Source: Health Products Regulatory Authority (ZA) Publisher: Dr. Reddys Laboratories (Pty) Ltd., Block B, 204 Rivonia Road, Morningside, Sandton, 2057
REDDITUX 100 concentrate for solution for infusion.
REDDITUX 500 concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear to opalescent; colourless to yellowish solution, essentially free from visible particles. |
Each vial of REDDITUX 100 contains 100 mg of rituximab concentrate for solution for infusion.
Each vial of REDDITUX 500 contains 500 mg of rituximab concentrate for solution for infusion.
Excipients with known effects: REDDITUX 100 and 500 contains 2,27 mmol (or 52,26 mg) and 11,36 mmol (or 261,34 mg) sodium per 10 ml and 50 ml vial respectively.
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 |
|---|
|
Polysorbate 80 |
REDDITUX 100: clear USP Type I 10 ml glass vials. The vials are closed with 20 mm grey butyl rubber stoppers laminated with a fluoro-polymer coating. The stoppers are smooth-finished, with a small cavity at the centre. Stoppered vials are capped with 20 mm, flip-off seals. The aluminium seal completely covers the rubber stopper and is capped with an orange polypropylene disc.
REDDITUX 500: clear USP Type I 50 ml glass vials. The vials are closed with 20 mm grey butyl rubber stoppers laminated with a fluoro-polymer coating. The stoppers are smooth-finished, with a small cavity at the centre. Stoppered vials are capped with 20 mm, flip-off seals. The aluminium seal completely covers the rubber stopper and is capped with an orange polypropylene disc.
Dr. Reddy’s Laboratories (Pty) Ltd., Block B, 204 Rivonia Road, Morningside, Sandton, 2057
REDDITUX 100: 56/26/0286
REDDITUX 500: 56/26/0287
31 May 2022
| Drug | Countries | |
|---|---|---|
| REDDITUX | Turkey, South Africa |
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