Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Pimobendan
Boehringer Ingelheim Vetmedica GmbH
QC01CE90
Pimobendan
5 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
pimobendan
Authorised
2012-11-05
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 5 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 5 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS _Povidone _ _Lactose monohydrate _ _Maize starch _ _Croscarmellose sodium _ _Citric acid, anhydrous _ _Artificial powdered beef flavour _ _Silica, colloidal anhydrous _ _Magnesium stearate _ Oblong, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P03. The tablets can be divided into equal parts. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). 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. 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. 3.3 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. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS The veterinary medicinal product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained ventricular tachycardia. The veterinary medicinal product has not been tested in cases of asymptomatic myxomat Baca dokumen lengkapnya