Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
CARVEDILOL; IVABRADINE HYDROCHLORIDE 5.39 mg EQV IVABRADINE
SERVIER (S) PTE LTD
C07FX06
TABLET, FILM COATED
CARVEDILOL 25mg; IVABRADINE HYDROCHLORIDE 5.39 mg EQV IVABRADINE 5 mg
ORAL
Prescription Only
Les Laboratories Servier Industrie
ACTIVE
2019-02-12
1 1. NAME OF THE MEDICINAL PRODUCT Carivalan film-coated tablets 6.25 mg/5 mg Carivalan film-coated tablets 6.25 mg/7.5 mg Carivalan film-coated tablets 12.5 mg/5 mg Carivalan film-coated tablets 12.5 mg/7.5 mg Carivalan film-coated tablets 25 mg/5 mg Carivalan film-coated tablets 25 mg/7.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Each film-coated tablet contains 25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Each film-coated tablet contains 25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Excipient with known effect: lactose monohydrate (68.055 mg for Carivalan 6.25/5 mg, 65.360 mg for Carivalan 6.25/7.5 mg, 78.710 mg for Carivalan 12.5/5 mg, 76.015 mg for Carivalan 12.5/7.5 mg, 85.530 mg for Carivalan 25/5 mg and 82.835 mg for Carivalan 25/7.5 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, hexagonal, film-coated tablet (6.25/5 mg) (longest diagonal 7.3 mm) engraved with CI2 on one face and on the other face. Yellow, hexagonal, film-coated tablet (6.25/7.5 mg) (longest diagonal 7.3 mm) engraved with CI3 on one face and on the other face. White, elliptic, film-coated tablet (12.5/5 mg) (10.6 mm x 5.3 mm) engraved with CI4 on one face and on the other face. Yellow, elliptic, film-coated tablet (12.5/7.5 mg) (10.6 mm x 5.3 mm) engraved with CI5 on one face and on the other face. White, octagonal, film-coated tablet (25/5 mg) (diamet Прочетете целия документ