Vetmedin 5 mg capsules

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Pimobendan

Dostępny od:

Boehringer Ingelheim Ltd

Kod ATC:

QC01CE90

INN (International Nazwa):

Pimobendan

Dawkowanie:

5 milligram(s)

Forma farmaceutyczna:

Capsule, hard

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

pimobendan

Wskazania:

Cardiovascular

Status autoryzacji:

Authorised

Data autoryzacji:

1999-10-01

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 5 mg capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule, 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
large breed dogs in conjunction with concomitant
standard therapy, 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).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Active Substance
Pimobendan
5.00
mg
Excipients
Titanium Dioxide ( E171)
1.232 mg
Sunset Yellow (E110)
0.308 mg
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