This product is a sterile, nonpyrogenic solutions containing isotonic concentrations of electrolytes in water for injection. The solution is isotonic. The solution is administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories.
Each 100 mL of Ringer's Injection, USP contains sodium chloride 860 mg, potassium chloride 30 mg and calcium chloride, dihydrate 33 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 147 mEq sodium (Na+), 4 mEq potassium (K+), 4 mEq calcium (Ca++) and 155 mEq chloride (Cl-). The electrolyte content is isotonic (309 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 5.4 (5.0 - 7.5).
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.
The solution is a parenteral fluid, nutrient and/or electrolyte replenisher.
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 ∙ 2 H2O), white fragments or granules freely soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCI, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solution inside the plastic container also can leach out certain chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.