Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
BUPRENORPHINE
Ceva Santé Animale
QN02AE01
BUPRENORPHINE
0.3 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Canine, Feline
Buprenorphine
Neurological Preparations
Authorised
2015-06-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetergesic Multidose, 0.3mg/ml, solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless solution for injection 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 administer by the intrathecal or peridural route. Do not use pre-operatively for Caesarian section (see Section 4.7). Do not use in animals with known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 1ml solution for injection contains: ACTIVE SUBSTANCE: Buprenorphine 0.3 mg As Buprenorphine hydrochloride 0.324 mg EXCIPIENT: Chlorocresol 1.35 mg For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/06/2015_ _CRN 7021268_ _page number: 1_ 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. The benefit: risk assessment for using the product should be made by the attending vet. Safety has not been fully evaluated in clinically compromised cats. Buprenorphine should be used with ca Prečítajte si celý dokument