Imatinib - 1 A Pharma Tablet, film coated 400mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB MESILATE

Available from:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC code:

L01XE01

INN (International Name):

IMATINIB MESILATE 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IMATINIB MESILATE 400 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2018-01-26

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB – 1 A PHARMA, 100 MG, FILM-COATED TABLETS
IMATINIB – 1 A PHARMA, 400MG, 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 – 1 A Pharma is and what it is used for
2. What you need to know before you take Imatinib – 1 A Pharma
3. How to take Imatinib – 1 A Pharma
4. Possible side effects
5. How to store Imatinib – 1 A Pharma
6. Contents of the pack and other information
1. WHAT IMATINIB – 1 A PHARMA IS AND WHAT IT IS USED FOR
Imatinib – 1 A Pharma 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 – 1 A PHARMA 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 – 1 A Pharma
inhibits the growth of the

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib – 1 A Pharma, 100 mg, film-coated tablets
_ _
Imatinib – 1 A Pharma, 400mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg imatinib (as mesilate).
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
Very dark yellow to brownish orange, round, biconvex film-coated
tablet with bevelled edges,
debossed with “NVR” on one side and “SA” and score between the
letters on the other side.
Approximate diameter 9.2 mm.
Very dark yellow to brownish orange, ovaloid, biconvex film-coated
tablet with bevelled edges,
debossed with “400” on one side and score on the other side and SL
on each side of the score.
Approximate length 19.2 mm and width 7.7 mm.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib – 1 A Pharma 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)