Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RAMIPRIL
Intervet Nederland B.V.
QC09AA05
RAMIPRIL
Tablet
RAMIPRIL 2,5 mg/stuk,
Oraal gebruik
Uitsluitend verkrijgbaar bij een dierenarts of op recept van een dierenarts bij een apotheek
Honden
Ramipril
NL/V/0245/003
1999-09-07
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 Lire le document complet