Negara: Inggris
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
buprenorphine hydrochloride 0.32 mg/ml
Dechra Limited
QN02AE01
Solution for injection
buprenorphine
Cats, Dogs
2008-01-10
Revised: March 2011 Amended pages 1/6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF VETERINARY MEDICINAL PRODUCT Buprenodale 0.3mg/ml solution for injection for dogs and cats. (AT, BE, BU, CZ, DE, FR, HU, IE, LU, NL, PL, SK, UK) Buprenodale Vet 0.3mg/ml solution for injection for dogs and cats. (DK, FI, IS, SE) Budale 0.3mg/ml solution for injection for dogs and cats. (ES, IT, PT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains: ACTIVE SUBSTANCE(S) Buprenorphine 0.3mg 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 Dogs and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Post-operative analgesia in the cat and dog. Potentiation of the sedative effects of centrally acting agents in the dog. 4.3 CONTRA-INDICATIONS The product should not be used 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 Revised: March 2011 Amended pages 2/6 Buprenorphine may occasionally 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. As buprenorphine is metabolised by the liver, its intensity and duration of action may be affected in animals with impaired liver function. In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk associated w Baca dokumen lengkapnya