Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
PROPOFOL
Abbott Laboratories Limited
QN01AX10
10 Mg/Ml
Emulsion for Injection
Anaesthetic/Analgesic
Canine
2012-04-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PropoFlo Plus, 10 mg/ml, emulsion for injection for dogs and cats. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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 dogs. Do not use in animals with known hypersensitivity to the active substance or to any of the excipients. Each ml contains: ACTIVE SUBSTANCE: Propofol 10 mg EXCIPIENT: Benzyl alcohol (E1519) 20 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2012_ _CRN 7011659_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This product is a stable emulsion; discard the vial if phase separation is observed. Shake the vial gently but thoroughly before withdrawing a dose. If this product is injected very slowly, an Lestu allt skjalið