Source: European Medicines Agency (EU) Revision Year: 2020 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.
| Pharmaceutical Form |
|---|
|
Powder and solvent 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 |
|---|
|
Powder: Potassium dihydrogen phosphate Solvent: 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
EU/1/98/084/001
Date of first authorisation: 09/10/1998
Date of latest renewal: 09/10/2008
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
