País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
PIMOBENDAN
Boehringer Ingelheim Ltd
QC01CE90
PIMOBENDAN
0.75 Mg/Ml
Solution for Injection
POM
Canine
Pimobendane
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 02/09/2016_ _CRN 7024279_ _page number: 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 initiation of treatment of congestive heart failure in dogs, following a risk:benefit assessment by the responsible veterinarian, taking into account the overall health status of the dog. Special precautions for the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek Leia o documento completo