Rixathon

Rixathon Storage

rituximab

Manufacturer:

Lek Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Full Prescribing Info
Storage
Shelf life: Unopened vial: 3 years at 2°C - 8°C.
Rixathon may be stored at temperatures up to a maximum of 30°C for a single period of up to 7 days, but not exceeding the original expiry date.
The new expiry date must be written on the carton. Upon removal from refrigerated storage, Rixathon must not be returned to refrigerated storage.
Diluted solution: After aseptic dilution in sodium chloride solution: Chemical and physical stability of RIXATHON diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤25°C).
After aseptic dilution in glucose solution: Chemical and physical stability of RIXATHON diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤25°C).
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.
Store in a refrigerator (2°C - 8°C).
Keep the container in the outer carton in order to protect from light.
For storage conditions of the unopened vial outside the refrigerator, see Shelf life as previously mentioned.
For storage conditions after dilution of the medicinal product, see Shelf life as previously mentioned.
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