Imatinib Koanaa

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

imatinib mesilate

Tilgjengelig fra:

Koanaa Healthcare GmbH

ATC-kode:

L01EA01

INN (International Name):

imatinib

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

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

Indikasjoner:

Imatinib Koanaa 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 Koanaa 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.

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2021-09-22

Informasjon til brukeren

41
B. PACKAGE LEAFLET
Medicinal product no longer authorised
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB KOANAA 80 MG/ML ORAL SOLUTION
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 Koanaa is and what it is used for
2.
What you need to know before you take Imatinib Koanaa
3.
How to take Imatinib Koanaa
4.
Possible side effects
5.
How to store Imatinib Koanaa
6.
Contents of the pack and other information
1.
WHAT IMATINIB KOANAA IS AND WHAT IT IS USED FOR
Imatinib Koanaa 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 KOANAA
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 inhibits the growth of
these cells.
IMATINIB KOANAA
IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASE

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Koanaa 80 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains imatinib mesilate equivalent to 80 mg
imatinib.
Excipients with known effect
One mL of solution contains 0.2 mg of sodium benzoate (E211) and 100
mg of liquid maltitol (E965).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Oral solution.
Clear yellow to brownish yellow coloured solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Koanaa 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 Koanaa 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 tre