Iressa

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Gefitinib 250mg

זמין מ:

AstraZeneca Limited

INN (שם בינלאומי):

Gefitinib 250 mg

כמות:

250 mg

טופס פרצבטיות:

Coated tablet

הרכב:

Active: Gefitinib 250mg Excipient: Croscarmellose sodium Ethanol Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Macrogol 300 Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium laurilsulfate Titanium dioxide

יחידות באריזה:

Blister pack, 30 tablets

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

SA Ajinomoto OmniChem NV

סממני תרפויטית:

Treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the EGFR tyrosine kinase.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C

תאריך אישור:

2002-07-26

עלון מידע

Iressa

CMI 061020
Copyright
1(5)
IRESSA
®
GEFITINIB 250 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
IRESSA. It does not contain all the
information that is known about IRESSA.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking IRESSA against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT IRESSA IS USED FOR
IRESSA belongs to a group of medicines called antineoplastics. These
medicines work by stopping cancer cells from
growing and multiplying.
IRESSA is used to treat non-small cell lung cancer, which is one type
of lung cancer.
Your doctor will have explained why you are being treated with IRESSA
and told you what dose to take.
Your doctor may prescribe this medicine for another use. Ask your
doctor if you want more information.
This medicine is available only with a doctor's prescription.
IRESSA is not addictive.
HOW IRESSA WORKS
IRESSA is a selective inhibitor of a growth factor that is found in
non-small cell lung cancer. By blocking the action of
the growth factor IRESSA may slow or stop the growth of non-small cell
lung cancer.
BEFORE YOU USE IRESSA
_WHEN YOU MUST NOT USE IT _
DO NOT USE IRESSA IF:

You are allergic to gefitinib or any of the other ingredients of
Iressa;
DO NOT USE
IRESSA
IF YOU ARE PREGNANT. It is not known if it is safe for you to take
IRESSA
while you are pregnant. It may affect
your baby if you take it at any time during pregnancy.
DO NOT BREASTFEED WHILE TAKING
IRESSA
.
IRESSA
passes into breast milk and therefore there is a possibility that the
breast-fed
baby may be affected.
DO NOT GIVE
IRESSA
TO CHILDREN. There is no experience of its use in children.
DO NOT TAKE
IRESSA
AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK.
DO NOT

מאפייני מוצר

I
RESSA
Data Sheet 061020
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
I
RESSA
®
250 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Excipient with known effect: Each tablet contains 163.5 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet (tablets)
Round, biconvex, brown, film-coated tablet intagliated with "IRESSA"
and "250" on one
side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with locally advanced or metastatic Non Small
Cell Lung Cancer
(NSCLC) whose tumours express activating mutations of the EGFR
tyrosine kinase.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of I
RESSA
is one 250 mg tablet once a day, taken with or without
food. If a dose of I
RESSA
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.
DOSAGE ADJUSTMENT
No dosage adjustment is required on the basis of patient age, body
weight, gender,
ethnicity, renal function or in patients with moderate to severe
hepatic impairment due to
liver metastases. Gefitinib exposure is increased in patients with
moderate to severe
I
RESSA
Data Sheet 061020
Copyright
2
hepatic impairment due to cirrhosis or hepatitis (see Section 5.2).
The