SKYRIZI 360 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

RISANKIZUMAB

Tillgänglig från:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC-kod:

L04AC18

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

RISANKIZUMAB 150 MG/ML

Administreringssätt:

S.C

Receptbelagda typ:

Required

Tillverkad av:

ABBVIE INC., USA

Terapiområde:

RISANKIZUMAB

Terapeutiska indikationer:

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.

Tillstånd datum:

2023-02-20

Bipacksedel

رغصأ يلفس فرط
ةشوطرخلل ربكأ يولع ءزج
ب2
ةشوطرخلا صحفإ
.ةيكيتسلاپلا ةينيصلا نم ةيانعب
ةشوطرخلا جارخإب مق
هعزن وأ ةشوطرخلا نم يولعلا ءزجلا ريودت
زوجي لا ●
ةشوطرخلا صحفإ
ىلع يوتحي دقو رفصأ ىتح
ً
اقئار لئاسلا ودبي نأ بجي ●
ىرت نأ ميلس رمأ اذه .ةفافش وأ ءاضيب
ةريغص تائيزج
رثكأ وأ ةدحاو ةعاقف
وأ ،هنول ر
ّ
يغت ،
ً
اركع لئاسلا ادب اذإ لامعتسلإا زوجي لا
●
ةريبك تائيزج وأ تاتف ىلع يوتحي
وأ ةققشتم ريغ فافشلا كيتسلاپلاو
ةشوطرخلا ءازجأ
●
ةروسكم
نإو ىتح(
ً
ادمجتم لئاسلا ناك اذإ لامعتسلإا زوجي
لا ●
.)باذ
نأ تفشتكإ ،اهتطقسأ اذإ ةشوطرخلا
لامعتسإ زوجي لا ●
.ةبوطعم تناك اذإ وأ ،ةصقان ءازجأ كلانه
ج2
يلفس فرط
رغصأ
زكرم ف
ّ
ظن
يلفسلا فرطلا
رغصلأا
ةشوطرخلل رغصلأا يلفسلا فرطلا ف
ّ
ظن
ةشوطرخلل رغصلأا يلفسلا فرطلا عقوم ددح
ةطساوب ةشوطرخلا نم رغصلأا يلفسلا
فرطلا ف
ّ
ظن ●
ةيلوحك ةدامض لامعتسإ ىلع صرحإ .ةيلوحك
ةدامض
ةشوطرخلا نم رغصلأا يلفسلا فرطلا زكرم
فيظنتل
دعب ةشوطرخلا نم رغصلأا يلفسلا فرطلا
سمل زوجي لا ●
فيظنتلا
يدومع لكشب ل
ِ
خدأ
د2
"ةقط"
نقحلا ةادأ لخاد يف ةفيظنلا ةشوطرخلا ل
ّ
مح
هعزن وأ ةشوطرخلا نم يولعلا ءزجلا ريودت
زوجي لا ●
لخاد يف ةشوطرخلا نم رغصلأا يلفسلا
فرطلا لخدأ
ً
لاوأ
●
نقحلا ةادأ
ىتح ،لفسلأل ةشوطرخلا نم يولعلا ءزجلا
ةوقب عفدإ ●

Produktens egenskaper

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