SIMPONI

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

GOLIMUMAB

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

L04AB06

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

GOLIMUMAB 50 MG / 0.5 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CILAG AG, SWITZERLAND

المجموعة العلاجية:

GOLIMUMAB

المجال العلاجي:

GOLIMUMAB

الخصائص العلاجية:

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.

تاريخ الترخيص:

2017-01-31

نشرة المعلومات

JC
Simponi
Solution for inj (Pen/Syringe)
Safety Information Card (Word)
A4
10
9
11
/
1
Heb+Eng
04.10.21
Keren
2
Heb+Eng+Arabic
01.11.21
Haneen
Client
SIM SOL SIC SH270921
)הספדהל אל( תואירבה דרשמ רתאל תדעוימה
word תסריג
סיטרכ
עדימ לפוטמל
רישכתל ינופמיס
ה סיטרכ
עדימ
תוחיטב עדימ ליכמ לפוטמל
י
( ינופמיסב לופיטה ךלהמבו ינפל ריכהל
ךילעש בושח
Simponi
.)
.ךב לופיטב ברועמה אפור לכל הז סיטרכ גצה
1 .
םימוהיז
התא רשאכ
לפוטמ
התא ,ינופמיסב
ףושח
רתוי
םימוהיזל
םירומח תויהל םילולעו רתוי ריהמ בצקב
חתפתהל םילולע םימוהיז .
םימוהיז ,ףסונב .רתוי
םימיוסמ
.בוש עיפוהל םילולע רבעב םהב תיקלש
_ _
_1.1_
_ _
_ :ינופמיסב לופיטה ינפל_
_ _
•
םא ךלש אפורל רפסל שי
התא
הקול
ב
םא ינופמיסב לופיט לבקל ןיא .םוהיז
התא
לבוס
מ
( תפחש
TB
םוהיז לכ וא )
רומח
.רחא
•
תקידב רובעל ךילע
רקס
עגמב תייה םא וא תפחשב רבעב תילח םא ךלש
אפורל רפסתש דואמ בושח .תפחשל
תו/תקידב ךיראתו גוס תא ןלהל דעתל ךלש
אפורהמ שקב אנא .רבעב תפחשב הלחש והשימ
םע בורק
רקסה
:תפחשל תו/הנורחאה
_________ הקידבה
__
___
______
______
___ הקידבה
______
__
________
____________
___ ךיראת
______
_
__
___
____________
______ ךיראת
_____
__
__________
_________
__ האצות
____________
_
__
__________
______ האצות
__
___
____________
_________
•
התא םא ךלש אפורל רפס
סיטיטפה ףיגנ לש אשנ
B
התאש דשוח וא
הז ףיגנ לש אשנ
.
_1.2_
_ _
_ ךלהמב_
_ :וירחאלו ינופמיסב לופיטה_
_ _
•
םא יאופר לופיט תלבקל דימ תונפל שי
םיעיפ�

خصائص المنتج

Page
1
of
29
SIMPONI_SPC_ 05_2023_SUB
1. NAME OF THE MEDICINAL PRODUCT
Simponi, solution for injection, in Auto-Injector pen or pre-filled
Syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml Auto-Injector pen/ pre-filled syringe contains 50 mg of
golimumab*.
One 1.0 ml Auto-Injector pen / pre-filled syringe contains 100 mg of
golimumab*.
* Human IgG1κ monoclonal antibody produced by a murine hybridoma cell
line with recombinant
DNA technology.
Excipient with known effect:
Each Auto-Injector pen / pre-filled syringe contains 20.5 mg sorbitol
per 50 mg dose.
Each Auto-Injector pen / pre-filled syringe contains 41.0 mg sorbitol
per 100 mg dose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in Auto-Injector pen (injection), SmartJect,
/pre-filled syringe (injection)
The solution is clear to slightly opalescent, colourless to light
yellow.
Patient reminder card
The marketing of Simponi is subject to 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
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