Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BISOPROLOL FUMARATE
MERCK TBK - Indonesia
BISOPROLOL FUMARATE
1.25 MG
TABLET SALUT SELAPUT
DUS, 5 BLISTER @ 10 TABLET SALUT SELAPUT
MERCK - Indonesia
2019-11-15
_Page 1 of 10 _ CONCOR® BISOPROLOL FUMARATE SELECTIVE BETA BLOCKING AGENTS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION CONCOR 1.25 MG Each film-coated tablet contains 1.25 mg Bisoprolol fumarate. CONCOR 2.5 MG Each film-coated tablet contains 2.5 mg Bisoprolol fumarate. CONCOR 5 MG Each film-coated tablet contains 5 mg Bisoprolol fumarate. CONCOR 10 MG Each film-coated tablet contains 10 mg Bisoprolol fumarate. 2. PHARMACEUTICAL FORM Film-coated tablet. 3. CLINICAL PARTICULARS 3.1 INDICATIONS CONCOR 1.25 MG, CONCOR 2.5 MG, CONCOR 5 MG, AND CONCOR 10 MG Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. CONCOR 5 MG AND CONCOR 10 MG - Treatment of hypertension - Treatment of coronary heart disease (angina pectoris) 3.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _TREATMENT OF HYPERTENSION OR ANGINA PECTORIS _ Adults: For both indications the dosage is 5 mg Bisoprolol fumarate once daily. If necessary, the dose may be increased to 10 mg Bisoprolol fumarate once daily. The maximum recommended dose is 20 mg once daily. In all cases the dosage is adjusted individually, in particular according to the pulse rate and therapeutic success. _TREATMENT OF STABLE CHRONIC HEART FAILURE _ The patients should have stable chronic heart failure without acute failure during the past six weeks and a mainly unchanged basic therapy during the past two weeks. They should be treated at optimal dose with an optimal dose with an ACE inhibitor (or other vasodilator in case of intolerance to ACE inhibitors) and a diuretic, and optionally cardiac glycosides, prior to the administration of Bisoprolol. Titration phase The treatment of stable chronic heart failure with bisoprolol is initiated according to the following titration scheme, individual adaptation may be necessary depending on how well the patient tolerates each dose, i.e. the dose is to be increased only, if the previous dose is well tolerated. DISETUJUI OLEH BP Olvassa el a teljes dokumentumot