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warnings and cautions
5 WARNINGS AND PRECAUTIONS Isoplate™ Solution Platelet Additive Solution [PAS-F] is NOT FOR DIRECT INTRAVENOUS INFUSION. Multiple transfusions of Isoplate™-stored platelets may lead to overdosage of potassium, magnesium and gluconate [See Overdosage (10) ]. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Do not reuse. Discard unused or partially used Isoplate™ Solution Platelet Additive Solution [PAS-F]. Protect from sharp objects. Verify that the Isoplate™ Solution Platelet Additive Solution [PAS-F] has been securely attached to the platelet additive solution line on the Trima Accel® disposable tubing set using aseptic technique. Isoplate™ Solution Platelet Additive Solution [PAS-F] is NOT FOR DIRECT INTRAVENOUS INFUSION. ( 5 ) Verify that the Isoplate™ Solution Platelet Additive Solution [PAS-F] has been securely attached to the platelet additive solution line on the Trima Accel® disposable tubing set using aseptic technique. ( 5 ) Multiple transfusions of Isoplate™-stored platelets may lead to overdosage of potassium, magnesium and gluconate ( 5 , 10 ).
6 ADVERSE REACTIONS Isoplate™ Solution Platelet Additive Solution [PAS-F] is added to Platelet Pheresis, Leukocytes Reduced PAS products after completion of a hyperconcentrated Trima Accel® apheresis collection procedure. It is not for direct intravenous infusion. Isoplate™ Solution Platelet Additive Solution [PAS-F] is not expected to cause adverse events other than those normally associated with platelet transfusion. Isoplate™ Solution Platelet Additive Solution [PAS-F] is added to leukoreduced hyperconcentrated platelets after the Trima Accel® apheresis procedure is complete. Isoplate™ Solution Platelet Additive Solution [PAS-F] is not expected to cause adverse events other than those normally associated with platelet transfusion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience No adverse reactions were reported in subjects infused with a small volume (< 10 mL) of radiolabeled platelets that had been stored for 5 days in 65% Isoplate™ Solution Platelet Additive Solution [PAS-F], but rinsed prior to infusion.