Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Elanco GmbH
QC09AA07
Benazepril hydrochloride
5 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
benazepril
Authorised
2016-04-22
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fortekor Flavour 5 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril (as hydrochloride) 4.6 mg (equivalent to 5 mg benazepril hydrochloride) EXCIPIENT(S):_ _ _ _ QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Cellulose microcrystalline Crospovidone Povidone K30 Basic butylated methacrylate copolymer Silicon dioxide anhydrous Silica colloidal anhydrous Sodium laurilsulphate Dibutyl sebacate Stearic acid Yeast powder Artificial powdered beef flavour Beige to light brown, ovaloid, divisible tablets, scored on both sides. The tablets can be divided into equal halves. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs and cats. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Dogs: Treatment of congestive heart failure. Cats: Reduction of proteinuria associated with chronic kidney disease. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 2 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 3.7). 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: 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 the veterinary medicinal product has not been established in dogs and cats below 2.5 kg body weight. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans. Pregnant women should take special Прочитајте комплетан документ