Label: SODIUM CHLORIDE- sodium chloride injection, solution

  • NDC Code(s): 63323-623-00, 63323-623-09, 63323-623-10, 63323-623-50, view more
    63323-623-51, 63323-623-57, 63323-623-59
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • HEALTH CARE PROVIDER LETTER

     

     0.9% SODIUM CHLORIDE INJECTION SOLUTION AVAILABILITY

    Subject: Importation of European Drug Product

    March 3, 2014

    Dear Healthcare Professional,

     

    Due to the current critical shortage of 0.9% Sodium Chloride Injection in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. Fresenius Kabi USA has initiated temporary importation of a European Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion into the U.S. market. The European product contains the same active ingredient in the same concentration as the 0.9% Sodium Chloride Injection products approved in the United States. The Sodium Chloride 0.9% Freeflex Injection Solution product is manufactured near Halden, Norway, at Fresenius Kabi Norge AS, an FDA inspected facility. At its most recent FDA inspection, this facility was found to be in compliance with current good manufacturing practices.

    At this time, FDA is not objecting to the importation and distribution of Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion, by Fresenius Kabi USA, to address the critical shortage of 0.9% Sodium Chloride Injection. Importation or distribution of Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion by any entity other than Fresenius Kabi USA, is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution products in the United States.

    Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentations of Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion:

     

    Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    Product Name

    Volume

    Ingredients

    Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    50 mL

    Each 50 mL contains:

    Sodium Chloride 450 mg, Water for Injections to 50 mL

     

    Total Electrolytes per 50 mL approx:

    Sodium 7.7 mmol*, Chloride 7.7 mmol*

    Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    100 mL

    Each 100 mL contains:

    Sodium Chloride 900 mg, Water for Injections to 100 mL

     

    Total Electrolytes per 100 mL approx:

    Sodium 15.4 mmol*, Chloride 15.4 mmol*

    Sodium Chloride 0.9% w/v for

    Intravenous Infusion

    500 mL

    Each 500 mL contains:

    Sodium Chloride 4.5 g, Water for Injections to 500 mL

     

    Total Electrolytes per 500 mL approx:

    Sodium 77 mmol*, Chloride 77 mmol*

    Sodium Chloride 0.9% w/v for Intravenous Infusion

    1000 mL

    Each 1000 mL contains:

    Sodium Chloride 9 g, Water for Injections to 1000 mL

     

    Total Electrolytes per 1000 mL approx:

    Sodium 154 mmol*, Chloride 154 mmol*

    * For monovalent ions, such as sodium and chloride, the numeric value of the millimole and milliequivalent are identical.

     

    Fresenius Kabi’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion is packaged in freeflex®, a flexible bag with self-sealing ports and made of multilayer Polyolefin film that is PVC-free, plasticizer-free, latex-free and non-DEHP.

      

    scfigure1                                                    scfigure2

     

    It is important to note that there are differences in the formatting and content of the labeling between the U.S. marketed 0.9% Sodium Chloride solutions, and Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion. Refer to comparison table attached.

     

    Differences Between U.S. Prescribing Information and Fresenius Kabi’s Prescribing Information

    Property

    0.9% Sodium Chloride U.S. Products

    Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    Active Ingredients

    Sodium 154 mEq/L*

    Sodium 154 mmol/L*

    Chloride 154 mEq/L*

    Chloride 154 mmol/L*

    Osmolarity 308 mOsmol/L (calc.)

    Osmolality 308 mOsmol/kg water** (calc.)

    Indications for Use

    See manufacturer’s package insert

    Normal saline can be used as the vehicle for many parenteral drugs and as a sterile irrigation medium.

    Contraindications

    See manufacturer’s package insert

    Sodium Chloride 0.9% is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention, edema, liver cirrhosis and irrigation during electrosurgical procedures.

    Warnings

    Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.

    Refer to Fresenius Kabi’s package insert or visit www.fresenius-kabi.us

    Adverse Reactions

    See manufacturer’s package insert

    Excessive amounts of sodium chloride may cause hypernatremia, hypokalemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.

     

    Hypernatremia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

     

    Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.

    Drug Interactions

    See manufacturer’s package insert

    Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

    Overdose and Treatment

    See manufacturer’s package insert

    Overdose 

    Infusion of excess intravenous fluid may cause hypervolemia and electrolyte imbalances. Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary edema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

     

    Treatment

    Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using I.V. hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions may require diazepam or other appropriate treatment.

    Container Type

    See manufacturer’s package insert

    Packaged in freeflex® bag. Made of multilayer polyolefin film. Non-DEHP, non-PVC, and latex-free.

    Barcode

    Readable U.S. barcodes

    Any barcodes on Fresenius Kabi’s Sodium Chloride 0.9% freeflex® solution will not be appropriately recognized by scanning systems used in the United States and should not be used.

    Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned.

    * For monovalent ions, such as sodium and chloride, the numeric value of the millimole and milliequivalent are identical

    ** 1 kilogram of water is equal to 1 liter of water

     

    Refer to the package insert for Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion for full prescribing information

    This communication and product information is available on the Fresenius Kabi USA web site www.fresenius-kabi.us as well as on the FDA Drug Shortage web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.

    REPORTING ADVERSE EVENTS:

    To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA Vigilance and Medical Affairs at 1-800-551-7176, Monday - Friday, between the hours of 8 a.m. and 5 p.m. (CST), or e-mail appmedicalinfo@APPpharma.com.

    Fresenius Kabi USA CONTACT NUMBERS: Please use the following contact numbers as appropriate:

    Reason To Call

    Department

    Number

    ADE Reporting/Clinical/Technical Info.

    Vigilance and Medical Affairs Dept.

    1-800-551-7176

    Product Availability & Ordering

    Customer Service Department

    1-888-386-1300

    Adverse events may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    • Online: www.fda.gov/medwatch/report.htm 
    • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    • Fax: 1-800-FDA-0178

     

    Sincerely,

    Melanie Power-Burns

    Senior Director, U.S. Quality & Compliance

     

     

     

                                                       Comparison Table of U.S. 0.9% Sodium Chloride Injection to Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    Fresenius Kabi                       

    Hospira

    Hospira

    Hospira

    Baxter

    Baxter

    Baxter

     

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     scfigure4

     scfigure5

     scfigure6

     scfigure7

      Product Image

                         Not  Available                   

     scfigure8

    Product

    Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    NDC #

    63323-623-50

    0409-7984-06

    0409-7984-13

    0409-7984-36

    0338-0049-11

    0338-0049-31

    0338-0049-41

    Volume

    50 mL

    50 mL

    50 mL

    50 mL

    50 mL

    50 mL

    50 mL

    Container Type

    freeflex®

    VisIV™ Flexible plastic container

    Flexible plastic container

    Flexible plastic container

    VIAFLEX plastic container

    VIAFLEX plastic container

    VIAFLEX plastic container

    Container Description

    Made of multilayer polyolefin film.

    Non-DEHP,

    non-PVC, and latex free.

    Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, non-latex.

    PVC container. Contains DEHP, non-latex.

    PVC container. Contains DEHP, non-latex.

    Preservative Free

    Yes

    Yes

    Yes

    Yes

    Yes

    Yes

    Yes

    Case Size

    60

    60

    48

    80 (Quad Pack)

    96 (Quad Pack)

    96 (Multi Pack)

    96

       

     

    Fresenius Kabi

    Hospira

    Hospira

    Hospira

    Baxter

    Baxter

    Baxter

     

    scfigure9 

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     scfigure11

    scfigure12 

    scfigure13 

     scfigure14

     scfigure15

    Product

    Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    NDC #

    63323-623-00

    0409-7984-11

    0409-7984-23

    0409-7984-37

    0338-0049-18

    0338-0049-38

    0338-0049-48

    Volume

    100 mL

    100 mL

    100 mL

    100 mL

    100 mL

    100 mL

    100 mL

    Container Type

    freeflex®

    VisIV™ Flexible plastic container

    Flexible plastic container

    Flexible plastic container

    VIAFLEX plastic container

    VIAFLEX plastic container

    VIAFLEX plastic container

    Preservative Free

    Yes

    Yes

    Yes

    Yes

    Yes

    Yes

    Yes

    Container Description

    Made of multilayer polyolefin film.

    Non-DEHP,

    non-PVC, and latex free.

    Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, non-latex.

    PVC container. Contains DEHP, non-latex.

    PVC container. Contains DEHP, non-latex.

    Case Size

    50

    60

    48

    80 (Quad Pack)

    96 (Quad Pack)

    96 (Multi Pack)

    96

      

     

    Fresenius Kabi

    Hospira

    Hospira

    Baxter

     

    scfigure16 

    scfigure17 

    scfigure18 

    scfigure19 

    Product

    Sodium Chloride 0.9% w/v for Intravenous Infusion

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    NDC #

    63323-623-59

    0409-7983-03

    0409-7983-55

    0338-0049-03

    Volume

    500 mL

    500 mL

    500 mL

    500 mL

    Container Type

    freeflex®

    Flexible plastic container

    Flexible plastic container

    VIAFLEX plastic container

    Preservative Free

    Yes

    Yes

    Yes

    Yes

    Container Description

    Made of multilayer polyolefin film.

    Non-DEHP,

    non-PVC, and latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, latex free.

    PVC container. Contains DEHP, non-latex.

    Case Size

    20

    24

    18

    24

        

     

    Fresenius Kabi

    Hospira

    Baxter

     

    scfigure20 

    scfigure21 

    scfigure22 

    Product

    Sodium Chloride 0.9% w/v for Intravenous Infusion

    0.9% Sodium Chloride Injection, USP

    0.9% Sodium Chloride Injection, USP

    NDC #

    63323-623-10

    0409-7983-09

    0338-0049-04

    Volume

    1000 mL

    1000 mL

    1000 mL

    Container Type

    freeflex®

    Flexible plastic container

    VIAFLEX plastic container

    Preservative Free

    Yes

    Yes

    Yes

    Container Description

    Made of multilayer polyolefin film.

    Non-DEHP,

    non-PVC, and latex free.

    Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free

    PVC container. Contains DEHP, non-latex.

    Case Size

    10

    12

    14

     

     

     

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  • MEDICATION GUIDE

    PATIENT LEAFLET:  INFORMATION FOR THE USER Close
  • DESCRIPTION

    Sterile isotonic solution of sodium chloride 9g/L in Water for Injections, containing no preservatives (normal saline).

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  • PHARMACOLOGY

    Sodium Chloride Injection 0.9% provides a source of sodium ions (154 mmol/L), chloride ions (154 mmol/L) and water.

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  • INDICATIONS

    Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid.

    It can also be used as a sterile irrigation medium.

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  • CONTRAINDICATIONS

    Sodium Chloride 0.9% is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention, oedema, liver cirrhosis and irrigation during electrosurgical procedures.

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  • PRECAUTIONS

    Do not use unless the solution is clear. The entire contents of the bag should be used promptly.

    When used as a vehicle for intravenous drug delivery, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.

    Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid/base balance may be necessary. Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids, corticotrophin or other drugs that may give rise to sodium retention. Sodium chloride should be administered with care to patients with congestive heart failure, hypertension, peripheral or pulmonary oedema, hypoproteinaemia, impaired renal function, urinary tract obstruction, pre-eclampsia and very young or elderly patients. Intravenous infusion during or immediately after surgery may result in sodium retention.

    Given that there is a possibility of systemic absorption of irrigation solutions, the same precautions apply.

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  • USE IN PREGNANCY

    Safety in pregnancy has not been established. Use is recommended only when clearly indicated.

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  • USE IN LACTATION

    Safety in lactation has not yet been established. Use of this product while breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn infant.

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  • PAEDIATRIC USE

    In paediatric use, the dose should be calculated for each patient based on clinical condition, including body weight and laboratory data.

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  • USE IN ELDERLY

    For use in elderly, the dose should be based on individual patient assessment, including weight, fluid and electrolyte status and renal and cardiac function.

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  • INTERACTIONS

    Additives may be incompatible with sodium chloride.

    Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

    Close
  • ADVERSE REACTIONS

    Excessive amounts of sodium chloride may cause hypernatraemia, hypokalaemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.

    Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

    Infusion of excess sodium chloride 0.9% solution may cause fluid overload or electrolyte imbalance. Intravenous administration of solutions may cause local reactions including pain, vein irritation and thrombophlebitis. Extravasation of solution may cause tissue injury.

    If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

    Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.

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  • DOSAGE AND ADMINISTRATION

    The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.

    For use in one patient, on one occasion only. It does not contain antimicrobials. Any unused portion should be discarded. Care should be taken with intravenous technique to avoid injection site reactions and infections.

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  • OVERDOSAGE

    Infusion of excess intravenous fluid may cause hypervolaemia and electrolyte imbalances. Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced,  while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

    Close
  • TREATMENT

    Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using I.V. hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions may require diazepam or other appropriate treatment.

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  • PRESENTATION AND STORAGE CONDITIONS

    Freeflex bags - Store below 25°C.

    50mL           AUST R 144596

    100mL         AUST R 144609

    250mL         AUST R 144632

    500mL         AUST R 29745

    1000mL       AUST R 47400

     

     

    Poison schedule of the medicine

    Australia: Nil

    New Zealand: General Sales Medicine

     

     

    Date of Approval: 9th May 2005

    Date of Most Recent Amendment: 16 July 2010

     

    Name and address of the sponsor Fresenius Kabi Australia Pty Limited

    964 Pacific Highway

    Pymble NSW 2073 Australia

    Tel: (02) 9391 5555

     

    Fresenius Kabi New Zealand Limited

    60 Pavilion Drive

    Airport Oaks, Auckland 2022

    New Zealand

    Freecall: 0800 144 892

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 50 mL Bag

    50 mL              Code FAH3038

    Sodium Chloride 0.9% Injection Solution

    for Intravenous Infusion

     

    50ml-bag 

     


    PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 100 mL Bag

    100 mL              Code FAH3015

    Sodium Chloride 0.9% Injection Solution

    for Intravenous Infusion

     

    100ml-bag 

     

    PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 500 mL Bag

    500 mL              Code K690521

    Sodium Chloride 0.9% w/v

    for Intravenous Infusion

     

    500ml-bag 

     

    PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 1000 mL Bag

    1000 mL              FAH1324

    Sodium Chloride 0.9% w/v

    for Intravenous Infusion

     

     1000ml-bag

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  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-623
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 9 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63323-623-50 60 in 1 BOX
    1 50 mL in 1 BAG
    2 NDC:63323-623-57 60 in 1 BOX
    2 50 mL in 1 BAG
    3 NDC:63323-623-00 50 in 1 BOX
    3 100 mL in 1 BAG
    4 NDC:63323-623-09 50 in 1 BOX
    4 100 mL in 1 BAG
    5 NDC:63323-623-59 20 in 1 BOX
    5 500 mL in 1 BAG
    6 NDC:63323-623-51 20 in 1 BOX
    6 500 mL in 1 BAG
    7 NDC:63323-623-10 10 in 1 BOX
    7 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug for use in drug shortage 02/18/2014
    Labeler - Fresenius Kabi USA, LLC (608775388)
    Establishment
    Name Address ID/FEI Business Operations
    Fresenius Kabi Norge AS 731170932 MANUFACTURE(63323-623)
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