תבנית:תרופה/סימפוני - Simponi

נתוני תרופה

במרשם

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	Undesirable effects
עלון לרופא והחמרות לעלון	עלון לרופא עלון לרופא החמרה לעלון החמרה לעלון החמרה לעלון החמרה לעלון החמרה לעלון

עלון לצרכן	עלון לצרכן עלון לצרכן עלון לצרכן

ערכים בוויקירפואה	ערכים קשורים בוויקירפואה
סימפוני ® במאגר משרד הבריאות

חיפוש מאמרים	-
מידע ברשת	-
שם יצרן	CILAG AG, SWITZERLAND
שם בעל הרישום	J-C HEALTH CARE LTD
רישיון	תאריך הגשה: 03/2010. רישיון מתאריך: 01/2017
תאריך עדכון אחרון	15/05/19

תאריך עדכון: 15/05/19

סימפוני - Simponi true

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