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PACKAGE LEAFLET: INFORMATION FOR THE USER
Imatinib Siegfried 400 mg film-coated tablets
Imatinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions,
ask your doctor, pharmacist or nurse.
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This medicine has been prescribed for you only. Do
not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk
to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Imatinib Siegfried is and what it is used for
2.
What you need to know before you take Imatinib Siegfried
3.
How to take Imatinib Siegfried
4.
Possible side effects
5.
How to store Imatinib Siegfried
6.
Contents of the pack and other information
1.
WHAT IMATINIB SIEGFRIED IS AND WHAT IT IS USED FOR
Imatinib Siegfried is a medicine
containing an active substance called imatinib. This medicine
works by inhibiting the growth of abnormal cells in
the diseases listed below. These include
some types of cancer.
IMATINIB SIEGFRIED IS A TREATMENT FOR
ADULTS 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.
In adult patients Imatinib Siegfried is used to treat
a late stage of Chronic Myeloid
Leukaemia
called “blast crisis.” In children and adolescents however it may b
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製品の特徴
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Siegfried 100 mg film-coated tablets
Imatinib Siegfried 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Siegfried 100 mg film-coated tablets:
Each film-coated
tablet contains 100 mg imatinib (as mesilate).
Imatinib Siegfried 400 mg film-coated tablets:
Each film-coated
tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Imatinib Siegfried
100 mg film-coated tablets are round tablets with light brown film
coating
and a diameter of 8 mm, score on one side, debossed with
“IM” on the same side and with
“100” on the other side.
Imatinib Siegfried 400 mg film-coated tablets are oval
tablets with light brown film coating,
17 mm long and 8 mm wide, score on both sides, debossed with
“IM” on one side and with
“400” on the other side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Siegfried is indicated for the treatment of
paediatric patients with newly diagnosed
Philadelphia chromosome (bcr-abl) positive
(Ph+) chronic myeloid
leukaemia (CML) for whom bone marrow transplantation is
not considered as the first line of treatment.
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paediatric patients with Ph+ CML in chronic phase
after failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
adult patients with Ph+ CML in blast crisis.
adult and paediatric patients with newly diagnosed
Philadelphia chromosome positive
acute lymphoblastic leukaemia (Ph+
ALL) integrated with chemotherapy.
adult patients with relapsed
or refractory P
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