IRESSA

Страна: Индонезия

Език: индонезийски

Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активна съставка:

GEFITINIB

Предлага се от:

ASTRAZENECA INDONESIA - Indonesia

INN (Международно Name):

GEFITINIB

дозиране:

250 MG

Лекарствена форма:

TABLET SALUT SELAPUT

Броя в опаковка:

DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT

Произведено от:

NIPRO PHARMA Corp - Japan

Дата Оторизация:

2018-06-29

Данни за продукта

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