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Simponi TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: golimumab

Brand name

(ARTG)

: SIMPONI golimumab (rmc) 50 mg solution for injection pre-filled syringe

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

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).

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • Clear to slightly opalescent, colourless to light yellow solution.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Refrigerate
  • Shelf lifetime is 3 Years.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 1 syringe (0.5 mL) pack
  • 3 syringes (0.5 mL) pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient golimumab

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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