SPL Set ID: dbed53b7-0109-4561-8342-0178ec8c64b0

Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table 1 below for summary of content and characteristics of this solution. Table 1 COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP mEq Potassium Added Size (mL) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 20 mEq 1000 50 1.79 6 3.1 0.2 563 pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na+) Potassium (K+) Chloride (Cl-) Lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 May contain HCl for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: 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. Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl 2 • 2H 2 O), white fragments or granules freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH 3 CH(OH)COONa], a 50% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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. Dextrose Structural Formula Calcium Chloride Structural Formula