SPL Set ID: aba60c84-94d9-46d0-bdbb-25e0c4e8cc41

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection. The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories. Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows: Sodium (Na + ) 40 mEq/liter Potassium (K + ) 13 mEq/liter Magnesium (Mg ++ ) 3 mEq/liter Chloride (Cl − ) 40 mEq/liter Bicarbonate (HCO 3 − ) as acetate 16 mEq/liter Caloric value (dextrose) 170 Calories/liter Tonicity Hypertonic Osmolarity 363 mOsmol/liter (calc.) pH (range) 5.0 (4.0 to 6.5) The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-M and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient 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: Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Acetate, USP is chemically designated CH 3 COOK, colorless crystals or white crystalline powder very soluble in water. Magnesium acetate is chemically designated Mg (C 2 H 3 O 2 ) 2 , colorless or white crystals very soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 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. structural formula dextrose