Χώρα: Αυστρία
Γλώσσα: Αγγλικά
Πηγή: HMA (Heads of Medicines Agencies)
buprenorphine 0.3 mg/ml
Dechra Limited
QN02AE01
Solution for injection
buprenorphine
Cats Non Food, Dogs Non Food, Horses Non Food
2013-07-31
Issue: October 2013 AN: 00696/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Buprenodale Multidose, 0.3 mg/ml solution for injection for dogs, cats and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Buprenorphine 0.3 mg As buprenorphine hydrochloride 0.324 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, cats and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Post-operative analgesia in the dog and cat. Post-operative analgesia, in combination with sedation, in the horse. Potentiation of the sedative effects of centrally acting agents in the dog and horse. 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. Please refer to section 4.11. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Issue: October 2013 AN: 00696/2012 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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. In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk associated with the use of the product. The be Διαβάστε το πλήρες έγγραφο