Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS (DOSIS HARIAN 200 MG), 1 AMPLOP @ 2 BLISTER @ 7 TABLET SALUT ...
2022-12-31
TREZILENT™ (alpelisib) 50 mg, 150 mg and 200 mg Film-coated tablets LEAFLET DISETUJUI OLEH BPOM: 19/12/2022 EREG10000512000255 EREG10000512000256 EREG10000512000257 SERIOUS WARNINGS AND PRECAUTIONS Treatment of Trezilent should be initiated by the physician experienced in the use of anti- cancer agents. The following serious adverse reactions were reported in patients treated with Trezilent. • Hypersensitivity, including anaphylactic reactions (see section 6 Warnings and precautions) • Severe cutaneous reactions including Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms and Erythema Multiforme (see section 6 Warnings and precautions) • Hyperglycemia, including hyperglycaemic hyperosmolar non-ketocic syndrome and some fatal cases of diabetic ketoacidosis (see section 6 Warnings and precautions) • Pneumonitis (see section 6 Warnings and precautions) 1 TRADENAME TREZILENT 50 mg film-coated tablets TREZILENT 150 mg film-coated tablets TREZILENT 200 mg film-coated tablets 1 DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM FILM-COATED TABLETS • 50 mg: Light pink, unscored, round and curved with beveled edges, imprinted with “L7” on one side and “NVR” on the other side. • 150 mg: Pale red, unscored, ovaloid and curved with beveled edges, imprinted with “UL7” on one side and “NVR” on the other side. • 200 mg: Light red, unscored, ovaloid and curved with beveled edges, imprinted with “YL7” on one side and “NVR” on the other side. ACTIVE SUBSTANCE Film-coated tablets containing alpelisib EXCIPIENTS Film-coated tablet core: Microcrystalline cellulose, mannitol, sodium starch glycolate, hypromellose and magnesium stearate. DISETUJUI OLEH BPOM: 19/12/2022 EREG10000512000255 EREG10000512000256 EREG10000512000257 Coating material: Hypromellose, titanium dioxide, macrogol / polyethylene glycol (PEG), talc, iron oxide red, and iron oxide black. Information might differ in some countries. 2 INDICATIONS Trezilent is an alpha-specific class I phosphati Lugege kogu dokumenti