Country: Austurríki
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
propofol 0 g/ml
Abbot Laboratories Ltd
QN01AX10
Emulsion for injection
propofol
Cats, Dogs
2012-03-21
Revised: March 2013 AN: 01360/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PropoFlo Plus, 10 mg/ml, emulsion for injection for dogs and cats (UK & IE) PropoVet Multidose 10 mg/ml emulsion for injection for cats and dogs (AT, BE, DK, ES, FI, FR, IS, LU, NL, NO, PT & SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Propofol, 10 mg/ml EXCIPIENT(S): Benzyl alcohol (E1519), 20 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. A white emulsion with no evidence of phase separation 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The veterinary medicinal product is indicated for therapeutic use in dogs and cats as a short-acting, intravenous general anaesthetic with a short recovery period: For procedures of short duration, lasting up to approximately 5 minutes. For induction of general anaesthesia where maintenance is provided by inhalation anaesthetic agents. For induction and short-term maintenance of general anaesthesia by administration of incremental doses of the product to effect for approximately half an hour (30 minutes), not to exceed the total dose stated in section 4.3. Revised: March 2013 AN: 01360/2012 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use for prolonged infusion (see section 4.5). Do not exceed a total dose in one anaesthetic episode of 24 mg/kg (2.4 ml/kg) of propofol in cats or Lestu allt skjalið