Injectable Drugs Propofol- ® Lipuro 10 mg/ml and 20 mg/ml Go for the original – Lipuro®-Technology by B. Braun B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany Tel. +49 5661 71-0 | www.bbraun.com X. 00.00.00/0 Nr. 000 0000A Propofol-®Lipuro 1% (10 mg/ml) Propofol-®Lipuro 2% (20 mg/ml) Composition Propofol-®Lipuro 1% (10 mg/ml) 1 ml emulsion for injection or infusion contains 10 mg Propofol. Excipients: Soya-bean oil, refined, medium-chain triglycerides, glyce- rol, egg lecithin, sodium oleate, water for injections. Propofol-®Lipuro 2% (20 mg/ml) 1 ml emulsion for injection or infusion contains 20 mg Propofol. Excipients: Soya-bean oil, refined, medium-chain triglycerides, glyce- rol, egg lecithin, sodium oleate, water for injections. Therapeutic indications Propofol-Lipuro 10 mg/ml is a short-acting intravenous general anaes- thetic for - induction and maintenance of general anaesthesia in adults and children > 1 month - sedation of ventilated patients >16 years of age in the intensive care unit - sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month. Propofol-Lipuro 20 mg/ml is a short-acting intravenous general anaes- thetic for - induction and maintenance of general anaesthesia in adults and children > 3 years - sedation of ventilated patients >16 years of age in the intensive care unit - sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years. Contraindications Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml are contrain- dicated in patients with a known hypersensitivity to propofol or to any of the excipients. Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml containing soya-bean oil and should not be used in patients who are hypersensitive to peanut or soya. Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml must not be used in patients of 16 years of age or younger for sedation for intensive care. Special warnings and precautions for use Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care). Patients should be constantly monitored and facilities for mainte- nance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure. Undesirable effects Induction and maintenance of anaesthesia or sedation with propofol is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side ef- fects of an anaesthetic/sedative agent, such as hypotension. The na- ture, severity and incidence of adverse events observed in patients receiving propofol may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken. Immune system disorders Very rare: Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotension Metabolism and Nutritional disorder Frequency not known (Not known as it cannot be estimated from the available clinical trial data.): Metabolic acidosis, hyperkalaemia, hy- perlipidaemia Psychiatric disorders Frequency not known: Euphoric mood, drug abuse (Drug abuse, predo- minantly by health care professionals.) Nervous system disorders Common: Headache during recovery phase Rare: Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery Very rare: Postoperative unconsciousness Frequency not known: Involuntary movements Cardiac disorders Common: Bradycardia (Serious bradycardias are rare. There have been isolated reports of progression to asystole.) Very rare: Pulmonary oedema Frequency not known: Cardiac arrhythmia, cardiac failure, (Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment.) Vascular disorders Common: Hypotension (Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of propofol.) Uncommon: Thrombosis and phlebitis Respiratory, thoracic and mediastinal disorders Common: Transient apnoea during induction Gastrointestinal disorders Common: Nausea and vomiting during recovery phase Very rare: Pancreatitis Hepatobiliary disorders Frequency not known: Hepatomegaly Musculoskeletal and connective tissue disorders Frequency not known: Rhabdomyolysis (Very rare reports of rhabdo- myolysis have been received where propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.) Renal and urinary disorders Very rare: Discolouration of urine following prolonged administration Frequency not known: Renal failure Reproductive system and breast Very rare: Sexual disinhibition General disorders and administration site conditions Very common: Local pain on induction (May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol- ®Lipuro local pain can also be minimised by the co-administration of lidocaine.) Investigations Frequency not known: Brugada type ECG Injury, poisoning and procedural complications Very rare: Postoperative fever Combinations of rhabdomyolysis, metabolic acidosis, hyperkalaemia, hyperlipidaemia, hepatomegaly, renal failure and cardiac failure, re- ported as “Propofol infusion syndrome”, may be seen in seriously ill patients who often have multiple risk factors for the development of the events. For prescription only! Version 10/2011 Marketing authorization holder B. Braun Melsungen AG Carl-Braun-Straße 1 D-34212 Melsungen, Germany See local Prescribing Information for full details, as Prescribing Information may vary from country to country. Product Total Volume Container Type Sales Unit Propofol-®Lipuro 10 mg/ml 200 mg/ 20 ml Glass Ampoule 5 x 20 ml 200 mg/ 20 ml Single Dose Glass Vial 10 x 20 ml 500 mg/ 50 ml Single Dose Glass Vial 10 x 50 ml 1000 mg/100 ml Single Dose Glass Vial 10 x 100 ml Product Total Volume Container Type Sales Unit Propofol-®Lipuro 20 mg/ml 1000 mg/50 ml Single Dose Glass Vial 10 x 50 ml
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Injectable Drugs
Propofol-®Lipuro 10 mg/ml and 20 mg/ml
Go for the original – Lipuro®-Technology by B. Braun
B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | GermanyTel. +49 5661 71-0 | www.bbraun.com X. 00.00.00/0 Nr. 000 0000A
Propofol-®Lipuro 1% (10 mg/ml)Propofol-®Lipuro 2% (20 mg/ml)CompositionPropofol-®Lipuro 1% (10 mg/ml)1 ml emulsion for injection or infusion contains 10 mg Propofol.Excipients: Soya-bean oil, re� ned, medium-chain triglycerides, glyce-rol, egg lecithin, sodium oleate, water for injections.Propofol-®Lipuro 2% (20 mg/ml)1 ml emulsion for injection or infusion contains 20 mg Propofol.Excipients: Soya-bean oil, re� ned, medium-chain triglycerides, glyce-rol, egg lecithin, sodium oleate, water for injections.Therapeutic indicationsPropofol-Lipuro 10 mg/ml is a short-acting intravenous general anaes-thetic for- induction and maintenance of general anaesthesia in adults and children > 1 month- sedation of ventilated patients >16 years of age in the intensive care unit- sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month. Propofol-Lipuro 20 mg/ml is a short-acting intravenous general anaes-thetic for- induction and maintenance of general anaesthesia in adults and children > 3 years- sedation of ventilated patients >16 years of age in the intensive care unit- sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years.ContraindicationsPropofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml are contrain-dicated in patients with a known hypersensitivity to propofol or to any of the excipients.Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml containing soya-bean oil and should not be used in patients who are hypersensitive to peanut or soya.Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml must not be used in patients of 16 years of age or younger for sedation for intensive care.
Special warnings and precautions for usePropofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care).Patients should be constantly monitored and facilities for mainte-nance of a patent airway, arti� cial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.Undesirable e� ectsInduction and maintenance of anaesthesia or sedation with propofol is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side ef-fects of an anaesthetic/sedative agent, such as hypotension. The na-ture, severity and incidence of adverse events observed in patients receiving propofol may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.Immune system disorders Very rare: Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotensionMetabolism and Nutritional disorder Frequency not known (Not known as it cannot be estimated from the available clinical trial data.): Metabolic acidosis, hyperkalaemia, hy-perlipidaemiaPsychiatric disorders Frequency not known: Euphoric mood, drug abuse (Drug abuse, predo-minantly by health care professionals.)Nervous system disorders Common: Headache during recovery phaseRare: Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recoveryVery rare: Postoperative unconsciousnessFrequency not known: Involuntary movementsCardiac disorders Common: Bradycardia (Serious bradycardias are rare. There have been isolated reports of progression to asystole.)Very rare: Pulmonary oedemaFrequency not known: Cardiac arrhythmia, cardiac failure, (Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment.)Vascular disorders Common: Hypotension (Occasionally, hypotension may require use of intravenous � uids and reduction of the administration rate of propofol.)
Uncommon: Thrombosis and phlebitisRespiratory, thoracic and mediastinal disordersCommon: Transient apnoea during inductionGastrointestinal disordersCommon: Nausea and vomiting during recovery phaseVery rare: PancreatitisHepatobiliary disordersFrequency not known: HepatomegalyMusculoskeletal and connective tissue disordersFrequency not known: Rhabdomyolysis (Very rare reports of rhabdo-myolysis have been received where propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.)Renal and urinary disorders Very rare: Discolouration of urine following prolonged administrationFrequency not known: Renal failureReproductive system and breast Very rare: Sexual disinhibitionGeneral disorders and administration site conditionsVery common: Local pain on induction (May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol-®Lipuro local pain can also be minimised by the co-administration of lidocaine.)InvestigationsFrequency not known: Brugada type ECGInjury, poisoning and procedural complicationsVery rare: Postoperative feverCombinations of rhabdomyolysis, metabolic acidosis, hyperkalaemia, hyperlipidaemia, hepatomegaly, renal failure and cardiac failure, re-ported as “Propofol infusion syndrome”, may be seen in seriously ill patients who often have multiple risk factors for the development of the events.For prescription only!Version 10/2011Marketing authorization holderB. Braun Melsungen AGCarl-Braun-Straße 1D-34212 Melsungen, Germany
See local Prescribing Information for full details, as Prescribing Information may vary from country to country.
ProductTotal
VolumeContainer
TypeSales Unit
Propofol-®Lipuro 10 mg/ml
200 mg/ 20 mlGlass
Ampoule 5 x 20 ml
200 mg/ 20 mlSingle Dose Glass Vial
10 x 20 ml
500 mg/ 50 mlSingle Dose Glass Vial
10 x 50 ml
1000 mg/100 mlSingle Dose Glass Vial
10 x 100 ml
ProductTotal
VolumeContainer
TypeSales Unit
Propofol-®Lipuro 20 mg/ml
1000 mg/50 mlSingle Dose Glass Vial
10 x 50 ml
Injectable Drugs
Lipuro®-Technology
Technology & Innovation: Propofol-®Lipuro is a highly innovative product from B. Braun’s unique Lipuro®-Technology, which uses MCT/LCT lipid emulsion as the drug delivery base with excellent solubility and stability.
Clinical approval: Since its launch in 1999, Propofol-®Lipuro has been administered to millions of patients in over 120 countries. Data from clinical studies have published in scores in prestigious medical journals.
Setting standards: Propofol-®Lipuro sets standards that inspire imitators. The clini-cal bene� ts of MCT/LCT are superior to LCT or MCT emulsions. To date, Propofol-®Lipuro remains the only formulation proven to reduce pain on injection.
Service continuity: In line with our slogan „Sharing Expertise“, Propofol-®Lipuro is further proof of B. Braun’s continued commitment to patients and doctors, hospital and community.
There is only one Propofol-®Lipuro. Go for the original.
Propofol-®Lipuro 10 mg/ml
Signi� cant reduction of injection pain
Rapid onset and quick recovery
Excellent anesthesia control
Propofol-®Lipuro 20 mg/ml
Reduced lipid and � uid load
Improved lung function
Enhanced liver function
Sustained immune function
Clinical bene� ts of innovation
There is only one Propofol-®Lipuro. Go for the original.
Injectable Drugs
Propofol-®Lipuro 10 mg/ml
Minimum pain. Maximum comfort.Local pain on propofol injection is a well-known problem inanesthesiology, especially in pediatric settings. Compared toconventional LCT or MCT emulsions, Propofol-®Lipuro has beenformulated with 30 % less free propofol in the aqueous phase (a).The result is a signi� cant reduction in pain at the injection site.
Fig. 1: Signi� cantly reduced injection pain. Adapted from (b).
60
50
40
30
20
10
0
% of Patients
37 % 64 %
12
10
8
6
4
2
0
0% 10.7%
% of Patients
Fig. 2: Signi� cantly reduced sensitivity to severe pain. Adapted from (c).
Proven clinical bene� tsB. Braun applied its over 30 years‘ experience with lipid emulsions in combining Lipuro®-Technology with propofol. The result, Propofol-®Lipuro 20 mg/ml is an anesthetic with outstanding safety and good tolerability. It is ideally suited for patients re-quiring long-term sedation.
a) Müller RH, Harnisch S. Physico chemical characterization of propofol-loaded emulsions and interaction with plasma proteins. Eur Hosp Pharm 2000; 6: 24-31
b) Larsen B, Beerhalter U, et al. Less pain on injection by a new formulation of propofol? A comparison with propofol LCT. Anaesthesist 2001; 50(11): 842-5
c) Rau J, Roizen MF, et al. Propofol in an emulsion of long- and medium-chain triglycerides: the e� ect on pain. Anesth Analg 2001; 93(2): 382-4
d) Marsili I, Iovinelli G, et al. Parenteral nutrition in COPD patients: long vs. medium- chain triglycerides (MCT). Clinical Nutrition 1992; 11: 45, special supplement
e) Waitzberg DL, Bellinati-Pires R, et al. E� ect of total parenteral nutrition with di� erent lipid emulsions on human monocyte and neutrophil funcions.
Nutrition 1997; 13: 128-132
Severe pain reported on questioningOverall incidence of pain on injection Ventilation period in COPD patients Neutrophils cell activity