Nibix 100 mg hard capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB MESILATE

Available from:

Aspen Healthcare Malta Limited 89, Level 0 Triq is-Siggiewi Siggiewi, SGW 2021, , Malta

ATC code:

L01XE

INN (International Name):

IMATINIB MESILATE 100 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

IMATINIB MESILATE 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-12-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIBIX 100 MG HARD CAPSULE
Imatinib
▼
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. You can help by reporting any side effects you
may get. See the end of section
4 for how to report side effects.
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 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.
-
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

Summary of Product characteristics

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▼
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Nibix 100 mg hard capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of imatinib (as mesilate).
Excipient with known effect: Each capsule contains 12.518 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Orange body and cap, capsules of size “3”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nibix 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.
The effect of Nibix on the outcome of bone marrow transplantation has
not been determined.
Nibix is indicated for
-
the treatment of adult
patients with Kit (CD
117) positive unresectable and/or metastatic
malignant gastrointestinal stromal tumours (GIST).
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-
the adjuvant treatment of adult patients who are at significant risk
of relapse following resection
of Kit (CD117)-positive GIST. Patien