Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 Прочетете целия документ