מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Lavet Pharmaceuticals Ltd
QC09AA07
Benazepril Hydrochloride
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Cardio Vascular ACE inhibitor
Authorized
2012-01-25
Revised: June 2020 AN: 00221/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Benefortin Flavour 2.5 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE Benazepril hydrochloride: 2.5 mg(equivalent to Benazepril 2.30 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 and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs: Treatment of congestive heart failure. Cats: Reduction of proteinuria associated with chronic kidney disease. 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. Revised: June 2020 AN: 00221/2020 Page 2 of 6 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 or cats) 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 efficacy and safety of benazepril has not been established in dogs and cats below 2.5 kg body weight. 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. Pregnant women should ta קרא את המסמך השלם