VETMEDIN CHEW 5 MG CHEWABLE TABLETS FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PIMOBENDAN

Available from:

Boehringer Ingelheim Ltd

ATC code:

QC01CE90

INN (International Name):

PIMOBENDAN

Dosage:

5 mg/tablet

Pharmaceutical form:

Tablets Chewable

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Pimobendane

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2015-10-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin Chew 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.
Brownish, oval, divisible tablet, scored on both sides.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
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).
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 section 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/12/2015_
_CRN 7022315_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The blood glucose should