Cimzia
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
28-04-2023
Valmisteyhteenveto
(SPC)
28-04-2023
Julkisesta arviointikertomuksesta
(PAR)
24-07-2019
Aktiivinen ainesosa:
Certolizumab pegol
Saatavilla:
UCB Pharma SA
ATC-koodi:
L04AB05
INN (Kansainvälinen yleisnimi):
certolizumab pegol
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Rheumatoid
Käyttöaiheet:
Rheumatoid arthritisCimzia, in combination with methotrexate (MTX), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriatethe treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with MTX.Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:Ankylosing spondylitis (AS)Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Axial spondyloarthritis without radiogra
Tuoteyhteenveto:
Revision: 34
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-10-01
Pakkausseloste
138
B. PACKAGE LEAFLET
139
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIMZIA 200 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
certolizumab pegol
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.
-
If you have any further questions, please ask your doctor, pharmacist
or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cimzia is and what it is used for
2.
What you need to know before you use Cimzia
3.
How to use Cimzia
4.
Possible side effects
5.
How to store Cimzia
6.
Contents of the pack and other information
Your physician will also give you a Patient Reminder Card, which
contains important safety information
of which you need to be aware before you are given Cimzia and during
treatment with Cimzia. Keep
this Patient Reminder Card with you.
1.
WHAT CIMZIA IS AND WHAT IT IS USED FOR
Cimzia contains the active substance certolizumab pegol, a human
antibody fragment. Antibodies are
proteins that specifically recognise and bind to other proteins.
Cimzia binds to a specific protein called
tumour necrosis factor α (TNFα). Thereby this TNFα is blocked by
Cimzia and this decreases
inflammation diseases such as in rheumatoid arthritis, axial
spondyloarthritis, psoriatic arthritis and
psoriasis. Medicines that bind to TNFα are also called TNF blockers.
Cimzia is used in adults for the following inflammatory diseases:
•
RHEUMATOID ARTHRITIS,
•
AXIAL SPONDYLOARTHRITIS
(including ankylosing spondylitis and axial spondyloarthritis without
radiographic evidence of ankylosing spondylitis),
•
PSORIATIC ARTHRITIS
•
PLAQUE PSORIASIS
RHEUMATOID ARTHRITIS
Cimzia is used to treat rheumatoid arthritis. Rheum
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cimzia 200 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Certolizumab pegol is a recombinant, humanised antibody Fab' fragment
against tumour necrosis
factor alpha (TNFα) expressed in _Escherichia coli_ and conjugated to
polyethylene glycol (PEG).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to opalescent, colourless to yellow solution. The pH of the
solution is approximately 4.7.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Rheumatoid arthritis _
Cimzia, in combination with methotrexate (MTX), is indicated for:
•
the treatment of moderate to severe, active rheumatoid arthritis (RA)
in adult patients when the
response to disease-modifying antirheumatic drugs (DMARDs) including
MTX, has been
inadequate. Cimzia can be given as monotherapy in case of intolerance
to MTX or when
continued treatment with MTX is inappropriate
•
the treatment of severe, active and progressive RA in adults not
previously treated with MTX or
other DMARDs.
Cimzia has been shown to reduce the rate of progression of joint
damage as measured by
X-ray and to improve physical function, when given in combination with
MTX.
_Axial spondyloarthritis _
Cimzia is indicated for the treatment of adult patients with severe
active axial spondyloarthritis,
comprising:
_Ankylosing spondylitis (AS) (also known as radiographic axial
spondyloarthritis) _
Adults with severe active ankylosing spondylitis who have had an
inadequate response to, or are
intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
_Axial spondyloarthritis without radiographic evidence of AS (also
known as non-radiographic axial _
_spondyloarthritis) _
Adults with severe active axial spondyloarthritis without radiographic
evidence of AS but with
objective signs of inflammation by elevated C-reactive protein (C
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