Nepexto

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

etanercept

Fáanlegur frá:

Biosimilar Collaborations Ireland Limited

ATC númer:

L04AB01

INN (Alþjóðlegt nafn):

etanercept

Meðferðarhópur:

Immunosuppressants

Lækningarsvæði:

Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis

Ábendingar:

Rheumatoid arthritisNepexto 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.Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Nepexto, 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 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 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.

Vörulýsing:

Revision: 10

Leyfisstaða:

Authorised

Leyfisdagur:

2020-05-20

Upplýsingar fylgiseðill

56
B.
PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEPEXTO 25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
NEPEXTO 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
etanercept
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Nepexto.
-
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 Nepexto is and what it is used for
2.
What you need to know before you use Nepexto
3.
How to use Nepexto
4.
Possible side effects
5.
How to store Nepexto
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT NEPEXTO IS AND WHAT IT IS USED FOR
Nepexto contains the active substance etanercept.
Nepexto is a medicine that is made from two human proteins. It blocks
the activity of another protein
in the body that causes inflammation. This medicine works by reducing
the inflammation associated
with certain diseases.
In adults (aged 18 and over), Nepexto can be used for:
•
moderate or severe
RHEUMATOID ARTHRITIS
(long-term autoimmune disorder that primarily affects
joints);
•
PSORIATIC ARTHRITIS
(a type of inflammatory arthritis which can affect any joint in the
body);
•
severe
AXIAL

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Nepexto 25 mg solution for injection in pre-filled syringe
Nepexto 50 mg solution for injection in pre-filled syringe
Nepexto 50 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nepexto 25 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 25 mg of etanercept.
Nepexto 50 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 50 mg of etanercept.
Nepexto 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).
The solution is clear to opalescent, colourless to yellow and is
formulated at pH 6.3 ± 0.2. The
osmolality of the solution is 310 ± 30 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Nepexto 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.
Nepexto can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Nepexto is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in
adults not previously treated with methotrexate.
3
Nepexto, alone or in combination with methotrexate, has been shown to
reduce the rate of progression
of jo