SPL Set ID: 3849b89c-c309-46fb-a1e2-53ff0c65077f

This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, ready-to-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. Composition (g/L) Osmolarity* (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Potassium Chloride Injection mEq Potassium/Container Potassium Chloride, USP (KCI) Potassium Chloride 10 mEq/100 mL 7.46 200 5.0 (4.0 to 8.0) 100 100 10 mEq/50 mL 20 mEq/100 mL 14.9 400 5.0 (4.0 to 8.0) 200 200 20 mEq/50 mL 40 mEq/100 mL 29.8 799 5.0 (4.0 to 8.0) 400 400 The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.