Sodium Chloride Injection 0.45%: Package Insert / Prescribing Info

Sodium Chloride Injection 0.45% Description

0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration.

Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.).

The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers.

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher.

Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® 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.

Sodium Chloride Injection 0.45% - Clinical Pharmacology

When administered intravenously, these solutions provide a source of water and electrolytes.

Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements.

Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome.

Sodium chloride in water dissociates to provide sodium (Na +) and chloride (Cl −) ions. Sodium (Na +) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl −) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na +) and chloride (Cl −) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na +) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Sodium Chloride Injection 0.45%

Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

Contraindications

None known.

Warnings

0.45% Sodium chloride injection 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.

The intravenous administration of 0.45% Sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

In patients with diminished renal function, administration of 0.45% Sodium chloride injection may result in sodium retention.

Precautions

Adverse Reactions/Side Effects

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium chloride injection (see Pediatric Use).

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

Sodium Chloride Injection 0.45% Dosage and Administration

The dose is dependent upon the age, weight and clinical condition of the patient.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS).

INSTRUCTIONS FOR USE:

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.

Flexible Plastic Container (freeflex® bag)

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.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® 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.

How is Sodium Chloride Injection 0.45% supplied

0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows:

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Manufactured for:

Lake Zurich, IL 60047



www.fresenius-kabi.com/us



Issued: September 2018

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sodium Chloride 1,000 mL Bag Label

NDC 63323-626-05 1,000 mL

0.45% Sodium Chloride Injection, USP

4.5 grams per 1,000 mL (4.5 mg per mL)

For intravenous use.

Rx only