Cardisure flavoured 10 mg Tablets For dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Eurovet Animal Health B.V.

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

10 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

pimobendan

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2011-07-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cardisure flavoured 10 mg Tablets For dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
10 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light brown, round tablets, scored on one side and plain on the other
side.
The tablets can be divided into 4 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
valvular insufficiency (mitral and/or tricuspid
regurgitation) or dilated cardiomyopathy.
4.3 CONTRAINDICATIONS
Do not use 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).
See also section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product should be administered on an empty stomach at least one
hour before meals, as absorption is reduced when
given with feed.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product is flavoured. To avoid accidental ingestion the tablets
should be stored out of reach of dogs.
An_ in vitro_ study in rat t