Sodium Chloride Injection, USP Product Monograph

1 INDICATIONS

Sodium Chloride Injection, USP 4 mmol / mL, is indicated:

• as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of millimoles of Sodium Chloride Injection, USP is taken and diluted for use.

2 CONTRAINDICATIONS

Sodium Chloride Injection, USP is contraindicated in patients with hypernatremia or fluid retention.

4 DOSAGE AND ADMINISTRATION

The dosage of Sodium Chloride Injection, USP 4 mmol / mL, as an additive in parenteral fluid therapy is predicated on the specific requirements of the patient after necessary clinical and laboratory information is considered and correlated. The appropriate volume is then withdrawn for proper dilution. Having determined the milliequivalents of sodium chloride to be added, divide by four to calculate the number of milliliters (mL) of Sodium Chloride Injection, USP 4 mmol / mL, to be used. Withdraw this volume aseptically and transfer this additive solution into appropriate intravenous solutions such as 5% dextrose injection. The final solution should be used in its entirety within four hours. The properly diluted solutions may be given intravenously or subcutaneously.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

Not for multiple-dose use. Do not inject without dilution. Use only if solution is clear. No preservative added; the contents of the vial should be promptly used.

DIRECTIONS FOR DISPENSING FROM PHARMACY BULK PACKAGE – Not for Direct Infusion:

Pharmacy Bulk Package is a single use vial for pharmacy use only.

Use Aseptic Technique

1. 1. During use, container must be stored and all manipulations performed in an appropriate laminar flow hood.
2. 2. To hang the 100 mL Pharmacy Bulk Vial use the ring sling (plastic hanger) provided and to hang the 200 mL Pharmacy Bulk Vial use the hanging vial label.
3. 3. Remove fliptop cap from vial and cleanse closure with antiseptic.
4. 4. 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. Any unused portion should be discarded within 4 hours after initial entry.
5. 5. 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.
6. 6. Inspect solution after admixing. Discard if the solution is discolored or particulates are observed.

5 OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (See 7 WARNINGS AND PRECAUTIONS).

For management of a suspected drug overdose, contact your regional poison control centre.

6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING

Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration only after dilution to replenish electrolytes. The preparation contains 4 mEq / mL (23.4%) sodium chloride in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq / mL solution is 8 mOsmol / mL (calculated). Sodium chloride is chemically designated NaCl, a white crystalline compound freely soluble in water.

A Pharmacy Bulk Package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Sodium Chloride Injection, USP is supplied in single use, flip-top vials, in boxes of 25, and in Pharmacy Bulk Packages.

7 WARNINGS AND PRECAUTIONS

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.

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 per kg per day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of TPN products and of the lock-flush solutions used in their administration.

Do not use unless the solution is clear and seal is intact.

Sodium Chloride Injection, USP must be diluted before infusion to avoid a sudden increase in the level of plasma sodium. Too rapid administration should be avoided.

Special caution should be used in administering sodium containing solutions to patients with severe renal impairment, cirrhosis of the liver, cardiac failure, or other edematous or sodium-retaining states.

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.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

7.1 Special Population

7.1.1 Pregnant Women

Teratogenic Effects:

Animal reproduction studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.

8 ADVERSE REACTIONS

This information is not available for this drug product.

9 DRUG INTERACTIONS

This information is not available for this drug product.

10 CLINICAL PHARMACOLOGY

This information is not available for this drug product.

11 STORAGE, STABILITY AND DISPOSAL

Store at 15 °C to 30 °C. Protect from freezing.

12 SPECIAL HANDLING INSTRUCTION

This information is not available for this drug product.

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Questions or concerns? 1-877-821-7724

Last revised: April 13, 2022