Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 6 ALUBLISTER @ 10 KAPSUL LUNAK
2022-10-11
Red font: Proposed CCDS 0286-11,15 OFEV NINTEDANIB COMPOSITION OFEV _ _ 100 MG SOFT CAPSULES 1 capsule contains 100 mg of nintedanib (= free base) corresponding to 120.4 mg 1_H_-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl- 1-piperazinyl)acetyl] amino]phenyl] amino]phenylmethylene]-2-oxo-, methyl ester, (3_Z_)-, ethanesulfonate (1:1) (=_ _nintedanib esilate)._ _ OFEV 150 MG SOFT CAPSULES 1 capsule contains 150 mg of nintedanib (= free base) corresponding to 180.6 mg 1_H_-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl- 1-piperazinyl)acetyl] amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester, (3_Z_)-, ethanesulfonate (1:1) (= nintedanib esilate)._ _ EXCIPIENTS *** Capsule fill: Medium chain triglycerides, hard fat, soya lecithin (E322) Capsule shell: Gelatine, glycerol 85 %, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), black ink (Opacode ® ) Black ink: Shellac glaze, iron oxide black (E172), propylene glycol (E1520)_ _ DISETUJUI BPOOM: 15/02/2022 ID: EREG10036412000481, EREG10036412000482 Red font: Proposed CCDS 0286-11,15 INDICATIONS/ USAGE OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Ofev is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD). DOSAGE AND ADMINISTRATION/ RECOMMENDED INTAKE Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment for which OFEV is indicated. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the Pročitajte cijeli dokument