Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Chanelle Pharmaceuticals Manufacturing Limited
QC09AA07
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
5 mg/tablet
Film Coated Tablet
POM
Canine
Benazepril
Cardiovascular
Authorised
2010-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bexepril 5 mg Film-coated tablet for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Benazepril 4.6 mg (equivalent to Benazepril Hydrochloride 5mg) EXCIPIENT: Titanium Dioxide (E171) 0.9348 mg Iron Oxide Yellow (E172) 0.0476 mg Quinoline Yellow Aluminum Lake (E104) 0.0176mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. A round yellow biconvex tablet with break line on one side. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs weighing more than 10 kg: Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy and/or mitral insufficiency. 4.3 CONTRAINDICATIONS Do not use in any dog that has evidence of cardiac output failure due, for example, to aortic stenosis. Do not use in animals known to be hypersensitive to the active substance or to any of the excipient(s). See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 28/09/2016_ _CRN 7024622_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS No evidence of renal toxicity to the product has been observed in dogs during clinical trials. However, as is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy. 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 adv Baca dokumen lengkap