Vasotop P 1.25 mg, tablet voor honden

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

RAMIPRIL

Dostępny od:

Intervet Nederland B.V.

Kod ATC:

QC09AA05

INN (International Nazwa):

RAMIPRIL

Forma farmaceutyczna:

Tablet

Skład:

RAMIPRIL 1,25 mg/stuk,

Droga podania:

Oraal gebruik

Typ recepty:

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

Grupa terapeutyczna:

Honden

Dziedzina terapeutyczna:

Ramipril

Status autoryzacji:

NL/V/0245/002

Data autoryzacji:

1999-09-07

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop P 1.25 mg tablet for dogs
In IE and NO the name of the veterinary medicinal product is Vasotop
1.25 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 tablet of Vasotop P 1.25 mg contains: 1.25 mg ramipril
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Beige oblong tablet with a score line on both sides.
Embossing: Upper side with 1.25 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.
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 product