Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
Golimumab, Quantity: 100 mg/mL
Janssen-Cilag Pty Ltd
Golimumab
Injection, solution
Excipient Ingredients: sorbitol; polysorbate 80; water for injections; histidine
Subcutaneous
3 syringes (1.0 mL), 1 syringe (1.0 mL)
(S4) Prescription Only Medicine
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).
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
Licence status A
2014-04-02
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_full_document
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_full_document