Vetmedin 0.75 mg/ml Solution for Injection for Dogs

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Pimobendan

Disponível em:

Boehringer Ingelheim Limited

Código ATC:

QC01CE90

DCI (Denominação Comum Internacional):

Pimobendan

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Dogs

Área terapêutica:

Cardio Vascular

Status de autorização:

Authorized

Data de autorização:

2014-08-07

Características técnicas

Revised: September 2017
AN: 00877/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 0.75 mg/ml solution for injection for dogs (AT, BE, CY, CZ,
DE, EL, ES,
HU, IE, LU, NL, PL, PT, RO, SK, UK
Vetmedin vet 0.75mg/ml solution for injection for dogs (IS, SE, FI,
NO, DK)
Vetmedin start 0.75mg/ml solution for injection for dogs (IT)
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.
A clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
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).
See also section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Page 1 of 5
Revised: September 2017
AN: 00877/2017
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.
Special precautions for 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