Vetmedin 3.5 mg/mL Oral Solution for Dogs

Nchi: Australia

Lugha: Kiingereza

Chanzo: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
21-06-2017

Viambatanisho vya kazi:

PIMOBENDAN

Inapatikana kutoka:

LUODA PHARMA PTY LTD

INN (Jina la Kimataifa):

pimobendan(3.5mg/mL)

Dawa fomu:

ORAL SOLUTION/SUSPENSION

Tungo:

PIMOBENDAN PYRIDAZINONE Active 3.5 mg/ml

Vitengo katika mfuko:

168mL; 21mL; 42mL

Darasa:

VM - Veterinary Medicine

Viwandani na:

LUODA PHARMA PTY LTD

Eneo la matibabu:

CARDIOVASCULAR SYSTEM

Bidhaa muhtasari:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - LARGE: [CONGESTIVE HEART FAILURE]; For the treatment of canine congestive heart failure (CHF) originating from dilated cardiomyopathy (DCM) or valvular insufficiency (mitral and/or tricuspid regurgitation). Also for the treatment of preclinical DCM in large breed dogs (etc.)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.

Idhini hali ya:

Registered

Idhini ya tarehe:

2023-07-01

Taarifa za kipeperushi

                                COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LUODA PHARMA PTY LTD
VETMEDIN 3.5 MG/ML ORAL SOLUTION FOR DOGS
81552/103342
LABEL NAME:
Vetmedin 3.5 mg/mL Oral Solution For Dogs
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
CONSTITUENT
STATEMENTS:
3.5 mg/mL pimobendan
CLAIMS:
Vetmedin® 3.5 mg/mL oral solution for dogs is 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 breed dogs. When used in
case 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:
21mL, 42mL, 168mL
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 (eg. aortic stenosis). RLP APPROVED
PRECAUTIONS:
Vetmedin® 3.5 mg/mL oral solution 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.
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 #-antagonist
propranolol.
SIDE EFFECTS:
A 
                                
                                Soma hati kamili