Imatinib Koanaa 100mg, film-coated Tablet

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

IMATINIB

Dostupné s:

Koanaa Healthcare Limited 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, HA85AW, Middlesex, United Kingdom

ATC kód:

L01XE01

INN (Mezinárodní Name):

IMATINIB 100 mg

Léková forma:

FILM-COATED TABLET

Složení:

IMATINIB 100 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Stav Autorizace:

Withdrawn

Datum autorizace:

2016-10-11

Informace pro uživatele

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB KOANAA 100 MG FILM-COATED TABLETS
IMATINIB KOANAA 400 MG 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 or 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 Koanaa is and what it is used for
2.
What you need to know before you take Imatinib Koanaa
3.
How to take Imatinib Koanaa
4.
Possible side effects
5.
How to store Imatinib Koanaa
6.
Contents of the pack and other information
1.
WHAT IMATINIB KOANAA
IS AND WHAT IT IS USED FOR
Imatinib Koanaa 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 KOANAA
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 Koanaa is used to treat a late stage of
chronic myeloid leukaemia
called “blast crisis.” In children and adolescents however it may
be used to treat all stages of
the illness.
IMATINIB KOANAA IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
−
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 o

Charakteristika produktu

Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Koanaa 100 mg film-coated tablets
Imatinib Koanaa 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of Imatinib (as mesilate)
Each film-coated tablet contains 400 mg of Imatinib (as mesilate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet:
100mg: Dark yellow to brownish orange colored, film-coated tablets,
round (7.00 mm), biconvex
with bevelled edges debossed with ’S’ and ‘1’ on either side
of break line on one side and plain on
other side. The tablet can be divided into equal doses.
400mg: Dark yellow to brownish orange colored, film-coated tablets,
capsule shaped (8.5 mm x
16.00 mm), biconvex with bevelled edges debossed with ’S’ and
‘2’ on either side of break line on
one side and plain on other side. The tablet can be divided into equal
doses.
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 bon