SPL Set ID: 4ea4397c-2fa4-4670-91e6-21ae498c88f7

Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose contains: Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.0–6.0) Calories per liter: 170 Calculated Osmolarity: 340 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29 Acetate (CH 3 COO - ) 23; Potassium 20; Magnesium 3; 1.5 mmole P/liter Phosphate (HPO ) 3 Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Acetate Trihydrate USP CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Dibasic Potassium Phosphate USP K 2 HPO 4 174.18 Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. 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. 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. 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. 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. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication site. Refer to the Directions for Use of the container. =4 special character Chemical Structure