CARDISURE FLAVOURED 2.5mg TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PIMOBENDAN

Available from:

Eurovet Animal Health BV

INN (International Name):

pimobendan(2.5mg/Tb)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

PIMOBENDAN PYRIDAZINONE Active 2.5 mg/Tb

Units in package:

100 tablets; 20 tablets; 250 tablets; 40 tablets; 50 tablets; 80 tablets

Class:

VM - Veterinary Medicine

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; DOG - LARGE: [PRECLINICAL DCM]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.See Contraindications, Precautions & Side Effects on label

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

CARDISURE FLAVOURED 2.5mg TABLETS FOR DOGS
81946/104467
Product Name:
APVMA Approval No:
Label Name:
CARDISURE FLAVOURED 2.5mg TABLETS FOR DOGS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 2.5 mg pimobendan
Claims:
For the treatment of canine congestive heart failure originating from
valvular insufficiency
(mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.
Net Contents:
20, 50, 100 or 250 tablets.
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated 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:
CARDISURE FLAVOURED TABLETS should only be administered to pregnant
and
lactating bitches if the expected therapeutic benefits outweigh the
potential risk.
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. RLP APPROVED
Side Effects:
A moderate positive chronotropic effect and vomiting may occur in rare
cases. However,
these effects are dose-dependent and can be avoided by reducing the
dose in those cases.
In rare cases transient diarrhoea, anorexia or lethargy have been
observed.
Dosage and
Administration:
The tablets should be administered orally at a dose range of 0.2 mg to
0.6 mg pimobendan/
kg body weight per day. The preferable daily dose is 0.5 mg
pimobendan/kg body weight.
The dose should be divided into two administrations (0.25 mg/kg body
weight, one half
dose in the morning and the other half approximately 12 hours later.
The mai

Summary of Product characteristics

Safety Data Sheet
Product Name: Cardisure
®
Flavoured tablets
Issue Date: 03/2018
Version No: 1
Page 1 of 11
SECTION 1: IDENTIFICATION
1.1 PRODUCT IDENTIFIER
PRODUCT NAME:
Cardisure
®
Flavoured Tablets (containing 1.25mg, 2.5mg, 5mg
or 10mg pimobendan)
SYNONYMS:
Pimocard, Pimosure
PROPER SHIPPING NAME:
Not Available
OTHER MEANS OF
IDENTIFICATION:
None
1.2 RELEVANT IDENTIFIED USES OF THE SUBSTANCES OR MIXTURE AND USES
ADVISED AGAINST
RECOMMENDED USES:
For the treatment of canine congestive heart failure originating
from valvular insufficiency (mitral and/or tricuspid
regurgitation) or dilated cardiomyopathy.
USES ADVISED AGAINST:
Not for human use.
1.3 DETAILS OF THE SUPPLIER OF THE SUBSTANCE OR MIXTURE
REGISTERED COMPANY
NAME:
Apex Laboratories Pty Ltd
ADDRESS:
Apex Laboratories Pty Ltd
ACN 614 716 700
2 Cal Close
Somersby NSW 2250
TELEPHONE:
1300 015 825 (Business hours: 08:30 – 17:30)
FAX:
[phone]
EMAIL:
[e-mail]
WEBSITE:
www.apexlabs.com.au
1.4 EMERGENCY TELEPHONE NUMBERS
13 11 26 (Poisons Information Centre)
SECTION 2: HAZARDS IDENTIFICATION
2.1 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
GHS CLASSIFICATION(S):
Specific target organ toxicity - single exposure - Category 3
(respiratory tract irritation)
Please note that respiratory irritation is unlikely to occur due to
physical form of the product and
how it is packaged
2.2 LABEL ELEMENTS
SIGNAL WORD:
WARNING
Safety Data Sheet
Product Name: Cardisure
®
Flavoured tablets
Issue Date: 03/2018
Version No: 1
Page 2 of 11
HAZARD STATEMENT(S):
H335
May cause respiratory irritation
PRECAUTIONARY STATEMENT(S) PREVENTION:
P261
Avoid breathing dust/fumes.
PRECAUTIONARY STATEMENT(S) RESPONSE:
P312
Call a POISON CENTER or doctor/physician if you feel unwell.
P304+P340
IF INHALED: Remove victim to fresh air and keep at rest in a
position comfortable for breathing.
PRECAUTIONARY STATEMENT(S) STORAGE:
P405
Store locked up.
PRECAUTIONARY STATEMENT(S) DISPOSAL:
P501
Dispose of contents/container in accordance with local
regulations.
2.3 OTHER HAZARD I