3% AND 5% SODIUM CHLORIDE INJECTION, USP IN VIAFLEX PLASTIC CONTAINER

3% and 5% 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 VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

3% and 5% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

3% and 5% Sodium Chloride Injection, USP 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% and 5% Sodium Chloride Injection, USP.

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% and 5% Sodium Chloride Injection, USP 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% and 5% Sodium Chloride Injection, USP 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% and 5% Sodium Chloride Injection, USP with particular caution to patients with severe renal impairment. In such patients administration of Sodium Chloride Injection, USP may result in sodium retention.

Excessive administration of 3% and 5% Sodium Chloride Injection, USP 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 VIAFLEX 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% and 5% Sodium Chloride Injection, USP in VIAFLEX plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C /104°F does not adversely affect the product.

For Information on Risk of Air Embolism – see PRECAUTIONS.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

07-19-00-0269

Rev. May 2018

Baxter and Viaflex are trademarks of Baxter International Inc.

LOT

EXP

2B1353

NDC 0338-0054-03

Hypertonic Saline

3% Sodium Chloride Injection USP

500mL

EACH 100 mL CONTAINS 3 g SODIUM CHLORIDE USP
pH MAY HAVE BEEN ADJUSTED WITH HYDROCHLORIC ACID
pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 513 CHLORIDE 513
OSMOLARITY 1027 mOsmol/L (CALC) HYPERTONIC MAY CAUSE
VEIN DAMAGE STERILE NONPYROGENIC SINGLE DOSE CONTAINER
ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF
AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE
MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE
AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES
CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY
STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID
EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER

PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

LOT

EXP

2B1373

NDC 0338-0056-03

Hypertonic Saline

5% Sodium Chloride Injection USP

500mL

EACH 100 mL CONTAINS 5 g SODIUM CHLORIDE USP
pH MAY HAVE BEEN ADJUSTED WITH HYDROCHLORIC ACID
pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 856 CHLORIDE 856
OSMOLARITY 1711 mOsmol/L (CALC) HYPERTONIC
MAY CAUSE VEIN DAMAGE STERILE NONPYROGENIC
SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE
CONSULT WITH PHARMACIST IF AVAILABLE WHEN
INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE
MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY
AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER
OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL
READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER

PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA