Vetmedin Chew 2.5 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

2.5 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

pimobendan

Authorization status:

Authorised

Authorization date:

2015-04-17

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2019
CRN0090MR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin Chew 2.5 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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One chewable tablet contains:
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ACTIVE SUBSTANCE:
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Pimobendan 2.5 mg
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EXCIPIENTS:
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Chewable tablet.
Brownish, oval, divisible tablet, scored on both sides.
The tablet can be divided into two 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
sections 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 sections 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).
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
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
tachycard