הומירה - Humira

הומירה - Humira
התוויות	Rheumatoid arthritis: Humira in combination with methotrexate is indicated for: - the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray adn to impove physical function when given in combination with methotrexate. Ankylosing spondylitis: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's disease : Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Psoriasis : Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or PUVA. Psoriatic arthritis : Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X- ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Polyarticular juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Rheumatoid arthritis: Humira in combination with methotrexate is indicated for: - the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray adn to impove physical function when given in combination with methotrexate. Ankylosing spondylitis: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's disease : Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Psoriasis : Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or PUVA. Psoriatic arthritis : Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X- ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Polyarticular juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

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הומירה - Humira


מרכיב פעיל	Adalimumab
קבוצה פרמקולוגית (ATC)	"SELECTIVE IMMUNOSUPPRESSIVE AGENTS"
שם התרופה	"הומירה®" (קישור לדף התרופה במאגר משרד הבריאות)
סל הבריאות	כלול
מסגרת הכללה בסל	תרופה מוגבלת לרישום ע"י רופא מומחה או הגבלה אחרת התרופה תינתן לטיפול במקרים האלה: 1. פסוריאזיס בהתקיים כל אלה: א. החולה סובל מאחד מאלה: 1. מחלה מפושטת מעל ל-50% של שטח גוף או PASI מעל 50; 2. נגעים באזורי גוף רגישים - אזורים אלו יכללו פנים, צוואר, קיפולי עור, כפות ידיים, כפות רגליים, אזור הגניטליה והישבן. ב. החולה קיבל שני טיפולים סיסטמיים לפחות ללא שיפור של 50% לפחות ב-PASI לאחר סיום הטיפול בהשוואה לתחילת הטיפול; . בהתייחס לחולה העונה על פסקה (1)(א)(2) החולה קיבל שני טיפולים סיסטמיים לפחות בלא שיפור משמעותי לאחר סיום הטיפול בהשוואה לתחילת הטיפול; ב. התרופה תינתן על פי מרשם של רופא מומחה בדרמטולוגיה. 2. דלקת מפרקים פסוריאטית פעילה ומתקדמת כאשר התגובה לתכשירים ממשפחת ה-DMARDs איננה מספקת; 3. אנקילוזינג ספונדילטיס קשה אם החולה לא הגיב לטיפול קונבנציונלי; במקרה של הוריאנט דמוי אנקילוזינג ספונדיליטיס הקשור בפסוריאזיס, תהיה ההוריה כמו באנקילוזינג ספונדיליטיס ראשונית; 4. מחלת קרוהן בדרגת חומרה בינונית עד קשה כאשר התגובה לטיפול קונבנציונלי לא הייתה מספקת; 5. מחלת קרוהן בדרגת חומרה בינונית עד קשה כאשר אין תגובה או כאשר יש חוסר סבילות לטיפול ב-INFLIXIMAB; 6. ארתריטיס אידיופטית מסוג Juvenile‏ (Juvenile idiopathic / rheumatoid arthritis) – בקטינים שמלאו להם 13 שנים וטרם מלאו להם 17 שנים הסובלים ממהלך מחלה רב-מפרקי פעיל כאשר התגובה לטיפול בתרופות ממשפחת ה-DMARDs לא הייתה מספקת או שאינם מסוגלים לקבל טיפול כאמור. עדכון סל התרופות 2012 טיפול בדלקת פרקים מסוג polyarticular juvenile idiopathic arthritis, הרחבת מסגרת הסל עבור ילדים בגילאים 4 ומעלה. עדכון סל התרופות 2013 טיפול ב-Ulcerative colitis לחולים שכשלו בטיפול ב-‏Infliximab .
התוויות	Rheumatoid arthritis: Humira in combination with methotrexate is indicated for: - the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray adn to impove physical function when given in combination with methotrexate. Ankylosing spondylitis: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's disease : Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Psoriasis : Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or PUVA. Psoriatic arthritis : Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X- ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Polyarticular juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Rheumatoid arthritis: Humira in combination with methotrexate is indicated for: - the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray adn to impove physical function when given in combination with methotrexate. Ankylosing spondylitis: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's disease : Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Psoriasis : Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or PUVA. Psoriatic arthritis : Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X- ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Polyarticular juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
שם יצרן	ABBOTT LABORATORIES LTD, ENGLAND
שם בעל הרישום	ABBOTT LABORATORIES S.A.
עלון לרופא	"עלון לרופא באנגלית"
עלון לצרכן	"עלון לצרכן בעברית"