KINERET

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Kaufe es jetzt

Gebrauchsinformation Gebrauchsinformation (PIL)
27-05-2024
Fachinformation Fachinformation (SPC)
27-05-2024

Wirkstoff:

Anakinra

Verfügbar ab:

A Menarini Australia Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

                                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
                                
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Fachinformation

                                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
®

                                
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