Nibix 400mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Imatinib mesilate

Prieinama:

Rivopharm (UK) Ltd

ATC kodas:

L01EA01

INN (Tarptautinis Pavadinimas):

Imatinib mesilate

Dozė:

400mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 08010500; GTIN: 5060388650551

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIBIX, 400 MG, CAPSULE, HARD
_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.
WHAT IS IN THIS LEAFLET
1.
What Nibix is and what it is used for
2.
What you need to know before you take Nibix
3.
How to take Nibix
4.
Possible side effects
5.
How to store Nibix
6.
Contents of the pack and other information
1.
WHAT NIBIX IS AND WHAT IT IS USED FOR
Nibix 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.
NIBIX 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, Nibix is used to treat a late stage of chronic
myeloid leukaemia called “blast crisis”. In
children and adolescents 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. Nibix inhibits the growth
of these cells.
NIBIX IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLAS

Prekės savybės

OBJECT 1
NIBIX, 400 MG, CAPSULE, HARD
Summary of Product Characteristics Updated 30-Jan-2017 | Rivopharm UK
Ltd
1. Name of the medicinal product
Nibix, 400 mg, capsule, hard
2. Qualitative and quantitative composition
Each capsule contains 400 mg of imatinib (as mesilate).
Excipients:
Each capsule contains 50.072 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Caramel body and cap, capsules of size “00”.
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 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 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-free survival in CML, on
haematological and cytogenetic
response rates in Ph+ ALL, MDS/M