REMSIMA 120 MGML S.C.

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

INFLIXIMAB

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L04AB02

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

INFLIXIMAB 120 MG/ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CELLTRION INC., SOUTH KOREA

المجال العلاجي:

INFLIXIMAB

الخصائص العلاجية:

Rheumatoid arthritis: Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:•Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs),including methotrexate, has been inadequate. •Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X ray,has been demonstrated.Crohn’s diseaseRemsima is indicated for:• Treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• Treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).Ulcerative colitisRemsima 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.Ankylosing spondylitisRemsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.Psoriatic arthritisRemsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.Remsima should be administered• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab 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.PsoriasisRemsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA).

تاريخ الترخيص:

2021-05-03

نشرة المعلومات

1986 - ו"משתה )םירישכת( םיחקורה תונקת יפל
ןכרצל ןולע
דבלב אפור םשרמ יפ לע תקוושמ הפורתה
ירוע-תת ל"מ/ג"מ 120 המיסמר שומישל ןכומ טעב תירוע-תת הקרזהל הסימת
:ותומכו ליעפה רמוחה
ג"מ 120 ליכמ שומישל ןכומ טעב תימעפ-דח הנמ
לש ל"מ 1 לכ
.(infliximab( באמיסקילפניא
.6-ו 2 םיפיעס האר :רישכתב םיינגרלאו
םיליעפ יתלב םירמוח
ליכמ הז ןולע .הפורתב שמתשת םרטב ופוס דע
ןולעה תא ןויעב ארק
אפורה לא הנפ ,תופסונ תולאש ךל שי םא
.הפורתה לע יתיצמת עדימ
.חקורה לא וא
איה .םירחאל התוא ריבעת לא .ךתלחמב
לופיטל המשרנ וז הפורת
.המוד םתלחמ יכ ךל הארנ םא וליפא םהל
קיזהל הלולע
ףסונ עדימל .ראלימיס-ויב רישכת וניה
ירוע-תת ל"מ/ג"מ 120 המיסמר
:תואירבה דרשמ רתאל תונפל שי
ראלימיס-ויב ירישכת לע
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/
Registration/Pages/Biosimilars.aspx םייק ירוע-תת ל"מ/ג"מ 120 המיסמר רישכתל
,ןולעל ףסונב יתוחיטב עדימ ליכמ הז סיטרכ .לפוטמל
יתוחיטב עדימ סיטרכ לופיטה ךלהמבו לופיטה תלחתה ינפל תעדל
ךילעש בושח .ויפ לע לועפלו ירוע-תת ל"מ/ג"מ 120
המיסמרב םרטב ןכרצל ןולעבו לפוטמל יתוחיטב עדימ
סיטרכב ןייעל שי ףסונ ןויעל סיטרכה תא רומשל שי .רישכתב
שומישה תליחת
.ךרוצה תדימב
?הפורתה תדעוימ המל .1
:)Rheumatoid arthritis( תינורגיש םיקרפמ תקלד
תדעוימ ,טאסקרטותמ םע בולישב ,ירוע-תת
ל"מ/ג"מ 120 המיסמר
:ב ינפוגה דוקפתה רופישל ןכו םינימסתהו
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خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Remsima 120 mg/ml S.C.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remsima 120 mg/ml S.C solution for subcutaneous injection in
pre-filled syringe
Each 1 mL single dose pre-filled syringe contains 120 mg of
infliximab*.
Remsima 120 mg/ml S.C. solution for subcutaneous injection in
pre-filled pen
Each 1 mL single dose pre-filled pen contains 120 mg of infliximab*.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in murine hybridoma
cells by recombinant DNA technology.
Excipient(s) with known effect
Sorbitol 45 mg per 1 mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, subcutaneous.
Clear to opalescent, colourless to pale brown solution.
Remsima is a biosimilar medicinal product that has been demonstrated
to be similar in quality, safety
and efficacy to the reference medicinal product Remicade. Please be
aware of any differences in the
indications between the biosimilar medicinal product and the reference
medicinal product. The
biosimilar is not to be switched with the reference medicinal product
unless specifically stated
otherwise. More detailed information regarding biosimilar medicinal
products is available on the
website of the Ministry of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_ _
Rheumatoid arthritis
Remsima, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as
well as the improvement in physical function in:
Patient safety information Card
The marketing of Remsima 120 mg/ml S.C. is subject to a risk
management plan (RMP)
including a 'Patient safety information card'.
The 'Patient safety information card', emphasizes important safety
information that the patient
should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
2

adult patients with active disease when the response to
dise