Imatinib Krka d.d. 400 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Imatinib mesilate

Disponible depuis:

KRKA, d.d., Novo mesto

Code ATC:

L01XE; L01XE01

DCI (Dénomination commune internationale):

Imatinib mesilate

Dosage:

400 milligram(s)

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

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

Domaine thérapeutique:

Protein kinase inhibitors; imatinib

Statut de autorisation:

Marketed

Date de l'autorisation:

2016-01-15

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB KRKA D.D. 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 doctorpharmacist 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 Krka d.d. is and what it is used for
2.
What you need to know before you take Imatinib Krka d.d.
3.
How to take Imatinib Krka d.d.
4.
Possible side effects
5.
How to store Imatinib Krka d.d.
6.
Contents of the pack and other information
1.
WHAT IMATINIB KRKA D.D. IS AND WHAT IT IS USED FOR
Imatinib Krka d.d. 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 KRKA D.D. 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 Krka d.d.
inhibits the
growth of these cells.
IMATINIB KRKA D.D. IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a

Résumé des caractéristiques du produit

Health Products Regulatory Authority
05 October 2022
CRN00D38C
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Krka d.d. 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg imatinib (as mesilate).
Excipient with known effect:
Each film-coated tablet contains 456 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Orange brown, oval (dimensions: 22 mm x 9 mm), biconvex film-coated
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Krka d.d. 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 Imatinib Krka d.d. on the outcome of bone marrow
transplantation has not been determined.
Imatinib Krka d.d. 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
(CD117)-positive GIST. Patients who have a low or very low risk of
recu