Label: SODIUM CHLORIDE injection, solution

  • NDC Code(s): 0264-7800-01, 0264-7800-90
  • Packager: B. Braun Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 18, 2019

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  • DESCRIPTION

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

    Sodium Chloride USP 0.9 g; Water for Injection USP qs

    pH: 4.5-7.0

    Calculated Osmolarity: 310 mOsmol/liter

    Concentration of Electrolytes (mEq/liter):

    Sodium 154

    Chloride 154

    0.9% Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

    The formula of the active ingredient is:

    IngredientMolecular FormulaMolecular Weight
    Sodium Chloride USPNaCl58.44

    Not made with natural rubber latex, PVC or DEHP.

    Ecoflac® Plus is made of medical grade polyethylene (PE) which is chemically inert and nontoxic. The material is free from additives like plasticizers, stabilizers, and antioxidants.

    Addition of medication should be accomplished using complete aseptic technique.

    The two separated and identical ports can be used for either drug admixture or delivery.

  • CLINICAL PHARMACOLOGY

    0.9% Sodium Chloride Injection USP provides electrolytes and is a source of water for hydration. It is 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.

  • INDICATIONS AND USAGE

    This intravenous solution is 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.

    0.9% Sodium Chloride Injection USP is also indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

  • CONTRAINDICATIONS

    This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

  • WARNINGS

    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.

    This container is not for pressure infusion.

  • PRECAUTIONS

    General

    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. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

    Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

    Additional essential electrolytes, minerals and vitamins should be supplied as needed.

    Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

    Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect.

    To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.

    Do not use plastic containers in series connection.

    If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

    This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

    Use only if solution is clear and container and seals are intact.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with 0.9% Sodium Chloride Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

    Pregnancy

    Teratogenic Effects

    Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

    Geriatric Use

    An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, 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.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

  • ADVERSE REACTIONS

    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.

    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.

  • OVERDOSAGE

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

  • DOSAGE AND ADMINISTRATION

    This solution is 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 technique. Mix thoroughly. Do not store after mixing.

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

  • HOW SUPPLIED

    0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in Ecoflac® Plus Containers. The 500 mL and 1000 mL containers are packaged 10 per case.

    NDCREF Size
    0264-7800-90EC80001000 mL
    0264-7800-01EC8001500 mL

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

  • SPL UNCLASSIFIED SECTION

    Revised: February 2018

    Ecoflac is a registered trademark of B. Braun Melsungen AG

    Rx only

  • Directions for Use of Ecoflac® Plus IV Container

    Caution: Do not use plastic IV containers in series connection.

    This container is not for pressure infusion.

    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 one sealing foil from the Ecoflac® Plus Twincap®.
      NOTE: Close air vent of infusion set.
    2. Attach administration set. Refer to complete directions accompanying set.
      NOTE: Insert the infusion set at 90º angle. Do not rotate the spike when piercing the port.

    To Add Medication

    Warning: Some additives may be incompatible.

    To Add Medication Before Solution Administration

    1. Remove one sealing foil from the Ecoflac® Plus Twincap®. If foil already removed, prepare medication site using strict aseptic technique.
    2. Using syringe with 18-21 gauge needle, puncture resealable medication port and inject. Always insert the needle at a right (90°) angle. Only insert the needle into the port up to the needle shaft. Inserting the needle beyond its hub will force the port open too wide. This will make resealing more difficult.
    3. Mix solution and medication thoroughly.
      NOTE: For drug admixture with a syringe it is important to avoid an increase in pressure inside the container by removing an equal amount of air to the volume of drug added.

    To Add Medication During Solution Administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18-21 gauge needle, puncture resealable medication port and inject. Always insert the needle at a right (90°) angle. Only insert the needle into the port up to the needle shaft. Inserting the needle beyond its hub will force the port open too wide. This will make resealing more difficult.
      NOTE: For drug admixture with a syringe it is important to avoid an increase in pressure inside the container by removing an equal amount of air to the volume of drug added.
    4. Mix solution and medication thoroughly.
  • SPL UNCLASSIFIED SECTION

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

    Made in Germany

    LD-571-2

  • PRINCIPAL DISPLAY PANEL - 500 mL

    0.9% Sodium Chloride Injection USP

    NDC 0264-7800-01

    REF EC8001

    500 mL

    Ecoflac® Plus Container

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

    pH: 4.5-7.0; Calc. Osmolarity: 310 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: This container is not for pressure infusion. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store after mixing.

    Recommended Storage: 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. See Package Insert.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Ecoflac is a registered trademark of B. Braun Melsungen AG.

    recycle symbol

    Manufactured for:

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

    LD-569-1

    704/12624988/0118

    LOT

    EXP

    500 mL Container Label

  • PRINCIPAL DISPLAY PANEL - 1000 mL

    0.9% Sodium Chloride Injection USP

    NDC 0264-7800-90

    REF EC8000

    1000 mL

    Ecoflac® Plus Container

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

    pH: 4.5-7.0; Calc. Osmolarity: 310 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: This container is not for pressure infusion. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store after mixing.

    Recommended Storage: 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. See Package Insert.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Ecoflac is a registered trademark of B. Braun Melsungen AG.

    recycle symbol

    Manufactured for:

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

    LD-575-1

    704/12625523/0318

    LOT

    EXP

    1000 mL Container Label

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7800
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-7800-0110 in 1 CARTON01/26/2018
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-7800-9010 in 1 CARTON07/09/2018
    21000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01963503/09/1988
    Labeler - B. Braun Medical Inc. (002397347)