Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Chanelle Pharmaceuticals Manufacturing Limited
QC09AA07
Benazepril hydrochloride
5 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
benazepril
Cardiovascular
Authorised
2010-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bexepril 5 mg Film-coated tablet for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Benazepril 4.6 mg (equivalent to Benazepril Hydrochloride 5mg) EXCIPIENT: Titanium Dioxide (E171) 0.9348 mg Iron Oxide Yellow (E172) 0.0476 mg Quinoline Yellow Aluminum Lake (E104) 0.0176mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. A round yellow biconvex tablet with break line on one side. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs weighing more than 10 kg: Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy and/or mitral insufficiency. 4.3 CONTRAINDICATIONS Do not use in any dog that has evidence of cardiac output failure due, for example, to aortic stenosis. Do not use in animals known to be hypersensitive to the active substance or to any of the excipient(s). See 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_ _8_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _6_ _2_ _2_ _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 product has been observed in dogs during clinical trials. How Lire le document complet