Imatinib 400mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Imatinib mesilate

Tilgængelig fra:

Milpharm Ltd

ATC-kode:

L01XE01

INN (International Name):

Imatinib mesilate

Dosering:

400mg

Lægemiddelform:

Tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 08010500

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB 100 MG FILM-COATED TABLETS
IMATINIB 400 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 is and what it is used for
2.
What you need to know before you take Imatinib
3.
How to take Imatinib
4.
Possible side effects
5.
How to store Imatinib
6.
Contents of the pack and other information 1. WHAT IMATINIB IS AND WHAT IT IS USED FOR
Imatinib 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 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.
In adult patients imatinib is used to treat a late stage
of Chronic Myeloid Leukaemia called “blast crisis.” In
children and adolescents however it may be used to
treat all stages of the illness.
-
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 gr

Produktets egenskaber

OBJECT 1
IMATINIB MILPHARM 400 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 09-Feb-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Imatinib Milpharm 400 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
400 mg
Brownish, oval, biconvex (approx. 5.7 mm x 17.3 mm), 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
• 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.
• Adult and paediatric 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 is indicated for
• 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-fre