Imatinib Aenorasis, 100 mg filmomhulde tabletten

দেশ: নেদারল্যান্ডস

ভাষা: ডাচ

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

সক্রিয় উপাদান:

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

থেকে পাওয়া:

AENORASIS S.A. 17 Trapezountos & A. Papandreou St., Melissia 151 27 ATHENS (GRIEKENLAND)

এটিসি কোড:

L01XE01

INN (আন্তর্জাতিক নাম):

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

ফার্মাসিউটিকাল ফর্ম:

Filmomhulde tablet

রচনা:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

প্রশাসন রুট:

Oraal gebruik

থেরাপিউটিক এলাকা:

Imatinib

পণ্য সারাংশ:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

অনুমোদন তারিখ:

2015-11-23

তথ্য লিফলেট

1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
IMATINIB AEORASIS, 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 Imatinib Aenorasis is and what it is used for
2. What you need to know before you take Imatinib Aenorasis
3. How to take Imatinib Aenorasis
4. Possible side effects
5. How to store Imatinib Aenorasis
6. Contents of the pack and other information
1.
WHAT IMATINIB AENORASIS IS AND WHAT IT IS USED FOR
Imatinib
Aenorasis
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 AENORASIS 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.
IMATINIB AENORASIS IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These

পণ্য বৈশিষ্ট্য

1
SAMENVATTING VAN VE PRODUCTKENMERKEN
1. NAAM VAN HET GENEESMIDDEL
Imatinib Aenorasis 100 mg filmomhulde tabletten.
Imatinib Aenorasis 400 mg filmomhulde tabletten
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.
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.
Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets,
21.6 mm long & 10.6mm
wide (± 5%) with a break-line on one side and ‘400’ 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/