REMICADE

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

INFLIXIMAB

Tilgængelig fra:

J-C HEALTH CARE LTD

ATC-kode:

L04AB02

Lægemiddelform:

POWDER FOR CONCENTRATE FOR INFUSION

Sammensætning:

INFLIXIMAB 100.0 MG/VIAL

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

JANSSEN BIOLOGICS B.V, THE NETHERLAND

Terapeutisk gruppe:

INFLIXIMAB

Terapeutisk område:

INFLIXIMAB

Terapeutiske indikationer:

- 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

Autorisation dato:

2014-12-31

Indlægsseddel

______________________________ :לפוטמה םש
_______________________________ :אפורה םש
_____________________ :אפורה לש ןופלט רפסמ
בושח יתוחיטב עדימ ליכמ הז לפוטמל
תרוכזת סיטרכ
.דקימרב לופיטה ךלהמבו ינפל תעדל ךילעש
.ךלש לופיטב ברועמה אפור לכל הז סיטרכ
תוארהל אנ
ינפל דקימר לש ׳ןכרצל ןולע׳ה תא ןויעב
אורקל אנ
.הפורתב שומישה תלחתה
________________ :דקימרב לופיטה תליחת ךיראת
_________________________ :תויחכונ ןתמ תורוצ
ירחסמה םשה תא ודעתת ךלש אפורהו התאש
בושח
.ךלש הפורתה לש הווצאה רפסמו
לש ךיראתהו גוסה תא דעתל ךלש אפורהמ
שקבל ךילע
:הטמ ,)TB( תפחשל ךלש )תו(הנורחאה רקסה
תקידב
__________ הקידב
__________ הקידב
__________ ךיראת
__________ ךיראת
_________ :האצות
_________ :האצות
ךתושרב שי ,יאופר תווצ שיא לצא רוקיב
לכבש אדו אנא
שמתשמ התאש תופסונה תופורתה לכ לש המישר
םג
.ןהב
___________________________ :תויגרלא תמישר
___________________ :תופסונ תופורת לש המישר
םימוהיז
דקימרב לופיטה ינפל
לק אוה םא םג ,םוהיז ךל שי םא ךלש אפורל
רפס ●
דואמ
תילח םעפ-יא םא ךלש אפורל רפסל דואמ בושח
●
והשימ םע בורק עגמב תייה םא וא ,)TB( תפחשב
ךל שי םא קודבי ךלש אפורה .תפחש ול
התייהש
גוסה תא דעתל ךלש אפורהמ שקבל ךילע .תפחש
תפחשל ךלש )תו(הנורחאה רקסה תקידב לש
ךיראתהו
סיטרכב
התא םא וא ,B סיטיטפה ךל שי םא ךלש אפורל
רפס ●
.B סיטיטפהה סוריו לש אשנ התאש דשוח וא
עדוי
דקימרב לופיטה ךלהמב

Produktets egenskaber

Page 1 of 35
Remicade_SPC_01_2024_sub
1.
NAME OF THE MEDICINAL PRODUCT
Remicade.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of infliximab. Infliximab is a chimeric
human-murine IgG1 monoclonal
antibody produced in murine hybridoma cells by recombinant DNA
technology. After reconstitution
each ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion .
The powder is a freeze-dried white pellet.
Patient reminder card Card
The marketing of Remicade is subject to a risk management plan (RMP),
including a "Patient
reminder card".
The "Patient reminder 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.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
- 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 prog