SPL Set ID: 190da07e-a616-46e6-b4e5-1c0ba39306e5

Lactated Ringer’s and Dextrose (5%) Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. Table 1 Size (mL) Composition (g/L) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH pH adjusted with Hydrochloric Acid NF. Ionic Concentration (mEq/L) Lactate Caloric Content (kcal/L) Dextrose, USP Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactated Ringer’s and Dextrose (5%) Injection, USP 500 1000 50 6 3.1 0.3 0.2 530 4.6 (4.0 to 6.0) 130 4 3 112 28 180 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2 Ingredients Molecular Formula Molecular Weight Sodium Chloride USP Na + Cl – 58.44 Sodium Lactate 112.06 Potassium Chloride USP K + Cl – 74.55 Calcium Chloride Dihydrate USP 147.02 Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site [see Dosage and Administration (2.3) ]. Sodium Lactate Calcium Chloride Dihydrate USP Dextrose USP