Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Buprenorphine
Richter Pharma AG
QN02AE01
Buprenorphine
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent analgesic
Authorized
2017-01-27
Revised: April 2020 AN: 01936/2019 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Buprevet 0.3 mg/ml Solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Buprenorphine (as hydrochloride) 0.3 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless to almost 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 use in cases of hypersensitivity to the active substance or to any of the excipients. Do not administer by the intrathecal or peridural route. Do not use pre-operatively for Caesarian section (see section 4.7). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I) 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. Revised: April 2020 AN: 01936/2019 Page 2 of 6 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 the substance is metabolised by the liver and its intensity and duration of action may be affected in such animals. The safety of buprenorphine has not been demonstrated in animals less than 7 weeks of age. Repeat administration earlier than the recommended repeat interval suggested in section 4.9 is not recommended. Long-term safety of buprenorphine in cats has not been investigated beyond 5 consecuti Preberite celoten dokument