Herceptin/Herceptin SC Storage

Herceptin IV: Store vials at 2°C - 8°C (WHO Climatic Zones I - IV).
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 Herceptin, 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 Herceptin to a patient with a known hypersensitivity to benzyl alcohol (see General: Benzyl alcohol under Precautions), Herceptin should be reconstituted with sterile water for injection. In case Herceptin is reconstituted with sterile water for injection, only one dose per Herceptin 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 24 hours at 2°C - 8°C.
From a microbiological point of view, the Herceptin 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 vials (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 sterile 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 up to 30 days at 2°C - 8°C and 24 hours at room temperature (≤ 30°C).
From a microbiological point of view, the Herceptin 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.
Herceptin SC: Store vials at 2°C - 8°C (WHO Climatic Zones I - IV). Do not freeze. Store in the original package in order to protect from light.
The vials should not be kept more than 6 hours at ambient temperature (do not store above 30°C).