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L04AJ
Complement inhibitors
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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××××
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Soliris is indicated for the treatment of patients with: -Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. Eculizumab has not been studied in clinical trials in patients with PNH below 11 years of age. -Atypical haemolytic uremic syndrome (aHUS). - Refractory generalized myasthenia gravis (gMG) in patients aged 6 years and above who are antiacetylcholine receptor (AChR) antibody-positive Soliris is indicated in adults for the treatment of: -Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibodypositive with a relapsing course of the disease who have received prior therapy
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| × ×ª×× × ×ס×
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ת×ר×× ××××× ×ס×
- 03/01/2010
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×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
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| atypical hemolytic uremic syndrome |
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| Paroxysmal nocturnal hemoglobinuria |
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ש×××ש ×ס×
-
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×ס×רת ××××× ×ס×
- ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- Paroxysmal nocturnal hemoglobinuria ××××× ××¢×× × ×¢× ××× ××××:
- ת××× ××¢×ר××× ×× (צר××× ×©× 12 ×× ×ת ×× ×× ××תר ××©× ×)
- ×××× ×× ×קק ××¢×ר×× ×©× ×¤××ת ×-12 ×× ×ת ×× ××©× × ××¢×× × ×¢× ××× ××××:
- ס×× ×××ר××¢ תר×××××× ×ס×× ×××× ×קש×ר ××××ת×
- ס××× ×פ×××¢× ××××ת×ת ×ש××¢×ת×ת (פ×× ×× ×§×¨×××× ×× ×ת×ת ×-30 ×××××××ר/×ק×)
- ××××× ××ר×××
×××פ×× ×תר××¤× ×× ××× ×ª× ×ש×××× ×¢× Ravulizumab ×× Pegcetacoplan ×× Crovalimab.
××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ××××××××××
- Atypical hemolytic uremic syndrome ×××תק××× ××× ××××:
- ××××× ×¢× ××ר××¢ ר×ש××, ××תק××× ×× ×××:
- ××××× ×¡××× ××××× ××ת×פ××× ×ª ××× ××× ××קר××× ×××פ××ת ××× ×¡×¤×קת ××××ת. רצ×× ×ת×× ×ת ××××× × ×××××§× ×× ××ת.
××¢× ××× ×× "×× ××× ××קר××× ×××פ××ת" = ×× ××× ×©×תק××××× ×× ×× ×××: ×××××××, תר××××צ××××¤× ××, ×ש×× ×× ×¢× ×©××¨× ×ª×××
- × ×©××× ×¡××× ××רת ×תס××× ×ª - ש×××ת HUS ××ק×ר ××××××, ש×××ת ADAMT13 (ר××ת ××¢× 5 ××××××)
- ××××× ×ש רקע ×שפ××ª× ×©× aHUS, ××× ××××× ××× ×¨×§×¢ ×שפ××ª× ×©× aHUS, ××תק××× ××× ××××:
- ×××× ×§×©× ×§××× ×ת (×××× CVA ×× ×× ×ר××)
- ×××× ×¢×××× ×פ×ס×פר××ס (××¢× ××× ×× ×ª×××ר ×¢××××ת ×פ×ס×פר××ס ××××¢×ר ש×פ×ר ×××ר 4 ××פ××× ×¤×ס×פר××ס ××××× 10 ××××× ×ר×ש×× ×× ×××××)
- ×××× ×©××××ª× ×××¨× (Relapse), ××תק××× ×× ×××:
- ××××× ×¡××× ××××× ××ת×פ××× ×ª ××× ××× ××קר××× ×××פ××ת ××× ×¡×¤×קת ××××ת. רצ×× ×ת×× ×ת ××××× × ×××××§× ×× ××ת.
××¢× ××× ×× "×× ××× ××קר××× ×××פ××ת" - ×× ××× ×©×תק××××× ×× ×× ×××: ×××××××, תר××××צ××××¤× ××, ×ש×× ×× ×¢× ×©××¨× ×ª×××
- × ×©××× ×¡××× ××רת ×תס××× ×ª - ש×××ת HUS ××ק×ר ××××××, ש×××ת ADAMT13 (ר××ת ××¢× 5 ××××××)
- ××××× ×ש רקע ×שפ××ª× ×©× aHUS, ××× ××××× ××× ×¨×§×¢ ×שפ××ª× ×©× aHUS, ××שר ××××× ×¡××× ××××× ×§×©× ×§××× ×ת (×××× CVA ×× ×× ×ר××)
- ×××× ×ס××× ××× ×¡×¤××§× ××××ת ס××¤× ×ת ×× ×רש ×××××××× ×ר×× ×ת ×¢× ×סת×× ×ת ××רת ××××× ×¤×¢××× ××¢×ר ××סת×× ×ת ××××××××ת.
××¢× ××× ××:
"×סת×× ×ת ××××××××ת" ×¢××ת ××¢××ת×ת ×××× ××××: ×××××××, תר××××צ××××¤× ××, ר×ת C3 × ××××.
"×סת×× ×ת ××רת" - ××× ××××: עצ××ת, ××××ת, ×××ת ××× ×× ×ר×ר×
- ×××× ×ס××× ××× ×¡×¤×קת ××××ת ס××¤× ×ת ××××¢×× ××שת×ת ×××× ×××××ת
- ×××× ×××ר ×שת×ת ×××× ×¢×§× ×× ×¡×¤×קת ××××ת ס××¤× ×ת ×¢× ×¨×§×¢ רפ××× ××ר, ×× ×××ר ×שת×ת ××××× ×ש ×××¤×¢× ×©× aHUS.
×××× ×× ××××ר ×ס××× ×××ר××¢ ר×ש×× ×××××¤× ×ת×ש×ר ×××ת×× ××ס×רת ×××××× ×©×××××¨× ××¢××ר ××××× ×¢× ××ר××¢ ר×ש×× ××××ר ×פסקת ××©× × 1.
××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×× ×¤×¨×××××× ×××××
- ×תר××¤× ×× ×ª×× ×ª× ×ש×××× ×¢× Ravulizumab
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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×ק×××× ××ק×
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Pharmacodynamic Properties
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| פר×ק×ק×× ××ק×
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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
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RxList WebMD Drugs.com
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| ×©× ×צר×
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ALEXION PHARMA GMBH, SWITZERLAND
|
| ×©× ××¢× ×ר×ש××
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ALEXION PHARMA ISRAEL LTD
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| ר×ש×××
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ת×ר×× ××ש×: 8/2009. ר×ש××× ×ת×ר××: 07/2015
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| ת×ר×× ×¢×××× ××ר××
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18/09/2024
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ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 18/09/2024
ALEXION
ס×××ר×ס - Soliris
true
השינוי האחרון נעשה בֹ־19 בספטמבר 2024 ב־03:12
