SPL Set ID: d3d29c8f-c326-4097-814a-7f4e08c67068

Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Size (mL) Composition (g/L) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH pH may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF. Ionic Concentration (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactate Lactated Ringer’s Injection, USP 250 500 1000 6 3.1 0.3 0.2 275 6.2 (6.0 to 7.5) 130 4 3 110 28 9 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 58.44 Sodium Lactate 112.06 Potassium Chloride USP 74.55 Calcium Chloride Dihydrate USP 147.02 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 Chloride USP Sodium Lactate Potassium Chloride USP Calcium Chloride Dihydrate USP