Benepali

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

etanercept

זמין מ:

Samsung Bioepis NL B.V.

קוד ATC:

L04AB01

INN (שם בינלאומי):

etanercept

קבוצה תרפויטית:

Immunosuppressants

איזור תרפויטי:

Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis

סממני תרפויטית:

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

leaflet_short:

Revision: 21

מצב אישור:

Authorised

תאריך אישור:

2016-01-13

עלון מידע

96
B. PACKAGE LEAFLET
97
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENEPALI 25 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 Benepali.
-
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 Benepali is and what it is used for
2.
What you need to know before you use Benepali
3.
How to use Benepali
4.
Possible side effects
5.
How to store Benepali
6.
Contents of the pack and other information
7.
Instructions for use (see overleaf)
1.
WHAT BENEPALI IS AND WHAT IT IS USED FOR
Benepali contains the active substance etanercept.
Benepali is a medicine that is made from two human proteins. It blocks
the activity of another protein
in the body that causes inflammation. Benepali works by reducing the
inflammation associated with
certain diseases.
In adults (aged 18 and over), Benepali can be used for:
•
moderate or severe
RHEUMATOID ARTHRITIS
;
•
PSORIATIC ARTHRITIS
;
•
severe
AXIAL SPONDYLOARTHRITIS
including
ANKYLOSING SPONDYLITIS
;
•
moderate or severe
PLAQUE
PSORIASIS
.
In each case Benepali is used, usually when other widely used
treatments have not worked well
enough or are not suitable for you.
For RHEUMATOID ARTHRITIS
, Benepali is usually used in combination with methotrexate, although
it may
also be used alone if treatment with methotrexate is unsuitable for
you. W

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Benepali 25 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe 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
Solution for injection (injection).
The solution is clear to slightly opalescent, colourless or pale
yellow, and is formulated at pH 6.2 ±
0.3. The osmolality of the solution is 325 ± 35 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Benepali 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.
Benepali can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Benepali is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in
adults not previously treated with methotrexate.
Benepali, 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 p