देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
BUPRENORPHINE (AS BUPRENORPHINE HYDROCHLORIDE PH.EUR.)
Le Vet Beheer B.V.
QN02AE01
BUPRENORPHINE (AS BUPRENORPHINE HYDROCHLORIDE PH.EUR.)
0.3 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Canine, Feline
Buprenorphine
Neurological Preparations
Authorised
2015-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Buprefelican Multidose 0.3 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ML CONTAINS: ACTIVE SUBSTANCE: Buprenorphine (as hydrochloride) 0.3 mg Equivalent to 0.324 mg buprenorphine hydrochloride EXCIPIENTS: Chlorocresol 1.35 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Post-operative analgesia in the dog and cat. Potentiation of the sedative effects of centrally acting agents in the dog. 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 known cases of hypersensitivity to the active substance or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/10/2016_ _CRN 7024502_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Buprenorphine may cause respiratory depression and as with other opioid drugs, care should be taken when treating animals with impaired respiratory function or animals that are receiving drugs that can cause respiratory depression. In case of renal, cardiac or hepatic dysfunction or shock, there may be greater risk associated with the use of the product. Safety has not been fully evaluated in clinically compromised cats. Buprenorphine should be used with caution in animals with impaired liver function, especially biliary tract disease, as t पूरा दस्तावेज़ पढ़ें