SODIUM CHLORIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an additive for total parenteral nutrition (TPN) and as an additive for carbohydrate containing I.V. fluids. 23.4% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.

Product summary:

23.4% Sodium Chloride Injection, USP (4 mEq/mL) is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preservative Free. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451722 /Issued: November 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE
FRESENIUS KABI USA, LLC
----------
451722 /Issued: November 2021
MAXIVIAL
Rx only
23.4% SODIUM CHLORIDE INJECTION, USP
400 MEQ (4 MEQ/ML)
ADDITIVE SOLUTION
PLASTIC FLIPTOP VIALS
PHARMACY BULK PACKAGE-
NOT FOR DIRECT INFUSION
CONCENTRATE
_CAUTION: MUST BE DILUTED FOR I.V. USE_
CONCENTRATED SOLUTION - For use only after dilution with compatible
intravenous fluids
to correct sodium deficiency when oral replacement is not feasible.
DESCRIPTION
23.4% Sodium Chloride Injection, USP Additive Solution is a sterile,
nonpyrogenic,
concentrated solution for intravenous administration ONLY AFTER
DILUTION to replenish
electrolytes. The preparations contain 23.4 g of sodium chloride (400
mEq each of Na+
and Cl ) in Water for Injection, USP.
The solution contains no bacteriostat, antimicrobial agent or added
buffer. The additive
may contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. The pH is
5.0 (4.5 to 7.0). The specific gravity is 1.15, and the osmolarity is
8008 mOsmol/L (calc).
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water. The molecular weight is 58.44 g/mol.
The Pharmacy Bulk Package is a sterile dosage form which contains
multiple single
doses for preparation of admixtures for intravenous infusion (see
DOSAGE AND
ADMINISTRATION).
CLINICAL PHARMACOLOGY
Sodium chloride in water dissociates to provide sodium (Na ) and
chloride (Cl ) ions.
These ions are normal constituents of the body fluids (principally
extracellular) and are
®
-
+
-
essential for maintaining electrolyte balance.
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of the
total cations at its normal plasma concentration of approximately 142
mEq/L. While the
sodium ion can diffuse across cell membranes, the intracellular sodium
is maintained at a
much lower concentration than extracellular sodium through the
expenditure of energy
by the cell (so called “sodium cation pump”). Loss o