Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 23.4% Sodium Chloride Injection, USP (4 mEq/mL) is supplied as follows: Product Code Unit of Sale Strength/Concentration Each 918961 NDC 63323-095-61 Unit of 20 400 mEq/100 mL (4 mEq/mL) NDC 63323-095-02 100 mL fill in a 100 mL Plastic Fliptop Vial Pharmacy Bulk Package 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 Fresenius Kabi Logo; PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Vial Label NDC 63323-095-02 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label NDC 63323-095-61 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only 20 x 100 mL Vials PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label
- HOW SUPPLIED 23.4% Sodium Chloride Injection, USP (4 mEq/mL) is supplied as follows: Product Code Unit of Sale Strength/Concentration Each 918961 NDC 63323-095-61 Unit of 20 400 mEq/100 mL (4 mEq/mL) NDC 63323-095-02 100 mL fill in a 100 mL Plastic Fliptop Vial Pharmacy Bulk Package 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 Fresenius Kabi Logo
- PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Vial Label NDC 63323-095-02 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label NDC 63323-095-61 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only 20 x 100 mL Vials PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label
Overview
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 ).
Indications & Usage
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.
Dosage & Administration
23.4% Sodium Chloride Injection, USP Additive Solution is administered intravenously only after addition to a larger volume of fluid. The dose, dilution and rate of injection are dependent upon the individual needs of each patient. In solutions for total parenteral nutrition (TPN), 120 mEq of sodium/day (range: 75-180 mEq/day) is the recommended adult dosage, whereas the recommended dosage is 3-4 mEq/kg/day for preterm infants. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion. Additives may be incompatible with the fluid dispensed from this container. Consult with pharmacist, if available. When admixing, use aseptic technique, mix thoroughly and do not store. Directions for Proper Use of Pharmacy Bulk Package Use Aseptic Technique During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. To hang the bottle use plastic hanger. Remove fliptop cap from vial and cleanse closure with antiseptic. Insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. The closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. Sequentially dispense aliquots of 23.4% Sodium Chloride Injection, USP into intravenous containers using appropriate transfer device. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling. Inspect solution after admixing. Discard if the solution is discolored or particulates are observed.
Warnings & Precautions
WARNINGS 23.4% Sodium Chloride Injection, USP is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, specifically osmotic demyelination syndrome, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly). Solutions containing sodium ions 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. In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium-free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
23.4% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing solutions. See WARNINGS and PRECAUTIONS .
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