Zuhera Caution For Usage

Incompatibilities: Zuhera should not be mixed or diluted with other products except those mentioned under Special Precautions for Disposal and Other Handling as follows.
Do not dilute with glucose solutions, since these cause aggregation of the protein.
Special precautions for disposal and other handling: Appropriate aseptic technique should be used.
Use of other reconstitution solvents should be avoided.
Reconstitution details are given in the table as follows: (see Table 8).

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During reconstitution, handle Zuhera carefully. Causing excessive foaming during reconstitution or shaking the reconstitution solution may result in problems with the amount of Zuhera that can be withdrawn from the vial.
Do not freeze the reconstituted solution.
Instructions for reconstitution-440 mg vial (multi-dose vial): Slowly inject 20 mL of bacteriostatic water for injection into the vial containing the lyophilised Zuhera, using a sterile syringe. Direct the stream into the lyophilised cake.
To aid reconstitution, the vial should be swirled gently. DO NOT SHAKE.
Slight foaming of the product may be seen upon reconstitution; this is not unusual. The vial should be allowed to stand undisturbed for approximately 5 minutes. Reconstituted Zuhera is a colourless to pale yellow, transparent solution. No particles should be visible.
Instructions for Dilution: Determine the volume of Zuhera solution required: Based on a loading dose of 4 mg Zuhera/kg, or a subsequent weekly dose of 2 mg Zuhera/kg: (see Equation 1).

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Based on a loading dose of 8 mg Zuhera/kg, or a subsequent 3-weekly dose of 6 mg Zuhera/kg: (see Equation 2).

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Withdraw the appropriate amount of solution from the vial, and add it to an infusion bag containing 250 mL of 0.9% sodium chloride solution.
Glucose/dextrose-containing solutions should not be used.
Mix the solution by inverting the bag gently (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).
Inspect visually for particulate matter and discoloration prior to administration.
No incompatibilities have been observed between trastuzumab and polyvinyl chloride, polyethylene or polypropylene bags.
Dispose of unused medicinal product in accordance with local regulations.
Zuhera has been developed as a similar biological medicinal product to Herceptin.