Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
benazepril 20 mg
Chanelle Pharmaceutical Manufacturing Ltd
QC09AA07
Film coated tablet
benazepril
Dogs Non Food
2012-06-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Forzepril 20 mg film-coated tablet for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Benazepril 18.42 mg (equivalent to Benazepril Hydrochloride 20 mg) EXCIPIENT: Titanium Dioxide (E171) Iron Oxide Yellow (E172) Iron Oxide Red (E172) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. A round reddish orange 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 40 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/08/2012_ _CRN 7011152_ _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 advice and show the label or the package l Read the complete document