Cosentyx
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-08-2023
Charakterystyka produktu
(SPC)
30-08-2023
Sprawozdanie z oceny publicznego
(PAR)
03-06-2023
Składnik aktywny:
Secukinumab
Dostępny od:
Novartis Europharm Limited
Kod ATC:
L04AC10
INN (International Nazwa):
secukinumab
Grupa terapeutyczna:
Immunosuppressants
Dziedzina terapeutyczna:
Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Wskazania:
Plaque psoriasisCosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old 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.Psoriatic arthritisCosentyx, 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 enthesitis-related 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.
Podsumowanie produktu:
Revision: 34
Status autoryzacji:
Authorised
Data autoryzacji:
2015-01-14
Ulotka dla pacjenta
140
B. PACKAGE LEAFLET
141
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSENTYX 75 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
secukinumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU (OR YOUR CHILD) START
USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you (or your child) only. Do not
pass it on to others. It
may harm them, even if their signs of illness are the same as yours
(or your child’s).
-
If you (or your child) get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cosentyx is and what it is used for
2.
What you need to know before you (or your child) use Cosentyx
3.
How to use Cosentyx
4.
Possible side effects
5.
How to store Cosentyx
6.
Contents of the pack and other information
1.
WHAT COSENTYX IS AND WHAT IT IS USED FOR
Cosentyx contains the active substance secukinumab. Secukinumab is a
monoclonal antibody which
belongs to a group of medicines called interleukin (IL) inhibitors.
This medicine works by neutralising
the activity of a protein called IL-17A, which is present at increased
levels in diseases such as
psoriasis, psoriatic arthritis and axial spondyloarthritis.
Cosentyx is used for the treatment of the following inflammatory
diseases:
•
Paediatric plaque psoriasis
•
Juvenile idiopathic arthritis, including enthesitis-related arthritis
and juvenile psoriatic arthritis
PAEDIATRIC PLAQUE PSORIASIS
Cosentyx is used to treat a skin condition called “plaque
psoriasis”, which causes inflammation
affecting the skin. Cosentyx reduces the inflammation and other
symptoms of the disease. Cosentyx is
used in adolescents and children (6 years of age and older) with
moderate to severe plaque psoriasis.
Using Cosentyx in plaque psoriasis will benefit you (or your child) by
leading to improvemen
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cosentyx 75 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 75 mg secukinumab in 0.5 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 (injection)
The solution is clear and colourless to slightly yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Juvenile idiopathic arthritis (JIA)
_Enthesitis-related arthritis (ERA) _
Cosentyx, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active
enthesitis-related arthritis in patients 6 years and older whose
disease has responded inadequately to,
or who cannot tolerate, conventional therapy (see section 5.1).
_ _
_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 (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cosentyx is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of conditions for which Cosentyx is indicated.
Posology
_Paediatric plaque psoriasis (adolescents and children from the age of
6 years) _
The recommended dose is based on body weight (Table 1) and
administered by subcutaneous injection
with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly
maintenance dosing. Each 75 mg
dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose
is given as one subcutaneous
injection of 150 mg. Each
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