מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Elanco Europe Ltd
QC09AA07
Benazepril Hydrochloride
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular ACE inhibitor
Authorized
2022-03-29
Issued: March 2022 AN: 01294/2020 Page 1 of 6 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BenazeVet 20 mg Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril hydrochloride 20 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Beige to light brown, ovaloid, divisible tablets, scored on both sides. The tablets can be divided into 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 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. Issued: March 2022 AN: 01294/2020 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 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 below 2.5 kg body weight. Special precautions to be taken by the person administering the veterinary medicinal product to animals The product may cause hypotension after ingestion. To avoid accidental ingestion, particularly by a child, unused part-tablets should be returned to the open blister space and inserted back into the carton. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child קרא את המסמך השלם