Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
guselkumab, Quantity: 100 mg
Janssen-Cilag Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80
Subcutaneous
1 pre-filled syringe
(S4) Prescription Only Medicine
Plaque psoriasis,TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,Psoriatic arthritis,TREMFYA is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior DMARD therapy.
Visual Identification: Clear, colourless to light 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
Registered
2018-03-15
TREMFYA® (220518) ACMI 1 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. TREMFYA ® _Guselkumab _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TREMFYA (pronounced trem-fye-ah). It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using TREMFYA against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT TREMFYA IS USED FOR TREMFYA contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works by neutralising the activity of a protein called IL-23, which is present in increased levels in people with psoriasis. TREMFYA is used to treat: • adults with moderate to severe plaque psoriasis, an inflammatory condition affecting the skin and nails. TREMFYA can improve skin clearance and nail appearance and reduce symptoms of psoriasis, such as scaling, shedding, flaking, itching, pain, and burning. • adults with active psoriatic arthritis, an inflammatory disease of the joints in which psoriasis usually occurs in association with arthritis. If you have active psoriatic arthritis, you will be given TREMFYA alone or in combination with a conventional Disease Modifying Anti- Rheumatic Drug (DMARD) such as methotrexate. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TREMFYA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed TREMFYA for another reason. BEFORE YOU USE TREMFYA _WHEN YOU MUST NOT USE IT _ DO NOT USE TREMFYA IF: 1. YOU HAVE AN ALLERGY TO GUSELKUMAB (THE ACTIVE INGREDIENT IN THE MEDI Pročitajte cijeli dokument
13.210211 Page 1 TREMFYA (220713) API This medicinal product is subject to additional monitoring in Australia. 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 . TREMFYA ® GUSELKUMAB AUSTRALIAN PRODUCT INFORMATION 1 NAME OF THE MEDICINE Guselkumab. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Each pre-filled syringe contains 100 mg of guselkumab per 1 mL solution. TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Each pre-filled pen contains 100 mg of guselkumab per 1 mL solution Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology. For a full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Solution for injection in a prefilled syringe or a pre-filled pen (One-Press® patient controlled injector). TREMFYA is a clear, colourless to light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Plaque psoriasis _ TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. _Psoriatic arthritis _ TREMFYA is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior DMARD therapy. ▼ 13.210211 Page 2 TREMFYA (220713) API 4.2 DOSE AND METHOD OF ADMINISTRATION TREMFYA is administered by subcutaneous injection. DOSAGE (DOSE AND INTERVAL) _Plaque psoriasis _ The recommended dose of TREMFYA is 100 mg at week 0, week 4 and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatme Pročitajte cijeli dokument