3% Sodium Chloride Injection, USP

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Rx only

3% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ^® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

3% Sodium Chloride Injection has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

3% Sodium Chloride Injection is indicated as a source of water and electrolytes.

None known.

Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 3% Sodium Chloride Injection.

Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Depending on the volume and rate of infusion, the intravenous administration of 3% Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Administer 3% Sodium Chloride Injection with particular caution to patients with or at risk for hypernatremia, hyperchloremia, hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism (for example, associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia). Certain medications may increase risk of sodium and fluid retention (see Drug Interactions).

Administer 3% Sodium Chloride Injection with particular caution to patients with severe renal impairment. In such patients administration of Sodium Chloride Injection may result in sodium retention.

Excessive administration of 3% Sodium Chloride Injection may lead to hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral edema and death) and sodium overload (which can lead to central and/or peripheral edema).

When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.

As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient's age, weight, clinical condition, concomitant treatment, and on the patient's clinical and laboratory response to treatment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Do not administer unless solution is clear and seal is intact.

All injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

3% Sodium Chloride Injection, USP in a single dose flexible plastic container, is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Check flexible container solution composition, lot number, and expiry date.

Do not remove solution container from its overwrap until immediately before use.

Use sterile equipment and aseptic technique.

To Open

1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
3. Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

1. Identify WHITE Additive Port with arrow pointing toward container.
2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
3. Hold base of WHITE Additive Port horizontally.
4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives.
5. Mix container contents thoroughly.

Preparation for Administration

1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
2. Use a non-vented infusion set or close the air-inlet on a vented set.
3. Close the roller clamp of the infusion set.
4. Hold the base of BLUE Infusion Port.
5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

Manufactured for:

Fresenius Kabi Logo

Lake Zurich, IL 60047

Made in Germany

www.fresenius-kabi.com/us

451532A

Revised: February 2020

NDC 63323-530-21

freeflex^®

500 mL

3% Sodium Chloride Injection, USP

15 grams per 500 mL (30 mg per mL)

Hypertonic Saline

For intravenous use. Rx only

NDC 63323-530-75           530175
3% Sodium Chloride Injection, USP,

15 grams per 500 mL

500 mL x 20 Single-Dose Container

Hypertonic Saline

For Intravenous Use

Rx only