البلد: إسبانيا
اللغة: الإنجليزية
المصدر: HMA (Heads of Medicines Agencies)
propofol 10 mg/ml
B. BRAUN MEDICAL S.A.
QN01AX10
Emulsion for injection
propofol
Dogs Non Food
2011-02-03
LABELLING AND PACKAGE LEAFLET Labelling and leaflet-Day 90-02.03.2011 LABELLING Labelling and leaflet-Day 90-02.03.2011 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD-BOXES CONTAINING GLASS AMPOULES 5 X 20 ML CARDBOARD-BOXES CONTAINING GLASS BOTTLES 1X50 ML; 1X100 ML; 10X50 ML; 10X100 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Propofol-Lipuro 10 mg/ml emulsion for injection Braun veterinary use 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml emulsion contains: Propofol 10 mg/ml Excipients: Soya-bean oil, Medium-chain triglycerides, glycerol, egg lecithin, sodium oleate and water for injections. 3. PHARMACEUTICAL FORM Sterile. Pyrogen free. Emulsion for injection. 4. PACKAGE SIZE (5 x 20 ml) (50 ml); (100 ml); (10 x 50 ml); (10 x 100 ml) 5. TARGET SPECIES Dogs. 6. INDICATION(S) Read the package leaflet before use. 7. METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP month/year Labelling and leaflet-Day 90-02.03.2011 Use immediately after opening the immediate package. Labelling and leaflet-Day 90-02.03.2011 11. SPECIAL STORAGE CONDITIONS Store below 25 ºC. Do not freeze. Keep the container in the outer carton. Shake the ampoule gently thoroughly before opening. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary me اقرأ الوثيقة كاملة
SPC-Day 90-02.03.2011 SUMMARY OF PRODUCT CHARACTERISTICS SPC-Day 90-02.03.2011 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Propofol- Lipuro 10 mg/ml emulsion for injection Braun veterinary use. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml emulsion contains: ACTIVE SUBSTANCE: Propofol 10 mg EXCIPIENTS: Soya-bean oil 50 mg Medium-chain triglycerides 50 mg Glycerol 25 mg Egg lecithin 12 mg Sodium oleate 0.3 mg Water for injections to. 1 ml 3. PHARMACEUTICAL FORM Emulsion for injection. White milky oil-in-water emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Short -acting intravenous general anaesthetic used for: general anaesthesia of short duration (less than 10 minutes) for procedures such as splinter removal, radiographs, wound treatment, etc. induction and maintenance of long-duration general anaesthesia. induction of anaesthesia and later maintenance with inhalation anaesthetics (gases). 4.3 CONTRAINDICATIONS The medicinal product must not be used in animal with a known hypersensitivity to propofol or to any of the excipients of the emulsion. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The duration of anaesthesia is considerably more prolonged in greyhounds than in other breed, therefore the dose should be adjusted. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The administration rate must be controlled since a too fast administration can cause apnoea and too slow it can eliminate the inductive effect. During the propofol administration facilities for اقرأ الوثيقة كاملة