Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PIMOBENDAN
Eurovet Animal Health B.V.
QC01CE90
PIMOBENDAN
5 Milligram
Tablets
POM
Canine
Pimobendane
Cardiovascular
Authorised
2011-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cardisure flavoured 5 mg Tablets For dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: ACTIVE SUBSTANCE: Pimobendan 5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Light brown, round tablets, scored on one side and plain on the other side. The tablets can be divided into 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. 4.3 CONTRAINDICATIONS Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product should be administered on an empty stomach at least one hour before meals, as absorption is reduced when given with feed. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/07/2016_ _CRN 7022256_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The product is flavoured. To avoid accidental ingestion the tablets should be stored out of reach of dogs. An _in vitro _study in rat tissue demonstrated that pimobendan increased glucose-induced insulin release from pancreatic - cells in a dose-dependent manner. If the product is administered to diabetic dogs, blood glucose levels should be carefully monitored. As pimobendan is metabolised in the liver, particular care should be taken w Prečítajte si celý dokument