[Wagg & Purr] Pimobendan 10 mg Chewable Tablets for Dogs

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra

Scarica Foglio illustrativo (PIL)
05-10-2022

Principio attivo:

PIMOBENDAN

Commercializzato da:

AVET HEALTH LIMITED

Forma farmaceutica:

ORAL BOLUS, CHEWABLE

Composizione:

PIMOBENDAN PYRIDAZINONE Active 10.0 mg/Tb

Confezione:

50 tablets

Classe:

VM - Veterinary Medicine

Area terapeutica:

CARDIOVASCULAR SYSTEM

Dettagli prodotto:

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

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-07-01

Foglio illustrativo

                                [Wagg & Purr] Pimobendan 10 mg Chewable Tablets for Dogs
92545/135876
Product Name:
APVMA Approval No:
Label Name:
[Wagg & Purr] Pimobendan 10 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 10 mg pimobendan.
Claims:
Wagg & Purr Pimobendan 10 mg Chewable 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 pre-clinical DCM in large breed dogs.
For the treatment of dogs with evidence of increased heart size
secondary to asymptomatic
(preclinical) myxomatous mitral valve disease to delay the onset of
clinical symptoms of
heart failure, to reduce heart size and to increase survival time.
Net Contents:
50 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).
Precautions:
Wagg & Purr Pimobendan 10 mg Chewable Tablets for Dogs should only be
administered
in pregnant and lactating bitches if the expected therapeutics
benefits overweigh the
potential risk. RLP APPROVED
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 β-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.
In the
                                
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