Vetmedin 1.25 mg chewable tablets for dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Pimobendan

Dostopno od:

Boehringer Ingelheim Ltd

Koda artikla:

QC01CE90

INN (mednarodno ime):

Pimobendan

Odmerek:

1.25 mg/tablet

Farmacevtska oblika:

Chewable tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Dogs

Terapevtsko območje:

pimobendan

Terapevtske indikacije:

Cardiovascular

Status dovoljenje:

Authorised

Datum dovoljenje:

2012-11-05

Lastnosti izdelka

Health Products Regulatory Authority
14 September 2017
CRN000W67
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 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.
Oblong, scored, mottled brown tablets with fine white spots, embossed
with
Boehringer Ingelheim logo and P01.
The tablet can be divided into equal parts.
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 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
dise