Imatinib AqVida Capsules Hard 100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB

Available from:

AqVida GmbH

ATC code:

L01XE01

INN (International Name):

IMATINIB

Pharmaceutical form:

HARD CAPSULE

Composition:

IMATINIB 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB AQVIDA 100 MG HARD CAPSULES
Imatinib
This medicine 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imatinib AqVida is and what it is used for
2.
What you need to know before you take Imatinib AqVida
3.
How to take Imatinib AqVida
4.
Possible side effects
5.
How to store Imatinib AqVida
6.
Contents of the pack and other information
1.
WHAT IMATINIB AQVIDA IS AND WHAT IT IS USED FOR
Imatinib AqVida 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 AQVIDA IS A TREATMENT 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 AqVida is intended for use in the most
advanced phase of the disease
(blast crisis). In children and adolescents, Imatinib AqVida can be
used in different phases of the
disease (chronic, accelerated phase and blast crisis).
IMATINIB AQVIDA IS ALSO A TREATMENT FOR ADULTS FOR:
•
PHILADELPHIA CHROMOSOME POSIT

Summary of Product characteristics

Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
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
Imatinib AqVida 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of imatinib (as mesilate).
Excipient(s) with known effect:
Each hard capsule contains 12.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Size “1” hard capsules with yellow body and cap.
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 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.
Page 2 of 27
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 surger