Cardisure Flavoured 5 mg Tablets for Dogs

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Pimobendan

Beschikbaar vanaf:

Eurovet Animal Health B.V.

ATC-code:

QC01CE90

INN (Algemene Internationale Benaming):

Pimobendan

farmaceutische vorm:

Tablet

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Dogs

Therapeutisch gebied:

Cardio Vascular

Autorisatie-status:

Authorized

Autorisatie datum:

2011-08-09

Productkenmerken

Revised: October 2016
AN: 00754/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cardisure flavoured 5 mg Tablets For dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
5 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
The product should be administered on an empty stomach at least one
hour
before meals, as absorption is reduced when given with feed.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Revised: October 2016
AN: 00754/2016
Page 2 of 6
The product is flavoured. To avoid accidental ingestion the tablets
should be
stored out of reach of dogs.
An _in vitro_ study in rat tissue demonstrated that pimobendan
increased glucose-
induced insulin release from pancreatic β-cells in a dose-dependent
manner. If
the product is administered to diabetic dogs, blood glucose levels
should be
carefully monitored.
As pimobendan is metabolised in the liver, particular care should be
taken when
administering the product to dogs with severe hepatic insufficiency.
Monitoring of cardiac function and morphology is recommended in
animals
treated with pimobendan.(See also section 4.6).
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
In case of accidental ingestion, seek medical adv