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2) Swirl the vial gently to aid reconstitution. Do not shake.
Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes.
The reconstituted Trastuzumab results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Determine the volume of the solution required: based on a loading dose of 4 mg trastuzumab/kg; based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight: See Equation 1.
Click on icon to see table/diagram/imageBased on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight: See Equation 2.
Click on icon to see table/diagram/imageThe appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution. Do not use with glucose-containing solutions. The bag should be gently inverted to mix the solution in order to avoid foaming. Once the infusion is prepared it should be administered immediately. If diluted aseptically, it may be stored for 24 hours (store at 2°C-8°C).
The concentrate made from 440 mg Trastuzumab, if diluted with supplied solvent, may be stored for 28 days at 2°C-8°C and may be used for multiple injections. The concentrate made from 440 mg or 150 mg Trastuzumab, if diluted with unsupplied water for injection, may be stored for 24 hours at 2°C-8°C.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
No incompatibilities between Trastuzumab and polyvinylchloride, polyethylene or polypropylene bags have been observed.
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