IRESSA gefitinib 250 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

gefitinib, Quantity: 250 mg

Boleh didapati daripada:

AstraZeneca Pty Ltd

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; sodium lauryl sulfate; magnesium stearate; hypromellose; macrogol 300; iron oxide red; iron oxide yellow; titanium dioxide

Laluan pentadbiran:

Oral

Unit dalam pakej:

30 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

IRESSA is indicated for the treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC), whose tumours express activating mutations of the EGFR tyrosine kinase.

Ringkasan produk:

Visual Identification: Round, biconvex, brown, film-coated tablet intagliated with 'IRESSA' and '250' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2003-04-28

Risalah maklumat

IRESSA™
_250 MG TABLETS_
_Gefitinib_
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
available information.
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 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.
BEFORE YOU USE
IRESSA
_WHEN YOU MUST NOT USE IT_
YOU MUST TELL YOUR DOCTOR IF YOU
HAVE ALLERGIES TO:
•
gefitinib, the active ingredient in
IRESSA
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
IRESSA may include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching, hives or flushed, red
skin
•
dizziness or light-headedness
•
back pain
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

Ciri produk

1 of 16
AUSTRALIAN PRODUCT INFORMATION
IRESSA
® (GEFITINIB)
1
NAME OF THE MEDICINE
Gefitinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Gefitinib is a white powder and a free base. It has pKas of 5.4 and
7.2 and therefore ionises
progressively in solution as the pH falls. Gefitinib can be defined as
sparingly soluble at pH 1, but
is practically insoluble above pH 7, with the solubility dropping
sharply between pH 4 and 6.
Gefitinib is achiral.
Excipients with known effect: Each tablet contains lactose
monohydrate. For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets (tablet).
The tablets are brown, round, biconvex, impressed with “IRESSA
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 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.
DOSAGE ADJUSTMENT
No dosage adjustment is required on the basis of patient age, body
weight, gender, e