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Zuhera

Zuhera Storage

trastuzumab

Manufacturer:

Duopharma HAPI

Distributor:

Duopharma HAPI
Full Prescribing Info
Storage
Store vials at 2°C to 8°C prior to reconstitution.
Store away from light.
Vials should not be used beyond the expiration date stamped on the vial; the reconstituted drug solution should be used as given as follows; and any unused portion must be discarded. DO NOT FREEZE DRUG THAT HAS BEEN RECONSTITUTED.
Shelf-Life: Shelf-life of the reconstituted solution: 440 mg (multi-dose vials): The reconstituted product is physically and chemically stable for 28 days at 2°C-8°C after dissolving in Bacteriostatic water for injection (1.1%). Do not freeze the reconstituted solution.
Shelf-life of the solution for infusion containing the reconstituted product: Infusion solution (0.9% Sodium Chloride) containing the reconstituted drug product is physically and chemically stable for 24 hours at 2°C to 8°C. From the perspective of microbiological safety, the Zuhera 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.
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