Imatinib Koanaa 100 mg Film-coated Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Imatinib mesylate

Saadav alates:

Koanaa Healthcare Limited

ATC kood:

L01XE; L01XE01

INN (Rahvusvaheline Nimetus):

Imatinib mesylate

Annus:

100 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Protein kinase inhibitors; imatinib

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2017-08-04

Infovoldik

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
film-coated tablets is and what it is used for
2.
What you need to know before you take Imatinib Koanaa film-coated
tablets
3.
How to take Imatinib Koanaa film-coated tablets
4.
Possible side effects
5.
How to store Imatinib Koanaa film-coated tablets
6.
Contents of the pack and other information
1.
WHAT IMATINIB KOANAA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Imatinib Koanaa film-coated tablets 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 FILM-COATED TABLETS 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 film-coated tablets 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 FILM-COATED TABLETS IS A TREATMENT FOR ADULTS AND
CHILDREN FOR:
−
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLA

Toote omadused

Health Products Regulatory Authority
30 November 2020
CRN00C245
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Koanaa 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of Imatinib (as mesilate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet:
Dark yellow to brownish orange coloured, 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.
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 Kit (CD 117) positive
unresectable and/or metastatic malignant gastrointestinal
stromal tumours (GIST).

the adjuvant treatment of adult patients who are at significant risk
of relapse following resection of Kit