SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
18-02-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
Golimumab, Quantity: 100 mg/mL
Available from:
Janssen-Cilag Pty Ltd
INN (International Name):
Golimumab
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sorbitol; polysorbate 80; water for injections; histidine
Administration route:
Subcutaneous
Units in package:
3 syringes (1.0 mL), 1 syringe (1.0 mL)
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
SIMPONI,Rheumatoid arthritis (RA),SIMPONI, in combination with methotrexate, is indicated for:,The treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. SIMPONI has also been shown to inhibit the progression of joint damage as measured by X-ray.,Psoriatic arthritis (PsA),SIMPONI, alone or in combination with methotrexate, is indicated for:,The treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. SIMPONI has also been shown to inhibit the progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,Axial Spondyloarthritis,Ankylosing spondylitis (AS),SIMPONI is indicated for:,The treatment of active ankylosing spondylitis in adult patients. Non-radiographic axial spondyloarthritis (nr-Axial SpA),SIMPONI is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).,Ulcerative colitis (UC),SIMPONI is indicated for: The treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. Patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Product summary:
Visual Identification: Clear to slightly opalescent, colourless to light yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-04-02
Patient Information leaflet
SIMPONI
®
(191120)ACMI
1
SIMPONI
®
SIMPONI®IV
_Golimumab (rmc) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMPONI/SIMPONI
IV. It does not contain all the
available information. It does not
take the place of talking to your
doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using SIMPONI
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
SIMPONI/SIMPONI IV
IS USED FOR
SIMPONI/SIMPONI IV contains the
active ingredient golimumab.
Golimumab is a human monoclonal
antibody that is produced by
recombinant technology. Monoclonal
antibodies are proteins that recognise
and bind to other specific proteins in
the body.
Golimumab acts by binding to a
specific protein in the body called
tumour necrosis factor (TNF) alpha.
In people with diseases such as
rheumatoid arthritis, psoriatic
arthritis and ankylosing spondylitis,
the body produces too much TNF,
which can cause the body's immune
system to attack normal healthy parts
of the body. SIMPONI/SIMPONI IV
can block the damage caused by too
much TNF.
SIMPONI is used to treat:
•
rheumatoid arthritis
•
psoriatic arthritis
•
ankylosing spondylitis and non-
radiographic axial
spondyloarthritis
•
ulcerative colitis.
SIMPONI IV is used to treat:
•
rheumatoid arthritis
•
psoriatic arthritis
•
ankylosing spondylitis.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an
inflammatory disease of the joints.
SIMPONI/SIMPONI IV is used in
patients who have not responded well
enough to previous treatments with
other disease-modifying medicines.
SIMPONI/SIMPONI IV is used with
a disease-modifying medicine called
methotrexate.
PSORIATIC ARTHRITIS
Psoriatic arthritis is an inflammatory
disease of the joints in which
psoriasis usually occurs in
association with arthritis. Often the
fingers and toes are affected,
although
Read the complete document
Summary of Product characteristics
SIMPONI (210208) API Page 1 of 54
CCDS190211
SIMPONI
®
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
SOLUTION FOR INJECTION IN A PRE-FILLED PEN, SMARTJECT
®
SIMPONI
®
IV
SOLUTION FOR INTRAVENOUS INFUSION IN A VIAL
AUSTRALIAN PRODUCT INFORMATION
1
NAME OF THE MEDICINE
Golimumab (rmc)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMPONI PRE-FILLED SYRINGE FOR SUBCUTANEOUS INJECTION
SIMPONI is supplied as a sterile solution in a Type 1 glass syringe
with a fixed stainless-
steel needle. The needle shields are manufactured from dry natural
rubber containing latex
(see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, “Allergic
reactions”). SIMPONI is available in two strengths: 50 mg of
golimumab in 0.5 mL and 100
mg of golimumab in 1 mL. SIMPONI is available in packs of 1 or 3*
pre-filled syringe(s).
SIMPONI SMARTJECT INJECTOR PEN FOR SUBCUTANEOUS INJECTION
SIMPONI is supplied as a sterile solution in a Type 1 glass syringe
with a fixed stainless-
steel needle. This syringe is contained in a single-use pre-filled pen
called “SmartJect”. The
needle shields are manufactured from dry natural rubber containing
latex (see section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE, “Allergic reactions”).
SIMPONI is
available in two strengths: 50 mg of golimumab in 0.5 mL and 100 mg of
golimumab in 1 mL.
SIMPONI is available in packs of 1 or 3* pre-filled pen(s).
* Not currently supplied in Australia.
SIMPONI IV VIAL FOR INTRAVENOUS INJECTION
SIMPONI IV is supplied as a colourless to light yellow solution in a
Type 1 glass vial with a
laminated serum stopper with aluminium seal and a dark blue coloured
flip-off button.
Each single use vial contains 50 mg golimumab per 4 mL vial (or 12.5
mg of golimumab per
mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
Product Information - Australia
SIMPONI (210208) DPI Page 2 of 54
CCDS190211
3
PHARMACEUTICAL FORM
SIMPONI
SUBCUTANEOUS
Solution for injection in pre-filled syringe or pre-filled pen, as a
clear to slightly opalescent,
colourless to lig
Read the complete document
