Product Information
Registration Status: ActiveSIMULECT FOR INJECTION 20mg/VIAL is approved to be sold in Singapore with effective from 1998-11-19. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN10441P.
This product contains Basiliximab 20mg/vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by NOVARTIS PHARMA STEIN AG in SWITZERLAND,NOVARTIS PHARMA AG in FRANCE, andTakeda Austria GmbH in AUSTRIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
A recombinant chimeric (murine/human) monoclonal antibody (IgG1k) that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor a-chain (IL-2R alpha, also known as CD25 antigen) on the surface of activated T-lymphocytes. It is a 144 kDa glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2R alpha.
Indication
For prophylactic treatment of kidney transplant rejection
Mechanism of Action
Basiliximab binds with high-affinity to the alpha-subunit (CD25) of the high-affinity IL-2 receptor. This inhibits IL-2 binding, which inhibits T-cell activation and prevents the body from mounting an immune response against the foreign kidney.
Clearance
* 41 +/- 19 mL/h [Adult patients undergoing first kidney transplantation] * 17 +/- 6 mL/h [pediatric patients undergoing renal transplantation] * 31 +/- 19 mL/h [adolescent patients undergoing renal transplantation]
Active Ingredient/Synonyms
chimeric mouse-human antiCD25 | Basiliximab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.