GLIVEC 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IMATINIB AS MESYLATE

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L01XX28

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

IMATINIB AS MESYLATE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS PHARMA PRODUKTIONS GMBH

المجموعة العلاجية:

IMATINIB

المجال العلاجي:

IMATINIB

الخصائص العلاجية:

Glivec is indicated for the treatment of adult patients and children 3 years of age and above with Ph+ chronic myeloid leukaemia (Ph+ -CML) in chronic phase accelerated phase or blast crisis. Glivec is also indicated for the treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).Glivec is also indicated for the treament of : * Adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.* Adult patients with relapsed or refractory Ph + ALL as monotherapy.* Adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. * Adult patients with myelodyspiastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet - derived growth factor receptor ) gene re- arrangements. * Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1- PDGFRalfa fusion kinase (mutational analysis or FISH demonstration fo CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alfa fusion kinase negative. * Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation.* Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

تاريخ الترخيص:

2023-12-31

نشرة المعلومات

:يلاتلا وحنلا ىلع حافتلا ريصع وأ ءاملا
نم سأك لخاد اهتباذإ ناكملإاب ،صارقلأا
علب كرودقمب نكي مل اذإ
.غلم 400 وذ صرق لكل للم 200 وأ ،غلم 100 وذ
صرق لكل للم 50 يلاوح لمعتسإ
●
.لماك لكشب صارقلأا/صرقلا نابوذ ىتح
ةقعلم ةطساوب كيرحتلا بجي
●
راثآ ىقبت نأ زئاجلا نم .لماك لكشب سأكلا
ىوتحم ةفاك برش اروف بجي صارقلأا/صرقلا
نابوذ دنع
●
.سأكلا لخاد ةبئاذلا/بئاذلا
صارقلأا/صرقلا
.هرطش نكمي لا غلم 400 صرق ،غلم 100 كﭭﯿلﭼ
صرق رطش ناكملإاب
ربكأ ايئاود ارادقم أطخلاب تلوانت اذإ
ةفرغ ىلإ وأ بيبطلا ىلإ اروف هجوت
،ءاودلا نم أطخلاب لفط علب اذإ وأ اطرفم
ايئاود ارادقم تلوانت اذإ
.يبط فارشإ جاتحت نأ زئاجلا نم .ءاودلا
ةبلع كعم رضحأو ىفشتسملا يف ئراوطلا
ءاودلا لوانت تيسن اذإ
دعوم برتقإ اذإ ،كلذ عم .كركذت لاح
هلوانت بجيف ،صصخملا تقولا يف ءاودلا
اذه لوانت تيسن اذإ
-
.يسنملا يئاودلا رادقملا لوانتت لاف
،مداقلا يئاودلا رادقملا لوانت
.ةيدايتعلإا تاقولأا لوادج بسحب ءاودلا
لوانت ةلصاوم بجي كلذ دعب
-
.يسنملا يئاودلا رادقملا نع ضيوعتلل
افعاضم ايئاود ارادقم لوانتت لا
-
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
.ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا
نع فقوتلا زوجي لا
رعشت تنك اذإ وأ بيبطلا كل هفصو امفيك
ءاودلا لوانت كرودقمب نكي مل اذإ ،�

خصائص المنتج

GLI FCT API May23 V17
EU SmPC
March 2022
1
1.
NAME OF THE MEDICINAL PRODUCT
GLIVEC

100 mg, GLIVEC

400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLIVEC

100 mg
Each film-coated tablet contains 100 mg imatinib (as mesylate).
GLIVEC

400 mg
Each film-coated tablet contains 400 mg imatinib (as mesylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
GLIVEC

100 MG FILM-COATED TABLETS, DIVISIBLE
Very dark yellow to brownish orange , round, biconvex
,
film-coated tablet with bevelled edges. Debossed
with “NVR” on one side and “SA” (score between the letters) on
the other side.
GLIVEC

400 MG FILM-COATED TABLETS, NOT DIVISIBLE
Very dark yellow to brownish orange, ovaloid, biconvex,film-coated
tablet, with bevelled edges. De-
bossed with “NVR” on one side and “SL” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glivec® is indicated for the
•
Treatment of adult patients and children 3 years of age and above with
Ph+ chronic myeloid
leukaemia (Ph+ -CML) in chronic phase, accelerated phase or blast
crisis.
•
Treatment of adult patients with Kit (CD117) positive unresectable
and/or metastatic malignant
gastrointestinal stromal tumours (GIST).
•
Adjuvant treatment of adult patients following complete gross
resection of Kit (CD117) positive
GIST.
•
Treatment
of
adult
patients
with
newly
diagnosed
Philadelphia
chromosome
positive
acute
lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
•
Treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy.
•
Treatment of adult patients with unresectable dermatofibrosarcoma
protuberans (DFSP) and adult
patients with recurrent and/or metastatic DFSP who are not eligible
for surgery.
•
Treatment
of
adult
patients
with
myelodysplastic/myeloproliferative
diseases
(MDS/MPD)
associated with PDGFR (platelet-derived growth factor receptor) gene
re-arrangements.
•
Treatment of adult patients with hypereosinophilic syndrome (HES)
and/or chro