Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Limited
QC01CE90
Pimobendan
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
2015-04-08
Revised: September 2017 AN: 01343/2016 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin Chew 2.5 mg chewable tablets for dogs (AT, BE, DE, IE, IT, LI, LU, NL, UK) Vetmedin vet. 2.5 mg chewable tablets for dogs (CY, DK, EL, ES, FI, IS, NO, PL, PT, SE) Vetmedin S 2.5 mg chewable tablets for dogs (BG, CZ, EE, FR, HR, HU, LT, LV, RO, SI, SK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 2.5 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). Page 1 of 7 Revised: September 2017 AN: 01343/2016 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 w Prečítajte si celý dokument