Herzuma Storage

Vials: Store vials at 2°C-8°C.
440 mg vials (multidose vials): Shelf-life of the reconstituted solution: Reconstituted solutions made with bacteriostatic water for injection for the 440 mg vial of Herzuma, as supplied, are stable for 28 days when stored refrigerated at 2°C - 8°C.
The reconstituted solution contains preservative and is therefore suitable for multiple use. Any remaining reconstituted solution should be discarded after 28 days.
When administering Herzuma to a patient with a known hypersensitivity to benzyl alcohol (see General: Benzyl alcohol under Precautions), Herzuma should be reconstituted with water for injection. In case Herzuma is reconstituted with water for injection, only one dose per Herzuma vial should be used. The reconstituted solution should be used immediately.
Any unused portion must be discarded.
Do not freeze the reconstituted solution.
Shelf-life of the solution for infusion containing the reconstituted product: The infusion solution (0.9% sodium chloride infusion solution) containing the reconstituted product is physically and chemically stable for 48 hours (do not store above 30°C).
From a microbiological point of view, the Herzuma infusion solution should be used immediately.
If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
150 mg vial (single-dose vials): Shelf-life of the reconstituted solution: The reconstituted product is physically and chemically stable for 48 hours at 2°C - 8°C after reconstitution with water for injection.
From a microbiological point of view, the reconstituted solution should be further diluted in infusion solution immediately. If not, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Do not freeze the reconstituted solution.
Shelf-life of the solution for infusion containing the reconstituted product: The infusion solution (0.9% sodium chloride infusion solution) containing the reconstituted product is physically and chemically stable for 48 hours (do not store above 30°C).
From a microbiological point of view, the Herzuma infusion solution should be used immediately.
If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.