Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
VetViva Richter GmbH
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular ACE inhibitor
Authorized
2013-02-12
Revised: 02 January 2024 AN: 03433/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KELAPRIL 20 mg, film-coated tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril Hydrochloride 20 mg (equivalent to Benazepril 18.4 mg) EXCIPIENTS: Titanium dioxide (E171) 0.52 mg Iron oxide red (E172) 0.06 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Reddish-pink, oval divisible film-coated tablets scored on both sides. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of congestive heart failure. 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 in pregnancy or lactation (see section 4.7). Revised: 02 January 2024 AN: 03433/2022 Page 2 of 7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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 Wash hands after use. 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 oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician. Pregnant women should take s Đọc toàn bộ tài liệu