Active ingredients: Anakinra
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Solution for injection (injection).
Clear, colourless-to-white solution for injection that may contain some product-related translucentto-white amorphous particles.
Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).
* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI). Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
Citric acid, anhydrous
Disodium edetate dihydrate
Water for injections
0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle. The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover. None of the syringe or needle shield components are made with natural rubber latex.
Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Not all pack sizes may be marketed.
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
EU/1/02/203/005 – 1-pack
EU/1/02/203/006 – 7-pack
EU/1/02/203/007 – 28-pack
Date of first authorisation: 8 March 2002
Date of latest renewal: 20 March 2007