
× ×ª×× × ×ª×¨×פ×
××רש×

| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
|
L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
|
| ×ר××× ×¤×¢×× (ATC5)
|
Â
|
| צ×רת ×ת×
|
ת××-×ר××× - I.V
|
| צ×רת ××× ××
|
×××§× ×××× ×ª תר××× ×××× ×¤××××, POWDER FOR CONCENTRATE FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
|
| ×ת××××
|
- Adult :- Crohn's disease: Treatment of moderate to severe active Crohn's disease in patients who have not responded despite of a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. Treatment of fistulising Crohn's disease in patients who have not responded despite of a full and adequate course of therapy with conventional treatment. - Paediatric Crohn's disease: Remicade is indicated for: Treatment of severe active crohn's disease in paediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid an immunomodulator and primary nutrition therapy or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy - Ankylosing spondylitis: Remicade is indicated for: treatment of ankylosing spondylitis in patients who have severe axial symptoms elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. - Psoriatic arthritis : Remicade is indicated for : Treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Remicade should be administered : either in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. - Remicade has been shown to improve physical function in patients with psoriatic arthritis and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. - Rheumatoid arthritis: Remicade in combination with methotrexate is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: Patients with active disease when the response to disease-modifying drugs including methotrexate has been inadequate. Patients with severe active and progressive disease not previously treated with methotrexate or other DMARDs. In this these patient populations a reduction in the rate of the progression of joint damage as measured by x-ray has been demonstrated - Psoriasis: Remicade is indicated for: Treatment of moderate to severe plaque psoriasis in adults who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or PUVA. - Ulcerative colitis: Remicade is indicated for: Treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to convential therapy including corticosteroids and 6-MP or AZA or who are intolerant to or have medical contraindications for such therapies.- Paediatric ulcerative colitis: Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 MP or AZA, or who are intolerant to or have medical contraindications for such therapies
|
| × ×ª×× × ×ס×
|
ת×ר×× ××××× ×ס×
- 16/01/2000
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
×רתר×××ס ר×××××××××ת â ×× ××××× ×× ×××× ×××פ×× ×-METHOTREXATE ××××פ×× ×ר×ש ×צ××¨× ×פ×תת ×ס××× ×× ××תס××× ××; ×××פ×× ×× ×ª× ×ש×××× ×¢× METHOTREXATE. ×ת××××ת ×××ª× ×××פ××: ×××פ×× ×××ס×× TNF ××××¢× ×¨×§ ××××× ×רתר×××ס ר×××××××××ת פע×××, ××תק××× ×× ××ª× ××× ×©×פ×ר×× ××××:
- 1. ×¢××ת ×§××× ×ת ××¢××ת×ת, ×¨× ××× ×ת ×תפק×××ת ×××קת פרק×× (RA) פע××× (×פ××ת 3 ×ת×× 4 ×××××):
- ×. פ×××¢× ×§××× ×ת ××××רת ××××× ××קת×ת (×××× ××× ×× ×¤×××ת) ××ספר פרק×× ×× ××× ×ת (×פ××ת 4 פרק××)
- ×. ×¢××ת ××¢××ת×ת ××××× ××קת×ת פע××× ××××רת â שק×עת ×× ×/×× CRP ××××ר×× ××× ×ר×× ××××¤× ×ש××¢××ª× (××ת×× ×××× ×××××).
- ×. ×¢××ת ×¨× ××× ×ת ××××רת ×ש×× ×××× ××פ××× ××× ×-RA ×צ××××× ××¨× ××× ×©× ×פרק×× ×× ×××¢××. ×ער×: ×§××× ×× ×§×××××ת ××ר××ת ×פרק×× (×××××× ×ש×× ××§××× × ×ס××¤× ×©× ×××××), ××× × ××××× ××ר×× ×××ª× ×××פ××.
- ×. פ×××¢× ×ª×¤×§×××ת ×¢×§× ×××× ×¤×¢××× ××××רת ×××××× ×ש××¢×ת×ת ×תפק××× ×××××××× ×©× ×××××× ××פע××××ª× ××¢××××.
- 2. × ×ס××× ××פ××× ×§××× ×תר×פ×ת ××××ת:
- ×. ××פ×× ×§× ×¨×ש×× ×תר×פ×ת ×× ×× ××קת××ת ×ס×× NSAID
- ×. ××פ×× ×§× ×©× × ×-3 תר×פ×ת ×פ××ת ××§××צת ×-DMARD ש××ת ××× ×ת××רקס×, ×××©× 3 ×××ש×× ×¨×¦×פ×× ×פ××ת. ×§××צת ×תר×פ×ת DMARD (Disease modifying antirheumatic drugs) ××××ת: ×ת××רקס×, ×××× ×××, ×× ××××ר×××××, ×××¤× ×צ××××××, ס××פ×ס××××, ×××ת××פר××, ××× ×צ××§×××. ×ש××× ××פ××× ××××ר ×××¢×ר ת×××× ×§××× ×ת ×××ר ××פ×× ×©× 3 ×××ש×× ×¨×¦×פ×× ×פ××ת ×××פ×× ×©× 3 תר×פ×ת ××§××צת ×-DMARD, ש××ת ××× ×ת××רקס×. ×ש××× ××פ×× ×-Infliximab ××××ר ×××¢×ר ת×××× ×§××× ×ת ×××ר ××פ×× ×-4 ×× ×ת ×©× ×ת×ש×ר ×××ª× ×ª×× ×ר×××. ×× ×××ת ×××ª× ×××פ×× ××ס×× TNF ××× ×ª× × ×××פ×× ×§× ×©×××©× ×¨×§ ×××ר ×ש××× ××פ××× ×תר×פ×ת ×§× ×©× × ×××¤× ×××ר××ת ××××ת:
- 1. ×××פ×× ×-Infliximab ×-Adult RA ××× ×ª× ×ש×××× ×¢× Methotrexate.
- 2. ×תר××¤× Etanercept ת×× ×ª×:
- ×. ×××פ×× ××××ת ×רתר×××ס ×ר×× ×ת ×צע×ר×× (Juvenile chronic arthritis) ×××ר ×ש××× ××פ××× ××ת××רקס×.
- ×. ×××פ×× ×-Adult RA ×××ר ×ש××× ××פ××× ×-DMARD ××ת××ר ××¢××, ××××ר ×ש××× ××פ××× ×-Infliximab. ש××רת רצף ××פ×× ×××ס×× TNF ×ש×ר ×רצף ×××פ××× ×××ª× ××ס×× TNF ×××××× ×שר ×¢× × ×¢× ××ת××××ת ××§××× ××ת ×××××ר×ת ××¤× × ×ª×××ת ×××פ××, ××××ª× ×ª×¨××¤× ×× ××ת×× ×××פ×× ××¤× × 01.01.02 ××§×××ת ××××× ×××¢×××ת ×××פ××. ××ש×ר ××ª× ×××פ×× ×××פ×× ×××ס×× TNF ××××× ×רתר×××ס ר×××××××××ת ××× ×ª× ×××ש×ר ×××¢×× ×ר×ש×ת ר××¤× ××××× ×ר××××××××××.
|
01/03/2002
|
ר×××××××××× |
|
Rheumatoid arthritis |
|
××××× ×ס××× ×××× ××××:
- (×) ×××ת קר××× ×¤×¢××× ××× ×× ×ת ×¢× ×××ר×, ×צ××¨× ××§×ת ×ס××× ×× ××תס××× ××.
- (×) ×××ת קר××× ×ס×× fistulizing - ×צ××¨× ×פ×תת ×ספר ×פ×ס××××ת ××× ×ר×-×¢×ר××ת ××× ×§××ת (draining enterocutaneous fistulas).
|
16/01/2000
|
×ס×ר××× ×ר×××××× |
|
Crohn's disease |
|
××קת ×פרק×× ×¨×××××××××ת ×× ××××× ×× ×××× ×××פ×× ×-Methtorexate ××××פ×× ×ר×ש ×צ××¨× ×פ×תת ×ס××× ×× ××תס××× ××; ×××פ×× ××× ×ª× ×ש×××× Methotrexate ××תק××× ×× ××ª× ××× ×××××
- 1. ×§×××ת ×¢××ת ×××קת ×פרק×× ×ס×× Rheumatoid arthritis פע××× ××ת×××ת ×ש×××©× ×ת×× ×××:
- ×. ×××× ××קת×ת ××ר××¢× ×פרק×× ×××תר
- ×. שק×עת ×× ×× C reactive protein ××¢× ×× ×ר××
- ×. ש×× ×××× ××פ××× ××× ×××קת ×פרק×× ×¨×××××××××ת ××פרק×× ×× ×××¢××
- ×. פ×××¢× ×ª×¤×§×××ת ×××ר ××צ×× ×××פ×× ×תר×פ×ת ×ש××××ת ××שפ×ת ×-NSAIDs (Non steroidal anti inflammatory drugs) ××תר×פ×ת ×ש××××ת ××שפ×ת DMARDs (Disease modifying antirheumatic drugs).
- 2. ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××××¦× ×©× ×¨××¤× ××××× ×ר××××××××××.
|
15/04/2005
|
ר×××××××××× |
|
Rheumatoid arthritis |
|
| ×× ×§×××××× × ×¡×¤×× ××××××ס ×§×©× â ×× ××××× ×× ×××× ×××פ×× ×§×× ×× ×¦××× ××. ×××פ×× ××× ×ª× ×ש×××× ×¢× Methotrexate, ×××¢× ×××§×¨× ×©× ××ר×ת × ×× ×תר××¤× ××ת. ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××××¦× ×©× ×¨××¤× ××××× ×ר××××××××××.
|
15/04/2005
|
ר×××××××××× |
|
Ankylosing spondylitis |
|
| ××קת ×פרק×× ×¤×¡×ר××××ת ×§×©× â ×× ××××× ×× ×××× ×××פ×× ×תר×פ×ת Salazopyrine, Methotrexate ××שפ×ת ×-DMARDs. ×××פ×× ××× ×ª× ×ש×××× ×¢× Methotrexate. (×××§×¨× ×©× ××ר××× × ×××× Ankylosing spondylitis ×קש×ר ×פס×ר××××ס ת××× ×××ר×× ××× ×-Ankylosing spondylitis ר×ש×× ×). ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××××¦× ×©× ×¨××¤× ××××× ×ר××××××××××.
|
15/04/2005
|
ר×××××××××× |
|
Psoriatic arthritis |
|
פס×ר××××ס ××תק××× ×× ××ª× ××× ××××
- ×. ××××× ×¡××× ×פס×ר××××ס ×פ×ש×ת ××¢× ×-50% ×©× ×©×× ×××£ ×× PASI ××¢× 50.
- ×. ×××פ×× ×¢× ×ת×ש×ר ××× ×ª× ×××××× ×שר ×§×××× ×פ××ת ×©× × ××פ×××× ×¡×ס××××× ××× ×©×פ×ר ×©× 50% ×פ××ת ×-PASI ×××ר ס××× ×××פ×× ××ש×××× ×ת×××ת ×××פ××.
- ×. ×× ××¢×©× ×©×××ש ××©×ª× ×ª×¨×פ×ת ××§×××¦× ×× (×תר×פ×ת ××§××ס ×פק×) ×ת×× 12 ×××ש××, ××× ×× ×§×××ת ×× ×¡××××ת ×× ×ª×פע×ת ××××× ×תר××¤× ×××××××ת ××ת.
- ×. ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××¨×©× ×©× ×¨××¤× ××××× ××ר××××××××.
|
15/05/2006
|
×¢×ר ××××
|
EFALIZUMAB, ALEFACEPT, ETANERCEPT, INFLIXIMAB
|
Psoriasis |
|
פס×ר××××ס, ××תק××× ×× ××ª× ××× ××××:
- 1. ××××× ×¡××× ×××× ××××:
- ×. ×××× ×פ×ש×ת ××¢× ×-50% ×©× ×©×× ×××£ ×× PASI ××¢× 50
- ×. × ××¢×× ×××××¨× ×××£ ר××ש××
- 2. ××××× ×§××× ×©× × ××פ×××× ×¡×ס××××× ×פ××ת ××× ×©×פ×ר ×©× 50% ×פ××ת ×-PASI ×××ר ס××× ×××פ×× ××ש×××× ×ת×××ת ×××פ××. ××ת×××ס ××××× ××¢×× × ×¢× ××××ר ×פסקת ××©× × (1)(×), ××××× ×§××× ×©× × ××פ×××× ×¡×ס××××× ×פ××ת ××× ×©×פ×ר ×ש××¢××ª× ×××ר ס××× ×××פ×× ××ש×××× ×ת×××ת ×××פ××
- 3. ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××¨×©× ×©× ×¨××¤× ××××× ××ר××××××××.
|
03/01/2010
|
×¢×ר ××××
|
ADALIMUMAB, IXEKIZUMAB, CERTOLIZUMAB PEGOL, USTEKINUMAB, SECUKINUMAB, TILDRAKIZUMAB, GUSELKUMAB, ETANERCEPT, INFLIXIMAB
|
פס×ר××××ס, Psoriasis |
|
| ××פ×× ××××ת ××¢× ××קת×ת ×ס×× Ulcerative colitis ×××ר ××צ×× ×× ×§××× ××פ×× ×ª×¨×פת××× ×§××××× |
01/03/2008 |
×ס×ר××× ×ר×××××× |
|
Ulcerative colitis |
|
|
| ש×××ש ×ס×
|
| ×ס×רת ××××× ×ס×
×. ×תר××¤× ×ª×× ×ª× ×××פ×× ××××× ×ס××× ×××× ××××:
- 1. ××פ×× ××××ת קר××× ××ר×ת ××××¨× ××× ×× ×ת ×¢× ×§×©× ×××××× ×©×××¦× ××פ×× ×§××× â ××פ×× ×× ××××××× ×× ××פ×× ×××××××
- 2. ×רתר×××ס ר×××××××××ת - ×× ××××× ×× ×××× ×××פ×× ×-METHOTREXATE ××××פ×× ×ר×ש ×צ××¨× ×פ×תת ×ס××× ×× ××תס××× ××; ×××פ×× ××× ×ª× ×ש×××× ×¢× METHOTREXATE ×××פ××£ ××ª× ×× ×¤×¡×§× ×
- 3. ××קת פרק×× ×¤×¡×ר××××ת ×§×©× ×× ××××× ×× ×××× ×××פ×× ×תר×פ×ת methotrexate, salazopyrin ××שפ×ת ×-DMARDs. ×××פ×× ××× ×ª× ×ש×××× ×¢× methotrexate;
- 4. ×× ×§×××××× × ×¡×¤×× ×××××ס ×§×©× ×× ××××× ×× ×××× ×××פ×× ×§×× ×× ×¦××× ××. ×××§×¨× ×©× ××ר××× × ×××× ×× ×§×××××× × ×¡×¤×× ××××××ס ×קש×ר ×פס×ר××××ס, ת××× ×××ר×× ××× ××× ×§×××××× × ×¡×¤×× ××××××ס ר×ש×× ×ת;
- 5. פס×ר××××ס - ××תק××× ×× ×××: ×. ××××× ×¡××× ×××× ××××: 1. ×××× ×פ×ש×ת ××¢× ×-50% ×©× ×©×× ×××£ ×× PASI ××¢× 50. 2. × ××¢×× ×××××¨× ×××£ ר××ש×× - ×××ר×× ××× ××××× ×¤× ××, צ×××ר, ×§×פ××× ×¢×ר, ×פ×ת ×××××, ×פ×ת ר×××××, ×××ר ××× ××××× ×××ש××; ×. ××××× ×§××× ×©× × ××פ×××× ×¡×ס××××× ×פ××ת ××× ×©×פ×ר ×©× 50% ×פ××ת ×-PASI ×××ר ס××× ×××פ×× ××ש×××× ×ת×××ת ×××פ××; ××ת×××ס ××××× ××¢×× × ×¢× ××××ר ×פסקת ××©× × (×)(2) - ××××× ×§××× ×©× × ××פ×××× ×¡×ס××××× ×פ××ת ××× ×©×פ×ר ×ש××¢××ª× ×××ר ס××× ×××פ×× ××ש×××× ×ת×××ת ×××פ××; ×. ×תר××¤× ×ª×× ×ª× ×¢× ×¤× ××¨×©× ×©× ×¨××¤× ××××× ××ר××××××××.
- 6. ××פ×× ××××ת ××¢× ××קת×ת ×ס×× Ulcerative colitis ×××××× ×©×××¦× ××פ×× ×§××× â ××פ×× ×× ××××××× ×× ××פ×× ×××××××;×. ×××פ×× ×תר××¤× ××××× ××¢×× × ×¢× ×ª× ×× ×¤×¡×§× (×) (2), ××× ×ª× ××תק××× ×× ×××: 1. ×§×××ת ×¢××ת ×××קת פרק×× (RA-Rheumatoid Arthritis) פע××× ××ת×××ת ×ש×××©× ×ת×× ×××: ×. ×××× ××קת×ת (×××× ××× ×× ×¤×××ת) ××ר××¢× ×¤×¨×§×× ×××תר; ×. שק×עת ×× ×× CRP ×××ר××× ××× ×ר×× ××××¤× ×ש××¢××ª× (××ת×× ×××× ×××××); ×. ש×× ×××× ××פ××× ××× ×-RA ×צ××××× ×¨× ××× ×©× ×פרק×× ×× ×××¢××; ×. פ×××¢× ×ª×¤×§×××ת ×××××רת ×××××× ×ש××¢×ת×ת ×תפק××× ×××××××× ×©× ××××× ××פע××××ª× ××¢××××. 2. ×××ר ××צ×× ×××פ×× ×תר×פ×ת ×ש××××ת ××שפ×ת ×-NSAIDs ××תר×פ×ת ×ש××××ת ××שפ×ת ×-DMARDs. ××¢× ××× ×× ××××ר ××צ×× ×××פ×× ×××¢×ר ת×××× ×§××× ×ת ×××ר ××פ×× ×§× ×¨×ש×× ×תר×פ×ת ×× ×× ××קת××ת ××שפ×ת ×-NSAIDs ×××פ×× ×§× ×©× × ×-3 תר×פ×ת ×פ××ת ××שפ×ת ×-DMARDs ש××ת ××× ×ת××רקס××, ×××©× 3 ×××ש×× ×¨×¦×פ×× ×פ××ת. 3. ×××פ×× ××× ×ª× ×××ש×ר ר××¤× ××××× ×ר××××××××××.
|
|
| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
|
Â
Â
|
| ××פ×ש ×××ר××
|
×××ר×× ×-PubMed
|
| ××××¢ ×רשת
|
RxList WebMD Drugs.com
|
| ×©× ×צר×
|
JANSSEN BIOLOGICS B.V, THE NETHERLAND
|
| ×©× ××¢× ×ר×ש××
|
J-C HEALTH CARE LTD
|
| ר×ש×××
|
ת×ר×× ××ש×: 06/2002. ר×ש××× ×ת×ר××: 12/2014
|
| ת×ר×× ×¢×××× ××ר××
|
15/05/19
|
ת×ר×× ×¢××××: 15/05/19
JANSSEN
ר×××§× - Remicade
true
×××ר××
×צפ××× ×××××¢ ××ר×× ×ר×פ××× ×ש
××××× ×¡ ××ש××× ×. ×× ××× × ×¨×©×× ××× ×¡ ×
×רש×× ×ר×פ××× ××× ×©× ×קצ××¢×ת רפ×××××.
השינוי האחרון נעשה בֹ־13 ביולי 2025 ב־11:10