Additive Formula 3

FDA label, Terumo BCT, Ltd, intravenous, effective 2026-01-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Administration Directions for connecting the ADDITIVE SOLUTION FORMULA 3 (AS-3) bag to the apheresis device. Automated RBC additive solution procedures: Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. For automated addition of the product, the system will prompt you to connect the bag.

Remove the overwrap by pulling down at notch, and remove the AS-3 bag. Before use, perform the following checks: Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date. Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.

Check for leaks by gently squeezing the bag. If leaks are found, discard the bag. Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used. Protect from sharp objects. Remove the protective cap from the port on the bag.

Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow. Proceed according to the apheresis device operator's manual.

Manual RBC additive solution procedures: Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. Seal the RBC product lines as close to the cassette as possible. Remove the overwrap by pulling down at notch, and remove the ADDITIVE SOLUTION FORMULA 3 bag. Before use, perform the following checks: Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date.

Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag. Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.

Protect from sharp objects. Remove the protective cap from the port on the bag. Insert the spike of the apheresis device tubing set into the spike port of the solution bag using aseptic technique and then hang the solution. Proceed according to the apheresis device operator's manual.

Contraindications

4 CONTRAINDICATIONS DO NOT INFUSE ADDITIVE SOLUTION FORMULA 3 (AS-3) DIRECTLY TO THE DONOR. DO NOT INFUSE AS-3 DIRECTLY TO THE DONOR. ( 4 )

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