Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Kela N.V.
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Cardio Vascular ACE inhibitor
Expired
2013-01-09
Revised: May 2013 AN: 01690/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KELAPRIL 2.5 mg, film coated tablets for dogs and cats [FR] KELAPRIL 2,5 film coated tablets for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE: 2.3 mg benazepril (equivalent to 2.5 mg benazepril hydrochloride) EXCIPIENTS: Titanium dioxide (E-171) 0,53 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, oval 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 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 (see section 4.7). Revised: May 2013 AN: 01690/2012 Page 2 of 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 of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy. The efficacy and safety of the product has not been established in dogs and cats below 2.5 kg body weight. 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 label or the package leaflet to the physician. Pregnant women should take special care to avoid accidental oral exposure because angiotensin c Izlasiet visu dokumentu