Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Tocilizumab
Roche Products Pty Ltd
Medicine Registered
ACTEMRA ® PRONOUNCED (ACT-TEM-RA) _contains the active ingredient tocilizumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ACTEMRA infusion. 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 ACTEMRA against the benefits they expect it will 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 ACTEMRA IS USED FOR ACTEMRA contains the active ingredient tocilizumab. ACTEMRA belongs to a group of medicines called anti-rheumatic agents. There are many different classes of anti-rheumatic agents. ACTEMRA belongs to a class called monoclonal antibodies. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body. ACTEMRA is used to treat active moderate to severe rheumatoid arthritis (RA). ACTEMRA is also used to treat active systemic juvenile idiopathic arthritis (sJIA) and active moderate to severe polyarticular juvenile idiopathic arthritis (pJIA) in children over 2 years of age. Some of the signs and symptoms of RA, pJIA and sJIA are caused by the actions of a protein called interleukin-6 receptor (IL-6R). For RA ACTEMRA can also prevent damage occurring to your joints and improve your ability to do your normal daily activities. ACTEMRA works by binding and blocking IL-6R thereby helping to relieve some of the signs and symptoms of RA, pJIA or sJIA. There are many different types of medicines used to treat RA, pJIA and sJIA. Your doctor, however, may have prescribed ACTEMRA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ACTEMRA HAS BEEN PRESCRIBED FOR YOU. ACTEMRA is not addictive. This medicine is available only with a doctor's prescription. For pJIA and sJIA ACTEMRA should be prescribed by a Lire le document complet
Actemra ® PI 131004 1 of 37 CDS 8.0 ACTEMRA _Tocilizumab (rch) _ CAS 375823-41-9 Tocilizumab is a recombinant humanised monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass which binds to human interleukin 6 (IL-6) receptors. It is composed of two heterodimers, each of which consists of a heavy and a light polypeptide chain. The light chain contains of 214 amino acids and the heavy chain 448 amino acids. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab has a molecular weight of approximately 148,000 Daltons. Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). DESCRIPTION ACTEMRA is a clear to opalescent, colourless to pale yellow sterile solution for intravenous (IV) infusion. ACTEMRA is supplied in preservative-free, non-pyrogenic single-use, clear glass vials. ACTEMRA is available in 10 mL and 20 mL vials containing 4 mL, 10 mL or 20 mL of tocilizumab concentrate (20 mg/mL). ACTEMRA also contains polysorbate 80, sucrose, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate and water for injections. PHARMACOLOGY _MECHANISM OF ACTION_ Tocilizumab is a recombinant humanised monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass. Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors, and has been shown to inhibit sIL-6R and mIL-6R-mediated signaling. IL-6 is a multi-functional cytokine, produced by a variety of cell types involved in local paracrine function as well as regulation of syst Lire le document complet