Vasotop P 0.625 mg, tablet voor honden

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RAMIPRIL

Beschikbaar vanaf:

Intervet Nederland B.V.

ATC-code:

QC09AA05

INN (Algemene Internationale Benaming):

RAMIPRIL

farmaceutische vorm:

Tablet

Samenstelling:

RAMIPRIL 0,625 mg/stuk,

Toedieningsweg:

Oraal gebruik

Prescription-type:

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

Therapeutische categorie:

Honden

Therapeutisch gebied:

Ramipril

Autorisatie-status:

NL/V/0245/001

Autorisatie datum:

2005-06-17

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop P 0.625 mg tablet for dogs
In IE and NO the name of the veterinary medicinal product is Vasotop
0.625 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 tablet of Vasotop P 0.625 mg contains: 0.625 mg ramipril
EXCIPIENTS:
Colourant: Brown ferric oxide (E172): 1.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Orange oblong tablet with a score line on both sides.
Embossing: One 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.
4.3
CONTRAINDICATIONS
3
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 of hypotension) occur
during treatment with the prod