IRESSA TABLET 250 mg

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

GEFITINIB

Disponibbli minn:

ASTRAZENECA SINGAPORE PTE LTD

Kodiċi ATC:

L01XE02

Dożaġġ:

250 mg

Għamla farmaċewtika:

TABLET, FILM COATED

Kompożizzjoni:

GEFITINIB 250 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

ASTRAZENECA UK LTD

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2003-05-22

Fuljett ta 'informazzjoni

1(15) 
11/AC/SG/ONC.000-120-187.10.0 

PACKAGE LEAFLET TEXT 

IRESSA 250 MG FILM-COATED TABLETS 
TRADE MARK 

PRESENTATION 

Brown, round, biconvex, film-coated tablet impressed with “IRESSA
250” on one side 
and plain on the other.

Each tablet contains 250 mg gefitinib. 

INDICATIONS 

IRESSA is indicated for the first line treatment of patients
with locally advanced or 
metastatic Non Small Cell Lung Cancer (NSCLC) who have activating
mutations of the 
EGFR TK (see ‘WARNINGS AND PRECAUTIONS’ section). 

IRESSA is indicated for the treatment of patients with
locally advanced or metastatic 
Non Small Cell Lung Cancer (NSCLC) after failure of
cytotoxic chemotherapy. 
Previous therapy should have included a platinum and a taxane. 

In a phase III double blind clinical trial comparing IRESSA to
placebo in patients with 
advanced NSCLC who had received 1 or 2 chemotherapy regimens,
IRESSA did not 
significantly prolong survival in the overall population or
in patients with 
adenocarcinoma. Pre-planned subgroup analyses showed there is a
statistically 
significant increase in survival for patients of Oriental ethnicity
treated with IRESSA 
compared to placebo
(See ‘PHARMACODYNAMICS PROPERTIES’ section). 

DOSAGE AND ADMINISTRATION 

IRESSA treatment should only be initiated by a
medical specialist experienced in the 
treatment of patients with advanced NSCLC. 

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 disper

Karatteristiċi tal-prodott

1
IRESSA
®
(GEFITINIB)
1.
NAME OF THE MEDICINAL PRODUCT
IRESSA 250 mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg gefitinib.
3.
PHARMACEUTICAL FORM
Brown, round, biconvex, film-coated tablet impressed with “IRESSA
250” on one side
and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IRESSA treatment should only be initiated by a medical specialist
experienced in the
treatment of patients with advanced NSCLC.
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 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 section 5.2).
2
DOSAGE ADJUSTMENT:
Patients with poorly tolerated diarrhoea or skin adverse drug