Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Ceva Santé Animale
QC09AA07
Benazepril hydrochloride
5 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats
benazepril
Cardiovascular
Authorised
2016-06-03
1. NAME OF THE VETERINARY MEDICINAL PRODUCT NELIO 5 mg TABLET FOR CATS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS ACTIVE SUBSTANCE: Benazepril hydrochloride .................................. 5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Clover shaped scored beige tablet, divisible into halves or quarters. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES Cats: Reduction of proteinuria associated with chronic kidney disease. 4.3 CONTRAINDICATIONS Do not use in case 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 SPECIAL PRECAUTIONS FOR USE IN ANIMALS Efficacy and safety of benazepril have not been established in cats of weight less than 2.5 kg. No evidence of renal toxicity to the veterinary medicinal product has been observed in 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. 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 label or the package leaflet to the physician. Pregnant women should take special care to avoid accidental oral exposure, because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In cats with chronic kidney disease, the product may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine Citiți documentul complet