País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Pimobendan
FATRO S.p.A.
QC01CE90
Pimobendan
10 milligram(s)
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
pimobendan
Authorised
2021-03-19
1. NAME OF THE VETERINARY MEDICINAL PRODUCT FATROBENDAN 10 mg, chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Pimobendan ………………….. 10 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Cellulose microcrystalline Carmellose sodium Pork liver powder Glycerol dibehenate Croscarmellose sodium Magnesium stearate Square brownish tablet with two break marks divisible into two or four equal parts. 3. CLINICAL INFORMATION 3.1. TARGET SPECIES Dogs. 3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES The product is indicated 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 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 3.7). 3.4. SPECIAL WARNINGS None. 3.5. SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan (see also section 3.6). Use with caution in epileptic dogs. The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals: People with known hypersensitivity to pimobendan or to any of the excipients should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use. Advice to doctors: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypo Leer el documento completo