Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Ecuphar NV
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular ACE inhibitor
Expired
2011-07-29
Revised: December 2016 AN: 01103/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actikor 20 mg Film-coated Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCE: Benazepril 18.4 mg (equivalent to 20 mg of benazepril hydrochloride). EXCIPIENT(S): For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Tan coloured, oval, biconvex, film-coated tablets with a breakline on one side and plain on the other side. The tablets can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs weighing more than 20 kg: Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy or mitral insufficiency. 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 stenosis or pulmonary stenosis. Do not use during pregnancy or lactation (section 4.7). Revised: December 2016 AN: 01103/2015 Page 2 of 6 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 to 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals ACE inhibitors have been found to affect the unborn child during pregnancy in humans. Pregnant women should take special care to avoid accidental exposure, including hand- to-mouth contact. Wash hands after use. Benazepril may cause hypotension after oral ingestion. In case of a Lesen Sie das vollständige Dokument