देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EVEROLIMUS
NOVARTIS INDONESIA - Indonesia
EVEROLIMUS
10.00 Mg
TABLET
DUS, 3 BLISTER @ 10 TABLET
NOVARTIS PHARMA STEIN AG - Switzerland
2020-02-17
Novartis Page 1 Leaflet Afinitor AFINITOR ® (EVEROLIMUS) 2.5 mg*, 5 mg and 10 mg tablets LEAFLET _* Disclaimer: Afinitor 2.5 mg tablet is not registered and marketed in Indonesia_ DISETUJUI OLEH BPOM : 08/09/2021 ID : EREG10000512100100 EREG10000512100101 Novartis Page 2 Leaflet Afinitor TRADE NAME(S) 2.5 MG TABLETS* Afinitor 2.5 mg tablets 5 MG TABLETS Afinitor 5 mg tablets 10 MG TABLETS Afinitor 10 mg tablets DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) TABLET White to slightly yellow, elongated tablets with a bevelled edge and no score. • 2.5 MG*: The tablets are engraved with “LCL” on one side and “NVR” on the other. • 5 MG: The tablets are engraved with “5” on one side and “NVR” on the other. • 10 MG: The tablets are engraved with “UHE” on one side and “NVR” on the other. ACTIVE SUBSTANCE TABLET • 2.5 MG*: Each tablet contains 2.5 mg everolimus. • 5 MG: Each tablet contains 5 mg everolimus. • 10 MG: Each tablet contains 10 mg everolimus EXCIPIENTS TABLET: Butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone and lactose anhydrous. INDICATIONS • AFINITOR is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib. • ADVANCED NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) AFINITOR is indicated for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic DISETUJUI OLEH BPOM : 08/09/2021 ID : EREG10000512100100 EREG10000512100101 Novartis Page 3 Leaflet Afinitor disease. The safety and effectiveness of AFINITOR in the preatment of patients with carcinoid tumors have not been established. • ADVANCED NEUROENDOCRINE TUMORS OF GASTROINTESTINAL (GI) OR LUNG ORIGIN AFINITOR is indicated for the treatment of unresectable or metastatic, well- differentiated (grade 1 or 2), non-functional neuroendocrine tumors of gastrointestinal or lung origin in adults पूरा दस्तावेज़ पढ़ें