Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Ecuphar NV
QC09AA07
Benazepril hydrochloride
20 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
benazepril
Cardiovascular
Authorised
2011-06-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Actikor 20 mg Film-coated Tablets for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCE: Benazepril 18.4 mg (equivalent to 20 mg of benazepril hydrochloride). EXCIPIENT(S): For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Tan coloured, oval, biconvex, film-coated tablets with a breakline on one side and plain on the other side. The tablets can be divided into two equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs weighing more than 20 kg: Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy or mitral insufficiency. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure. Do not use in cases of cardiac output failure due to aortic stenosis or pulmonary stenosis. Do not use during pregnancy or lactation (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_ _ _ _1_ _5_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _2_ _9_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals No evidence of renal toxicity to the veterina Прочитать полный документ