Imatinib Boston Biopharma 100mg Hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB MESILATE

Available from:

Boston Biopharma Limited Malta Life Sciences Park, Building 2, Level 0, San Gwann SGN 3000, Malta

ATC code:

L01XE01

INN (International Name):

IMATINIB MESILATE 100 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

IMATINIB MESILATE 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2016-02-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB BOSTON BIOPHARMA 100 MG HARD CAPSULES
Imatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
-
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 Boston Biopharma is and what it is used for
2.
What you need to know before you take Imatinib Boston Biopharma
3.
How to take Imatinib Boston Biopharma
4.
Possible side effects
5.
How to store Imatinib Boston Biopharma
6.
Contents of the pack and other information
1.
WHAT IMATINIB BOSTON BIOPHARMA IS AND WHAT IT IS USED FOR
Imatinib Boston Biopharma 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 BOSTON BIOPHARMA 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.
•
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 leukaemi

Summary of Product characteristics

Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Boston Biopharma 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of imatinib (as mesilate).
Excipient(s) with known effect:
Each hard capsule contains 12.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
White to slightly yellow powder in a size “1” hard capsule with
yellow body and cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib is indicated for the treatment of
•
adult and 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.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or 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 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 advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic
leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
Imatinib is indicated for
•
the treatment of adult patients with unresectable dermatofibrosarcoma
protuberans (DFSP) and
adult patients with recurrent and/or metastatic DFSP who are not
eligible fo