Active ingredients: Basiliximab
Simulect 20 mg powder and solvent for solution for injection or infusion.
Powder and solvent for solution for injection or infusion.
Each vial contains 20 mg basiliximab*.
One ml of the reconstituted solution contains 4 mg basiliximab.
* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor α-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Basiliximab is a murine/human chimeric monoclonal antibody (IgG1κ) that is directed against the interleukin-2 receptor α-chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
Potassium dihydrogen phosphate
Disodium phosphate, anhydrous
Water for injections
Simulect powder: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Solvent: Colourless glass ampoule, type I glass, containing 5 ml water for injections. Simulect is also available in vials with 10 mg basiliximab.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Date of first authorisation: 09/10/1998
Date of latest renewal: 09/10/2008