Vetmedin 2.5 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

2.5 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

pimobendan

Authorization status:

Authorised

Authorization date:

2012-11-05

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 2.5 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
2.5 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
_Povidone _
_Lactose monohydrate _
_Maize starch _
_Croscarmellose sodium _
_Citric acid, anhydrous _
_Artificial powdered beef flavour _
_Silica, colloidal anhydrous _
_Magnesium stearate _
Oblong, scored, mottled brown tablets with fine white spots, embossed
with Boehringer Ingelheim
logo and P02.
The tablets can be divided into equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of canine congestive heart failure originating from
dilated cardiomyopathy or
valvular insufficiency (mitral and/or tricuspid valve regurgitation).
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.
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.
3.3
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.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
The veterinary medicinal product has not been tested in cases of
asymptomatic DCM in Dobermans
with atrial fibrillation or sustained ventricular tachycardia.
The veterinary medicinal product has not been tested in cases of
asymptomatic myx