VETMEDIN 5 MG CAPSULES 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(5mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

PIMOBENDAN PYRIDAZINONE Active 5.0 mg/Cp

Units in package:

100 Caps

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

CARDIOVASCULAR SYSTEM

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CONGESTIVE HEART FAILURE, PRECLINICAL MYXOMATOUS MITRAL VALVE DISEASE]; DOG - LARGE: [CONGESTIVE HEART FAILURE, PRECLINICAL MYXOMATOUS MITRAL VALVE DISEASE]; For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation); also for treatment of preclinical DCM in large breed dogs.Should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where augmentation of cardiac output is not possible for functional or anatomical reasons.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
VETMEDIN 5 MG CAPSULES FOR DOGS
53562/105925
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
VETMEDIN 5 MG CAPSULES FOR DOGS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each capsule contains 5 mg pimobendan
CLAIMS:
Vetmedin® capsules are indicated for:
The treatment of canine congestive heart failure originating from
dilated cardiomyopathy 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:
100 capsules
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® Capsules should only be administered to pregnant and
lactating bitches if the
expected therapeutic benefits overweigh the potential risk. RLP APPROVED
Studies into the effect of pimobendan on the reproductive function of
male dogs have not
been conducted.
The use in dogs not showing signs of cardiac disease is not
recommended.
In pharmacological studies no interaction between the cardiac
glycoside ouabain and
pimobendan was detected. The pimobendan induced increase in
contractility of the heart
is attenuated in the presence of the calcium antagonist verapamil and
the B-antagonist
propranolol.
SIDE EFFECTS:
A moderate positive chronotropic effect and vomiting may occur in rare
cas

Summary of Product characteristics

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ1I4
September 2012
ISSUED by BOEHRING
Issue Date :
VETMEDIN® CAPSULES FOR DOGS
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETMEDIN® CAPSULES 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® capsules 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.
Hazard classification according to the criteria of NOHSC.
Dangerous goods classification according to the Australia Dangerous
Goods
Code.
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 capsule contains 1.25 mg pimobendan
2.5 mg capsule contains 2.5 mg pimobendan
5 mg capsule contains 5 mg pimobendan
INFORMATION ON
COMPOSITION
NAME
CAS
PROPORTION
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 mouth thoroughly with water. If
symptoms
develop seek medical attention.
INGESTION
Wash affected area thoroughly with soap and water. If symptoms develop
seek
medical attention.
SKIN
If in eyes, hold eyelids apart and flush the eyes continuously with
running
water. Contin