Imatinib 400mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Imatinib mesilate

Доступно од:

Wockhardt UK Ltd

АТЦ код:

L01XE01

INN (Међународно име):

Imatinib mesilate

Дозирање:

400mg

Фармацеутски облик:

Tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 08010500; GTIN: 5012727912721 5012727913018

Информативни летак

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
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 ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DI

Карактеристике производа

OBJECT 1
IMATINIB 400MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 22-Aug-2017 | Wockhardt UK
Ltd
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
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.
• 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 ob