Vetmedin 5 mg Flavour Tablets

Summary of Product characteristics

                                Revised: July 2012
AN: 01262/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 5 mg Flavour Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each flavour tablet contains:
ACTIVE SUBSTANCE
Pimobendan
5 mg / tablet
EXCIPIENT
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Meat flavoured single-scored tablet
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
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
conjuction 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
The product 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).
Page 1 of 5
Revised: July 2012
AN: 01262/2011
See also section 4.7.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
This product should be used only in dogs with cardiac insufficiency.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS:

In case of accidental ingestion, seek medical advice immediately and
show
the package leaflet or the label to the physician

Wash hands after use

Advice to doctors:
accidental ingestion, especially by a child, may lead to the
occurrence of tachycardia, orthostatic hypotension, flushing of the
face and
headaches.
4.6
ADVERSE REACTIONS
A moderate positive chronotropic effect and vomiting may occur in rare
cases.

                                
                                Read the complete document