VETMEDIN 10 MG CHEWABLE TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PIMOBENDAN

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

pimobendan(10mg/Tb)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

PIMOBENDAN PYRIDAZINONE Active 10.0 mg

Units in package:

50 tablets

Class:

VM - Veterinary Medicine

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

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]; For the treatment of canine congestive heart failure (CHF) originating from dilated cardiomyopathy (DCM) or valvular insufficiency (mitral and/or tricuspid regurgitation). Also for the treatment of preclinical DCM in large breed dogs (etc.)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.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
PRODUCT NAME:
VETMEDIN 10MG CHEWABLE TABLETS FOR DOGS
ELABEL APPLICATION NO:
DC14-75625249E71
APVMA APPROVAL NO:
69391/101048
PRODUCT NO:
69391
VERSION NO:
4.0
APPLICATION STARTED:
2014-Nov-10 14:25:03
VERSION CREATED:
2015-Jul-15 12:35:39
STARTED BY:
Lisa Wade
PRINTED:
2015-Sep-08 16:32:20
LABEL NAME:
VETMEDIN 10MG CHEWABLE TABLETS FOR DOGS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains 10 mg pimobendan.
CLAIMS:
Vetmedin® 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 preclinical 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.
NET CONTENTS:
White high density polyethylene screw-necked bottle with polypropylene
child-resistant
closure containing 50 beef flavoured palatable 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).
PRECAUTIONS:
Vetmedin® Chewable Tablets should only be administered to pregnant
and lactating
bitches if the expected therapeutic benefits overweigh the potential
risk. RLP APPROVED
For Official Use Only
Studies into the effect of pimobendan on the reproductive function of
male dogs have