Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
pimobendan
Boehringer Ingelheim Ltd
QC01CE90
2.5 Milligram
Capsules Hard
Canine
Cardiovascular
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 2.5 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule, orange-brown/white in colour. 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 valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. When used in cases of valvular insufficiency in conjunction with frusemide, 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 Vetmedin capsules 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 (eg. aortic stenosis). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Active Substance Pimobendan 2.50 mg Excipients Titanium Dioxide ( E171) 1.3227 mg Ferric Oxide Red (E172) 0.0496 mg Ferric Oxide Yellow (E172) 0.2480 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/08/2013_ _CRN 7015504_ _page number: 1_ This product should only be used in dogs with cardiac insufficiency. Do not exceed the recommended dose. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMIN Lugege kogu dokumenti