Imatinib Teva B.V.

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

imatinib mesilate

Tilgængelig fra:

Teva B.V.

ATC-kode:

L01XE01

INN (International Name):

imatinib

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Terapeutiske indikationer:

Imatinib Teva B.V. 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 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 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 B.V. is indicated for: , The 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. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

Autorisation status:

Withdrawn

Autorisation dato:

2017-11-15

Indlægsseddel

78
B. PACKAGE LEAFLET
Medicinal product no longer authorised
79
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB TEVA B.V. 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 B.V.
is and what it is used for
2. What you need to know before you take Imatinib Teva B.V.
3. How to take Imatinib Teva B.V.
4. Possible side effects
5. How to store Imatinib Teva B.V.
6. Contents of the pack and other information
1.
WHAT IMATINIB TEVA B.V. IS AND WHAT IT IS USED FOR
Imatinib Teva B.V.
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 B.V. IS A TREATMENT 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 Teva B.V. is intended for use in the most
advanced phase of the disease (blast
crisis). In children and adolescents, Imatinib Teva B.V. can be used
in different phases of the disease
(chronic, accelerated phase and blast crisis).
IMATINIB TEVA IS ALSO A TREATMENT FOR ADULTS AND CHILDREN FOR:
-
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL)
. Leukaemia
is a cancer of white blood cells. These white cell

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Teva B.V. 100 mg film-coated tablets
Imatinib Teva B.V. 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Teva B.V. 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Imatinib Teva B.V. 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 B.V. 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 B.V. 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 B.V. 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 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 Ph+ ALL as monotherapy.
•
Adult patients with myelodysplastic/myeloproliferative di