
× ×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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| צ×רת ×ת×
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ת××-×ר××× - I.V
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| צ×רת ××× ××
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תר××× ×××× ×ª ת×××¡× ×××× ×¤××××, CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
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| ×ת××××
|
Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).
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| × ×ª×× × ×ס×
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ת×ר×× ××××× ×ס×
- 11/01/2018
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ××ר××ת ×ש×××ש ×תר××¤× DINUTUXIMAB BETA (Dinutuximab beta Apeiron) ×. ×תר××¤× ×ª×× ×ª× ×××פ×× ×× ××ר×××ס×××× ×ס×××× ××××, ××××× ××¢×× × ×¢× ××× ××××: 1. ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ×ש×× ×××× ××קצ×× ××ש×× ×ª×××× ×××§×ת ×××¢××, ××× ×§××× ××פ×× ×××× ×× ×¢×¦× ××¢×ר ×שת×ת ת×× ×××¢ (Stem cell transplantation). 2. ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת, ××× ×ª××ת ×ס×××ס ×××× ×©×ר×ת. ×ש×× ×××× ×× ×××× ××××× ×××× ×××פ×× ×××ת ×××× ×תר×פ×ת â Dinutuximab beta, Naxitamab. ×. ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×× ××××× ××××××××××.
|
03/02/2022 |
××× ×§×××××× |
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Neuroblastoma, × ××ר×××ס×××× |
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| ××ר××ת ×ש×××ש ×תר××¤× DINUTUXIMAB BETA (Dinutuximab beta Apeiron) ×. ×תר××¤× ×ª×× ×ª× ×××פ×× ×× ××ר×××ס×××× ×ס×××× ××××, ××××× ××¢×× × ×¢× ××× ××××: 1. ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ×ש×× ×××× ××קצ×× ××ש×× ×ª×××× ×××§×ת ×××¢××, ××× ×§××× ××פ×× ×××× ×× ×¢×¦× ××¢×ר ×שת×ת ת×× ×××¢ (Stem cell transplantation). 2. ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת, ××× ×ª××ת ×ס×××ס ×××× ×©×ר×ת. ×. ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×× ××××× ××××××××××.
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11/01/2018 |
××× ×§×××××× |
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Neuroblastoma, × ××ר×××ס×××× |
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ש×××ש ×ס×
-
|
×ס×רת ××××× ×ס×
- ××ר××ת ×ש×××ש ×תר××¤× DINUTUXIMAB BETA (Dinutuximab beta Apeiron)
- ×. ×תר××¤× ×ª×× ×ª× ×××פ×× ×× ××ר×××ס×××× ×ס×××× ××××, ××××× ××¢×× × ×¢× ××× ××××:
- 1. ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ×ש×× ×××× ××קצ×× ××ש×× ×ª×××× ×××§×ת ×××¢××, ××× ×§××× ××פ×× ×××× ×× ×¢×¦× ××¢×ר ×שת×ת ת×× ×××¢ (Stem cell transplantation).
- 2. ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת, ××× ×ª××ת ×ס×××ס ×××× ×©×ר×ת.
×ש×× ×××× ×× ×××× ××××× ×××× ×××פ×× ×××ת ×××× ×תר×פ×ת â Dinutuximab beta, Naxitamab.
- ×. ××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 ×××××
|
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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| ××פ×ש ×××ר××
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×××ר×× ×-PubMed
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| ××××¢ ×רשת
|
RxList WebMD Drugs.com
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| ×©× ×צר×
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RECORDATI NETHERLANDS B.V., THE NETHERLANDS
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| ×©× ××¢× ×ר×ש××
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MEDISON PHARMA LTD
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| ר×ש×××
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ת×ר×× ××ש×: 6/2017. ר×ש××× ×ת×ר××:
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| ת×ר×× ×¢×××× ××ר××
|
12/06/2025
|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 12/06/2025
RECORDATI
×§×ר×××× - Qarziba
true
השינוי האחרון נעשה בֹ־12 ביוני 2025 ב־05:20