SPL Set ID: 9a5247a1-cc05-442d-b2d0-950f887f03c2

ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Table 1: Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose Monohydrate USP C 6 H 12 O 6 ∙ H 2 O 198.17 Trisodium Citrate Dihydrate USP C 6 H 9 Na 3 O 9 294.10 Sodium Chloride USP NaCl 58.44 Monobasic Sodium Phosphate Monohydrate USP NaH 2 PO 4 ∙ H 2 O 137.99 Citric Acid Monohydrate USP C 6 H 8 0 7 ∙ H 2 O 210.14 Adenine USP C 5 H 5 N 5 135.13 Water for Injection USP H 2 O 18.00 Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.