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Store vials at 2°C - 8°C (in a refrigerator). Keep the container in the outer carton in order to protect from light.
After aseptic dilution in 0.9% aqueous saline solution: [Adding information following in-use stability study] The prepared infusion solution of rituximab in 0.9% aqueous saline solution is physically and chemically stable for 30 days at 2°C - 8°C and plus an additional 24 hours at room temperature.
After aseptic dilution in 5% aqueous dextrose solution: The prepared infusion solution of rituximab in 5% aqueous dextrose solution is physically and chemically stable for 24 hours at 2°C - 8°C plus an additional 12 hours at
room temperature.
From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
