Enbrel
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
11-01-2024
Svojstava lijeka
(SPC)
11-01-2024
Izvješće o ocjeni javnog
(PAR)
03-09-2014
Aktivni sastojci:
etanercept
Dostupno od:
Pfizer Europe MA EEIG
ATC koda:
L04AB01
INN (International ime):
etanercept
Terapijska grupa:
Immunosuppressants
Područje terapije:
Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Psoriasis; Arthritis, Rheumatoid
Terapijske indikacije:
Rheumatoid arthritis Enbrel 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. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, 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 Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two 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. Enbrel has not been studied in children aged less than two years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel 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 spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment 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 nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment 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 psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,
Proizvod sažetak:
Revision: 72
Status autorizacije:
Authorised
Datum autorizacije:
2000-02-02
Uputa o lijeku
223
B. PACKAGE LEAFLET
224
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENBREL 25 MG POWDER FOR SOLUTION FOR INJECTION
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 Enbrel.
•
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
Information in this leaflet is organised under the following 7
sections:
1.
What Enbrel is and what it is used for
2.
What you need to know before you use Enbrel
3.
How to use Enbrel
4.
Possible side effects
5.
How to store Enbrel
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT ENBREL IS AND WHAT IT IS USED FOR
Enbrel is a medicine that is made from two human proteins. It blocks
the activity of another protein in
the body that causes inflammation. Enbrel works by reducing the
inflammation associated with certain
diseases.
In adults (aged 18 and over), Enbrel 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, Enbrel 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
combination with methotrexat
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Enbrel 25 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 25 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
Powder for solution for injection (powder for injection).
The powder is white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Enbrel 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.
Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults
not previously treated with methotrexate.
Enbrel, 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
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
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.
3
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when
the response to pr
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