Quốc gia: Hy Lạp
Ngôn ngữ: Tiếng Anh
Nguồn: HMA (Heads of Medicines Agencies)
pimobendan 5 mg
Boehringer Ingelheim Vetmedica GmbH
QC01CE90
Chewable tablet
pimobendane
Dogs
2012-01-27
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 5 mg chewable tablets for dogs (AT, BG, CY, CZ, EE, EL, HU, LV, LT, PL, RO, SI, SK, ES, IS, LI, PT) [Pimobendan Vetmedica 5 mg chewable tablets for dogs (BE, FI, FR, IE, IT, LU, NL, SE, UK) Pimobendan Boehringer Ingelheim Vetmedica GmbH 5 mg chewable tablets for dogs (NO) The name ‘the product’ will be used in the Product Information] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 5 mg EXCIPIENTS: For a 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 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). 4.3 CONTRAINDICATIONS [The product] is not to be used 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 [the product] is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function (see also 4.7). 3 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE Đọc toàn bộ tài liệu
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 1.25 mg chewable tablets for dogs (AT, BG, CY, CZ, EE, EL, HU, LV, LT, PL, RO, SI, SK, ES, IS, LI, PT) [Pimobendan Vetmedica 1.25 mg chewable tablets for dogs (BE, FI, FR, IE, IT, LU, NL, SE, UK) Pimobendan Boehringer Ingelheim Vetmedica GmbH 1.25 mg chewable tablets for dogs (NO) The name ‘the product’ will be used in the Product Information] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 1.25 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Oblong, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P01. 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). 4.3 CONTRAINDICATIONS [The product] is not to be used 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 [the product] is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function (see also 4.7). 3 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PREC Đọc toàn bộ tài liệu