CORMEDIN 1.25 MG TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PIMOBENDAN

Available from:

JUROX PTY LIMITED

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

PIMOBENDAN PYRIDAZINONE Active 1.25 mg/ta

Units in package:

112 tablets; 14 tablets; 28 tablets; 42 tablets; 56 tablets; 84 tablets

Class:

VM - Veterinary Medicine

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

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

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

CORMEDIN 1.25 MG TABLETS FOR DOGS
83487/122623
Product Name:
APVMA Approval No:
Label Name:
CORMEDIN 1.25 MG 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:
CORMEDIN 1.25 MG TABLETS FOR DOGS 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 breeds. 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:
14 tablets
28 tablets
42 tablets
56 tablets
84 tablets
112 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:
CORMEDIN TABLETS FOR DOGS 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 of the heart
is attenuated in the presence of the calcium antagonist verapamil and
the ß- antagonist
propranolol.
Side Effects:
A moderate positive chronotropic effect and vomiting may occur in rare
cases. However,
these effects are dose-dependent

Summary of Product characteristics

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Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 11 26 FROM ANYWHERE IN AUSTRALIA
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
CORMEDIN 1.25 MG TABLETS FOR DOGS
CORMEDIN 2.5 MG TABLETS FOR DOGS
CORMEDIN 5 MG TABLETS FOR DOGS
PRODUCT IDENTIFIER:
Tablet containing 1.25 mg Pimobendan
Tablet containing 2.5 mg Pimobendan
Tablet containing 5 mg Pimobendan
PRODUCT CODE:
521105 (1.25 mg), 521110 (2.5 mg), 521115 (5 mg)
RECOMMENDED USE:
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 breeds.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
EMAIL:
[e-mail]
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS
13 11 26 (24 hours)
INFORMATION CENTRE:
EMERGENCY TELEPHONE
1800 023 312 (9am – 5pm, Monday to Friday)
NUMBER:
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS: This product has been assessed according to
GHS and is classified as follows:
GHS CATEGORY
HAZARD CODE
HAZARD STATEMENT
Skin Corrosion/Irritation Category 2
H315
Causes skin irritation
Serious Eye Damage Category 1
H318
Causes serious eye damage
SIGNAL WORD: DANGER
GHS PICTOGRAMS:
Corrosion Exclamation
Mark
Document:
Effective Date:
Issue Date:
Rev:
Review Date:
Status:
Title: CORMEDIN TABLETS FOR DOGS
25-May-2020
SDS-AU124
25-May-2020
PAGE 1 OF 7
1.0
25-May-2025
Current
SAFETY DATA SHEET
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Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 11 26 FROM ANYWHERE IN AUSTRALIA
PRECAUTIONARY STATEMENTS:
Prevention
P101
If medical advice is needed, have product container or label at hand.
P102
Keep out of reach of children.
P103
Read carefully and follow all instructions.
P264
Wash hands thoroughly after handling.
P280
Wear protective

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
CORMEDIN
®
Tablets for Dogs
ACTIVE CONSTITUENTS
Each tablet contains 1.25 mg, 2.5 mg or 5 mg pimobendan.
ACTIONS
Pimobendan is a benzimidazole-pyridazinone derivative, and is a
non-sympathomimetic, non-glycoside inotropic substance with
potent vasodilatative properties.
Pimobendan exerts its stimulatory myocardial effect by a dual
mechanism of action: increase in calcium sensitivity of cardiac
myofilaments and inhibition of phosphodiesterase (type III). It also
exhibits a vasodilating action through an inhibitory action on
phosphodiesterase III activity. Following oral administration of
pimobendan, the absolute bioavailability of the active principal is
60 – 63%.
The mean plasma protein binding is 93%. The plasma elimination
half-life of pimobendan is approximately 30 minutes and the main
active metabolite elimination half-life is approximately 2 hours.
Almost the entire dose is eliminated via faeces.
INDICATIONS
CorMedin Tablets for Dogs 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 breeds. 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.
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
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