× ×ª×× × ×ª×¨×פ×
××רש×
| ק×××¦× ×¤×¨×ק×××××ת (ATC4)
|
L01XL
Antineoplastic cell and gene therapy
|
| ×ר××× ×¤×¢×× (ATC5)
|
Â
|
| צ×רת ×ת×
|
ת××-×ר××× - I.V
|
| צ×רת ××× ××
|
DISPERSION FOR INFUSION
××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
|
| ×ת××××
|
Kymriah is indicated for the treatment of: - Paediatric and young adult patients up to and including 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. - Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary or secondary central nervous system lymphoma- Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
|
| × ×ª×× × ×ס×
|
ת×ר×× ××××× ×ס×
- 16/01/2019
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ××××ר×× ×××××× ××××פ××× ×××רת ×× ×¢×××× (רפרק××ר×ת) ×ס×× Diffuse large B cell lymphoma, ×××ר ×©× × ×§××× ××פ×× ×××¢××. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×××ת ×××× â Axicabtagene ciloleucel, Tisagenlecleucel.
|
16/01/2019 |
××××××××× |
|
DLBCL, Diffusa large B cell lymphoma |
|
| ××××× ×××××ר×× ×¦×¢×ר×× ×©×××× ××× 3 ×©× ×× ×××¨× ×××× ××× 25 ×©× ×× ×××××× ×××ק××× ×××רת ×× ×¢×××× (רפרק××ר×ת) ×ס×× CD19+ B cell Acute Lymphoblastic Leukemia (ALL). ××¢× ××× ×× ×××× ×××רת ת×××ר ××××× ×©×§××× ×©× × ×§××× ××פ×× ×§××××× ×× ×©×¢×ר ×שת×× ×©× ×ª×× ×××¢ ××××פ××××××.
|
16/01/2019 |
××××××××× |
|
ALL, Acute lymphoblastic leukemia |
|
| ××××ר×× ×××××× ××××פ××× ×¤×××ק××ר×ת ×××רת ×× ×¨×¤×¨×§××ר×ת ×××ר ש×××©× ×§××× ××פ×× ×§××××× ×××¢××. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×××ת ×××× â Axicabtagene ciloleucel, Tisagenlecleucel.
|
01/02/2023 |
××××××××× |
|
×××פ××× ×¤×××ק××ר×ת, Follicular lymphoma |
|
| ××××× ×××××ר×× ×¦×¢×ר×× ×©×××× ××× 3 ×©× ×× ×××¨× ×××× ××× 25 ×©× ×× ×××××× ×××ק××× ×××רת ×× ×¢×××× (רפרק××ר×ת) ×ס×× CD19+ B cell Acute Lymphoblastic Leukemia (ALL). ××¢× ××× ×× ×××× ×××רת ת×××ר ××××× ×©×§××× ×©× × ×§××× ××פ×× ×§××××× ×× ×©×¢×ר ×שת×× ×©× ×ª×× ×××¢ ××××פ××××××. ××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×××ת ×××× â Brexucabtagene autoleucel, Tisagenlecleucel.
|
01/02/2023 |
××××××××× |
|
ALL, Acute lymphoblastic leukemia |
|
|
ש×××ש ×ס×
-
|
×ס×רת ××××× ×ס×
- ×. ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- 1. ××××× ×××××ר×× ×¦×¢×ר×× ×©×××× ××× 3 ×©× ×× ×××¨× ×××× ××× 25 ×©× ×× ×××××× ×××ק××× ×××רת ×× ×¢×××× (רפרק××ר×ת) ×ס×× CD19+ B cell Acute Lymphoblastic Leukemia (ALL).
××¢× ××× ×× ×××× ×××רת ת×××ר ××××× ×©×§××× ×©× × ×§××× ××פ×× ×§××××× ×× ×©×¢×ר ×שת×× ×©× ×ª×× ×××¢ ××××פ××××××
- 2. ××××ר×× ×××××× ××××פ××× ×××רת ×× ×¢×××× (רפרק××ר×ת) ×ס×× Diffuse large B cell lymphoma, ×××ר ×©× × ×§××× ××פ×× ×××¢××.
××××× ××××ª× ×××× ××××× ×××× ×××פ×× ×××ת ×××× â Axicabtagene ciloleucel, Tisagenlecleucel.
- ×. ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ××××××××××.
|
|
| ×ת××ת ××× ××
|
Posology and method of administration
|
| ×ת××××ת × ××
|
Contraindications
|
| ת×פע×ת ×××××
|
Undesirable effects
|
| ת××××ת ××× ×ª×¨×פת××ת
|
Interaction with other medicinal products and other forms of interaction
|
| ש×××ש ×××ר××× ××× ×§×
|
Pregnancy and Lactation
|
| פר×ק×××× ××ק×
|
Pharmacodynamic Properties
|
| פר×ק×ק×× ××ק×
|
Pharmacokinetic Properties
|
| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
|
Â
Â
|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 29/01/2025
NOVARTIS
ק××ר×× - Kymriah
true
השינוי האחרון נעשה בֹ־29 בינואר 2025 ב־13:45
