Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Pimobendan
Dechra Regulatory B.V.
QC01CE90
Pimobendan
3.5 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
pimobendan
Authorised
2019-09-13
Health Products Regulatory Authority 02 February 2022 CRN00CPGY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cardisure 3.5 mg/ml Oral Solution for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains ACTIVE SUBSTANCE: Pimobendan 3.5 mg EXCIPIENTS: Benzyl alcohol (E1519) 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. Clear, colourless, semi-viscous liquid. 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 in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). Do not use in dogs with severe impairment of liver function, as pimobendan is metabolised mainly via the liver. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The 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). Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches. To avoid accidental ingestion, do not leave the filled syringe unattended and store the bottle and used syringe in the original carton in order to prevent children from getting access to the product. Close bottle tightly wit Read the complete document