GEFITINIB-TEVA FC TABLET 250MG

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Gefitinib

제공처:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC 코드:

L01EB01

약제 형태:

TABLET, FILM COATED

구성:

Gefitinib 250 mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

Teva Pharmaceutical Industries, Ltd.

승인 상태:

ACTIVE

승인 날짜:

2023-03-02

제품 특성 요약

GEFITINIB-TEVA FC TABLET 250MG
PRESENTATION
Light brown to brown, round standard convex tablet, debossed “250
mg” on one
side of the tablet and plain on the other side. Each tablet contains
250 mg gefitinib.
INDICATIONS
Gefitinib 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.
DOSAGE AND ADMINISTRATION
Gefitinib treatment should only be initiated by a medical specialist
experienced in
the treatment of patients with advanced NSCLC.
The recommended dose of Gefitinib is one 250 mg tablet once a day,
taken with
or without food. If a dose of Gefitinib 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.
Gefitinib is not recommended for use in children or adolescents as
safety and
effectiveness in these patient populations has not been studied.
No dosage adjustment is required on the basis of patient age, body
weight,
gender, ethnicity, mild to moderate renal impairment or in patients
with moderate
to severe hepatic impairment due to liver metastases (see
‘PHARMACOKINETIC
PROPERTIES’ section).
DOSAGE ADJUSTMENT: Patients with poorly tolerated diarrhoea or skin
adverse
drug reactions may be successfully managed by providing a brief (up to
14
days) therapy interruption followed by