Active ingredients: Canacinumab
Ilaris 150 mg powder for solution for injection.
Powder for solution for injection.
The powder is white.
One vial contains 150 mg of canakinumab*.
After reconstitution, each ml of solution contains 150 mg canakinumab.
* fully human monoclonal antibody produced in mouse hybridoma Sp2/0 cells by recombinant DNA technology
For a full list of excipients, see section 6.1.
Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype. Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.
Sucrose
Histidine
Histidine hydrochloride monohydrate
Polysorbate 80
150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).
Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Not all pack sizes may be marketed.
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom
23.10.2009
EU/1/09/564/001-002