Simulect 10mg and 20mg powder and solvent for solution for injection or infusion (2012)
Active ingredients: Basiliximab
Product Name and Form
Simulect 10 mg powder and solvent for solution for injection or infusion.
Simulect 20 mg powder and solvent for solution for injection or infusion.
Powder and solvent for solution for injection or infusion.
White powder.
Qualitative and Quantitative Composition
Each vial contains 10 or 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 a 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.
Powder
Potassium dihydrogen phosphate
Disodium phosphate, anhydrous
Sodium chloride
Sucrose
Mannitol (E421)
Glycine
Solvent
Water for injections
Pack sizes and Marketing
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 10 mg / 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 / 20 mg basiliximab.
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom
Date of first authorisation: 09/10/1998
Date of latest renewal: 09/10/2008
Simulect m10 mg powder and solvent for solution for injection or infusion: EU/1/98/084/002
Simulect 20 mg powder and solvent for solution for injection or infusion: EU/1/98/084/001