Vetmedin 5 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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:

2012-11-12

Summary of Product characteristics

Revised: July 2019
AN: 00275/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 5 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
pimobendan
5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Oval, scored, mottled brown tablets with fine white spots, embossed
with Boehringer
Ingelheim logo and P03.
The tablet can be divided into equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from
dilated
cardiomyopathy or valvular insufficiency (mitral and/or tricuspid
valve regurgitation)
(See also section 4.9).
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 (see
section 4.4 and 4.5).
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 (see
section 4.4 and 4.5).
Revised: July 2019
AN: 00275/2019
Page 2 of 7
4.3
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 (see also 4.7).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product has not been tested in cases of asymptomatic DCM in
Dobermans with
atrial fibrillation or sustained ventricular tachycardia.
The product has not been tested in cases of asymptomatic myxomatous
mitral valve
disease in dogs with significant supra