SPL Set ID: a9910e09-5aea-4ee1-a35e-ae4abf8b80b4

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 contains: Sodium Chloride USP 0.6 g, Sodium Lactate 0.31 g, Potassium Chloride USP 0.03 g, Calcium Chloride Dihydrate USP 0.02 g, Water for Injection USP qs. pH adjusted with Hydrochloric Acid NF pH: 6.75 (6.0–7.5) Calculated Osmolarity: 275 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 130, Potassium 4, Calcium 3, Chloride 110, Lactate (CH 3 CH(OH)COO − ) 28 The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portions should be discarded. Lactated Ringer's Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Sodium Lactate CH 3 CH(OH)COONa 112.06 Potassium Chloride USP KCl 74.55 Calcium Chloride Dihydrate USP CaCl 2 •2H 2 O 147.01 The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.