Vetmedin 5 mg Hard Capsules

Summary of Product characteristics

                                Revised: December 2011
AN: 00622/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin® 5 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active Substance
Pimobendan
5.0 mg
Excipients
Titanium Dioxide (E171) 1.2320 mg/capsule
Sunset Yellow (E110) 0.3080 mg/capsule
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard
Orange /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.
Page 1 of 6
Revised: December 2011
AN: 00622/2011
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).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
i
Special precautions for use in animals
This product should only be used in dogs with cardiac
insufficiency. Do not exceed the recommended dose.
ii
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
Incase of accidental ingestion, seek medical advice immediately and
show the package leaflet or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A moderate positive chronotropic effect and vomiting may occur in rare
cases.
However, these effects are dose-dependent and may b
                                
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