COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled syringe

Active ingredient:

Secukinumab, Quantity: 150 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Secukinumab

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: polysorbate 80; nitrogen; trehalose dihydrate; histidine hydrochloride monohydrate; methionine; water for injections

Administration route:

Subcutaneous

Units in package:

1 syringe, 2 syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Plaque psoriasis,COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.,Psoriatic arthritis,COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis including axial manifestations of psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.,Axial spondyloarthritis (axSpA) with or without radiographic damage,Ankylosing spondylitis (axSpA with radiographic damage) COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.,Non-radiographic axial spondyloarthritis (axSpA without radiographic damage),COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change, who have had an inadequate response to, or are intolerant to, NSAIDs.,Juvenile Idiopathic Arthritis (JIA),Enthesitis-Related Arthritis (ERA),Cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD.,Juvenile Psoriatic Arthritis (JPsA),Cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD.,Hidradenitis Suppurativa (HS),COSENTYX 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.

Product summary:

Visual Identification: Clear, colourless-slightly yellow liquid in pre-assembled 1 mL glass syringe, with needle, needle shield, plunger, & safety device in blister; 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: Child resistant closure and restricted flow insert

Authorization status:

Registered

Authorization date:

2015-01-12