SKYRIZI 600 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

RISANKIZUMAB

から入手可能:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATCコード:

L04AC18

医薬品形態:

CONCENTRATE FOR SOLUTION FOR INFUSION

構図:

RISANKIZUMAB 60 MG/ML

投与経路:

I.V

処方タイプ:

Required

製:

ABBVIE INC., USA

治療領域:

RISANKIZUMAB

適応症:

Skyrizi is indicated for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.

承認日:

2023-02-20

情報リーフレット

يزيرياكس لامعتسإ نع تفقوت اذإ
،
ً
اقبسم بيبطلا ةراشتسإ نودب يزيرياكس
لامعتسإ نع فقوتلا زوجي لا
.دوعت نأ نكمي كيدل ضارعلأا نإف ،جلاعلا
نع تفقوت اذإ ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ
لامعتسإ زوجي لا عض .ءاود اهيف لمعتست ةرم لك يف يئاودلا
رادقملا نم دكأتلاو
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا رشتسإ ،ءاودلا اذه لامعتسإ لوح ةيفاضإ
ةلئسأ كيدل ترفوت اذإ
.يلديصلا وأ بيبطلا
ةيبناجلا ضارعلأا .4
ىدل ةيبناج
ً
اضارعأ ببسي دق يزيرياكس لامعتسإ نإ
،ءاود لكب امك
زئاجلا نم .ةيبناجلا ضارعلأا ةمئاق نم
شهدنت لا .نيلمعتسملا ضعب
.اهنم
ً
ايأ يناعت لاأ
ةريطخ ةيبناج ضارعأ
يروف لكشب ةيبط ةدعاسم يقلتل هجوتلا وأ
بيبطلا عم ثدحتلا كيلع
:لثم ،ريطخ ثولتل ضارعأ كيدل تدج
ُ
و اذإ
يليل ق
ّ
رعت ،ازنإولفنلإاب ةهيبش ضارعأ ،ةنوخس
●
رباع ريغ لاعس ،سفنتلا يف قيض وأ قاهرإب
روعشلا ●
تلاصيوحب قفارتي ملؤم يدلج حفط وأ
،ملؤمو رمحأ ،نخاس دلج ●
.يزيرياكس لامعتسإ ةلصاوم كناكمإب ناك
اذإ اميف كبيبط ررقي فوس
ةيفاضإ ةيبناج ضارعأ
:ةيلاتلا ةيبناجلا ضارعلأا ىدحإ ترهظ
اذإ كبيبطل
ِ
كحإ رهظت ضارعأ( (
very common
(
ً
ادج ةعئاش ةيبناج ضارعأ
:(10 نيب نم 1 لمعتسم نم رثكأ ىدل
يف ملأ لثم ضارعأب قفارتت يتلا يولعلا
يسفنتلا زاهجلا يف تاثولت ●
فنلأا يف ناقتحإو ةرجنحلا
1-10 ىدل رهظت ضارعأ( (
common
(

製品の特徴

SKY 360-600 JAN24_SPC_clean Page 1 of 16
1
NAME OF THE MEDICINAL PRODUCT
Skyrizi
®
600 mg concentrate for solution for infusion
Skyrizi
®
360 mg solution for injection in Pre-filled cartridge
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skyrizi 600 mg concentrate for solution for infusion
Each vial contains 600 mg of risankizumab in 10.0 mL of solution
(60mg/mL).
Skyrizi 360 mg solution for injection in Pre-filled cartridge
Each Pre-filed cartridge contains 360 mg of risankizumab in 2.4 mL
solution (150
mg/mL).
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal
antibody
selective to the interleukin (IL)-23 protein produced in Chinese
Hamster Ovary cells
using recombinant DNA technology.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Skyrizi 600 mg concentrate for solution for infusion (infusion)
The solution is colourless to slightly yellow and clear to slightly
opalescent
Skyrizi 360 mg solution for injection (injection)
The solution is colourless to yellow and clear to slightly opalescent.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Risankizumab is indicated for the treatment of patients 16 years and
older with
moderately to severely active Crohn's disease who have had an
inadequate response
to, lost response to, or were intolerant to conventional therapy or a
biologic therapy,
or if such therapies are not advisable.
4.2
Posology and method of administration
Skyrizi is intended for use under the guidance and supervision of a
physician
experienced in the diagnosis and treatment of conditions for which
Skyrizi is
indicated.
Posology
SKY 360-600 JAN24_SPC_clean Page 2 of 16
The recommended dose is 600 mg administered by intravenous infusion at
Week 0,
Week 4, and Week 8, followed by 360 mg administered by subcutaneous
injection at
Week 12, and every 8 weeks thereafter.
Missed dose
If a dose is missed, the dose should be administered as soon as
possible. Thereafter,
dosing should be resumed at the regular scheduled time.
Special populations
Elderly (aged 65 years and ove