Pimocard 1.25 mg flavoured tablets for dogs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Pimobendan

Dostępny od:

Eurovet Animal Health B.V.

Kod ATC:

QC01CE90

INN (International Nazwa):

Pimobendan

Dawkowanie:

1.25 mg/tablet

Forma farmaceutyczna:

Tablet

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

pimobendan

Wskazania:

Cardiovascular

Status autoryzacji:

Authorised

Data autoryzacji:

2016-01-22

Charakterystyka produktu

Health Products Regulatory Authority
05 October 2017
CRN000V2M
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pimocard 1.25 mg flavoured tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
Active substance:
Pimobendan 1.25 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light brown round tablets, scored on one side and plain on the other
side.
The tablets can be divided into 2 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from
valvular
insufficiency (mitral and/or tricuspid regurgitation) or dilated
cardiomyopathy.
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
None.
Health Products Regulatory Authority
05 October 2017
CRN000V2M
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Blood glucose should be tested regularly during treatment in dogs with
existing
diabetes mellitus.
Monitoring of cardiac function and morphology is recommended in
animals treated
with pimobendan.
See also section 4.6.
The tablets are flavoured. In order to avoid any accidental ingestion,
store tablets out
of reach of animals.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
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, orthostatic hypotension, flushing of the
face and
headaches.
This