SIMPONI SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

GOLIMUMAB

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

GOLIMUMAB

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

CILAG AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SIMPONI
® SOLUTION FOR INJECTION
GOLIMUMAB 50MG/0.5ML
GOLIMUMAB 100MG/1ML
1
WHAT IS IN THIS LEAFLET
1.
What SIMPONI
®
is used for
2.
How SIMPONI
®
works
3.
Before you use SIMPONI
®
4.
How to use SIMPONI
®
5.
While you are using SIMPONI
®
6.
Side effects
7.
Storage and Disposal of
SIMPONI
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SIMPONI
® IS USED FOR
SIMPONI
®
is a prescription medicine
that is approved for the treatment of
adult patients with rheumatoid
arthritis, psoriatic arthritis, ankylosing
spondylitis, non-radiographical axial
spondyloarthritis, and ulcerative
colitis.
HOW SIMPONI
® WORKS
In these diseases, the body produces
too much of a substance called tumor
necrosis factor alpha (TNF-alpha).
Too much of this substance causes
your body’s immune system to attack
healthy tissue and results in
inflammation. Blocking TNF-alpha
with SIMPONI
®
can reduce
inflammation associated with these
diseases, but can also reduce your
immune system’s ability to fight off
infections.
BEFORE YOU USE SIMPONI
®
-
_When you must not use it _
Do not use SIMPONI
®
if:
•
If you are allergic
(hypersensitive) to golimumab or
any of the other ingredients of this
medicine.
•
If you have tuberculosis (TB) or
any other severe infection.
•
If you have moderate or severe
heart failure.
If you are not sure if any of the above
applies to you, talk to your doctor,
pharmacist or nurse before using
SIMPONI
®
.
-
_Before you start to use it _
Before receiving treatment with
SIMPONI
®
, tell your doctor if you:
•
have any kind of infection even if
it is very minor.
•
have an infection that won't go
away or a history of infection that
keeps coming back.
•
have had TB (tuberculosis), or if
you have recently been near
anyone who might have TB. Your
doctor will evaluate you for TB
and perform a skin or a blood test.
If your doctor feels that you are at
risk for TB, he or she may start
treating you for TB before

Ciri produk

PRODUCT NAME
SIMPONI
®
Solution for Injection
SIMPONI
®
IV 12.5mg/1ml Concentrate for Solution for Infusion
DOSAGE FORMS AND STRENGTHS
Golimumab is a human IgG1κ monoclonal antibody that exhibits multiple
glycoforms with predicted
molecular masses ranging from 149802 daltons to 151064 daltons.
Golimumab is produced by a
recombinant cell line cultured by continuous perfusion and is purified
by a series of steps that includes
measures to inactivate and remove viruses.
SIMPONI is available as a solution for injection for subcutaneous (SC)
administration in the following
presentations:
PRE-FILLED SYRINGE:
•
Each 50 mg single-use pre-filled syringe contains 50 mg golimumab per
0.5 mL syringe.
•
Each 100 mg single-use pre-filled syringe contains 100 mg golimumab
per 1.0 mL syringe.
AUTOINJECTOR/PRE-FILLED PEN:
•
Each 50 mg single-use autoinjector/pre-filled pen contains 50 mg
golimumab per 0.5 mL in an
autoinjector/pre-filled pen.
•
Each 100 mg single-use autoinjector/pre-filled pen contains 100 mg
golimumab per 1.0 mL in an
autoinjector/pre-filled pen.
SIMPONI is available as a solution for intravenous (IV) infusion:
SINGLE-USE VIAL
Each single-use vial contains 50 mg golimumab per 4 mL vial (or 12.5
mg of golimumab per mL).
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
SIMPONI
® SOLUTION FOR INJECTION
_Rheumatoid arthritis (RA): _
SIMPONI, by SC administration, in combination with methotrexate (MTX),
is indicated for:
•
the treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response
to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX
has been inadequate.
•
the treatment of severe, active, and progressive rheumatoid arthritis
in adults not previously treated
with MTX.
SIMPONI, in combination with MTX, has been shown to reduce the rate of
progression of joint damage as
measured by X-ray and to improve physical function.
_Psoriatic arthritis (PsA): _
SIMPONI, by SC administration, alone or in combination with MTX, is
in