País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Pimobendan
Boehringer Ingelheim Ltd
QC01CE90
Pimobendan
0.75 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
pimobendan
Cardiovascular
Authorised
2014-08-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 0.75 mg/ml solution for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Pimobendan 0.75 mg Excipients: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To initiate 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 hypersensitivity to the active substance or to any of the excipients. 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). See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _4_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _4_ _5_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In case of accidental subcutaneous injection temporary swelling and mild to slight resorptive inflammatory reactions can occur at or below the injection site. For single administration only. The product should be used for the initiatio Leia o documento completo