ERELZI etanercept (rch) 50 mg in 1 mL solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Etanercept, Quantity: 50 mg/mL

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: citric acid; sucrose; water for injections; sodium chloride; lysine hydrochloride; sodium citrate dihydrate; sodium hydroxide; hydrochloric acid

Administration route:

Subcutaneous

Units in package:

1 pre-filled syringe containing 1 mL solution, 4 pre-filled syringes each containing 1 mL solution, 12 pre-filled syringes each containing 1 mL solution, 2 pre-filled syringes each containing 1 mL solution

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults,Rheumatoid Arthritis,Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ERELZI 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. ERELZI 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 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.,Active disease is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4.,Children and Adolescents,Paediatric patients weighting less than 62.5 kg should not receive ERELZI. Paediatric patients weighting less than 62.5 kg should be accurately dosed on a mg/kg basis with other etanercept products.,Juvenile Idiopathic Arthritis,Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs.,Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.,Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,Etanercept has not been studied in children aged less than 2 years.,Paediatric Plaque Psoriasis,Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant PASI response is not achieved.

Product summary:

Visual Identification: Colourless to slightly yellowish solution. Clear to slightly opalescent solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2017-11-30