Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Atipamezole hydrochloride
Laboratorios SYVA, S.A.U
QV03AB90
Atipamezole hydrochloride
5 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
atipamezole
Neurological Preparations
Authorised
2011-10-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alzane 5 mg/ml, solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active ingredients Atipamezole hydrochloride 5.0 mg (equivalent to 4.27 mg atipamezole base) Excipients Methyl parahydroxybenzoate (E 218) 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear and colourless sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Atipamezole hydrochloride is a selective 2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance or to any of the excipients. Do not use in breeding animals or animals suffering from hepatic, renal or cardiac diseases. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _6_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _9_ _1_ _3_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals After administration of the product, the animals should be allowed to rest in a quiet place. During recovery animals should not be left unattended. Make sure the animal has regained a normal swallowing Đọc toàn bộ tài liệu