Storing and Handling TOFIDENCE

Before dilution¹:

Thermometer depicting Tofidence storage conditions

When stored in a refrigerator
at 2°C–8°C...

Tofidence™ has a shelf life of 24 months

...TOFIDENCE has a
shelf life of 27 months (400
mg/20 mL) and 30 months
(80 mg/4 mL and 200
mg/10 mL)*

Child reaching for Tofidence under caution sign

Keep out of the sight and
reach of children

After dilution¹:

TOFIDENCE may be stored at temperatures up to a maximum of 30°C...

...for a single period of up to 48 hours, not exceeding the original expiry date*

...for a single period of up to 48 hours, and up to 4 days in a refrigerator at 2°C–8°C not exceeding the original expiry date^{*, **}

Refrigerator with caution sign illustrating removal instructions

Once removed from refrigerated storage, TOFIDENCE must not be returned to the refrigerator

* Keep the vial(s) in the outer carton in order to protect from light.

**Chemical and physical in-use stability after dilution in 9 mg/mL sodium chloride has been demonstrated for 48 hours at 30ºC and up to 4 days in a refrigerator at 2°C–8°C. From a microbiological point of view, the solution prepared in 9 mg/mL sodium chloride for infusion 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.