taking or using other drugs »).•history of skin reaction when exposed to the sun or UV rays (tanning cabinet),•chickenpox. This drug is not recommended due to exceptionally severe skin infection.The use of this drug is not recommended in patients with fructose intolerance, a syndrome of malabsorption of glucose and galactose or a sucrase/isomaltase deficit (rare hereditary diseases). During treatment:•signs of infection or aggravation of symptoms, inform your doctor. Like any non-steroidal anti-inflammatory drugs , ketoprofen may mask the symptoms of an underlying infection (like fever)•in case of gastrointestinal hemorrhage, (discharge of blood through the mouth or stool, black coloration of stool), stop the treatment and immediately contact a doctor or a medical emergency service.•if suggestive signs of allergy to this drug, especially asthma, urticaria, or sudden swelling of the face and neck (see What are the possible undesirable effects ?), stop the treatment and immediately contact a doctor. This medication contains 0.6 g of sucrose per ml, which must be considered in case of low sugar diet or in case of diabetes. This medicine contains a non-steroidal anti-inflammatory drug : ketoprofen.Your child should not take together with Profenid other medications containing aspirin and/or non-steroidal anti-inflammatory drugs. Read carefully the lea�ets of the other medications that your child takes to ensure the absence of aspirin and/or non-steroidal anti-inflammatory drugs.Taking or using other drugs: Tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including medicines obtained without a prescription, because there are certain medicines that should not be taken simultaneously and others that may require a modification of the dose when taken together. Always inform your doctor or pharmacist if your child uses or receives one of the following medications before taking Profenid :•acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs,•corticosteroids,•oral anticoagulants such as warfarin, injectable heparin, antiplatelet or other thrombolytic agents such as ticlopidine,•lithium,•methotrexate,•angiotensin converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists, •certain antidepressants (selective serotonin reuptake inhibitors),
•deferasirox, •cyclosporin, tacrolimus.•Patients should be advised not to take concomitantly metronidazole and Profenid® Syrup, due to potential interaction of metronidazole with the excipient propylene glycol.Pregnancy and lactation Pregnancy: This drug is intended for infant and child. However, in exceptional circumstances when used in women of childbearing age, the following facts must be remembered: During the first trimester of pregnancy (12 weeks of amenorrhea or 12 weeks after the first day of your last period), your doctor may, if necessary, prescribe this medicine for you. From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medicine will not be used unless advised by your doctor and taken for a brief period. Prolonged use of this medication is strongly not advised. Beyond 5 months of pregnancy (beyond 24 weeks of amenorrhea), you should not under any circomstances take this medicine, because its effects on your child can have serious consequences especially at the cardiopulmonary and renal level, even with a single intake. If you have taken this medicine while you were pregnant for more than five months, talk to your obstetrician / gynecolo-gist so that you will be given appropriate supervision.Lactation:In case of lactation, the use of this drug should be avoided. Ask your doctor or pharmacist for advice before taking any medication.Effects on the ability to drive vehicles or operate machinesIn rare cases, taking this drug can cause dizziness, drowsiness, convulsions or visual disturbances. It is advisable not to drive or operate machinery if any of these symptoms occurs. Important information regarding certain components of Profenid 1mg/ml syrupThis medicine contains sucrose.3. How to take Profenid 1mg/ml syrup?Dosage: The dose depends on the weight of your child. If you do not know the weight of your child, weigh him to be able to give him the most appropriate dose. The usual dose is 0.5 mg/kg/intake, 3 to 4 times daily, without exceeding 2 mg/kg/day.Frequency of administration: The intakes must be spaced by a minimum interval of 4 hours. If you feel that the effect of Profenid is too strong or too weak, consult your doctor or pharmacist.Duration of treatment: Usually 2 to 3 days. If the fever persists for more than 3 days, or in case of insufficient efficacy or occurrence of any other signs, do not continue treatment without the advice of your doctor.Method and route of administration: Orally.Close the bottle after each use.If your child has a fever above 38.5°C: You can improve the efficacy of the drug treatment through the following measures:•uncover your child,•make him drink regularly,•do not leave your child in a place that is too hot,•and eventually, bathe him in water with a temperature that is 2°C lower than that of the child.If despite of the treatment, fever persists for more than 3 days, consult your doctor again. If you have used Profenid 1mg/ml syrup more than you should:Immediately consult your doctor or pharmacist.If you forget to take Profenid 1mg/ml syrup: Do not take a double dose to compensate for the single dose that you forgot to take.4. What are the possible undesirable e�ects ?Like all medicines, Profenid 1mg/ml syrup is likely to cause undesirable effects, although not everyone is affected. Undesirable e�ects reported during clinical trials in infants and children:•allergic reactions: edema of the face, urticaria. You should immediately stop the treatment and notify your doctor.•digestive disorders: nausea, vomiting, abdominal pain, diarrhea. You should notify your doctor.Undesirable e�ects reported with ketoprofen in infants and children:•Exceptionally, severe infections of the skin were observed in case of chickenpox.Undesirable e�ects reported with ketoprofen in adults:•Allergic reactions can occur :- skin: skin eruption, itching, urticaria, aggravation of chronic urticaria, - respiratory: asthma, difficulty of breathing especially in subjects allergic to aspirin or to non-steroidal anti-inflammatory drugs,- general: very rarely, sudden swelling of the face and neck (Quincke's disease –angioneurotic edema), anaphylactic (allergic) shock •May also occur :- gastrointestinal hemorrhage (see warnings). This is more frequent when the dose used is high, - skin reaction when exposed to the sun or UV rays (tanning cabinet),- exceptionally, peeling of the skin which can rapidly spread in a severe way in the whole body.In all these cases, you must immediately stop the treatment and notify your doctor.•During treatment, it is also possible to occur:- digestive disorders: nausea, vomiting, diarrhea, constipation, stomach aches, gastrointestinal discomfort, more rarely, inflammation of the intestine, - headache, dizziness, drowsiness, exceptionally convulsions and mood disorders, tinnitus, disturbed vision, hypertension, loss of hair or body hair, edema.In all these cases, you must notify your doctor:•Cases of gastric ulcer or intestinal perforation, renal impairment and hepatitis were observed.•Some biological modifications may possibly require a control of blood and kidney profiles. If you notice any undesirable effects not listed in this leaflet, or if certain undesirable effects become severe, inform your doctor or pharmacist.5. How to store Profenid 1mg /ml syrup?Keep out of reach and sight of children.Do not use Profenid after the expiry date mentioned on the bottle.The expiry date refers to the last day of the month.Store at a temperature not exceeding 30°C.Do not use Profenid if you see any visible signs of deterioration.Medicines should not be disposed of via wastewater or household waste Ask your pharmacist about what should be done with unused medications. These measures will help protect the environment.6. Additional informationWhat does Profenid 1 mg/ml syrup contain ?The active substance is :Ketoprofen 1.00 mg per 1 ml of syrup.The other components are :Propylene glycol, glycerol, sucrose syrup, sodium citrate, caramel(E 150), mixed fruit aroma, sodium hydroxide solution (30%), purified water.What is Profenid 1 mg/ml syrup and content of the outer packaging?Syrup, bottle of 100 ml.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
Produced by SANOFI Egypt s.a.e Under license of SANOFI / France
This insert was last approved in September2012
S2
Syrup 1mg /ml
Brand name: Profenid syrupArtwork type: LeafletVersion number (Revision): S2 (A1)Bar code: 1206SAP identification no.: E042714 Country: EgyptDate: 21.08.2012Designer: Gamal HabibDimensions: 400 x 200 mmLogo version: A1Minimum point size of text: 7 Pt.Colors:Panton Reflex blue
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Signature in VISTAlink 1/6
Reason: Market marketing validation Signed by: Mohamed Fawzy (Egypt marketing department team) Signature date: 23/10/2012 14:16:31
Signature in VISTAlink 2/6
Reason: Market medical affairs validation Signed by: Tamer Talaat (Egypt medical affairs team) Signature date: 23/10/2012 14:31:54
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Reason: Market regulatory validation Signed by: Ehsan Abdelmeguid (Egypt regulatory affairs team) Signature date: 24/10/2012 14:31:14
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Reason: Plant final technical validation Signed by: Gamal Habib (Cairo packaging team) Signature date: 24/10/2012 14:36:42
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Reason: Plant quality validation Signed by: Madlen Samir (Cairo quality assurance team) Signature date: 08/11/2012 14:14:46
Signature in VISTAlink 6/6
Reason: Plant ready to print Signed by: Gamal Habib (Cairo packaging team) Signature date: 08/01/2013 13:49:49
E042714 - Pamph Profenid Syrup S@n
This document has been digitally signed by the following people within the VISTAlink system,
following the sanofi-aventis group guidelines.
Plant: CAIRO- EGYPT
Packaging material code: E042714
Packaging material name: Pamph Profenid Syrup S@n
Second packaging material code:
VISTAlink folder number: 952511
VISTAlink PDF version: 7
Reason Signed by Date
Market marketing validation Mohamed Fawzy (Egyptmarketing department team) 23/10/2012 14:16:31
Market medical affairs validation Tamer Talaat (Egypt medicalaffairs team) 23/10/2012 14:31:54
Market regulatory validation Ehsan Abdelmeguid (Egyptregulatory affairs team) 24/10/2012 14:31:14
Plant final technical validation Gamal Habib (Cairo packagingteam) 24/10/2012 14:36:42
Plant quality validation Madlen Samir (Cairo qualityassurance team) 08/11/2012 14:14:46
Plant ready to print Gamal Habib (Cairo packagingteam) 08/01/2013 13:49:49
08/01/2013 13:49 - VISTAlink folder 952511 - Page 2/2
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