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

| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
|
L01FA CD20 (Clusters of Differentiation 20) inhibitors
|
| ×ר××× ×¤×¢×× (ATC5)
|
Â
|
| צ×רת ×ת×
|
ת××-×ר××× - I.V
|
| צ×רת ××× ××
|
תר××× ×××× ×ª ת×××¡× ×××× ×¤××××, CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
|
| ×ת××××
|
Rixathon is indicated for the following indications: * Non-Hodgkinâs lymphoma (NHL): Rixathon is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-hodgkinâs lymphoma. Rixathon is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy.Rixathon is indicated for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP chemotherapy. Rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * Chronic lymphocytic leukaemia (CLL): Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rixathon or patients refractory to previous Rixathon plus chemotherapy.* Granulomatosis with polyangiitis and Microscopic polyangiitis: Rixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with polyangiitis (GPA) (Wegenerâs Granulomatosis (WG) and Microscopic polyangiitis (MPA).*pemphigus vulgaris (PV):Rixathon is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV)
|
| × ×ª×× × ×ס×
|
ת×ר×× ××××× ×ס×
- 09/03/1999
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ××פ×× ×-ANCA associated vasculitis ××¢××ר ××××× ×- Wegener's granulomatosis (WG) ×× Microscopic polyangitis (MPA) ××¢×× ×× ×¢× ××× ××××: 1. ×××××× ×××ר ××צ×× ××פ×× ×צ××§××פ×ספ××××, ×ר××ת ××××× ×©×× ×××××× ××§×× ××פ×× ×צ××§××פ×ספ×××× |
|
|
|
|
|
| ××פ×× ×ש××× ×¢× Methotrexate ××רתר×××ס ר×××××××××ת ש×× ××××× ×××פ×× ××× ×××× ××¡× ×-TNF ××× ×פ××ת. |
|
|
|
|
|
| ××××§××× ×ס×× CLL, ×ש×××× ×¢× ××××תרפ××, ××¢××ר ××××× ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת ש×× ××פ×× ×-RITUXIMAB ×× ×-OBINUTUZUMAB ×× ×-OFATUMUMAB ××¢×ר ××××× ×× |
|
|
|
|
|
| ×××§××× ×ס×× CLL, ××§× ××פ×× ×¨×ש×× ××¢××ר ××××× ××××¢×××× ×××פ×× ×ש××× ×¢× ××××תרפ×× ×××××× Fludarabine + Cyclophosphamide |
|
|
|
|
|
| ××פ×× ××××§× ××××פ××× ×ס×× non Hodgkin's פ××××§××ר×ת, ××××× ×××רת ×× ×¨×¤×¨×§××ר×ת. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×ª×××; |
|
|
|
|
|
| ×××פ××× ×ס×× CLL/SLL ××§× ××פ××× ×¨×ש××, ××¢××ר ××××× (××××פ×××) ש×ת×××ת ××××ª× ×× ××××× ×××××, ×ר×× ×¡×¤×רת ×ת××× ×××× ×× ×פר×פר××× ××××ª× ×ª×§×× × ×× × ××××. ×××פ×× ××× ×ª× ×ש×××× ×¢× ××××תרפ×× ×ª×× ×ר×××ת. |
|
|
|
|
|
| ×××פ××× non Hodgkin's ××ר×× × ××××, ×ש×××× ×¢× ××××תרפ×× ×ª×× ×ר×××ת, ××§× ××פ××× ×¨×ש××. |
|
|
|
|
|
| ×××פ××× non Hodgkins ×ס×× B פ××××§××ר×ת ××§× ××פ××× ×¨×ש××. |
|
|
|
|
|
| ×××פ××× ×ס×× non Hodgkins ××רס×××ת ×ס×× CD-20 positive diffuse large B-cell. |
|
|
|
|
|
| ×××פ××× ×ס×× B-cell non Hodgkins ××ר×× × ×××× (low grade) ×××רת ×× ×¨×¤×¨×§××ר×ת. |
|
|
|
|
|
| ××פ×× ×××××ר×× ×¢× Pemphigus vulgaris ××ר×ת ××××¨× ××× ×× ×ת ×¢× ×××ר×, ××§× ×¨×ש×× ×ש×××× ×¢× ×¡×ר×××××× |
30/01/2020 |
×¢×ר ×××× |
|
Pemphigus vulgaris |
|
|
ש×××ש ×ס×
-
|
×ס×רת ××××× ×ס×
- 1. ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- ×. ×××פ××× ×ס×× B-cell non Hodgkins ××ר×× × ×××× (low grade) ×××רת ×× ×¨×¤×¨×§××ר×ת.
- ×. ×××פ××× ×ס×× non Hodgkins ××רס×××ת ×ס×× CD-20 positive diffuse large B-cell.
- ×. ×××פ××× non Hodgkins ×ס×× B פ××××§××ר×ת ××§× ××פ××× ×¨×ש××.
- ×. ×××פ××× non Hodgkin's ××ר×× × ××××, ×ש×××× ×¢× ××××תרפ×× ×ª×× ×ר×××ת, ××§× ××פ××× ×¨×ש××.
- ×. ×××פ××× ×ס×× CLL/SLL ××§× ××פ××× ×¨×ש××, ××¢××ר ××××× (××××פ×××) ש×ת×××ת ××××ª× ×× ××××× ×××××, ×ר×× ×¡×¤×רת ×ת××× ×××× ×× ×פר×פר××× ××××ª× ×ª×§×× × ×× × ××××. ×××פ×× ××× ×ª× ×ש×××× ×¢× ××××תרפ×× ×ª×× ×ר×××ת.
- ×. ××פ×× ××××§× ××××פ××× ×ס×× non Hodgkin's פ××××§××ר×ת, ××××× ×××רת ×× ×¨×¤×¨×§××ר×ת. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×ª×××;
- ×. ××פ×× ××××§× ××××פ××× ×ס×× non Hodgkin's פ××××§××ר×ת, ×××××× ×©××××× ×××פ×× ××× ××קצ××. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×ª×××
- ×. ×××§××× ×ס×× CLL, ××§× ××פ×× ×¨×ש×× ××¢××ר ××××× ××××¢×××× ×××פ×× ×ש××× ×¢× ××××תרפ×× ×××××× Fludarabine + Cyclophosphamide. ×ת×ש×ר ×× ×ש×ש ×××פ×× ××××§× ×××××× ××××ר.
- ×. ×××§××× ×ס×× CLL, ×ש×××× ×¢× ××××תרפ××, ××¢××ר ××××× ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת ש×× ××פ×× ×-RITUXIMAB ×× ×-OBINUTUZUMAB ×× ×-OFATUMUMAB ××¢×ר ××××× ××. ×ת×ש×ר ×× ×ש×ש ×××פ×× ××××§× ×××××× ××××ר.
- ×. ×××§××× ×ס×× CLL, ×ש×××× ×¢× Bendamustine, ××¢××ר ××××× ×¢× ×××× ×××רת ×× ×¨×¤×¨×§××ר×ת ×¢××ר ××××× ×©×× ×××××× ××§×× ×ש×× ×××××ª×¨×¤× ××××× Fludarabine. ×ת×ש×ר ×× ×ש×ש ×××פ×× ××××§× ×××××× ××××ר.
- ××. ××פ×× ×ש××× ×¢× Methotrexate ××רתר×××ס ר×××××××××ת ש×× ××××× ×××פ×× ××× ×××× ××¡× ×-TNF ××× ×פ××ת.
- ××. ××פ×× ×-ANCA associated vasculitis ××¢××ר ××××× ×- Wegener's granulomatosis (WG) ×× Microscopic polyangitis (MPA) ××¢×× ×× ×¢× ××× ××××:
- 1. ×××××× ×××ר ××צ×× ××פ×× ×צ××§××פ×ספ××××, ×ר××ת ××××× ×©×× ×××××× ××§×× ××פ×× ×צ××§××פ×ספ××××.
××××, ×××× ×××©× ××× ×©××× × ×××× ××§×× ××פ×× ×צ××§××פ×ספ×××× ××קר×× ×××××:
- ×. ××××× ××¢×× ×× ×¢× ×× ×××××:
- 1. ××××× ×ס××××× ×-AAV ×¢× ×¤× ×××רת EUVAS - ×××× ×פ×ש×ת ××ער×ת ×ת ×××××ת ×× ×××ר ×××× ×.
- 2. ××××× ×¢× ×××× ×¤×¢××× ×¢× ×¤× ×§×¨××ר××× ×× ×©× BVAS (××¢×¨× ×©× BVAS>0) ×¢× ××£ ×××פ×× ×צ××§××פ×ספ×××× ×פ××ת ×תק××¤× ×©× 4 ×××ש××. ×× ××××× ×¢× ×ª××ת ×××פ×× ×ס×ר×××××× ××ר×ת ××פ×× ×צ××§××פ×ספ×××× ×××©× ×©× ×ר××¢× ×××ש×× ×פ××ת.
- ×. ××××× ××¢×× ×× ×¢× ××× ××××:
- 1. ×פ××× ×× ×××× ×סק×××××××ת פע××× ××ר×ת ××פ×× ×צ××§××פ×ספ×××× ×××©× 4 ×××ש××.
- 2. ××××× ×©×פת××× ×ת××§××ת ×¢× ×פסקת ×××פ×× ×ס×ר×××××× ×× ××××× ×ס×פרס××, ×××¤× EUVAS ××××ר×× ×¢× ×××× ×§×©× ×××¢×ר××ת ××××ת×ת.
- 2. ×× ×©×× ××××ר×× ×××× ×פ×ר××ת, ×× ××§× ××פ×× ×¨×ש××.
- 2. ×××× ×ת××××ת ×-× ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×××× ×§×××××× ×× ×¨××¤× ××××× ××××××××××.
- 3. ×××× ×ת×××× ×"× ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×ר×××××××××××.
- 4. ×××× ×ת×××× ×"× ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ××××× ×ר××××××××××× ×× × ×¤×¨××××××.
|
|
| ×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××§×××× ×××§×
|
Pharmacodynamic Properties
|
| פר××§××§×× ×××§×
|
Pharmacokinetic Properties
|
| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
|
Â
Â
|
| ××פ×ש ×××ר××
|
×××ר×× ×-PubMed
|
| ××××¢ ×רשת
|
RxList WebMD Drugs.com
|
| ×©× ×צר×
|
SANDOZ GMBH SCHAFTENAU, AUSTRIA
|
| ×©× ××¢× ×ר×ש××
|
SANDOZ PHARMACEUTICALS ISRAEL LTD
|
| ר×ש×××
|
ת×ר×× ××ש×: 7/2018. ר×ש××× ×ת×ר××:
|
| ת×ר×× ×¢×××× ××ר××
|
01/03/2025
|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 01/03/2025
SANDOZ
ר×קסת×× - Rixathon
true
השינוי האחרון נעשה בֹ־1 במרץ 2025 ב־20:05