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MABTHERA CONCENTRATE FOR SOLUTION FOR INFUSION 500mg/50ML

Product Information

Registration Status: Active

SIN09946P

MABTHERA CONCENTRATE FOR SOLUTION FOR INFUSION 500mg/50ML is approved to be sold in Singapore with effective from 1998-08-22. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN09946P.

This product contains Rituximab 10mg/ml in the form of INJECTION. It is approved for INTRAVENOUS use.

This product is manufactured by GENENTECH INC in UNITED STATES, andRoche Diagnostics GmbH in GERMANY.

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.

Product Reference
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Description

Rituxan is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids

Indication

For treatment of CD20-positive non-Hodgkins lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Mechanism of Action

The Fab regions of rituximab binds to the CD20 antigen on B lymphocytes, while the Fc domain recruits antibodies and complements to mediate cell lysis.

Clearance

* 0.34 L/day [RA patients]

Active Ingredient/Synonyms

AntiCD20 | Rituximab |


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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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