Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PIMOBENDAN
Boehringer Ingelheim Ltd
QC01CE90
PIMOBENDAN
1.25 mg/tablet
Tablets Chewable
POM
Canine
Pimobendane
Cardiovascular
Authorised
2012-11-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 1.25 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: pimobendan 1.25 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Oblong, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P01. The tablet can be divided into equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). (See also section 4.9). For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease (see section 4.4 and 4.5). 4.3 CONTRAINDICATIONS Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis). Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function (see also 4.7). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained ventricular tachycardia. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/11/2015_ _CRN 7020972_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions Citiți documentul complet