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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.

Pharmaceutical form

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.

Chemical substance
Description
Basiliximab

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.

List of excipients

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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

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