Imatinib 400mg Film-Coated Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Imatinib

זמין מ:

Wockhardt UK Limited

קוד ATC:

L01X

INN (שם בינלאומי):

Imatinib

כמות:

400 milligram(s)

טופס פרצבטיות:

Film-coated tablet

מסלול נתינה (של תרופות):

oral use

יחידות באריזה:

10, 30 and 90 film-coated tablets.

סוג מרשם:

Product subject to prescription which may not be renewed (A)

תוצרת:

CP Pharmaceuticals Ltd

קבוצה תרפויטית:

protein-tyrosine kinase inhibitor

איזור תרפויטי:

OTHER ANTINEOPLASTIC AGENTS

סממני תרפויטית:

Imatinib 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. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) an

מצב אישור:

Not marketed

תאריך אישור:

2015-09-25

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB 100MG FILM-COATED TABLETS
IMATINIB 400MG FILM-COATED TABLETS
Imatinib
(referred to as Imatinib Tablets in the remainder of this leaflet)
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 Tablets are and what they are used for
2.
What you need to know before you take Imatinib Tablets
3.
How to take Imatinib Tablets
4.
Possible side effects
5.
How to store Imatinib Tablets
6.
Contents of the pack and other information
1.
WHAT IMATINIB TABLETS ARE AND WHAT THEY ARE USED FOR
Imatinib Tablets 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 TABLETS 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 Tablets inhibits the growth of these cells.
IMATINIB TABLETS IS ALSO A TREATMENT FOR A

מאפייני מוצר

Health Products Regulatory Authority
08 January 2020
CRN0095LK
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib 400mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Brownish, oval, biconvex, film-coated tablets embossed with 400 on one
side and NI on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib 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 lymophoblastic
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 rearrangment.

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