Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)
Ecuphar NV
QC09AA07
BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)
20 Milligram
Film Coated Tablet
POM
Canine
Benazepril
Cardiovascular
Authorised
2011-06-17
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). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/07/2016_ _CRN 7022293_ _page number: 1_ 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 medic Lugege kogu dokumenti