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warnings and cautions
5 WARNINGS AND PRECAUTIONS Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged. Do not transfer the solution bag directly into the sterile field. Do not reuse. Discard unused or partially used solution bags. Discard the product if the Needleless Access Valve (NAV) does not function as intended. Aseptically prepare the NAV before use. Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged. Use aseptic technique throughout all procedures to ensure donor safety and quality. ( 5 )
6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product 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 injection of blood products containing citrate anticoagulant. The recipient of the blood product 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 .