País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
LAVET Pharmaceuticals Ltd
QC09AA07
Benazepril hydrochloride
20 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
benazepril
Cardiovascular
Authorised
2012-01-27
Health Products Regulatory Authority 24 June 2020 CRN009RKY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Benefortin Flavour 20 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE Benazepril hydrochloride 20.0 mg (equivalent to Benazepril 18.4 mg) EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Brownish, oval, divisible, tablet scored on both sides. 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 Dogs: Treatment of congestive heart failure. 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 or pulmonary stenosis. Do not use during 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 renal toxicity of the veterinary medicinal product has been observed in dogs during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash hands after use. In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician. Health Products Regulatory Authority 24 June 2020 CRN009RKY Page 2 of 4 Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pr Leer el documento completo