País: Reino Unido
Língua: inglês
Origem: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Chanelle Pharmaceuticals Manufacturing Ltd
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular ACE inhibitor
Expired
2010-04-22
Revised: June 2015 AN: 01655/2014 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bexepril 20mg Film-coated tablet for dogs (BE& IE) Bexepril 20mg Film-coated tablet for dogs (BG, CY, CZ, DK, EL, ES, HU, LU, NL, NO, PT, RO, SI, SK & UK) Sirdis 20mg Film-coated tablet for dogs (IT) Bexepril 20mg Film-coated tablets for dogs (PL) Bexepril l 20 Film-coated tablet for dogs (FR) Bexepril 20mg Film-coated tablet for dogs, Benazeprilhydochlorid (AT) Benadog Flavour 20 mg Film-coated tablets for dogs, Benzeprilhydochlorid (DE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Benazepril 18.42mg (equivalent to Benazepril Hydrochloride 20mg) EXCIPIENT: Titanium Dioxide (E171) 3.4176mg Iron Oxide Yellow (E172)_ _0.3424mg Iron Oxide Red (E172) 0.24mg For the 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. Revised: June 2015 AN: 01655/2014 Page 2 of 5 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 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 a Leia o documento completo