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Amgevita 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: adalimumab

Brand name

(ARTG)

: AMGEVITA adalimumab (rch) 40mg/0.8mL injection solution 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)

Rheumatoid Arthritis,AMGEVITA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. AMGEVITA can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis AMGEVITA in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis AMGEVITA is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis AMGEVITA is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis AMGEVITA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohns Disease in Adults and Children (6 years and older) AMGEVITA is indicated for the treatment of moderate to severe Crohns disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; who have had an inadequate response to conventional therapies or, who have lost response to or are intolerant of infliximab.,Ulcerative colitis AMGEVITA is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,Psoriasis in Adults and Children AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis Suppurativa AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • Liquid, practically free from particles

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
  • 2 pack
  • 4 pack
  • 6 pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient adalimumab

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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