
× ×ª×× × ×ª×¨×פ×
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| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
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L01FX Other monoclonal antibodies and antibody drug conjugates
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| ×ר××× ×¤×¢×× (ATC5)
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Â
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| צ×רת ×ת×
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ת××-×ר××× - I.V
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| צ×רת ××× ××
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×××§× ×××× ×ª ת×××¡× ×ר×××ת ××¢×ר××, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
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| ×ת××××
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⢠BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B- precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.⢠BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.⢠BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.⢠BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B precursor ALL as part of the consolidation therapy.Limitations of use: After failure of two previous treatments and with no CNS involvement.
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| × ×ª×× × ×ס×
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ת×ר×× ××××× ×ס×
- 21/01/2016
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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
|
| ××× ×תרפ×× ×××××ר×× ×¢× Philadelphia chromosome-negative CD19+ B cell precursor acute lymphoblastic leukemia (ALL) ××פ××× ×¨×ש×× × ×× ×©× ×× ×¢× ×××× ×©×ר×ת ××× ××××ת (MRD â minimal residual disease) ××¢×¨× ×©× 0.1% ×××¢××
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30/01/2020 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ××××× ×××ר×× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia (ALL)) ×¢×××× ×× ×××רת (Relapsed / Refractory). ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×תר××¤× ××ת ×××× ××תר×פ×ת ××פ×ר××ת ×××× - Blinatumomab, Inotuzumab ozogamicin, ×××¢× ××××× ×שר ×× ×ש×× ×ª×××× ××× ××××ת ×××ר × ×ס××× ××פ××× ×©× ××××ר ××פ×× ××× ×××ת ××תר×פ×ת ××××ר×ת. |
30/01/2020 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ××××× ×× × ×©× × ×××¢×× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-negative CD19+ B cell precursor acute lymphoblastic leukemia (ALL) ×¢×××× ×× ×××רת (Relapsed / Refractory). |
16/01/2019 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ×תר××¤× ×ª×× ×ª× ×××פ×× ×××××× ×××ר×× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia (ALL)) ×¢×××× ×× ×××רת (Relapsed / Refractory). |
12/01/2017 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ×תר××¤× ×ª×× ×ª× ×××פ×× ×××××× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia (ALL) ×××××× ×××ר××, ××× ×תק××××× ×× ××ª× ××× ×××××: ×. ××××× ×××× ××רת ×××× ××××× ××©× × ×ר×ש×× × ×©×××ר ××פ×× ×××××ª×¨×¤× ××שת×ת ×× ×¢×¦× (first relapse) (×¢× ×©× × ××שת×ת ×× ×עצ×). ×. ××××× ×××¢×× ××שת×ת ×× ×¢×¦× ××××× ××ת (×שת×× ×©× ××). ×. ×××× ×©× ××××× × ×¡×¤×¨ ×ספר ××ס××× ×× ××× ×-50%. ×. ××ª× ×תר××¤× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×× ×¨××¤× ××××× ××××××××××. |
21/01/2016 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ××××ר ×××× ××××§ ×××פ×× ×§×× ×¡××××צ××, ×××××× ×××× ×××§××× ×ס×× Philadelphia chromosome negative CD19 positive B-precursor ALL ×ס×××× ××××, ×××רת ×××× ×¨×ש×× ×. ××¢× ××× ×× ×××©× ×ת ×ס×××× ×××× ×ª×××ר ××××©× ×ת ××תר×שת ×ת×× ×¤××ת ×-6 ×××ש×× ×ס××× ×××פ×× ×ר×ש×× ×. |
03/02/2022 |
××× ×§×××××× |
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Acute lymphoblastic leukemia, ALL |
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| ×××× ×תרפ××, ×××××× ×××ר×× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-positive CD19 positive B cell precursor acute lymphoblastic leukemia (ALL)) × ×©× ×ת ×× ×¢×××× (Relapsed / Refractory), ש×××¦× ××פ×× ××פ××ת ×©× × ××¢××× tyrosine kinase ×ש×× ×§×××ת ×¢×××¨× ×פשר×ת ××פ×××ת ××רת. ××©× ×××פ×× ××ת×××× ×× ×× ××¢×× ×¢× ××××©× ×××××¨× ××פ××. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×תר××¤× ××ת ×××× ××תר×פ×ת ××פ×ר××ת ×××× - Blinatumomab, Inotuzumab ozogamicin, ×××¢× ××××× ×שר ×× ×ש×× ×ª×××× ××× ××××ת ×××ר × ×ס××× ××פ××× ×©× ××××ר ××פ×× ××× ×××ת ××תר×פ×ת ××××ר×ת.
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19/02/2025 |
××××××××× |
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Acute lymphoblastic leukemia, ALL |
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ש×××ש ×ס×
-
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×ס×רת ××××× ×ס×
- ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ×××:
- ××××× ×××ר×× ××××§×× ××××§××× ×ס×× B cell Philadelphia chromosome-negative precursor acute lymphoblastic leukemia (ALL) (×¢×××× ×× ×××רת) Relapsed/Refractory.
××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×תר××¤× ××ת ×××× ××תר×פ×ת ××פ×ר××ת ×××× - Blinatumomab, Inotuzumab ozogamicin. ×××¢× ××××× ×שר ×× ×ש×× ×ª×××× ××× ××××ת ×××ר × ×ס××× ××פ××× ×©× ××××ר ××פ×× ××× ×××ת ××תר×פ×ת ××××ר×ת
- ×××× ×תרפ××, ×××××× ×××ר×× ××××§×× ××××§××× ×ס×× - Philadelphia chromosome positive CD19 positive B cell precursor acute lymphoblastic leukemia (ALL) × ×©× ×ת ×× ×¢×××× (Relapsed / Refractory), ש×××¦× ××פ×× ××פ××ת ×©× × ××¢××× tyrosine kinase ×ש×× ×§×××ת ×¢×××¨× ×פשר×ת ××פ×××ת ××רת.
××©× ×××פ×× ××ת×××× ×× ×× ××¢×× ×¢× ××××©× ×××××¨× ××פ××. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×תר××¤× ××ת ×××× ××תר×פ×ת ××פ×ר××ת ×××× - Blinatumomab, Inotuzumab ozogamicin. ×××¢× ××××× ×שר ×× ×ש×× ×ª×××× ××× ××××ת ×××ר × ×ס××× ××פ××× ×©× ××××ר ××פ×× ××× ×××ת ××תר×פ×ת ××××ר×ת
- ××××× ×× × ×©× × ×××¢×× ××××§×× ××××§××× ×ס×× Philadelphia chromosome-negative CD19+ B cell precursor acute lymphoblastic leukemia (ALL) ×¢×××× ×× ×××רת (Relapsed / Refractory).
××¢× ××× ×× ×××× ×××רת ת×××ר ××××× ×©×§××× ×©× × ×§××× ××פ×× ×§××××× ×× ×©×¢×ר ×שת×× ××××× ××ת ×©× ×ª×× ×××¢ ××××פ××××××. ×××פ×× ×× ××× ×ª× ×××פ×× ××××§×
- ×××× ×תרפ×× ×××××ר×× ×¢× Philadelphia chromosome-negative CD19+ B cell precursor acute lymphoblastic leukemia (ALL) ××פ××× ×¨×ש×× × ×× ×©× ××× ×¢× ×××× ×©×ר×ת ××× ××××ת (MRD - minimal residual disease) ××¢×¨× ×©× 0.1 ×××××× ×××¢××
- ××××ר ×××× ××××§ ×××פ×× ×§×× ×¡××××צ××, ×××××× ×××× ×××§××× ×ס×× Philadelphia chromosome negative CD19 positive B-precursor ALL ×ס×××× ××××, ×××רת ×××× ×¨×ש×× ×.
××¢× ××× ×× ×××©× ×ת ×ס×××× ×××× ×ª×××ר ××××©× ×ת ××תר×שת ×ת×× ×¤××ת ×-6 ×××ש×× ×ס××× ×××פ×× ×ר×ש×× ×
- ××ª× ×תר××¤× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×× ×¨××¤× ××××× ××××××××××
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| ×ת××ת ××× ××
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Posology and method of administration
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| ×ת××××ת × ××
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Contraindications
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| ת×פע×ת ×××××
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Undesirable effects
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| ת××××ת ××× ×ª×¨×פת××ת
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Interaction with other medicinal products and other forms of interaction
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| ש×××ש ×××ר××× ××× ×§×
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Pregnancy and Lactation
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| פר××§×××× ×××§×
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Pharmacodynamic Properties
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| פר××§××§×× ×××§×
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Pharmacokinetic Properties
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| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
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Â
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ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 14/06/2025
AMGEN
×××× ×¡×××× - Blincyto
true
השינוי האחרון נעשה בֹ־14 ביוני 2025 ב־12:12