FATROBENDAN 1.25 mg, chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

FATRO S.p.A.

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

1.25 milligram(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

pimobendan

Authorization status:

Authorised

Authorization date:

2021-03-19

Summary of Product characteristics

_/_1.
NAME OF THE VETERINARY MEDICINAL PRODUCT_ _
FATROBENDAN 1.25 mg, chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Pimobendan …………………..1.25 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Cellulose microcrystalline
Carmellose sodium
Pork liver powder
Glycerol dibehenate
Croscarmellose sodium
Magnesium stearate
Square brownish tablet with two break marks divisible into two or four
equal parts.
3.
CLINICAL INFORMATION
3.1.
TARGET SPECIES
Dogs.
3.2.
INDICATIONS FOR USE FOR EACH TARGET SPECIES
The product is indicated for the treatment of canine congestive heart
failure originating from
dilated cardiomyopathy or valvular insufficiency (mitral and/or
tricuspid valve regurgitation).
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 (see also section 3.7).
3.4.
SPECIAL WARNINGS
None.
3.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Monitoring of cardiac function and morphology is recommended in
animals treated with
pimobendan (see also section 3.6).
Use with caution in epileptic dogs.
The tablets are flavoured. In order to avoid any accidental ingestion,
store tablets out of reach of
the animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
People with known hypersensitivity to pimobendan or to any of the
excipients should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet
or the label to the physician.
Wash hands after use.
Advice to doctors: accidental ingestion, especially by a child, may
lead to the occurrence of
tachycardia, orthost