Country: United Kingdom
Bahasa: Inggeris
Sumber: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Animal Health UK Ltd
QC01CE90
Pimobendan
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
2014-08-07
Revised: September 2019 AN: 01494/2018 Page 1 of 5 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. Clear colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 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). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: September 2019 AN: 01494/2018 Page 2 of 5 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. Before treatment, diagnosis should be made by the means of a comprehensive physical and cardiac examination which should include echocardiography or radiography where appropriate. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY A Baca dokumen lengkap