Vasotop 0,625 mg Tabletten
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-01-2013
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Active ingredient:
ramipril 0.62 mg
Available from:
Intervet Deutschland GmbH
ATC code:
QC09AA05
Pharmaceutical form:
Tablet
Therapeutic group:
ramipril
Therapeutic area:
Dogs Non Food
Authorization date:
2010-06-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop P 0.625mg, tablet for dogs
In DK, IE, NO and SE, the name of the veterinary medicinal product is Vasotop 0.625 mg
tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance.
1 tablet Vasotop P 0.625mg contains: 1.25 mg Ramipril
Excipients:
Colouring matters: Brown ferric oxide (E172): 1.0 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Beige oblong tablet with 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
Dog
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.
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