Lifmior
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
20-02-2020
Vara einkenni
(SPC)
20-02-2020
Opinber matsskýrsla
(PAR)
20-02-2020
Virkt innihaldsefni:
etanercept
Fáanlegur frá:
Pfizer Europe MA EEIG
ATC númer:
L04AB01
INN (Alþjóðlegt nafn):
etanercept
Meðferðarhópur:
Immunosuppressants
Lækningarsvæði:
Arthritis, Psoriatic; Spondylitis, Ankylosing; Psoriasis
Ábendingar:
Rheumatoid arthritis;Juvenile idiopathic arthritisPsoriatic arthritis;Axial spondyloarthritis;Plaque psoriasis;Paediatric plaque psoriasis.
Vörulýsing:
Revision: 8
Leyfisstaða:
Withdrawn
Leyfisdagur:
2017-02-13
Upplýsingar fylgiseðill
138
B. PACKAGE LEAFLET
Medicinal product no longer authorised
139
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIFMIOR 25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
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 (BOTH SIDES) 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 Alert Card, which contains
important safety information
that you need to be aware of before and during treatment with LIFMIOR.
•
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 LIFMIOR is and what it is used for
2.
What you need to know before you use LIFMIOR
3.
How to use LIFMIOR
4.
Possible side effects
5.
How to store LIFMIOR
6.
Contents of the pack and other information
7.
Instructions for preparing and giving an injection of LIFMIOR (See
overleaf)
1.
WHAT LIFMIOR IS AND WHAT IT IS USED FOR
LIFMIOR is a medicine that is made from two human proteins. It blocks
the activity of another protein
in the body that causes inflammation. LIFMIOR works by reducing the
inflammation associated with
certain diseases.
In adults (aged 18 and over), LIFMIOR can be used for moderate or
severe RHEUMATOID ARTHRITIS,
PSORIATIC ARTHRITIS, severe AXIAL SPONDYLOARTHRITIS including
ANKYLOSING SPONDYLITIS, and moderate
Lestu allt skjalið
Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
LIFMIOR 25 mg powder and solvent 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. Etanercept is a
dimer of a chimeric protein genetically engineered by fusing the
extracellular ligand binding domain
of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc
domain of human IgG1. This Fc
component contains the hinge, CH
2
and CH
3
regions, but not the CH
1
region of IgG1. Etanercept
contains 934 amino acids and has an apparent molecular weight of
approximately 150 kilodaltons. The
specific activity of etanercept is 1.7 x 10
6
units/mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection (powder for injection).
The powder is white. The solvent is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
LIFMIOR 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.
LIFMIOR can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
LIFMIOR is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in
adults not previously treated with methotrexate.
LIFMIOR, alone or in combination with methotrexate, has
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