Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Etanercept, Quantity: 50 mg
Samsung Bioepis AU Pty Ltd
Etanercept
Injection, solution
Excipient Ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate heptahydrate; sodium chloride; sucrose; water for injections
Subcutaneous
Pack of 1 (starter pack), Pack of 4
(S4) Prescription Only Medicine
Adults (18 years and older),Rheumatoid Arthritis,Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Brenzys 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. Etanercept 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.
Visual Identification: Pre-filled syringe: a clear type I glass barrel, with rubber plunger, stainless steel needle and rubber needle shield.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-07-22
_ _ Version 13.0 _Brenzys_ _®_ _ - etanercept_ Page 1 / 11 BRENZYS ® ETANERCEPT SOLUTION FOR INJECTION (PRE-FILLED SYRINGE) BRENZYS ® ETANERCEPT SOLUTION FOR INJECTION (AUTO-INJECTOR) EACH SYRINGE OR AUTO-INJECTOR CONTAINS ETANERCEPT 50 MG CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Brenzys. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Brenzys against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BRENZYS IS USED FOR Brenzys is used in adults for the treatment of: rheumatoid arthritis ankylosing spondylitis non-radiographic axial spondyloarthritis (nr-AxSpA) psoriatic arthritis plaque psoriasis. Tumour necrosis factor (TNF) is a naturally occurring chemical messenger in your bloodstream. TNF plays a role in causing pain and swelling in the joints. Brenzys is a biotechnology- derived protein that works by binding to TNF and preventing it from acting. This reduces the pain and swelling of rheumatoid arthritis and psoriasis, helps to treat the skin lesions of psoriasis and psoriatic arthritis, and improves the condition of patients with ankylosing spondylitis and nr-AxSpA. Your doctor may have prescribed Brenzys for another reason. Ask your doctor if you have any questions about why Brenzys has been prescribed for you. This medicine is available only with a doctor's prescription. Brenzys is not addictive. Brenzys is not indicated for use in children less than 18 years of age. Other etanercept products are available for use in children. BEFORE YOU USE BRENZYS _WHEN YOU MUST NOT USE IT _ DO NOT USE BRENZYS IF: 1. YOU HAVE AN ALLERGY TO BRENZYS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of a সম্পূর্ণ নথি পড়ুন
Version:13.0 Page 1 of 42 AUSTRALIAN PRODUCT INFORMATION – BRENZYS ® (ETANERCEPT) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Etanercept Brenzys is a biosimilar medicine to Enbrel ® . The evidence for comparability supports the use of Brenzys for the listed indication(s). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. 50 mg solution for injection in Auto-injector Each Auto-injector contains 50 mg of etanercept. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection (injection) Brenzys solution for injection in the pre-filled syringe and in the Auto-injector is a clear, colourless or pale yellow solution with a pH of 6.2 ± 0.3. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Brenzys is indicated for the treatment of: _ADULTS (≥ 18 YEARS) _ RHEUMATOID ARTHRITIS Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Brenzys 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. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Version:13.0 Page 2 of 42 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 elevate সম্পূর্ণ নথি পড়ুন