Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Buprenorphine hydrochloride
Ecuphar NV
QN02AE01
Buprenorphine hydrochloride
0.3 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
buprenorphine
Authorised
2008-05-16
Health Products Regulatory Authority 21 March 2019 CRN008XS8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Buprecare 0.3 mg/ml Solution for Injection for Dogs and Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ampoule contains: Buprenorphine 0.3 mg/ml as buprenorphine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog Post-operative analgesia. Potentiation of the sedative effects of centrally-acting agents. CatPost-operative analgesia. 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 The product should not be used 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Buprenorphine may occasionally cause significant 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. Health Products Regulatory Authority 21 March 2019 CRN008XS8 Page 2 of 5 Buprenorphine should be used with caution in animals with impaired liver function, especially biliary tract disease, as the substance is metabolised by the liver and its intensity and duration of action may be affected in some animals. In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk associated with the use of the product. The benefit:risk ratio for using the product should be made by the attending vet. Safety has not been fully evaluated in clinically compromised cats. The safety of buprenorphine has not been demonstrated in anim Read the complete document