RYMTI etanercept 25 mg in 0.5 mL solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Etanercept, Quantity: 25 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sucrose; sodium citrate dihydrate; water for injections; sodium chloride; monobasic sodium phosphate dihydrate; glycine

Administration route:

Subcutaneous

Units in package:

4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RYMTI is indicated for the treatment of:,Adults,Rheumatoid Arthritis,Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). RYMTI can be used in combination with methotrexate.,Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,Psoriatic Arthritis,The signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.,Plaque Psoriasis,Adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,Ankylosing Spondylitis,The signs and symptoms of active ankylosing spondylitis in adults.,Non-Radiographic Axial Spondyloarthritis,Treatment of

Product summary:

Visual Identification: Clear to opalescent, colourless to yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-10-01