Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Anakinra
A Menarini Australia Pty Ltd
Medicine Registered
CONSUMER MEDICINE INFORMATION KINERET ® (ANAKINRA) Page 1 of 9 INVIDA AUSTRALIA PTY LIMITED KINERETCMI03SEP10-VER3 KINERET _(anakinra) _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about Kineret (anakinra). 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 taking Kineret against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START USING KINERET AND KEEP IT WITH THE MEDICINE. You may need to read it again. What Kineret is used for Kineret is a medicine that is used to reduce the pain and swelling associated with active rheumatoid arthritis (RA) in adults. Kineret is a man-made protein that is similar to a naturally occurring protein found in the body called interleukin-1 receptor antagonist (IL-1Ra). In people with RA, the body produces too much of certain proteins that lead to joint damage. One of these proteins is called interleukin-1 (IL-1). Too much IL-1 contributes to the pain, swelling and stiffness associated with RA. Kineret can block the action of IL-1. Only you and your doctor can determine how well Kineret ® is working for you. The time it takes to see improvement in symptoms varies from person to person. In clinical Lesen Sie das vollständige Dokument
KINI-V03 Page 1 of 9 KINERET ® (ANAKINRA) NAME OF THE MEDICINE Kineret ® is the Swedish Orphan Biovitrum AB (publ) trademark for anakinra (rbe). DESCRIPTION Kineret ® (anakinra) is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Kineret ® differs from native human IL-1Ra in that it has an additional single methionine residue at its amino terminus. Kineret ® consists of 153 amino acids and has a molecular weight of 17.3 kilodaltons. It is produced by recombinant DNA technology using an _E. coli_ bacterial expression system. Kineret ® is supplied in single use pre-filled syringes as a sterile, clear, colourless-to-white, preservative-free solution for daily subcutaneous (SC) administration. The solution may contain some small translucent-to-white particles of protein. PHARMACOLOGY Kineret ® blocks the biological activity of interleukin-1 (IL-1) by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI) which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiological responses including inflammatory and immunological responses. IL-1 has a broad range of activities including cartilage degradation by its induction of the rapid loss of proteoglycans as well as stimulation of bone resorption. The levels of the naturally occurring IL-1Ra in synovium and synovial fluid from rheumatoid arthritis (RA) patients are not sufficient to compete with the elevated amount of locally produced IL-1. PHARMACOKINETICS The absolute bioavailability of the commercial formulation has not been definitively established. However, the absolute bioavailability of development formulations was high (> 80%) for a 70 mg SC bolus injection and the commercial formulation is likely to be comparable. In patients with RA, maximum plasma concentrations of Kineret ® Lesen Sie das vollständige Dokument