Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
benazepril hydrochloride 20 mg
Le Vet B.V
QC09AA07
Tablet
benazepril
Dogs Non Food
2011-07-07
PART I B 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NL: Benazepril hydrochloride LeVet 20 mg tabletten voor honden AT: Benakor 20 mg, Tabletten für Hunde BE: Benakor F 20 mg tabletten voor honden CZ: Benakor F 20 mg, tablety pro psy EE: Benakor F 20 mg tabletid koertele ES: Benakor 20 mg comprimidos para perros FI: Benakor vet 20 mg tabletti FR: Benakor F 20 comprimés pour chiens IE: Benakor 20 mg tablets for dogs IT: Benakor 20 mg compresse per cani LU: Benakor F 20 mg comprimés pour chiens NO: Benakor vet. 20 mg tabletter til hund PL: Benakor F 20 mg tabletki dla psów PT: Benakor 20 mg comprimidos para cães SK: Benakor F 20 mg tablety pre psov 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril hydrochloride 20 mg EXCIPIENT(S): Colourant: Iron oxides (E172) 8 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Orange oblong divisible tablets, with a break mark on one side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs: Treatment of congestive heart failure. 4.3 CONTRAINDICATIONS Do not use in case 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. 2 Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use in pregnancy or lactation (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 ren Read the complete document