Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Buprenorphine
Animalcare Limited
QN02AE01
Buprenorphine
0.3 milligram(s)/millilitre
Solution for injection
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Cats, Dogs
buprenorphine
Neurological Preparations
Authorised
2011-12-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Buprenorphine (as buprenorphine hydrochloride) 0.3 mg EXCIPIENTS Chlorocresol 1.35 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES DOG Post-operative analgesia. Potentiation of the sedative effects of centrally-acting agents. CAT Post-operative analgesia. 4.3 CONTRAINDICATIONS Do not administer by the intrathecal or peridural route. Do not use pre-operatively for Caesarean section (see Section 4.7). Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _4_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _2_ _9_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of the veterinary medicinal product in the below circumstances should only be in accordance with the benefit/risk assessment by the responsible veterinarian. Buprenorphine may occasionally cause significant respiratory depression and, as with other opioid drugs, care should be ta Perskaitykite visą dokumentą