国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Elanco Europe Ltd
QC09AA07
Benazepril Hydrochloride
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Cardio Vascular ACE inhibitor
Authorized
2021-03-10
Issued: March 2021 AN: 01339/2020 Page 1 of 6 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BenazeVet 2.5 mg Tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril hydrochloride 2.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Beige, ovaloid, divisible tablets, scored on both sides. 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 known 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 i. 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 Issued: March 2021 AN: 01339/2020 Page 2 of 6 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 bodyweight. ii. 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 package leaflet or the label to the physician. 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 pregnancy in humans. 4.6 ADVERS 阅读完整的文件