SPL Set ID: 0db56c7a-2b8f-4593-8591-2c481c92b2cf

Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na + ) 130; potassium (K + ) 4; calcium (Ca ++ ) 3; chloride (Cl¯) 109 and lactate (CH 3 CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl 2 • 2H 2 O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C 3 H 5 NaO 3 , a 60% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. 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. Not made with natural rubber latex, PVC or DEHP. Structural Formula