Leutipol 100 mg, filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

מרכיב פעיל:

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

זמין מ:

Pharos Pharmaceutical Oriented Services Ltd Lesvou str. (end), Thesi Loggos Industrial Zone 14452 METAMORFOSSI ATTIKIS (GRIE

קוד ATC:

L01XE01

INN (שם בינלאומי):

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Imatinib

leaflet_short:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

תאריך אישור:

1900-01-01

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEUTIPOL 100 MG, FILMOMHULDE TABLETTEN
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 Leutipol is and what it is used for
2. What you need to know before you take Leutipol
3. How to take Leutipol
4. Possible side effects
5. How to store Leutipol
6. Contents of the pack and other information
1.
WHAT LEUTIPOL IS AND WHAT IT IS USED FOR
Leutipol 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.
LEUTIPOL 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 inhibits the growth of these cells.
LEUTIPOL IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood
diseases in which some blood cells start growing out of control

מאפייני מוצר

1. NAME OF THE MEDICINAL PRODUCT
Leutipol 100 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Dark yellow to brownish-orange, round shaped, film-coated tablets of
10.1 mm (± 5%)
diameter with a break-line on one side and ‘100’ on the other
side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib 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 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 (CD117)-positive GIST. Patients who have a low or
very low risk of
recurrence should not receive adjuvant treatment.
•
the treatment of adult patients with unresectable dermatofibrosarcoma
pr