VETMEDIN 5 MG CHEWABLE TABLETS FOR DOGS

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ակտիվ բաղադրիչ:

PIMOBENDAN

Հասանելի է:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (Միջազգային անվանումը):

pimobendan(5mg/Tb)

Դեղագործական ձեւ:

ORAL BOLUS, CHEWABLE

Կազմը:

PIMOBENDAN PYRIDAZINONE Active 5.0 mg/Tb

Միավորները փաթեթում:

50tablets

Դաս:

VM - Veterinary Medicine

Թերապեւտիկ խումբ:

DOG | BITCH | CASTRATE | PUPPY

Թերապեւտիկ տարածք:

CARDIOVASCULAR SYSTEM

Թերապեւտիկ ցուցումներ:

CONGESTIVE HEART FAILURE | DILATED CARDIOMYOPATHY | MITRAL AND/OR TRICUSPID REGUR | VALVULAR INSUFFICIENCY

Ապրանքի ամփոփագիր:

Poison schedule: 4; Withholding period: WHP: N/A; 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).Should NOT be used 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). See Precautions on label also.

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2023-07-01

Տեղեկատվական թերթիկ

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
PRODUCT NAME:
VETMEDIN 5 MG CHEWABLE TABLETS FOR DOGS
ELABEL APPLICATION NO:
DC14-24070078E12
APVMA APPROVAL NO:
60798/101024
PRODUCT NO:
60798
VERSION NO:
6.0
APPLICATION STARTED:
2014-Sep-15 16:05:01
VERSION CREATED:
2015-Aug-05 12:56:48
STARTED BY:
Lisa Wade
PRINTED:
2015-Aug-05 15:31:31
LABEL NAME:
VETMEDIN 5 MG CHEWABLE TABLETS FOR DOGS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains 5 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). RLP APPROVED
For Official Use Only
PRECAUTIONS:
Vetmedin® 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

Ապրանքի հատկությունները

CS: 1.9.46
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ1I5
September 2012
ISSUED by BOEHRING
Issue Date :
VETMEDIN® CHEWABLE TABLETS FOR DOGS
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETMEDIN® CHEWABLE TABLETS FOR DOGS
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: [phone]
Fax: [phone]
TELEPHONE/FAX
NUMBER
[e-mail]
EMAIL
Vetmedin® chewable tablets are indicated for the treatment of canine
congestive heart failure originating from dilated cardiomyopathy or
valvular
insufficiency (mitral and/or tricuspid regurgitation).
RECOMMENDED USE
2. HAZARDS IDENTIFICATION
Not classified as hazardous
NON-HAZARDOUS SUBSTANCE.
NON-DANGEROUS GOODS.
Not Classified as Hazardous according to criteria of National
Occupational
Health & Safety Commission, Australia (NOHSC).
Not Classified as Dangerous Goods according to the Australian Code for
the
Transport of Dangerous Goods by Road and Rail. (7th edition)
HAZARD
CLASSIFICATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
Pimobendan, a benzimidazole-pyridazinone derivative, is a
non-sympathomimentic, non-glycoside
inotropic substance with potent vasodilatative properties.
1.25 mg beef flavoured palatable chewable tablet contains 1.25 mg
pimobendan
5 mg beef flavoured palatable chewable tablet contains 5 mg pimobendan
2.5 mg beef flavoured palatable chewable tablet contains 2.5 mg
pimobendan
INFORMATION ON
COMPOSITION
NAME
RISK PHRASE
CAS
PROPORTION
HAZARD SYMBOL
INGREDIENTS
Pimobendan
(3(2H)-Pyridazinone,
4,5-dihydro-6-[2-
(4-methoxyphenyl)-1H-be
nzimidazol-5-yl]-5-meth
yl-)
74150-27-9
<=2 %
Ingredients determined
not to be hazardous
-
Balance
4. FIRST AID MEASURES
No special precautions required. However, if inhaled, remove affected
person
from contaminated area. Keep at rest until recovered. If symptoms
persist seek
medical attention.
INHALATION
Do not induce vomiting. Wash out mo