Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Pimobendan
Eurovet Animal Health B.V.
QC01CE90
Pimobendan
1.25 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
pimobendan
Cardiovascular
Authorised
2016-01-22
Health Products Regulatory Authority 05 October 2017 CRN000V2M Page 1 of 6 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pimocard 1.25 mg flavoured tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: Active substance: Pimobendan 1.25 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Light brown round tablets, scored on one side and plain on the other side. The tablets can be divided into 2 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. 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 None. Health Products Regulatory Authority 05 October 2017 CRN000V2M Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus. Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan. See also section 4.6. The 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 animals 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 hypotension, flushing of the face and headaches. This Lire le document complet