Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GEFITINIB
ASTRAZENECA INDONESIA - Indonesia
GEFITINIB
250 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
NIPRO PHARMA CORPORATION - Japan
2019-10-01
1 of 15 IRESSA ® 250 MG _gefitinib _ FILM-COATED TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of gefitinib. For excipients, see _List of excipients. _ PHARMACEUTICAL FORM Brown, round, biconvex, film-coated tablet impressed with “IRESSA 250” on one side and plain on the other. THERAPEUTIC INDICATIONS • IRESSA TM (ZD1839, gefitinib) is indicated for the naïve treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of EGFR TK (see section Special warning and precautions for use), • IRESSA is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR TK, who have previously received chemotherapy or who are not suitable for chemotherapy. POSOLOGY AND METHOD OF ADMINISTRATION Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anticancer therapies. The recommended dose of IRESSA is one 250 mg tablet once a day, taken with or without food. If a dose of IRESSA is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. Where dosing of whole tablets is not possible, such as patients who are only able to swallow liquids, tablets may be administered as a dispersion in water. The tablet should be dropped into half a glass of drinking water (non-carbonated), without crushing, and the glass stirred until the tablet has dispersed (approximately 15 minutes) and the contents subsequently drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The liquid can also be administered via a nasogastric tube. IRESSA is not recommended for use in children or adolescents as safety and effectiveness in these patient populations has not been studied. No do Belgenin tamamını okuyun