Vasotop P 2.5 mg, tablet voor honden

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

RAMIPRIL

Disponible desde:

Intervet Nederland B.V.

Código ATC:

QC09AA05

Designación común internacional (DCI):

RAMIPRIL

formulario farmacéutico:

Tablet

Composición:

RAMIPRIL 2,5 mg/stuk,

Vía de administración:

Oraal gebruik

tipo de receta:

Uitsluitend verkrijgbaar bij een dierenarts of op recept van een dierenarts bij een apotheek

Grupo terapéutico:

Honden

Área terapéutica:

Ramipril

Estado de Autorización:

NL/V/0245/003

Fecha de autorización:

1999-09-07

Ficha técnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop P 2.5 mg tablet for dogs
In IE and NO the name of the veterinary medicinal product is Vasotop
2.5 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 tablet of Vasotop P 2.5 mg contains: 2.5 mg ramipril
EXCIPIENTS:
Colourant: Yellow ferric oxide (E172): 0.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Yellow oblong tablet with a score line on both sides.
Embossing: Upper side with 2.5 on both sides of the score line –
Lower side: V on both sides of the
score line.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
treatment
of
congestive
heart
failure
(according
to
New
York
Heart
Association
(NYHA)
classification grade II, III & IV) caused by valvular insufficiency
due to chronic degenerative valvular
heart disease (endocardiosis) or cardiomyopathy, with or without
adjunct therapy with the diuretic
furosemide and/or the cardiac glycosides digoxin or methyldigoxin.
Class
Clinical signs
II
Fatigue shortness of breath, coughing etc. become evident when
ordinary exercise is
exceeded. Ascites may appear at this stage.
III
Comfortable at rest, but exercise capacity is minimal.
IV
No capacity for exercise. Disabling clinical signs are present even at
rest.
In patients treated concurrently with the product and furosemide, the
dose of the diuretic can be
reduced to achieve the same diuretic effect as treatment with
furosemide alone.
3
4.3
CONTRAINDICATIONS
Do not use in any dog with haemodynamically relevant stenosis (e.g.
aortic stenosis, mitral valve
stenosis) or obstructive hypertrophic cardiomyopathy.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If signs of apathy or ataxia (potential signs o