Sodium Chloride

Each 100 mL of 0.9% Sodium Chloride Injection USP contains:

Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH: 5.6 (4.5–7.0)     Calculated Osmolarity: 308 mOsmol/liter
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 154     Chloride 154

Each 100 mL of 0.45% Sodium Chloride Injection USP contains:

Sodium Chloride USP 0.45 g; Water for Injection USP qs
pH: 5.6 (4.5–7.0)     Calculated Osmolarity: 154 mOsmol/liter, hypotonic
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 77     Chloride 77

Sodium Chloride Injections USP are sterile, nonpyrogenic, isotonic and contain no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

Sodium Chloride Injections USP provide electrolytes and are a source of water for hydration. They are capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.

0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion.

0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.

0.45% Sodium Chloride Injection USP is primarily a hydrating solution and may be used to assess the status of the kidneys, since more water is provided than is required for excretion of salt. It may also be used in the treatment of hyperosmolar diabetes where the use of dextrose is inadvisable and there is a need for large amounts of fluid without an excess of sodium ions.

Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.

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. Anaphylaxis has occasionally been reported.

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Cerebral edema and myelinolysis have been reported.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

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 the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use.)

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

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

Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL^® Plus Containers. The 1000 mL containers are packaged 12 per case; the 500 mL containers are packaged 24 per case.

Rx only

Revised: September 2019
EXCEL is a registered trademark of B. Braun Medical Inc.

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

• Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
• Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
• Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove foil cover from sterile set port at bottom of container as shown in Figure A, Steps 1 and 2.
   Figure A - Step 1 Illustration     Figure A - Step 2 Illustration
   
2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

1. Prepare medication site.
2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in use position and continue administration.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-002-932   LD-629-1

0.9% Sodium Chloride
Injection USP

REF Q8000
NDC 0264-5802-00

 1000 mL
EXCEL^® PLUS CONTAINER

Each 100 mL contains: Sodium Chloride USP 0.9 g;
Water for Injection USP qs

pH adjusted with HCl NF
pH: 5.6 (4.5-7.0); Calc. Osmolarity: 308 mOsmol/liter

Electrolytes (mEq/liter): Na⁺ 154; Cl^– 154

Sterile, nonpyrogenic. Single-dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult
with pharmacist. When introducing additives, use aseptic
techniques. Mix thoroughly. Do not store.

Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.]

Avoid excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

 Other

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-357
LD-630-1

EXP
LOT

1000 mL Container Label Q8000

0.9% Sodium Chloride
Injection USP

REF Q8001
NDC 0264-5802-10

500 mL
EXCEL^® PLUS CONTAINER

Each 100 mL contains: Sodium Chloride USP 0.9 g;
Water for Injection USP qs

pH adjusted with HCl NF
pH: 5.6 (4.5–7.0); Calc. Osmolarity: 308 mOsmol/liter

Electrolytes (mEq/liter): Na⁺ 154; Cl^– 154

Sterile, nonpyrogenic. Single-dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear and
container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult with
pharmacist. When introducing additives, use aseptic techniques. Mix
thoroughly. Do not store.

Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.]

Avoid excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check for
minute leaks by squeezing container firmly. If leaks are found, discard solution as
sterility may be impaired. 

Not made with natural rubber latex, PVC or DEHP.

Rx only

 Other

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-358
LD-631-1

EXP
LOT

500 mL Container Label Q8001

0.45% Sodium Chloride
Injection USP

REF Q8020
NDC 0264-5804-00

 1000 mL
EXCEL^® PLUS CONTAINER

Each 100 mL contains: Sodium Chloride USP 0.45 g;
Water for Injection USP qs

pH adjusted with HCl NF
pH: 5.6 (4.5-7.0); Calc. Osmolarity: 154 mOsmol/liter,
hypotonic

Electrolytes (mEq/liter): Na⁺ 77; Cl^– 77

Sterile, nonpyrogenic. Single-dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.

WARNINGS: Some additives may be incompatible. Consult
with pharmacist. When introducing additives, use aseptic
techniques. Mix thoroughly. Do not store.

Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.]

Avoid excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

 Other

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-360
LD-632-1

EXP
LOT

1000 mL Container Label Q8020