Vetmedin Chew 2.5 mg Chewable Tablets for Dogs

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Pimobendan

Dostopno od:

Boehringer Ingelheim Limited

Koda artikla:

QC01CE90

INN (mednarodno ime):

Pimobendan

Farmacevtska oblika:

Chewable tablet

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Dogs

Terapevtsko območje:

Cardio Vascular

Status dovoljenje:

Authorized

Datum dovoljenje:

2015-04-08

Lastnosti izdelka

Revised: September 2017
AN: 01343/2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin Chew 2.5 mg chewable tablets for dogs (AT, BE, DE, IE, IT,
LI, LU, NL,
UK)
Vetmedin vet. 2.5 mg chewable tablets for dogs (CY, DK, EL, ES, FI,
IS, NO, PL, PT,
SE)
Vetmedin S 2.5 mg chewable tablets for dogs (BG, CZ, EE, FR, HR, HU,
LT, LV, RO,
SI, SK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
2.5 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).
Page 1 of 7
Revised: September 2017
AN: 01343/2016
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 w