Imatinib Actavis

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

imatinib

Saatavilla:

Actavis Group PTC ehf

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

imatinib

Terapeuttinen ryhmä:

Protein kinase inhibitors, Antineoplastic agents

Terapeuttinen alue:

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

Käyttöaiheet:

Imatinib Actavis 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 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-PDGFR rearrangement;, 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. , The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Actavis is indicated for: , 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. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2013-04-17

Pakkausseloste

75
B. PACKAGE LEAFLET
Medicinal product no longer authorised
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB ACTAVIS 50 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 Actavis is and what it is used for
2.
What you need to know before you take Imatinib Actavis
3.
How to take Imatinib Actavis
4.
Possible side effects
5.
How to store Imatinib Actavis
6.
Contents of the pack and other information
1.
WHAT IMATINIB ACTAVIS IS AND WHAT IT IS USED FOR
Imatinib Actavis 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 ACTAVIS 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 Actavis is intended for use in the most
advanced phase of the disease (blast
crisis). In children and adolescents, Imatinib Actavis can be used in
different phases of the disease
(chronic, accelerated phase and blast crisis).
-
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 leukaem

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Actavis 50 mg hard capsules
Imatinib Actavis 100 mg hard capsules
Imatinib Actavis 400 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Actavis 50 mg hard capsules
Each hard capsule contains 50 mg imatinib (as mesilate).
Imatinib Actavis 100 mg hard capsules
Each hard capsule contains 100 mg imatinib (as mesilate).
Imatinib Actavis 400 mg hard capsules
Each hard capsule contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Imatinib Actavis 50 mg hard capsules
Hard capsule of size 3 with light yellow cap and light yellow body
imprinted with “50 mg” in black
ink.
Imatinib Actavis 100 mg hard capsules
Hard capsule of size 1 with light orange cap and light orange body
imprinted with “100 mg” in black
ink.
Imatinib Actavis 400 mg hard capsules
Hard capsule of size 00 with orange opaque colour cap and body
imprinted with “400 mg” in black
ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Actavis 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