Cardisure Oral Solution

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PIMOBENDAN

Available from:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

PIMOBENDAN PYRIDAZINONE Active 1.5 mg/ml

Units in package:

25 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Cardisure Oral Solution
84375/110276
Label Name:
Cardisure Oral Solution
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
1.5 mg/mL PIMOBENDAN
Claims:
For the treatment of canine congestive heart failure originating from
dilated cardiomyopathy
or valvular insufficiency (mitral and/or tricuspid regurgitation)
Net Contents:
25 mL
Directions for Use:
Read the enclosed leaflet before using this product
Restraints:
Contraindications:
This product is contraindicated for use in cases of hypertrophic
cardiomyopathies or
clinical conditions where an augmentation of cardiac output is not
possible for functional or
anatomical reasons (e.g. aortic stenosis).
Precautions:
Cardisure Oral Solution 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 doges 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 RLP APPROVED
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
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:
Shake well before use.
Cardisure Oral Solution should be administered orally at a dose range
of 0.1 mg to 0.3
mg pimobendan/kg bodyweight twice daily. The ideal dose is 0.25 mg
pimobendan/kg
body weight (equivalent to 0.167 mL Cardisure Oral Solution/kg
bodyweight) twice daily
administered approximately 12 hours apart. Each dose should be