1. Adults 1) Rheumatoid arthritis - Administration alone or in combination with methotrexate in moderate to major adult active rheumatoid arthritis that does not respond appropriately to DMARDs (Disease-Modifying anti Rheumatic Drugs) including methotrexate. - Administration alone if there is no tolerance to methotrexate or it is inappropriate to continue the treatment of methotrexate. - Major active and progressive rheumatoid arthritis that has not been previously treated with methotrexate - Delayed progression of structural damage associated with the disease as measured by X-ray when administered alone or in combination with methotrexate in patients with rheumatoid arthritis 2) Psoriatic arthritis Active and progressive psoriatic arthritis that has not responded appropriately to DMARDs (Disease-Modifying anti Rheumatic Drugs) 3) Axial spondylarthritis - Ankylosing spondylitis: Major ankylosing spondylitis with inadequate response to existing treatment - Radiologically unidentified axial spondylitis: Major axial spondyloarthritis that is not identified radiologically but shows objective signs of inflammation such as CRP increase and/or MRI For patients who do not respond appropriately to nonsteroidal anti-inflammatory drugs (NSAIDs) 4) Psoriasis Moderate or major psoriasis that does not respond to systemic therapy, including cyclosporine, methotrexate, or PUVA, or is contraindications or has no tolerability
2. Children 1) Juvenile idiopathic arthritis - Multiple arthritis (positive or negative rheumatoid factor) and extended oligoarthritis in children over the age of 2 and adolescents who do not respond appropriately to methotrexate or have no tolerability - Psoriatic arthritis in adolescents over the age of 12 who do not respond appropriately to methotrexate or have no tolerability - Enthesitis-related arthritis in adolescents over the age of 12 who do not respond appropriately to existing treatment or have no tolerability
Active Ingredient and Capacity
Etanercept 25 mg/0.5 mL, 50 mg/1.0 mL
Appearance & Packaging Unit An injection that is a colorless or light yellow, clear or milky liquid in a colorless transparent prefilled syringe 50mg/1.0mL prefilled syringe x 1/box, 50mg/1.0mL prefilled syringe x 4/box, 25mg/0.5mL prefilled syringe x 1/box, 25mg/0.5mL prefilled syringe x 4/box
Storage / Shelf Life In a hermetic container, protect from light and keep refrigerated (2~8℃). 36 months
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