দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Pimobendan
Alfasan Nederland B.V
QC01CE90
Pimobendan
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
pimobendan
2022-10-07
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cardisan 1.25 mg chewable tablets for dogs (AT, BE, BG, CY, CZ, DE, EE, EL, ES, FR, HR, HU, IE, IT, LV, LT, LU, MT, NL, PL, PT, RO, SI, SK, UK(NI)) Cardisan Vet 1.25 mg chewable tablets for dogs (DK, FI, IS, NO, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Pimobendan 1.25 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Citric acid Povidone Lactose monohydrate Cellulose, microcrystalline Croscarmellose sodium Chicken flavour Yeast (dried) Silica, colloidal hydrated Magnesium stearate Chewable tablet. Light brown with brown spots, round and convex 8 mm tablet with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 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). 3.3 CONTRAINDICATIONS Do not use pimobendan in cases of hypertrophic cardiomyopathies or in clinical conditions where an improvement in cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE 3 Special precautions for safe use in the target species: The blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus. Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function. Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan. (See also section 3.6). The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals. Special precautions to be taken by the person administering the veterinary medicinal product to anim সম্পূর্ণ নথি পড়ুন