국가: 영국
언어: 영어
출처: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Animal Health UK Ltd
QC01CE90
Pimobendan
Capsule, hard
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
1999-07-21
Revised: November 2018 AN: 00957/2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin® 5 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Active Substance Pimobendan 5.0 mg Excipients Titanium Dioxide (E171) 1.2320 mg/capsule Sunset Yellow (E110) 0.3080 mg/capsule For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsule, hard Orange /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. Revised: November 2018 AN: 00957/2018 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). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE i Special precautions for use in animals This product should only be used in dogs with cardiac insufficiency. Do not exceed the recommended dose. ii Special precautions to be taken by the person administering the veterinary medicinal product to animals Incase of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and may be avoided by 전체 문서 읽기