SODIUM CHLORIDE- sodium chloride injection, solution 
CODAN US CORPORATION

----------

0.9% Sodium Chloride Injection, USP
in FLEBOFLEX and FLEBOFLEX LUER Plastic Container

DESCRIPTION

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below:

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

CONTRAINDICATIONS

None known.

WARNINGS

Hypersensitivity

Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% 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.

Electrolyte Imbalances

Fluid Overload

Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema.

Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use.

Hyponatremia

Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP.

The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See Drug Interactions.

Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

Hypernatremia

Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.

Certain medications such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see Drug Interactions.

Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.

PRECAUTIONS

Patients with Severe Renal Impairment

Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see Warnings). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions

Other Products that Affect Fluid and/or Electrolyte Balance
Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Lithium
Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.

Other Drugs that Increase the Risk of Hyponatremia
Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Pregnancy

There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman.

Pediatric Use

The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See Dosage and Administration).

Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Consider monitoring renal function in elderly patients.

ADVERSE REACTIONS

Post-Marketing Adverse Reactions

The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following:

General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria.

Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

Metabolism and nutrition disorders: Hypernatremia, hyponatremia, hyperchloremic metabolic acidosis.

Nervous System Disorders: Hyponatremic encephalopathy.

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.

OVERDOSAGE

Excessive administration of 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death.

Excessive administration of Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See Warnings and Adverse Reactions.

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.

Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

DOSAGE AND ADMINISTRATION

Important Administration Instructions

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

HOW SUPPLIED

The available sizes of 0.9% Sodium Chloride Injection, USP are shown below:

Size (mL)   NDCCatalog No.Item No.
Fleboflex bags :  
50 (115 units in one carton)    81826-001-01 NS0050 26.9459
100 (70 units in one carton)    81826-001-11 NS0100 26.9460
250 (28 units in one carton)    81826-001-21 NS0250 26.9461
500 (20 units in one carton)    81826-001-31 NS0500 26.9462
1000 (10 units in one carton)    81826-001-41 NS1000 26.9463
  
Fleboflex Luer bags :    Not distributed by CODAN US Corporation
50 (90 units in one carton)  
100 (50 units in one carton)  
250 (32 units in one carton)  
500 (24 units in one carton)  
1000 (10 units in one carton)  

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.

DIRECTIONS FOR USE OF FLEBOFLEX AND FLEBOFLEX LUER PLASTIC CONTAINERS

For Information on Risk of Air Embolism – see Dosage and Administration.

To Open
Peel off the overwrap and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration
1.Suspend container from eyelet support.
2. Fleboflex bags: Remove plastic protector from outlet port at bottom of container.
    Fleboflex Luer bags: Break the twist-off administration port by means of torsion.
3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication
Additives may be incompatible.

To add medication before solution administration
1. Prepare medication site.
2. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
3. Mix solution and medication thoroughly.

To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
4. Remove container from intravenous pole and/or turn to an upright position.
5. Mix solution and medication thoroughly.
6. Return container to in-use position and continue administration.

Distributed by:
CODAN US Corporation
Santa Ana, CA 92704

Manufactured by:
Laboratorios Grifols, S.A.
30565 Murcia - SPAIN

Printed in SPAIN

Rev. 08/2020

GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A.

3060502 (Internal reference)

CODAN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NS0500 Item No. 26.9462

NDC 81826-001-31


0.9% Sodium Chloride
Injection, USP


500 mL

Fleboflex Container

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
[see USP controlled Room Temperature.] Avoid excessive heat.

CODAN

Manufactured for Codan US Corporation
Santa Ana, CA  92704
Product of Spain

LOT           EXP         1002033

Num.: IN HOUSE CONTROL NUMBER

20 x 500 mL

500 mL Carton

NDC 81826-001-32

0.9% Sodium Chloride Injection, USP

500 mL

For Intravenous use
Single dose container

Rx Only

Each 100 mL contains 900 mg Sodium Chloride USP; pH 4.5 to 7.0
Sodium 154 mEq/L Chloride 154 mEq/L; Osmolarity 308 mOsmol/L (calc)

Sterile Non pyrogenic. 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. Additives may be 
incompatible. Consult with pharmacist if available. When introducing
additives, use aseptic technique. Mix thoroughly. Do not store.
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to
30°C (59° to 86°F). [see USP Controlled Room Temperature.] Store unit in
moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not
adversely affect the product. Avoid excessive heat. Read package insert for
full information.

Grifols and Fleboflex are trademarks of Grifols, S.A.

Manufactured for Codan US Corporation
Santa Ana, CA  92704
Product of Spain

4000798
DATA MATRIX

Fleboflex Container
(PVC-free and DEHP-free)
The container closure is not made with natural rubber latex.

CODAN

NS0500
Item No. 26.9462


LOT XXXXXX
EXP MM-YYYY
INTERNAL REFERENCE

500 mL Container
SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81826-001
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698, Sodium Cation - UNII:LYR4M0NH37) SODIUM CHLORIDE9 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81826-001-01115 in 1 CARTON08/05/2021
1NDC:81826-001-0250 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:81826-001-1170 in 1 CARTON08/05/2021
2NDC:81826-001-12100 mL in 1 BAG; Type 0: Not a Combination Product
3NDC:81826-001-2128 in 1 CARTON08/05/2021
3NDC:81826-001-22250 mL in 1 BAG; Type 0: Not a Combination Product
4NDC:81826-001-3120 in 1 CARTON08/05/2021
4NDC:81826-001-32500 mL in 1 BAG; Type 0: Not a Combination Product
5NDC:81826-001-4110 in 1 CARTON08/05/2021
5NDC:81826-001-421000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20795605/25/2017
Labeler - CODAN US CORPORATION (058027475)
Registrant - LABORATORIOS GRIFOLS SA (461842294)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Grifols, S. A.463720681manufacture(81826-001)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS GRIFOLS SA461842294analysis(81826-001)

Revised: 7/2021
Document Id: dd85f8a5-3995-4592-8df2-9a0ffeef6edd
Set id: aa06e286-75c6-4d7a-959f-6008d38aa6e5
Version: 1
Effective Time: 20210716
 
CODAN US CORPORATION