País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Pimobendan
Boehringer Ingelheim Ltd
QC01CE90
Pimobendan
1.25 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
pimobendan
Cardiovascular
Authorised
2015-10-09
Health Products Regulatory Authority 14 September 2017 CRN000W67 Page 1 of 7 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin Chew 1.25 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 1.25 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Brownish, oval, divisible tablet, scored on both sides. The tablet can be divided into equal halves. 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 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 sections 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 sections 4.4 and 4.5). Health Products Regulatory Authority 14 September 2017 CRN000W67 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 section 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 supraventri Llegiu el document complet