SKYRIZI 75 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RISANKIZUMAB

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

L04AC18

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

RISANKIZUMAB 75 MG / 0.83 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

Therapeutic area:

RISANKIZUMAB

Therapeutic indications:

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).

Authorization date:

2020-01-16

Patient Information leaflet

لامعتسلإا تاميلعت .7
يزيرياكس لامعتسإ لبق اهلماكب 7 ةرقفلا
أرقإ ءاجرلا
فرعت نأ مهملا نم ،يزيرياكس نقحت نأ لبق
ةدعاسمل ةجاحب تنك اذإ كبيبط وأ ةضرمملا
،يلديصلا عم ثدحت .ةنقحلا ءاطعإ لبق
يزيرياكس نقح ةيفيك لوح
ً
اداشرإ ىقلتت نأ كيلع ●
يزيرياكس نقح كيلع ىتم فرعت يكل ،كب
ةصاخلا يونسلا ميوقتلا ةحول يف
خيراوتلا م
ِّ
لع ●
اهلامعتسإ دعوم نيحي نأ ىلإ ءوضلا نم
ءاودلا ةيامحل ةيلصلأا ةبلعلا يف
يزيرياكس ظفحإ ●
ىلع يوتحي دقو رفصلأل لئام ىتح
ً
اقئار لئاسلا ودبي نأ بجي .ةريبك تاميسج
وأ تاتف ىلع يوتحي وأ
ً
اركع لئاسلا ناك اذإ نقحلا زوجي لا ●
ةفافش وأ ءاضيب ةريغص تاميسج
ةنقحملا ضخ زوجي لا ●
.
ً
ايلعف نقحلا ليبق ىتح ةربلإا ءاطغ عزن
يف ثيرت ●
ةيلديصلل ءاودلا اذه عاجرإب مق
)EXP( ةيحلاصلا خيرات ىضقنإ اذإ ●
)باذ ولو ىتح( ةرم تاذ لئاسلا دمجت اذإ ●
تررضت وأ ةنقحملا تطقس اذإ ●
ً
اصقان وأ
ً
اروسكم يقرولا ةحيوللا ءاطغ ناك اذإ ●
.نقحلا لبق ةقيقد 30 ىتح 15 ةدمل ،رشابملا
سمشلا ءوض نع
ً
اديعب ،ةفرغلا ةرارح ةجردب اهكرتأو
داربلا نم ةوبعلا جرخأ :رثكأ حيرم نقحل
)نخاس ءام يف وأ ڤيووركيملا لخادب ،
ً
لاثم( ىرخأ ةقيرط ةيأب يزيرياكس نيخست
زوجي لا ●
نقحلل
ً
ازهاج نوكت نأ ىلإ ةوبعلا لخاد
نيتنقحملا ظفحإ ●
يزيرياكس لمعتست ةرم لك يف هاندأ
تاميلعتلا عبتإ
1
ةلحرملا
:يوتسم

Summary of Product characteristics

Page 1 of 20
SKY API SEP22_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 selective to the
interleukin (IL)-23 protein 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
Skyrizi is intended for use under the guidance and supervision of a
physician