סימפוני - Simponi

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נתוני תרופה
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במרשם RxIcon.png
קבוצה פרמקולוגית (ATC4)

L04AB
Tumor necrosis factor alpha (TNF-α) inhibitors

מרכיב פעיל (ATC5) *Golimumab 50MG / 0.5 ML ‏L04AB06
  • Golimumab 50MG / 0.5 ML ‏L04AB06
  • Tumor necrosis factor alpha (tnf-a) inhibitors L04AB ‏L04AB06
  • 7290014577299 לא ‏L04AB06
  • 7290008099967 לא ‏L04AB06
  • 972 south curry pike,bloomington indiana, usa Manufacture of Simponi pre-filled syringe (PFS), Release: Sterility and Endotoxin testing only, Stability: Sterility testing only: ‏L04AB06
  • 9900 blackweel road, rockville, md l20850, usa Preparation of C524A Working Cell Banks , mycoplasma and In-Vitro assay for adventitious agents ‏L04AB06
  • 358 technology drive, malvern pa 19355, USA mycoplasma and In-Vitro assay for adventitious agents ‏L04AB06
  • Hochstrasse 201, CH-8205 SCHAFFHAUSEN, SWITZERLAND Assembly of the Simponi PFS with a Centocor Autoinjector or UltraSafe Passive Delivery System, labeling, and packaging, Functional testing (release and stability) of the Simponi PFS with a Centocor Autoinjector or UltraSafe Passive Delivery System, Release: Glidability and Sterility testing only, Stability: Sterility testing only ‏L04AB06
  • Barnahely, ringaskiddy co. cork, ireland Cell culture, purification, and analytical testing of process intermediates and SIMPONI® bulk drug substance (formulated bulk) and stability testing, , Release testing of the Simponi PFS, Stability testing of the SIMPONI PFS ‏L04AB06
  • Einsteeinweg 101, 2333 CB LEIDEN, THE NETHERLANDS Cell culture, purification, and analytical testing of process intermediates and SIMPONI bulk drug substance (formulated bulk) and stability testing, Mycoplasma and In-Vitro Assay for Adventitious Agents, Preparation of C524A Working Cell Banks, Release testing of the Simponi PFS, Stability testing of the SIMPONI PFS ‏L04AB06
  • 200 great vally parkway, malvern, pa 19355, USA Preparation of C524A Working Cell Banks ‏L04AB06
  • Golimumab 50MG / 0.5 ML ‏L04AB06
צורת מתן S.C
צורת מינון SOLUTION FOR INJECTION
התוויה
Rheumatoid Arthritis :Simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.Juvenile idiopathic arthritis: Polyarticular juvenile idiopathic arthritis (pJIA)Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.Simponi 100 mg is not recommended in children aged less than 18.Psoriatic Arthritis :Simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.Ankylosing Spondylitis :Simponi is indicated for the treatment of adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy.Non-radiographic axial spondyloarthritis (nr-Axial SpA):Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDS).Ulcerative colitis (UC) :Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
תופעות לוואי
עלון לרופא
עלון לצרכן סימפוני ® במאגר משרד הבריאות
ערכים בוויקירפואה ערכים קשורים בוויקירפואה
חיפוש מאמרים מאמרים ב-PubMed
מידע ברשת RxList WebMD Drugs.com
שם יצרן CILAG AG, SWITZERLAND
שם בעל הרישום J-C HEALTH CARE LTD
רישיון תאריך הגשה: 03/2010. רישיון מתאריך: 01/2017


תאריך עדכון: 15/09/18


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