Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Pimobendan
CP-Pharma Handelsgesellschaft mbH
QC01CE90
Pimobendan
1.25 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
pimobendan
Authorised
2020-07-17
Health Products Regulatory Authority 11 August 2020 CRN009SMP Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pimotab 1.25 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Pimobendan 1.25 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Light brown with brown spots, round and convex tablet with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 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 dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). (See also section 4.9). 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). 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 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. 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 4.6). 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 animals This product may cause tachycardia, orthostatic hypotension, flushing of the face and headaches. To avoid accidental ingestion, especially by a child, unused tablet parts should Baca dokumen lengkapnya