Vetmedin 0.75 mg/ml Solution for Injection for Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Pimobendan

Tilgængelig fra:

Boehringer Ingelheim Animal Health UK Ltd

ATC-kode:

QC01CE90

INN (International Name):

Pimobendan

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Cardio Vascular

Autorisation status:

Authorized

Autorisation dato:

2014-08-07

Produktets egenskaber

Revised: September 2019
AN: 01494/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 0.75 mg/ml solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Pimobendan
0.75 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To initiate treatment of canine congestive heart failure originating
from valvular
insufficiency (mitral and/or tricuspid regurgitation) or dilated
cardiomyopathy.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in cases of hypertrophic cardiomyopathies or clinical
conditions where an
augmentation of cardiac output is not possible for functional or
anatomical reasons
(e.g. aortic stenosis).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2019
AN: 01494/2018
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of accidental subcutaneous injection temporary swelling and
mild to slight
resorptive inflammatory reactions can occur at or below the injection
site.
For single administration only.
The product should be used for the initiation of treatment of
congestive heart failure
in dogs, following a risk:benefit assessment by the responsible
veterinarian, taking
into account the overall health status of the dog. Before treatment,
diagnosis should
be made by the means of a comprehensive physical and cardiac
examination which
should include echocardiography or radiography where appropriate.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label to the physician.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY A