Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PIMOBENDAN
Boehringer Ingelheim Ltd
QC01CE90
1.25 Milligram
Tablets
Cardiovascular
Canine
2006-06-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 1.25 mg Flavour Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Pimobendan 1.25 mg EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets. Meat flavoured, oval scored mottled brown tablets with fine white spots. The tablets can be divided into equal halves. 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. When used in cases of valvular insufficiency in conjunction with furosemide, the product has been shown to improve the quality of life and extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathy in large breed dogs in conjunction with concomitant standard therapy, the product has been shown to improve the quality of life and to extend life expectancy in treated dogs. 4.3 CONTRAINDICATIONS The veterinary medicinal product should not be used 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 None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/04/2011_ _CRN 7009844_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental inge Read the complete document