Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Chanelle Pharmaceuticals Manufacturing Limited
QC09AA07
Benazepril hydrochloride
20 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
benazepril
Cardiovascular
Authorised
2010-06-04
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bexepril 20mg Film-coated tablet for dogs 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 _ _ Forthe full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. A round reddish orange biconvex tablet with a cross break line on one side. The tablets can be divided into equal halves or quarters. 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. 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 leaflet to the physician. Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child during pregnancy in humans. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) On rare occasions, transient signs of hypotension, such as lethargy and ataxia may occur. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Do not use i Прочитайте повний документ