Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Simulect 20 mg powder and solvent for solution for injection or infusion.
Simulect 20 mg powder for solution for injection or infusion.
| Pharmaceutical Form |
|---|
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Simulect 20 mg powder and solvent for solution for injection or infusion: Powder and solvent for solution for injection or infusion. White powder. Simulect 20 mg powder for solution for injection or infusion: Powder for solution for injection or infusion. White powder. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Basiliximab |
Basiliximab is a murine/human chimeric monoclonal antibody (IgG1Îș) 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 |
|---|
|
Simulect 20 mg powder and solvent for solution for injection or infusion: Powder: Potassium dihydrogen phosphate Solvent: Water for injections Simulect 20 mg powder for solution for injection or infusion: Potassium dihydrogen phosphate |
Simulect 20 mg powder and solvent for solution for injection or infusion:
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.
Simulect 20 mg powder for solution for injection or infusion:
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.
Simulect is also available in vials with 10 mg basiliximab.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Simulect 20 mg powder and solvent for solution for injection or infusion: EU/1/98/084/001
Simulect 20 mg powder for solution for injection or infusion: EU/1/98/084/004
Date of first authorisation: 09 October 1998
Date of latest renewal: 09 October 2008
| Drug | Countries | |
|---|---|---|
| SIMULECT | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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