CIMZIA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CERTOLIZUMAB PEGOL

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

L04AB05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CERTOLIZUMAB PEGOL 200 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

UCB PHARMA S.A., BELGIUM

Therapeutic area:

CERTOLIZUMAB PEGOL

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 methotrexate, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. 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 methotrexate.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 radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Crohn's Disease :CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.Plaque psoriasis:Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.

Authorization date:

2019-07-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a physician’s prescription only
CIMZIA
EACH PRE-FILLED SYRINGE CONTAINS: Certolizumab pegol 200 mg in 1 ml
solution for
injection.
THE SOLUTION IS INTENDED FOR SUBCUTANEOUS INJECTION ONLY.
For a list of inactive ingredients and allergens in the medicinal
product, see section
‘Important information about some of this medicine’s
ingredients’ and section 6,
‘Additional information.’
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE
AND KEEP IT.
This leaflet contains concise information about the medicine. If you
have any further
questions, contact the physician or the pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on
to others. It may harm them, even if it seems to you that their
illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
RHEUMATOID ARTHRITIS
Cimzia is indicated for the treatment of moderate to severe rheumatoid
arthritis in
adults, in combination with methotrexate, when the response to the
treatment with
other medicines (disease-modifying antirheumatic drugs) including
methotrexate, was
inadequate. Cimzia can also be given as monotherapy if the combination
with
methotrexate is not possible.
Cimzia in combination with methotrexate reduce the signs and symptoms
of your
disease, slow down the damage to the cartilage and bone of the joints
caused by the
disease and improve your physical function and performance of daily
tasks.
AXIAL
SPONDYLOARTHRITIS
–
INCLUDING
ANKYLOSING
SPONDYLITIS
AND
AXIAL
SPONDYLOARTHRITIS WITHOUT RADIOGRAPHIC EVIDENCE OF ANKYLOSING
SPONDYLITIS
Cimzia is also indicated for the treatment of adult patients with
severe active axial
spondyloarthritis, including:

Adults with severe active ankylosing spondylitis who have had an
inadequate
response
to,
or
are
intolerant
to
nonsteroidal
anti-inflammatory
drugs
(NSAIDs).

Adults with severe active axial spondyloarthritis without radiogr

Summary of Product characteristics

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SUMMARY OF PRODUCT
CHARACTERISTICS
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.
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
methotrexate, has been
inadequate.
Cimzia can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
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
methotrexate.
_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
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objective signs of inflammation by elevated C-reactive protein (CRP)
and /or magnetic resonance
imaging (MRI), who have had an inadequate respo