국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
benazepril hydrochloride
Novartis Animal Health UK Ltd
QC09AA07
20 Milligram
Tablets
Canine
Cardiovascular
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR Flavour 20 mg tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Benazepril hydrochloride 20 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Beige to light brown, ovaloid, 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 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. 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/07/2012_ _CRN 7012474_ _page number: 1_ 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. 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 take special care to avoid accidental oral exposure because angiotensin 전체 문서 읽기