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×רש×× ×ר×פ××× ××× ×©× ×קצ××¢×ת רפ×××××.
× ×ª×× × ×ª×¨×פ×
××רש×

| ××× ×× ×× × ×ספ××
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L01EA BCR-ABL tyrosine kinase inhibitors
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פ××× - PER OS
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×××××ת ×צ×פ×ת פ×××, FILM COATED TABLETS ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
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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 for 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.
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ת×ר×× ××××× ×ס×
- 01/04/2004
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×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
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×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
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| ××פ×× ×ש××× ××××× ×××ר ×ס××× ×××××× ×¡×ר××××× ××××ר ×ס×× (CD117) Kit ××××× ×××ר ××¡×¨× ×× ×ת××, ××צ×× ×ס×××× ×××× ×××רת ××××× |
01/04/2004 |
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| ×××× ×××ר ×ס××× ×-(Dermatofibrosarcoma protuberans) DFSP |
01/04/2004 |
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| ×××× ×××ר ×ס××× ××ס××צ×××××ס ס×ס×××ת ××רס×××ת (ASM) |
01/04/2004 |
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| ×××× ×××ר ×ס××× ××××§××× ×××××× ×פ×××ת ×ר×× ×ת (CEL) |
01/04/2004 |
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| ×××× ×××ר ×ס××× ×תס××× ×ª ××פר×××××× ×פ×××ת (HES) |
01/04/2004 |
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| ×××× ×××ר ×ס××× ×תס××× ×ª ×××××××ספ×ס××ת (MDS) ×× ×××× ×××××פר×××פר××××ת (MPD) ×קש××¨× ×-PDGFR gene rearrangements |
01/04/2004 |
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| ×××× ×ס××× ×-ALL ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ×× |
01/04/2004 |
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| ×××× ×××ר ×ס××× ×××××××× ×¡×ר×××××× ××××ר××, ×ר×רת××× ×× ×××ª× × ××ª× ×× ××סר×, ×©× ×ער×ת ××¢×××× ×ס×× Gastrointestinal stromal tumors |
01/04/2004 |
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| ××××× ×¡××× ×-CML ×ש×× ××××ס×× (Blast crisis) ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ×× |
01/04/2004 |
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| ××××× ×¡××× ×-CML ×ש×× ××תק×× (Accelerated) |
01/04/2004 |
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| ××××× ×¡××× ×-CML ×ש×× ××ר×× × ×¢× ××××§× ××××§××ר×ת ×××××ת ×××¤×¨×¢× Bcr/Abl |
01/04/2004 |
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| ××××× ×¡××× ×-CML ×ש×× ××ר×× × ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ×× |
01/04/2004 |
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×ס×רת ××××× ×ס×
- ×. ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- ×. ××××× ×¡××× ×-CML ×ש×× ××ר×× × ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ××.
- ×. ××××× ×¡××× ×-CML ×ש×× ××ר×× × ×¢× ××××§× ××××§××ר×ת ×××××ת ×××¤×¨×¢× Bcr/Abl.
- ×. ××××× ×¡××× ×-CML ×ש×× ××תק×× (Accelerated) ×××תק××× ××× ××××:
- ×. ש××¢×ר ×××ס××× ××× ××¢×¦× ×©××× ×× ×××× ×-5% ×× × ××× ×-20%.
- ×. ש××¢×ר ×××ס××× ××פר×××××צ×××× ×××× ××× ××××§×¤× ×× ××× ××¢×¦× ×©××× ×× ×××× ×-20%.
- ×. ש××¢×ר ××××פ×××× ××× ××××§×¤× ×× ××× ××¢×¦× ×©××× ×× ×××× ×-20%.
- ×. תר××××צ××××¤× ×× (פ××ת ×-100 X 109/L) ×©× ×ר×× ×©×× ×ת×צ×× ××××פ×× ×תר×פ×.
- ×. ××פעת ×פרע×ת ×ר×××ס×××××ת × ×סף ×¢× ××ר×××ס×× ×¤××××פ××.
- ×. ××××× ×¡××× ××תק×××ת ספ×× ××××××.
- ×. ××××× ×¡××× ×-CML ×ש×× ×××ס×× (Blast crisis) ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ×× ×××תק××× ××× ××××:
- ×. ש××¢×ר ×××ס××× ××× ××××§×¤× ×× ××× ××¢×¦× ×©××× ×× ×××× ×-20%.
- ×. ××פעת ×××× ×קס×ר×-×××××ר×ת ש××× × ××××× ××§×©×¨× ××××¤× ×× ××××.
- ×. ×××× ×××ר ×ס××× ×××××××× ×¡×ר×××××× ××××ר×× ×ר×רת××× ×× ×××ª× × ××ª× ×× ×××¡×¨× ×©× ×ער×ת ××¢×××× ×ס×× Gastrointestinal stromal tumors
- ×. ×××× ×ס××× ×-ALL ×¢× ××××§× ×¦××××× ××ת ×××××ת ××ר×××ס×× ×¤××××פ××
- ×. ×××× ×××ר ×ס××× ×תס××× ×ª ×××××××ספ×ס××ת (MDS) ×× ×××× ×××××פר×××פר××××ת (MPD) ×קש××¨× ×-PDGFR gene re-arrangements
- ×. ×××× ×××ר ×ס××× ×תס××× ×ª ××פר×××××× ×פ×××ת (HES)
- ×. ×××× ×××ר ×ס××× ××××§××× ×××××× ×פ×××ת ×ר×× ×ת (CEL)
- ×. ×××× ×××ר ×ס××× ××ס××צ×××××ס ס×ס×××ת ××רס×××ת (ASM)
- ××. ×××× ×××ר ×ס××× ×-DFSP (Dermatofibrosarcoma protuberans).
- ××. ××פ×× ×ש××× ××××× ×××ר ×ס××× ×××××× ×¡×ר××××× ××××ר ×ס×× Kit (CD117) ××××× ×××ר ××¡×¨× ×× ×ת××, ××צ×× ×ס×××× ×××× ×××רת ×××××. ××©× ×××פ×× ×ת×ש×ר ×× ××¢×× ×¢× ×©××ש ×©× ××.
×××רת ס×××× ×××× â ××× ××××××:
- ×. ××××× ×©××××× ×¢××× ×¢× 3 ס"×.
- ×. High grade (××¤× ×©××××ר ×¢"× ×¤×ª××××): ××××××ת ×ר×××ת, פרפ×רצ××, ××××, ××××צר×ת ××צס, ×××××.
- ×. קר××¢× ×©× ×××××× (××¤× × ×× ××××× ×× ×ת×× ××סרת×)
- ×. ×××§××: ×תרסר××× ×× ×××¢× ×××§.
- ×. ×¢××××ת ××תפש××ת ××××× ×× ×ת×× / ×-PET CT ×××¡×¨× ×××× ×©× ×××××× ×××ר×ר×ת (ש×× IV ××× ×¢××ת ×©× ××××)
- ×. ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×¨××¤× ××××× ×××××××××× ×× ×¨××¤× ××××× ×××× ×§×××××× ××××¤× ×××× ×§×××××× ××× ×§×××××ת.
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ת×ר×× ×¢××××: 14/05/19
NOVARTIS
×××××§ - Glivec
true
השינוי האחרון נעשה בֹ־18 ביוני 2025 ב־15:29