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Hertraz

Hertraz Storage

trastuzumab

Manufacturer:

Biocon Biologics Ltd

Distributor:

Biocon Biologics Phils
Full Prescribing Info
Storage
Store in a refrigerator (2-8°C).
Store away from light.
Vials should not be used beyond the expiry date stamped on the vial, the reconstituted drug solution should be used immediately and any unused portion must be discarded. Do not freeze the drug that has been reconstituted.
The drug solution for infusion diluted in bags/bottles containing 0.9% Sodium Chloride for Injection, USP, may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours prior to use.
Shelf Life: 150 mg: 48 months when stored under recommended storage conditions i.e. 2°C to 8°C.
Shelf-Life of the Reconstituted Solution: 150 mg (Multi-dose use vials): Reconstituted solutions made with BWFI (bacteriostatic water for injection), containing 1.1 % benzyl alcohol as a preservative for 150 mg vials of Hertraz, as supplied, are stable for 28 days when stored refrigerated at 2°C to 8°C. The reconstituted solution contains preservative and is therefore suitable for multiple uses. Any remaining reconstituted solution should be discarded after 28 days. 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 (do not store above 30°C).
From a microbiological point of view, the Trastuzumab infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibilities 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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