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5 DOSAGE AND ADMINISTRATION

5.1 Dosage Recommendations
SAPHNELO must be diluted prior to intravenous administration [see Dosage and Administration (5.2)].
The recommended dosage of SAPHNELO is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.

Missed dose
If a planned infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions.



5.2 Instructions for Preparation and Administration
SAPHNELO is supplied as a single-dose vial. Prepare the diluted infusion solution using aseptic technique, by the following procedure:

1. Visually inspect the vial for particulate matter and discoloration. SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution. Discard the vial if the solution is cloudy, discolored or visible particles are observed. Do not shake the vial.

2. Withdraw and discard 2 mL of solution from a 50 mL or 100 mL 0.9% Sodium Chloride Injection,
infusion bag.

3. Withdraw 2 mL of solution from the vial of SAPHNELO and add it to the infusion bag. Mix the solution by gentle inversion. Do not shake.

4. Each vial is intended for one time use only. Discard any unused portion remaining in the vial.

5. Administer the infusion solution immediately after preparation.
6. If the infusion solution is not administered immediately, store the diluted solution of SAPHNELO at room temperature (15°C to 25°C) for up to 4 hours, or refrigerated (2°C to 8°C) for up to 24 hours. Do not freeze. Protect from light. If refrigerated, allow the diluted SAPHNELO solution to reach room temperature prior to administration.

7. Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter.

8. To ensure the complete dose of SAPHNELO has been administered, flush the entire infusion line with 25 mL of 0.9% Sodium Chloride Injection at the end of the infusion.

9. Do not co-administer other medicinal products through the same infusion line.

10. Dispose of any unused medicinal product or waste material in accordance with local requirements.