Vetmedin 10 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Pimobendan

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Pharmaceutical form:

Chewable tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular

Authorization status:

Authorized

Authorization date:

2013-11-27

Summary of Product characteristics

                                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 
                                
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