Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Secukinumab, Quantity: 150 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Secukinumab
Injection, solution
Excipient Ingredients: trehalose dihydrate; water for injections; methionine; nitrogen; polysorbate 80; histidine hydrochloride monohydrate
Subcutaneous
1 pen, 2 pens
(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: Pen containing a clear, colourless-slightly yellow liquid in 1 mL glass syringe, with seal bridges, cap, and label.; 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
Licence status A
2015-01-12
COSENTYX ® C O S E N T Y X ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING COSENTYX? COSENTYX contains the active ingredient secukinumab. COSENTYX is used to treat plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. For more information, see Section 1. Why am I using COSENTYX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE COSENTYX? Do not use if you have ever had an allergic reaction to secukinumab or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use COSENTYX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with COSENTYX and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE COSENTYX? • Your healthcare provider will prescribe the dose of COSENTYX that is right for you. Use COSENTYX exactly as prescribed. • Do not try to inject COSENTYX yourself until you or your caregiver has been shown how by your healthcare provider. • If you have forgotten to inject a dose of COSENTYX, do not take a double dose to make up for the dose you missed. More instructions can be found in Section 4. How do I use COSENTYX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING COSENTYX? THINGS YOU SHOULD DO • DISCONTINUE TREATMENT AND TELL YOUR DOCTOR OR PHARMACIST IMMEDIATELY IF YOU GET ANY SIGNS OR SYMPTOMS OF A POTENTIALLY SERIOUS INFECTION OR AN ALLERGIC REACTION DURING TREATMENT WITH COSENTYX. • TELL YOUR DOCTOR YOU ARE TAKING COSENT Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument