Imatinib Teva

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

imatinib

Saatavilla:

Teva B.V.

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

imatinib

Terapeuttinen ryhmä:

Antineoplastic agents, Protein kinase inhibitors

Terapeuttinen alue:

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

Käyttöaiheet:

Imatinib Teva is indicated for the treatment ofAdult 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 Teva is indicated forthe treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. 

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-01-07

Pakkausseloste

86
B. PACKAGE LEAFLET
87
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB TEVA 100 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.
-
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 Teva
is and what it is used for
2.
What you need to know before you take Imatinib Teva
3.
How to take Imatinib Teva
4.
Possible side effects
5.
How to store Imatinib Teva
6.
Contents of the pack and other information
1.
WHAT IMATINIB TEVA IS AND WHAT IT IS USED FOR
Imatinib Teva
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 TEVA 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 leukaemia is a form of leukaemia in
which certain abnormal
white cells (named lymphoblasts) start growing out of control.
Imatinib Teva inhibits the
growth of these cells.
IMATINIB TEVA IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood
diseas

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Teva 100 mg film-coated tablets
Imatinib Teva 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Teva 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Imatinib Teva 400 mg film-coated tablets
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Imatinib Teva 100 mg film-coated tablets
Dark yellow to brownish orange round film-coated tablets with a score
line on one side. The tablet is
debossed with “IT” and “1” at each side of the score line. The
diameter of the film-coated tablet is
approximately 9 mm.
The tablet can be divided into equal doses.
Imatinib Teva 400 mg film-coated tablets
Dark yellow to brownish orange oblong film-coated tablets with a score
line on one side. The tablet is
debossed with “IT” and “4” at each side of the score line. The
length of the film-coated tablet is
approximately 20 mm and the width is approximately 10 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Teva 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.