SKYRIZI 150 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

RISANKIZUMAB

可用日期:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC代码:

L04AC18

药物剂型:

SOLUTION FOR INJECTION

组成:

RISANKIZUMAB 150 MG / 1 ML

给药途径:

S.C

处方类型:

Required

厂商:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

治疗领域:

RISANKIZUMAB

疗效迹象:

Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.Psoriatic ArthritisSkyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of activepsoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

授权日期:

2022-05-31

资料单张

1986 -)تارضحتسم( ةلديصلا ةمظنأ بجومب
كلهتسملل ةرشن
طقف بيبط ةفصو بسح ءاودلا اذه ق
ّ
وسي
غلم 150
TM
يزيرياكس
نقحلل زهاج ملق نمض نقحلل لولحم
يف غلم 150 باموزيكناسير ىلع يوتحي نقحلل
زهاج ملق لك :اهزيكرتو ةلاعفلا ةداملا
Risankizumab 150 mg/1 mL ،للم 1
"ةيفاضإ تامولعم" 6 ةرقفلا رظنأ ءاجرلا ـ
ةيساسحلا تادلومو ةلاعفلا ريغ داوملا
ةمئاقل
.ةرشنلا هذه يف
تامولعم ىلع ةرشنلا هذه يوتحت .ءاودلل
كلامعتسإ لبق اهتياهن ىتح نعمتب ةرشنلا
أرقإ
.يلديصلا وأ بيبطلا عجار ،ةيفاضإ ةلئسأ
كيدل ترفوت اذإ .ءاودلا نع ةزجوم
نأ كل ادب ولو ىتح مهرضي دق وهف .نيرخلآل
هيطعت لا .كلجأ نم جلاعلل ءاودلا اذه فص
ُ
و
.كتلاحل ةهباشم ةيبطلا مهتلاح
؟ءاودلا صصخم ضرغ يلأ .1
ةيحيوللا ةيفدصلا
ىدل ،ةديدشلا ىتح ةطسوتملا ةيحيوللا
)psoriasis( ةيفدصلا جلاعل صصخم يزيرياكس
.يزاهج جلاعل نيحشرملا رابكلا
يفدصلا لصافملا باهتلإ
لصافملا باهتلإ جلاعل صصخم ،)
MTX
( تاسكيرتوتيم ةكراشمب وأ هدرفمب
،يزيرياكس
رثكأ وأ دحاو ءاودب قباس جلاعل ةيفاك
ريغ ةباجتسإ نم اوساق نيذلا رابكلا ىدل
طشنلا يفدصلا
.جلاعلا لمحت مهناكمإب نكي مل وأ
DMARDs
ةعومجم نم مزيتامورلل داضم :ةيجلاعلا ةليصفلا
.نيكولرتنإ تاطبثم نم ،يعانملا زاهجلا
تاطبثم نم
.باهتللإا ببسي يذلا ،'IL-23' ىمسملا مسجلا
يف نيتورپ بجح قيرط نع يزيرياكس لمعي
ةيحيوللا ةيفدصلا
ةط

产品特点

Page 1 of 20
SKY 150 75 API APR23_CL
1.
NAME OF THE MEDICINAL PRODUCT
Skyrizi
® 150 mg solution for injection in pre-filled pen
Skyrizi
® 150 mg solution for injection in pre-filled syringe
Skyrizi
® 75 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skyrizi 150 mg solution for injection in pre-filled pen
Each pre-filled pen contains 150 mg risankizumab in 1 -mL solution.
Skyrizi 150 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 150 mg risankizumab in 1 -mL
solution.
Skyrizi 75 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 75 mg risankizumab in 0.83 -mL
solution.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal
antibody produced in Chinese
Hamster Ovary cells using recombinant DNA technology.
Excipients with known effect (75 mg solution for injection only)
This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Skyrizi 150 mg solution for injection in pre-filled pen and in
pre-filled syringe
The solution is colourless to yellow and clear to slightly opalescent
Skyrizi 75 mg solution for injection in pre-filled syringe
The solution is colourless to slightly yellow and clear to slightly
opalescent. The liquid may contain
tiny white or clear particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plaque Psoriasis
Skyrizi is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are
candidates for systemic therapy.
Psoriatic Arthritis
Skyrizi, alone or in combination with methotrexate (MTX), is indicated
for the treatment of active
psoriatic arthritis in adults who have had an inadequate response or
who have been intolerant to one or
more disease-modifying antirheumatic drugs (DMARDs).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use under the guidance and
supervision of a physician
experienced in the d