Hertraz Caution For Usage

Incompatibilities: Trastuzumab must not be mixed or diluted with other medicinal products except those mentioned under "Instructions for Reconstitution" as follows.
Do not dilute with glucose solutions since these cause aggregation of the protein.
Reconstitution details: See Table 14.

Click on icon to see table/diagram/image

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reconstitution or shaking the reconstituted solution may result in problems with the amount of Trastuzumab that can be withdrawn from the vial.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.
Instructions for reconstitution: 150 mg vial (multi-dose vial): Using a sterile syringe, slowly inject 7.2 mL of bacteriostatic water for injection into the vial containing the lyophilised Hertraz, directing the stream into the lyophilised cake.
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 particles.
Instructions for dilution: Determine the volume of the solution required: 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.

Click on icon to see table/diagram/image

Based 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.

Click on icon to see table/diagram/image

The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution.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/dextrose 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 (do not store above 30°C).
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
No incompatibilities between trastuzumab and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Special Precautions for Disposal and Other Handling: Any unused medicinal product should be disposed of in accordance with the local requirements.