COSENTYX SOLUTION FOR INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SECUKINUMAB

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L04AC10

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SECUKINUMAB 150 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA AG.,SWITZERLAND

Therapeutic area:

SECUKINUMAB

Therapeutic indications:

- Plaque psoriasis: Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. - Paediatric plaque psoriasis: Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. - Psoriatic arthritis: Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. - Axial spondyloarthritis (axSpA) : •Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. •Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of 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 in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs). - Juvenile idiopathic arthritis (JIA) •Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitisrelated arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. •Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.Hidradenitis suppurativa (HS)Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy

Authorization date:

2020-07-31

Patient Information leaflet

)ةيجراخلا نذلأا باهتلإ( ةيجراخلا نذلأا
ثولت
∙
)ةمحتلملا باهتلإ( خافتنإو رارمحإ ،ةكحب
قفارتي نينيعلا نم زارفإ
∙
)ىرش( ةكحب قفارتي حفط ∙
ةيلفسلا ةيسفنتلا قرطلا يف تاثولت
∙
)ءاعملأا يف لكاشمل تاملاع( زاربلا يف مد
وأ نزولا نادقف ،لاهسإ ،نطبلا يف ملاآو
تاصلقت
∙
نيمدقلاو نيديلا عباصأ فارطأ يفو
نيمدقلا نطاب يف ،نيديلا يتحار يف ةكاح
ةريغص تلاصيوح ∙
)
dyshidrotic eczema
(
مدقلا تايرطف
∙
:)10,000 نيب نم نيلمعتسم 1-10 ىدل رهظت يتلا
ضارعأ( ةردان ةيبناج ضارعأ
ةيقأت ةمدصب قفارتي داح يسسحت لعف در ∙
املؤم وأ اكاح نوكي دق يذلا ،مسجلا يف
ةعساو ةقطنم حطس ىلع دلجلا رشقتو رارمحإ
∙
)
exfoliative dermatitis
(
ةيجسفنب وأ ءارمح ةريغص تاءوتن عم يدلج
حفط ىلإ يدؤي دق يذلا ةريغص ةيومد ةيعوأ
باهتلإ
∙
)
vasculitis
(
:)دعب ددحي مل اهعويش ضارعأ( فورعم ريغ
عويش تاذ ةيبناج ضارعأ
)ءيرملا يف ]رطفلا نم عون[
تاضيبملا ءاد
لمشي( ةيطاخملا ةيشغلأاو دلجلل يرطف
ثولت
∙
)
pyoderma gangrenosum
ـ ينيرغنغلا دلجلا حيقت( دلجلا يف حرقت
لكشتو ملؤم خافتنإ
∙ )كلفط يناعي وأ( تنأ يناعت امدنع وأ
ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ
،يبناج ضرع رهظ اذإ
.بيبطلا ةراشتسإ كيلع ،ةرشنلا هذه يف
ركذي مل يبناج ضرع نم ةيبناج ضارعأ نع غيلبتلا
ةيبناج ضارعأ نع غيلبت" طبارلا ىلع
طغضلا ةطساوب ةحصلا ةرازول ةيبناج
ضارعأ نع غيلبتلا ناكملإا�

Summary of Product characteristics

COS API Nov23 V12
Based on EU SmPC May 2023
1.
NAME OF THE MEDICINAL PRODUCT
Cosentyx
®
Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cosentyx 75 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 75 mg secukinumab in 0.5 ml.
Cosentyx 150 mg solution for injection in pre-filled syringe/pen
Each pre-filled syringe/pen contains 150 mg secukinumab in 1 ml.
Cosentyx 300 mg solution for injection in pre-filled syringe/pen
Each pre-filled syringe/pen contains 300 mg secukinumab in 2 ml.
Secukinumab is a recombinant fully human monoclonal antibody produced
in Chinese Hamster Ovary
(CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe/pen
The solution is clear and colourless to slightly yellow.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Adult Plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are candidates
for systemic therapy.
Paediatric plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque
psoriasis in children and adolescents
from the age of 6 years who are candidates for systemic therapy.
Hidradenitis suppurativa (HS)
Cosentyx is indicated for the treatment of active moderate to severe
hidradenitis suppurativa (acne inversa)
in adults with an inadequate response to conventional systemic HS
therapy (see section 5.1).
Psoriatic arthritis
Cosentyx, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active
psoriatic arthritis in adult patients when the response to previous
disease-modifying anti-rheumatic drug
(DMARD) therapy has been inadequate (see section 5.1).
COS API Nov23 V12
Based on EU SmPC May 2023
Axial spondyloarthritis (axSpA)
_Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) _
Cosentyx is indicated for the treatment of active ankylosing
spondylitis in adults who have responded
inadequately to conventional therapy.
_Non-radiographic ax