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warnings and cautions
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 .