Land: Storbritannien
Sprog: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
VetViva Richter GmbH
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Cardio Vascular ACE inhibitor
Authorized
2013-02-11
Revised: January 2024 AN: 03433/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KELAPRIL 5 mg, film-coated tablets for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril Hydrochloride 5 mg (equivalent to Benazepril 4.6 mg) EXCIPIENTS: Titanium dioxide (E171) 0.52 mg Iron oxide yellow (E172) 0.06 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light yellow, oval divisible film-coated tablets scored on both sides. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog, cat 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dog: Treatment of congestive heart failure. Cat: Reduction of proteinuria associated with chronic kidney disease. 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. Revised: January 2024 AN: 03433/2022 Page 2 of 8 Do not use in pregnancy or lactation (see section 4.7). 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 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 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 Læs hele dokumentet