Vetmedin 1.25 mg Flavoured Chewable Tablets for Dogs

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Hent Indlægsseddel (PIL)
14-11-2017

Aktiv bestanddel:

PIMOBENDAN

Tilgængelig fra:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Lægemiddelform:

ORAL BOLUS, CHEWABLE

Sammensætning:

PIMOBENDAN PYRIDAZINONE Active 1.25 mg/Tb

Enheder i pakken:

100 tablets; 50 tablets

Klasse:

VM - Veterinary Medicine

Terapeutisk område:

CARDIOVASCULAR SYSTEM

Produkt oversigt:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE, PRECLINICAL MYXOMATOUS MITRAL VALVE DISEASE]; DOG - LARGE: [PRECLINICAL DCM, PRECLINICAL MYXOMATOUS MITRAL VALVE DISEASE]

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

                                Vetmedin 1.25 mg Flavoured Chewable Tablets for Dogs
84157/109802
Product Name:
APVMA Approval No:
Label Name:
Vetmedin 1.25 mg Flavoured Chewable Tablets for Dogs
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 1.25 mg pimobendan
Claims:
Vetmedin Flavoured Chewable Tablets are indicated for:
The treatment of canine congestive heart failure (CHF) originating
from dilated
cardiomyopathy (DCM) or valvular insufficiency (mitral and/ or
tricuspid regurgitation).
The treatment of pre-clinical DCM in large breed dogs. When used in
cases of preclinical
DCM in large breed dogs, pimobendan significantly prolonged the time
to the onset of CHF
or sudden death, and also resulted in prolongation of the time to
death due to all causes.
Doberman Pinscher dogs with preclinical DCM treated with pimobendan
also demonstrated
a significant reduction in Left Ventricular Internal Diameter in both
systole and diastole
(LVIDs/d) in response to therapy.
The treatment of dogs with evidence of increased heart size secondary
to asymptomatic
(preclinical) myxomatous mitral valve disease to delay the onset of
clinical symptoms of
heart failure, to reduce heart size and to increase survival time.
Net Contents:
50 tablets
100 tablets
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated for use in cases of hypertrophic
cardiomyopathies or clinical
conditions where an augmentation of cardiac output is not recommended
for functional or
anatomical reasons (e.g. aortic stenosis). RLP APPROVED
Precautions:
Vetmedin Flavoured Chewable Tablets should only be administered to
pregnant and
lactating bitches if the expected therapeutic benefits overweigh the
potential risk.
Studies into the effect of pimobendan on the reproductive function of
male dogs have not
been conducted.
In pharmacological studies no interaction between the cardiac
glycoside ouabain and
pimobendan was detected. The pimobendan induced increase in
contractility
                                
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