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Revised: 30 September 2009
AN: 00187/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin® 1.25 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active Substance
Pimobendan
1.25 mg/capsule
Excipients
Titanium Dioxide (E171)
0.976 mg/capsule
Ferric Oxide Yellow (E172)
0.0439 mg/capsule
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard
yellow/white in colour
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
valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated
cardiomyopathy.
When used in cases of valvular insufficiency in conjunction with
frusemide, the product has been shown to improve the quality of life and
extend life expectancy in treated dogs.
When used in a limited number of cases of dilated cardiomyopathy in
conjunction with frusemide, enalapril and digoxin the product has been
shown to improve the quality of life and to extend life expectancy in treated
dogs.
4.3
CONTRAINDICATIONS
Vetmedin capsules should not be used in cases of hypertrophic
cardiomyopathies or clinical conditions where an augmentation of cardiac
output is not possible for functional or anatomical reasons (e.g. aortic
stenosis).
Revised: 30 September 2009
AN: 00187/2009
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i
Special precautions for use in animals
This product should be used only in dogs with cardiac insufficiency.
Do not exceed the recommend dosage.
ii
Special precautions to be taken by the person administering the
veterinary medicinal product to
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