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Remsima 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: infliximab

Brand name

(ARTG)

: REMSIMA infliximab (rmc) 100mg Powder for Injection vial

What this medicine is used for

(ARTG)

Rheumatoid Arthritis in adults,REMSIMA, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:,- patients with active disease despite treatment with methotrexate,- patients with active disease who have not previously received methotrexate.,REMSIMA should be given in combination with methotrexate. Efficacy and safety in Rheumatoid Arthritis have been demonstrated only in combination with methotrexate.,Ankylosing Spondylitis,REMSIMA is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,Psoriatic arthritis,REMSIMA is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (DMARD) therapy. REMSIMA may be administered in combination with methotrexate.,Psoriasis,REMSIMA is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. Safety and efficacy beyond 12 months have not been established.,Crohns Disease in Adults and in Children and adolescents (6 to 17 years),REMSIMA is indicated for the treatment of moderate to severe Crohns disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,Refractory Fistulising Crohns Disease,REMSIMA is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,Ulcerative colitis in Adults and in Children and adolescents (6 to 17 years),REMSIMA is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, powder for
  • Intravenous Infusion
  • white lyophilised powder in individually boxed single-use glass vials with rubber stoppers and aluminium crimps protected by plastic caps.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Do not Freeze
  • Refrigerate
  • Shelf lifetime is 36 Months.

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 pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient infliximab

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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