Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Pimobendan
Ceva Santé Animale
QC01CE90
Pimobendan
1.25 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
pimobendan
Cardiovascular
Authorised
2018-06-01
Health Products Regulatory Authority 14 April 2021 CRN00C3KY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zelys 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 Round in shape beige to light brown tablet, with single score line on one side. The tablets can be divided into two 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 valve regurgitation) or dilated cardiomyopathy. (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). 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. 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) The chewable 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 Accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches. Unused part-tablets should be returned to the open blister space, or to the bottle and inserted back into the outer packaging. Keep in a safe place ou Belgenin tamamını okuyun