국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
Belimumab, Quantity: 120 mg
GlaxoSmithKline Australia Pty Ltd
Belimumab
Injection, powder for
Excipient Ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80
Intravenous Infusion
5 mL
(S4) Prescription Only Medicine
BENLYSTA is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. ANA titre greater than or equal to 1:80 and/or anti-dsDNA titre greater than or equal to 30 IU/mL) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,The safety and efficacy of BENLYSTA have not been evaluated in patients with severe active central nervous system lupus.
Visual Identification: A white to off-white cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-10-18
BENLYSTA _FOR INJECTION_ _belimumab (rmc) 120 mg and 400 mg powder; belimumab (rmc) 200 mg in 1 mL solution_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given BENLYSTA. This leaflet answers some common questions about BENLYSTA. It does not contain all of 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 expected benefits of you being given BENLYSTA against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BENLYSTA IS USED FOR? BENLYSTA contains belimumab which belongs to a group of medicines called monoclonal antibodies. BENLYSTA is used to treat lupus (systemic lupus erythematosus, SLE) in adults (18 years of age and over). Lupus is a disease of the immune system (the body system that fights infection). People with active lupus often have high levels of a protein called BLyS in their blood. BENLYSTA binds to BLyS and limits the activity of BLyS. You will be given BENLYSTA as well as your usual treatment for lupus. Your doctor may have prescribed BENLYSTA for another reason. BENLYSTA is not addictive. BEFORE YOU ARE GIVEN BENLYSTA _DO NOT RECEIVE IF:_ YOU MUST NOT RECEIVE BENLYSTA IF: • you have ever had an allergic reaction to belimumab or any of the ingredients listed toward the end of this leaflet. (See "Ingredients"). Check with your doctor if this applies to you. • the expiry date (EXP) printed on the pack has passed. • the packaging is torn or shows signs of tampering. _TELL YOUR DOCTOR IF:_ YOU MUST TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • you have had an allergic reaction (hypersensitivity) to foods, dyes, preservatives or any other medicines or injections. You may be given medicines before you are given BENLYSTA to help reduce any inf 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION BENLYSTA (BELIMUMAB) POWDER FOR INJECTION BENLYSTA (BELIMUMAB) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Belimumab (rmc). _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Belimumab is a human IgG1 monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS). It has a molecular weight of approximately 147 kDa. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system. POWDER FOR INTRAVENOUS INFUSION Each vial contains a sufficient amount of belimumab to deliver 120 mg in 1.5 mL or 400 mg in 5 mL when reconstituted as recommended with sterile Water for Injections. After reconstitution, each mL of solution contains 80 mg belimumab. SOLUTION FOR SUBCUTANEOUS INJECTION Each pre-filled syringe or auto-injector delivers 200 mg belimumab in 1 mL (200 mg/mL). LIST OF EXCIPIENTS WITH KNOWN EFFECT For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM POWDER FOR INTRAVENOUS INFUSION BENLYSTA is a sterile, white to off-white lyophilized powder in a single-use vial. SOLUTION FOR SUBCUTANEOUS INJECTION A clear to opalescent, colourless to pale yellow solution in a single-use, pre-filled syringe or auto-injector. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BENLYSTA is indicated as add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. ANA titre ≥ 1:80 and/or anti-dsDNA titre ≥30 IU/mL) despite standard therapy. 2 The safety and efficacy of BENLYSTA have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. 4.2 DOSE AND METHOD OF ADMINISTRATION POWDER FOR INTRAVENOUS INFUSION BENLYSTA treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of SLE. BENLYSTA infusions should be administered in an environment where full resuscitation facilities are avai 전체 문서 읽기