Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RUXOLITINIB PHOSPHATE
NOVARTIS INDONESIA - Indonesia
RUXOLITINIB PHOSPHATE
26.40 MG
TABLET
DUS, 1 BLISTER @ 14 TABLET
NOVARTIS PHARMA STEIN AG - Switzerland
2019-11-29
JAKAVI ® RUXOLITINIB DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) 5 mg tablets: round curved white to almost white tablets with ‘NVR’debossed on one side and ‘L5’ debossed on the other side 15 mg tablets: ovaloid curved white to almost white tablets with ‘NVR’ debossed on one side and ‘L15’ debossed on the other side 20 mg tablets: elongated curved white to almost white tablets with ‘NVR’ debossed on one side and ‘L20’ debossed on the other side ACTIVE SUBSTANCE(S) Ruxolitinib phosphate Ruxolitinib 5 mg per tablet Ruxolitinib 15 mg per tablet Ruxolitinib 20 mg per tablet ACTIVE MOIETY Ruxolitinib EXCIPIENTS Cellulose, microcrystalline; Lactose monohydrate; Magnesium stearate; Silica, colloidal anhydrous; Sodium starch glycolate (Type A); Hydroxypropylcellulose; Povidone Each 5 mg tablet contains 71.45 mg of lactose monohydrate Each 15 mg tablet contains 214.35 mg of lactose monohydrate Each 20 mg tablet contains 285.80 mg of lactose monohydrate INDICATIONS _MYELOFIBROSIS _ Jakavi ® is indicated for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. _POLYCYTHEMIA VERA _ Jakavi is indicated for the treatment of patients with polycythemia who are resistant to or intolerant of hydroxyurea. DISETUJUI OLEH BPOM: 19/06/2023 ID:EREG10000512200291- EREG10000512200296 Novartis Page 2 Product Information Jakavi ® (ruxolitinib) DOSAGE REGIMEN AND ADMINISTRATION MONITORING INSTRUCTIONS BLOOD CELL COUNTS: a blood cell count must be performed before initiating therapy with Jakavi. Complete blood counts should be monitored every 2 to 4 weeks until doses are stabilized, and then as clinically indicated (see section Warnings and precautions). STARTING DOSE The recommended starting dose of Jakavi in myelofibrosis (MF) is based on platelet counts (see Table 1): TABLE 1 STARTING DOSES IN MYELOFIBROSIS PLATELET COUNT STARTING DOSE Greater than 200,000/mm 3 100,000 to 200,000/mm 3 75,000 to Izlasiet visu dokumentu