Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Benazepril hydochloride
Elanco GmbH
QC09AA07
Benazepril hydochloride
2.5 milligram(s)
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
benazepril
Authorised
2020-11-20
Health Products Regulatory Authority 15 January 2021 CRN00C1TW Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT BenazeVet 2.5 mg Tablets for cats and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril hydrochloride 2.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Beige, ovaloid, divisible tablets, scored on both sides. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs: Treatment of congestive heart failure. Cats: Reduction of proteinuria associated with chronic kidney disease. 4.3 CONTRAINDICATIONS Do not use in known 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 or pulmonary stenosis. Do not use during pregnancy or lactation (section 4.7). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or cats) 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. The efficacy and safety of the veterinary medicinal product has not been established in dogs and cats below 2.5 kg bodyweight. ii. 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 immediately and show the package leaflet or the label to the physician. Health Products Regulatory Authority 15 January 2021 CRN00C1TW Page 2 of 5 Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the u Przeczytaj cały dokument