Additive Formula 3

1 INDICATIONS AND USAGE Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2) .] Use only with Trima Accel red blood cell (RBC) apheresis collections. ( 1 )

2 DOSAGE AND ADMINISTRATION AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. ( 2 ) AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operator's manual. ( 2.1 ) Follow the directions for connecting the AS-3 bag to the tubing set of a blood collection system. ( 2.2 ) 2.1 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. 2.2 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.

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 )

5 WARNINGS AND PRECAUTIONS Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality. Do not reuse. Discard unused or partially used solution bags. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality. ( 5 ) Do not reuse. Discard unused or partially used solution bags.

6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products to patients. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Citrate reactions or toxicity may occur with the infusion of blood containing citrate. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8 USE IN SPECIFIC POPULATIONS ADDITIVE SOLUTION FORMULA 3 (AS-3) has not been studied in controlled clinical trials with specific populations.