Država: Avstrija
Jezik: angleščina
Source: HMA (Heads of Medicines Agencies)
propofol 1 % w/v
Norbrook Laboratories Limited
QN01AX10
Emulsion for injection
propofol
Cats, Dogs
2010-09-29
Revised: February 2011 AN: 01771/2009 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norofol 10mg/ml Emulsion for Injection for cats and dogs (UK, BG, CZ, LT, RO, SI, SK) Vetofol 10mg/ml Emulsion for Injection for cats and dogs (AT, CY, EE, FI, DE, EL, LV, PT, ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Propofol 10.0mg Excipients For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. A white homogeneous emulsion with no appearance of visible droplets or extraneous foreign particles. 4. CLINICAL PARTICULARS 4.1 _TARGET SPECIES:_ Dogs and cats. 4.2 _INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:_ Norofol Injection is indicated for use in dogs and cats as a short-acting, intravenous general anaesthetic for procedures of short duration, lasting up to 5 minutes; for the induction and maintenance of general anaesthesia using incremental doses to effect; for the induction of general anaesthesia where maintenance is provided by inhalation anaesthetics. 4.3 _CONTRAINDICATIONS:_ Do not use in animals that are hypersensitive to the active substance or any of the excipients. Revised: February 2011 AN: 01771/2009 Page 2 of 6 4.4 _SPECIAL WARNINGS FOR EACH TARGET SPECIES:_ If Norofol Injection is injected very slowly, an inadequate plane of anaesthesia can occur. Shake the vial gently but thoroughly before Preberite celoten dokument