Imatinib medac

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

imatinib

Available from:

Medac

ATC code:

L01XE01

INN (International Name):

imatinib

Therapeutic group:

Protein kinase inhibitors

Therapeutic area:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome

Therapeutic indications:

Imatinib medac 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;paediatric patients with Ph+CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase;adult and paediatric 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 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;adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.The effect of imatinib on the outcome of bone marrow transplantation has not been determined.In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Product summary:

Revision: 5

Authorization status:

Withdrawn

Authorization date:

2013-09-25

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB MEDAC 100 MG HARD CAPSULES
IMATINIB MEDAC 400 MG HARD CAPSULES
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.
•
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 medac is and what it is used for
2.
What you need to know before you take Imatinib medac
3.
How to take Imatinib medac
4.
Possible side effects
5.
How to store Imatinib medac
6.
Contents of the pack and other information
1.
WHAT IMATINIB MEDAC IS AND WHAT IT IS USED FOR
Imatinib medac 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 MEDAC IS A TREATMENT FOR ADULTS AND CHILDREN AND ADOLESCENTS
FOR:
•
CHRONIC MYELOID LEUKAEMIA (CML) IN BLAST CRISIS. 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. Imatinib medac inhibits the growth of these cells.
Blast crisis is the most
advanced stage of this disease.
•
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.
Imati

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib medac 100 mg hard capsules
Imatinib medac 400 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib medac 100 mg hard capsules
Each hard capsule contains 100 mg of imatinib (as mesilate).
Imatinib medac 400 mg hard capsules
Each hard capsule contains 400 mg of imatinib (as mesilate).
Excipient(s) with known effect:
Imatinib medac 100 mg hard capsules
Each hard capsule contains 12.518 mg lactose monohydrate.
Imatinib medac 400 mg hard capsules
Each hard capsule contains 50.072 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Imatinib medac 100 mg hard capsules
Size “3” hard capsules with orange body and cap.
Imatinib medac 400 mg hard capsules
Size “00” hard capsules with caramel body and cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib medac 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.
•
paediatric patients with Ph+ CML in chronic phase after failure of
interferon-alpha therapy, or in
accelerated phase.
•
adult and paediatric 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 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.
•
adult patients with unresectable dermatofibrosarcoma protuberans
(DFSP) and adult patients
with recurrent and/or metastatic DFSP w