Ország: Egyesült Királyság
Nyelv: angol
Forrás: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Ltd
Pimobendan
Expired
Revised: 30 September 2009 AN: 00187/2009 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin® 1.25 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Active Substance Pimobendan 1.25 mg/capsule Excipients Titanium Dioxide (E171) 0.976 mg/capsule Ferric Oxide Yellow (E172) 0.0439 mg/capsule For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsule, hard yellow/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 conjunction with frusemide, enalapril and digoxin 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 (e.g. aortic stenosis). Revised: 30 September 2009 AN: 00187/2009 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i Special precautions for use in animals This product should be used only in dogs with cardiac insufficiency. Do not exceed the recommend dosage. ii Special precautions to be taken by the person administering the veterinary medicinal product to Olvassa el a teljes dokumentumot