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Herticad

Herticad Storage

trastuzumab

Manufacturer:

BIOCAD

Distributor:

Ambitech
Full Prescribing Info
Storage
Store at temperatures between 2-8°C.
Infusion solutions should be used immediately after dilution. Do not use Trastuzumab if the patient notices any particulate matter or discoloration prior to administration.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Always keep this medicine in the closed original pack at a temperature of 2°C-8°C in a refrigerator. After reconstitution with water for injections the reconstituted solution is physically and chemically stable for 24 hours at 2°C-8°C. Any remaining reconstituted solution should be discarded.
After reconstitution with solvent supplied with vials containing 440 mg of trastuzumab the reconstituted solution is physically and chemically stable for 28 days at 2°C-8°C under controlled and validated aseptic conditions. Any remaining reconstituted solution should be discarded.
Solutions of Trastuzumab for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection for 24 hours at 2°C-8°C.
From a microbiological point of view, the reconstituted solution of Trastuzumab with water for injections and Trastuzumab infusion solution should be used immediately. The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Each vial containing 150 mg of trastuzumab is reconstituted with 7.2 mL of water for injections (not supplied). Use of other reconstitution solvents should be avoided.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Each vial containing 440 mg of trastuzumab is reconstituted with 20.0 mL of solvent (supplied) or water for injections (not supplied). Use of other reconstitution solvents should be avoided.
This yields a 20 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Trastuzumab should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Trastuzumab that can be withdrawn from the vial.
The reconstituted solution should not be frozen.
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