SPL Set ID: 0130d7c8-d067-4528-beb7-166559c33be9

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be added to blood products collected for extracorporeal processing, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal processing set. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier. The solution is non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Table 1: Active Ingredients Ingredients Molecular Formula Molecular Weight (%w/v) Citric Acid, Monohydrate C 6 H 8 O 7 192.12 Dextrose Monohydrate C 6 H 12 O 6 ∙ H 2 O 198.17 Sodium Citrate Dihydrate C 6 H 9 Na 3 O 9 294.10 Water for Injection H 2 O 18.00 Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The solution bag is not made with natural rubber latex or PVC. The solution bag is made from a polyolefin film. It contains materials that have been tested to demonstrate the suitability of the solution bag for storing pharmaceutical solutions. The solution contact layer is a polyolefin. The solution bag is nontoxic and biologically inert. The solution bag is a closed system and is not dependent upon entry of external air during administration. The solution bag is covered with a clear overwrap to provide protection from the physical environment. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier.