Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Secukinumab, Quantity: 150 mg
Novartis Pharmaceuticals Australia Pty Ltd
Secukinumab
Injection, powder for
Excipient Ingredients: histidine hydrochloride monohydrate; nitrogen; polysorbate 80; sucrose; water for injections
Subcutaneous
2 vials, 1 vial
(S4) Prescription Only Medicine
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.
Visual Identification: Colourless 6 mL glass vials, chlorobutyl rubber stopper with fluorocarbon layer on the product side, aluminum cap with plastic flip off lid; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-01-12
1 This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting- problems. AUSTRALIAN PRODUCT INFORMATION COSENTYX ® (SECUKINUMAB [RCH]) 75 MG/0.5 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150 MG/1 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150 MG/1 ML SOLUTION FOR INJECTION IN PREFILLED PEN 150 MG POWDER FOR INJECTION IN VIAL 300 MG/2 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE 300 MG/2 ML SOLUTION FOR INJECTION IN PREFILLED PEN 1 NAME OF THE MEDICINE Secukinumab (rch) Chemical name: Recombinant human monoclonal anti-human Interleukin-17A (IL-17A, IL-17) antibody of the IgG1/kappa isotype 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Secukinumab is a recombinant fully human monoclonal antibody selective for interleukin-17A. Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary (CHO) cells. 3 PHARMACEUTICAL FORM POWDER FOR INJECTION Each vial of powder for injection contains 150 mg of secukinumab as a lyophilised cake in glass vials. SOLUTION FOR INJECTION Solution for injection in a single-use, 0.5mL pre-filled syringe containing 75 mg secukinumab. Solution for injection in a single-use, 1 mL pre-filled syringe and/or pen (auto-injector) containing 150 mg of secukinumab. Solution for injection in a single-use, 2 mL pre-filled syringe and/or pen (auto-injector) containing 300 mg of secukinumab. ▼ 2 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 (DMAR Citiți documentul complet