Vetmedin Chew 1.25 mg chewable tablets for dogs

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Pimobendan

Dostupno od:

Boehringer Ingelheim Ltd

ATC koda:

QC01CE90

INN (International ime):

Pimobendan

Doziranje:

1.25 mg/tablet

Farmaceutski oblik:

Chewable tablet

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Dogs

Područje terapije:

pimobendan

Terapijske indikacije:

Cardiovascular

Status autorizacije:

Authorised

Datum autorizacije:

2015-10-09

Svojstava lijeka

Health Products Regulatory Authority
14 September 2017
CRN000W67
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin Chew 1.25 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
Pimobendan 1.25 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Brownish, oval, divisible tablet, scored on both sides.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from
dilated
cardiomyopathy or valvular insufficiency (mitral and/or tricuspid
valve regurgitation).
(See also section 4.9).
For the treatment of dilated cardiomyopathy in the preclinical stage
(asymptomatic
with an increase in left ventricular end-systolic and end-diastolic
diameter) in
Doberman Pinschers following echocardiographic diagnosis of cardiac
disease (see
sections 4.4 and 4.5).
For the treatment of dogs with myxomatous mitral valve disease (MMVD)
in the
preclinical stage (asymptomatic with a systolic mitral murmur and
evidence of
increased heart size) to delay the onset of clinical symptoms of heart
failure (see
sections 4.4 and 4.5).
Health Products Regulatory Authority
14 September 2017
CRN000W67
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use pimobendan in hypertrophic cardiomyopathies or in diseases
in which an
improvement in cardiac output cannot be achieved for functional or
anatomical
reasons (e.g. aortic stenosis).
Since pimobendan is metabolised mainly via the liver, it should not be
used in dogs
with severe impairment of liver function (see also section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product has not been tested in cases of asymptomatic DCM in
Dobermans with
atrial fibrillation or sustained ventricular tachycardia.
The product has not been tested in cases of asymptomatic myxomatous
mitral valve
disease in dogs with significant supraventri