CIMZIA certolizumab pegol (rbe) 200 mg/mL solution for injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Certolizumab pegol, Quantity: 200 mg

Tilgjengelig fra:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

INN (International Name):

Certolizumab pegol

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: sodium acetate; sodium chloride; water for injections

Administreringsrute:

Subcutaneous

Enheter i pakken:

2

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Rheumatoid arthritis Cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. ? Combined with MTX in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (DMARDs) or ? As monotherapy in case of a contraindication or intolerance to MTX (see Section 4.2 Dose and Method of Administration). Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray, when given in combination with MTX. Cimzia in combination with MTX is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX or other DMARDs.,Psoriatic arthritis Cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (DMARDs) has been inadequate. Cimzia has been shown to improve physical function.,Ankylosing spondylitis Cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (NSAID).,Non-radiographic Axial Spondyloarthritis Cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).,Plaque psoriasis Cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Produkt oppsummering:

Visual Identification: Clear to opalescent, colourless to yellow liquid, essentially free of visible particles.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-02-10

Informasjon til brukeren

Cimzia®
1
CIMZIA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CIMZIA®?
Cimzia® contains the active ingredient certolizumab pegol. Cimzia®
is used to treat several inflammatory diseases.
For more information, see Section 1. Why am I using Cimzia®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIMZIA®?
Do not use if you have ever had an allergic reaction to certolizumab
pegol or any of the ingredients listed at the end of the
CMI.
Do not use if you have tuberculosis or a severe infection or are
taking another drug called Anakinra.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cimzia®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cimzia® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CIMZIA®?
•
Follow all directions given to you by your doctor and other health
professionals carefully including:
•
how many injections to take (the initial dose is usually 2 injections
every 2 weeks, then 1 injection every 2 weeks)
More instructions can be found in Section 4. How do I use Cimzia®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIMZIA®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cimzia®.
THINGS YOU
SHOULD NOT DO
•
Do not inject yourself with this medicine unless you have been trained
by a healthcare professional.
•
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Cimzia®
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep this medicine out of the sigh

Preparatomtale

Page 1
AUSTRALIAN PRODUCT INFORMATION
CIMZIA
® (CERTOLIZUMAB PEGOL)
200 MG/ML INJECTION
1
NAME OF THE MEDICINE
Certolizumab pegol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cimzia injection contains 200 mg certolizumab pegol per mL.
Certolizumab pegol is a recombinant, humanised antibody Fab' fragment
that is expressed in an
_Escherichia coli_
bacterial expression system, subsequently purified and conjugated to
polyethylene
glycol (PEG).
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
200 MG/ML INJECTION IN A SINGLE-USE PRE-FILLED SYRINGE OR PRE-FILLED
PEN (AUTOCLICKS®)
Cimzia
®
injection is a sterile clear to opalescent solution that is colourless
to yellow, essentially free
of visible particles.
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS
Cimzia is indicated for the treatment of moderate to severe active
rheumatoid arthritis (RA) in adult
patients.
•
Combined with MTX in case of either an inadequate response or
intolerance to previous
therapy with one or more disease modifying antirheumatic drugs
(DMARDs) or
•
As monotherapy in case of a contraindication or intolerance to MTX
(see Section 4.2 Dose
and Method of Administration).
Cimzia has been shown to reduce the rate of progression of joint
damage as measured by X-ray, when
given in combination with MTX.
Cimzia in combination with MTX is indicated for the treatment of
severe, active and progressive
rheumatoid arthritis in adults not previously treated with MTX or
other DMARDs.
PSORIATIC ARTHRITIS
Cimzia is indicated for the treatment of adult patients with active
psoriatic arthritis where response to
previous disease modifying antirheumatic drug therapy (DMARDs) has
been inadequate. Cimzia has
been shown to improve physical function.
Page 2
ANKYLOSING SPONDYLITIS
Cimzia is indicated for the treatment of adult patients with active,
ankylosing spondylitis who have
been intolerant to or have had inadequate response to at least one
nonsteroidal anti-inflammatory drug
(NSAID).
NON-RAD