Država: Francija
Jezik: angleščina
Source: HMA (Heads of Medicines Agencies)
benazepril 18.42 mg
Laboratorios Calier
QC09AA07
Tablet
benazepril
Dogs
2012-12-02
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: BANACEP vet 20 mg film-coated tablet for dogs [BE, EL, DE, ES, IT, NL, PL, PT, UK] BANACEP vet 20 film-coated tablet for dogs [FR] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each divisible tablet contains: Active substance: Benazepril ......................................... 18.42 mg (equivalent to Benazepril Hydrochloride 20 mg) EXCIPIENTS: Titanium dioxide (E171)................... 1.929 mg Iron oxide yellow (E172) .................. 0.117 mg Iron oxide red (E172) ....................... 0.014 mg Iron oxide black (E172)....................0.004 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Film-coated tablets Beige oblong biconvex film-coated divisible tablets. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS: 4.1 TARGET SPECIES: Dogs 4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: In dogs weighing more than 20 kg bw: Treatment of congestive heart failure. 4.3 . CONTRAINDICATIONS: Do not use in cases of known hypersensitivity to ACE inhibitors or to any ingredient of the product. Do not use in any dog that has evidence of cardiac output failure, for example, due to aortic stenosis. See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS No evidence of renal toxicity to benazepril has been observed in dogs. However, as is routine in cases of chronic renal insufficiency, it is recommended to monitor plasma creatinine and ur Preberite celoten dokument