Erelzi
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
01-02-2024
Charakterystyka produktu
(SPC)
01-02-2024
Sprawozdanie z oceny publicznego
(PAR)
04-01-2021
Składnik aktywny:
etanercept
Dostępny od:
Sandoz GmbH
Kod ATC:
L04AB01
INN (International Nazwa):
etanercept
Grupa terapeutyczna:
Immunosuppressants
Dziedzina terapeutyczna:
Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Wskazania:
Rheumatoid arthritisErelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease‑modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis‑related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.Etanercept has not been studied in children aged less than 2 years.Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease‑modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.Axial spondyloarthritisAnkylosing spondylitis (AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non‑radiographic axial spondyloarthritisTreatment of adults with severe non‑radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non‑steroidal anti‑inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet‑A light (PUVA).Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Authorised
Data autoryzacji:
2017-06-23
Ulotka dla pacjenta
69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERELZI 25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ERELZI 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
etanercept
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
Your doctor will also give you a Patient Card, which contains
important safety information that
you need to be aware of before and during treatment with Erelzi.
If you have any further questions, ask your doctor, pharmacist or
nurse.
This medicine has been prescribed for you or a child in your care. Do
not pass it on to others. It
may harm them, even if their signs of illness are the same as yours or
those of the child you are
caring for.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Erelzi is and what it is used for
2.
What you need to know before you use Erelzi
3.
How to use Erelzi
4.
Possible side effects
5.
How to store Erelzi
6.
Contents of the pack and other information
7.
Instructions for Use of the Erelzi pre-filled syringe
1.
WHAT ERELZI IS AND WHAT IT IS USED FOR
Erelzi is a medicine that is made from two human proteins. It blocks
the activity of another protein in
the body that causes inflammation. Erelzi works by reducing the
inflammation associated with certain
diseases.
In adults (aged 18 and over), Erelzi can be used for moderate or
severe RHEUMATOID ARTHRITIS, PSORIATIC
ARTHRITIS, severe AXIAL SPONDYLOARTHRITIS including ANKYLOSING
SPONDYLITIS, and moderate or severe
PSORIASIS – in each case usually when other widely used treatments
have not worked well enough or are
not suitable for you.
For RHEUMATOID ARTHRITIS, Erelzi is usually used in combination with
methotrexate, although it may
also be used alone if treatment with methotrexate is unsuitable for
you. Whether used alone or in
com
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Erelzi 25 mg solution for injection in pre-filled syringe
Erelzi 50 mg solution for injection in pre-filled syringe
Erelzi 50 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erelzi 25 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 25 mg of etanercept.
Erelzi 50 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 50 mg of etanercept.
Erelzi 50 mg solution for injection in pre-filled pen
Each pre-filled pen contains 50 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion
protein produced by recombinant
DNA technology in a Chinese hamster ovary (CHO) mammalian expression
system.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Solution for injection (injection) in pre-filled pen (SensoReady pen)
The solution is clear or slightly opalescent, colourless to slightly
yellowish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Erelzi in combination with methotrexate is indicated for the treatment
of moderate to severe active
rheumatoid arthritis in adults when the response to disease-modifying
antirheumatic drugs, including
methotrexate (unless contraindicated), has been inadequate.
Erelzi can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment
with methotrexate is inappropriate.
Erelzi is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults
not previously treated with methotrexate.
Etanercept, alone or in combination with methotrexate, has been shown
to reduce the rate of progression
of joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
3
Treatment of polyarthritis (rheumatoid factor positive or negative)
and extended oligoarthritis in
children and adolescents from the age of 2 years who have had an
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