Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration.
Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium (Na+) 77 mEq; chloride (Cl−) 77 mEq. The osmolarity is 154 mOsmol/L (calc.).
The pH is 5.6 (4.5 to 7.0).
This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required, the unused portion should be discarded.
0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a clear multilayer polyolefin plastic film. 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.
Indications and Usage for Sodium Chloride Injection 0.45%
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
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