Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Truxima 100 mg concentrate for solution for infusion.
Truxima 500 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, colourless liquid with pH of 6.3-6.8 and osmolality of 329-387 mOsmol/kg. |
Truxima 100mg concentrate for solution for infusion:
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Truxima 500 mg concentrate for solution for infusion:
Each mL contains 10 mg of rituximab.
Each 50 mL vial contains 500 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Excipients with known effects:
Each 10 mL vial contains 2.3 mmol (52. 6 mg) sodium.
Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rituximab |
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95% of all B cell non-Hodgkin’s lymphomas. |
| List of Excipients |
|---|
|
Sodium chloride |
Truxima 100 mg concentrate for solution for infusion:
Clear Type I glass vial with butyl rubber stopper containing 100 mg of rituximab in 10 mL. Pack of 2 vials.
Truxima 500 mg concentrate for solution for infusion:
Clear Type I glass vial with butyl rubber stopper containing 500 mg of rituximab in 50 mL. Pack of 1 vial.
Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Truxima 100 mg concentrate for solution for infusion: EU/1/16/1167/002
Truxima 500 mg concentrate for solution for infusion: EU/1/16/1167/001
Date of first authorisation: 17 February 2017
Date of latest renewal: 15 November 2021
| Drug | Countries | |
|---|---|---|
| TRUXIMA | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
© 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.
