REDISTRA (IMATINIB TABLETS 400MG)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

10 Tablets; 30 Tablets

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Page 1
REDISTRA (IMATINIB TABLETS 100MG)
REDISTRA (IMATINIB TABLETS 400MG)
_IMATINIB _(100MG AND 400MG)
WHAT IS IN THIS LEAFLET
1.
What Redistra is used for
2.
How Redistra works
3.
Before you use Redistra
4.
How to use Redistra
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Redistra
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT REDISTRA IS USED FOR
Redistra is a medicine containing an
active substance called imatinib.
Redistra is used in the treatment for
adult and children for:
•
Chronic myeloid leukaemia (CML).
Leukaemia is a cancer of white blood
cells. These white cells usually help
the body to fight infection. Chronic
myeloid leukaemia is a form of
leukaemia in which certain abnormal
white cells (named myeloid cells)
start growing out of control.
•
Philadelphia chromosome positive
acute lymphoblastic leukaemia (Ph-
positive ALL). Leukaemia is a cancer
of white blood cells. These white cells
usually help the body to fight
infection. Acute lymphoblastic
leukaemia is a form of leukaemia in
which certain abnormal white cells
(named lymphoblasts) start growing
out of control. Redistra inhibits the
growth of these cells
Redistra is also used in the treatment
for adult for:
•
Myelodysplastic/myeloproliferative
diseases (MDS/MPD). These are a
group of blood diseases in which
some blood cells start growing out of
control. Redistra inhibits the growth
of these cells in a certain subtype of
these diseases
•
Hypereosinophilic syndrome
(HES) and/or chronic eosinophilic
leukaemia (CEL). These are blood
diseases in which some blood cells
(named eosinophils) start growing
out of control. Redistra inhibits the
growth of these cells in a certain
subtype of these diseases.
•
Gastrointestinal stromal tumours
(GIST). GIST is a cancer of the
stomach and bowels. It arises from
uncontrolled cell growth of the
supporting tissues of these organs.
•
Dermatofibrosarcoma protuberans
(

Ciri produk

1
For the use of an oncologist or a hospital or a laboratory only
PRESCRIBING INFORMATION
REDISTRA (IMATINIB TABLETS 100MG)
REDISTRA (IMATINIB TABLETS 400MG)
COMPOSITION
_REDISTRA (Imatinib Tablets 100 mg) _
Each film coated tablet contains:
Imatinib Mesylate Ph.Eur. equivalent to Imatinib 100 mg
Colours: Titanium Dioxide, Iron Oxide Yellow, Iron Oxide Red
_REDISTRA (Imatinib Tablets 400 mg) _
Each film coated tablet contains:
Imatinib Mesylate Ph.Eur. equivalent to Imatinib 400 mg
Colours: Titanium Dioxide, Iron Oxide Yellow, Iron Oxide Red
PRODUCT DESCRIPTION:
_REDISTRA (Imatinib Tablets 100 mg) _
Yellow to brownish orange, round film coated tablets debossed with
“1” on one side and score line on the other
side.
_REDISTRA (Imatinib Tablets 400 mg) _
Yellow to brownish orange, ovaloid film coated tablets debossed with
“4” on one side and score line on the
other side.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS:
• Redistra is indicated for the treatment of adult and pediatric
patients with newly diagnosed chronic myeloid
leukemia (CML) as well as for the treatment of adult and pediatric
patients with CML in blast crisis, accelerated
phase, or in chronic phase after failure of interferon-alpha therapy.
2
• adult patients with unresectable and/or metastatic malignant
gastrointestinal stromal tumours (GIST).
• adjuvant treatment of adult patients following resection of GIST.
Patients who have a low or very low risk of
recurrence should not receive adjuvant treatment.
• adult and pediatric patients with newly diagnosed Philadelphia
chromosome positive acute lymphoblastic
leukemia (Ph+ ALL) integrated with chemotherapy.
• adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with platelet-derived
growth factor receptor (PDGFR) gene re-arrangements.
• adult patients with hypereosinophilic syndrome (HES) and/or
chronic eosinophilic leukemia (CEL) with
F1P1L1-PDGFRα rearrangement.
• adult patien