Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Pimobendan
Boehringer Ingelheim Animal Health UK Ltd
QC01CE90
Pimobendan
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
2013-11-27
Revised: March 2024 AN: 00447/2023 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 10 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: Pimobendan 10 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS _Povidone_ _Lactose monohydrate_ _Maize starch_ _Croscarmellose sodium_ _Citric acid, anhydrous_ _Artificial powdered beef flavour_ _Silica, colloidal anhydrous_ _Magnesium stearate_ Oblong, scored, mottled brown tablets with fine white spots, embossed with Boehringer Ingelheim logo and P04. The tablets can be divided into equal parts. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease. Revised: March 2024 AN: 00447/2023 Page 2 of 7 For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure. 3.3 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. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS The veterinary medicinal product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation Read the complete document