Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Animal Health UK Ltd
QC01CE90
Pimobendan
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
2012-11-12
Revised: July 2019 AN: 00275/2019 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 5 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: pimobendan 5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Oval, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P03. The tablet can be divided into equal parts. 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 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). For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure (see section 4.4 and 4.5). Revised: July 2019 AN: 00275/2019 Page 2 of 7 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. The product has not been tested in cases of asymptomatic myxomatous mitral valve disease in dogs with significant supra Διαβάστε το πλήρες έγγραφο