Additive Formula 3

Generic name: dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine
Dosage form: intravenous solution

Indications and Usage for Additive Formula 3

Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]

Additive Formula 3 Dosage and Administration

General Dosing Information

ADDITIVE SOLUTION FORMULA 3 (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed.

• For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.
• To add the product manually, refer to the apheresis system operator's manual to determine the recommended dose.

For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

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.

1. Remove the overwrap by pulling down at notch, and remove the AS-3 bag.
2. 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.
3. Remove the protective cap from the port on the bag.
4. Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.
5. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them ..