Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

INDICATIONS AND USAGE Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2) .] Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is an anticoagulant for blood collection for use only with apheresis devices. ( 1 )

DOSAGE AND ADMINISTRATION Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is added to tubing sets during apheresis procedures. ( 2 ) Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. ( 2.1 ) Follow the directions for connecting the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag to the apheresis system. ( 2.2 ) 2.1 General Dosing Information Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A is added to tubing sets during apheresis procedures. The solution is connected to the tubing set in an apheresis collection. For automated apheresis, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion. For instructions on the use of the solution with an apheresis device and tubing set, see that device's operator's manual. 2.2 Administration Ensure solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed. Inspect the bag. Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration. Use only if the solution is clear and free of particulate matter. Protect the bag from sharp objects. Use aseptic technique throughout all procedures. Directions for connecting the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag to the apheresis device. At the prompt to connect anticoagulant to the apheresis device tubing set: Remove the overwrap by pulling down at the notch, and remove the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A bag. Before use, perform the following checks [See Warnings and Precautions (5) .] : Check for leaks by gently squeezing the bag. If you find leaks, discard the bag. Ensure that the solution is the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and the expiration date has not passed. Inspect the solution in adequate light. Do not use bags that show cloudiness, haze, or particulate matter. Remove the protective cap from the port on the bag. Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution. Proceed according to the apheresis device's operator's manual. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

WARNINGS AND PRECAUTIONS Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure product quality and donor safety. Do not reuse. Discard unused or partially used solution bags. Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients. Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration. Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure product quality and donor safety. Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients. ( 5 )

CONTRAINDICATIONS None. There are no known contraindications associated with the use of the product. None. ( 4 )

DRUG INTERACTIONS There are no known significant interactions between Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and food or other drug products. There are no known significant interactions between Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A and food or other drug products. ( 7 )

ADVERSE REACTIONS The following potential adverse events are associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. 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. Report suspected adverse reactions to Terumo BCT, Inc. or the FDA. The following potential adverse reactions are safety-related harms associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. 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 .

Mechanism of Action Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade. The following ingredients are key components of the solution: Citric Acid for pH regulation Sodium Citrate for anticoagulation Dextrose for isotonicity This solution has no pharmacological effect.