Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Belimumab
GlaxoSmithKline UK Ltd
L04AA26
Belimumab
120mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5000123113859
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ BENLYSTA 120 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION BENLYSTA 400 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION belimumab 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. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Benlysta is and what it is used for 2. What you need to know before you are given Benlysta 3. How Benlysta is used 4. Possible side effects 5 How to store Benlysta 6. Contents of the pack and other information 1. WHAT BENLYSTA IS AND WHAT IT IS USED FOR BENLYSTA IS A MEDICINE USED TO TREAT LUPUS (systemic lupus erythematosus, SLE) in adults (18 years of age and older) whose disease is still highly active despite standard treatment. Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, and is thought to involve a type of white blood cells called _B cells_ . Benlysta contains BELIMUMAB ( _a monoclonal antibody_ ). It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus. You will be given Benlysta as well as your usual treatment for lupus. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BENLYSTA _ _ DO NOT RECEIVE BENLYSTA: • if you are ALLERGIC to belimumab or any of the other ingredients of this medicine _(listed in section 6)._ CHECK WITH YOUR DOCTOR if th Przeczytaj cały dokument
OBJECT 1 BENLYSTA 120 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 27-Nov-2017 | GlaxoSmithKline UK This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Benlysta 120 mg powder for concentrate for solution for infusion. Benlysta 400 mg powder for concentrate for solution for infusion. 2. Qualitative and quantitative composition Benlysta 120 mg powder for concentrate for solution for infusion. Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml. Benlysta 400 mg powder for concentrate for solution for infusion. Each vial contains 400 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml. Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for concentrate for solution for infusion. White to off-white powder. 4. Clinical particulars 4.1 Therapeutic indications Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1). 4.2 Posology and method of administration Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy. Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions. Patients have been reported to develop symptoms of acute hypersensitivity several hours after the i Przeczytaj cały dokument