Label: A3419-20 SINGLE SHOT EPIDURAL 20G TUOHY- anesthesia conduction kit

  • NDC Code(s): 51688-9345-2, 65282-1510-1
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated July 19, 2016

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  • DESCRIPTION

    Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9 mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.

    Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium Chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.

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  • CLINICAL PHARMACOLOGY

    Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of Fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants.

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  • INDICATIONS & USAGE

    Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isotonic single dose vehicle, solvent, or diluent for substances to be administered intravenously, intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.

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  • WARNINGS

    Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis.

    Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving corticos-teroids, corticotropin or other drugs that may give rise to sodium retention. For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.

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  • PRECAUTIONS

    Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the vial or ampul. Do not open ampul until it is to be used.

    Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection.

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  • PREGNANCY

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

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  • ADVERSE REACTIONS

    Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

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  • OVERDOSAGE

    When used as a diluent, solvent or intravascular flushing solution, this parental preparation is unlikely to pose a threat of sodium chloride or fluid overload except possible in very small infants. In the event these should occur, reevaluate the patient and institute appropriate corrective measures.

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  • DOSAGE & ADMINISTRATION

    Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.

    Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    INSTRUCTIONS FOR USE

    To open ampuls, using gauze, place thumb and forefinger on color line, break at constriction.

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  • HOW SUPPLIED

    5 mL ampuls packaged in box of 25 each (NDC-65282-1505-1)
    10 mL ampuls packaged in box of 25 each (NDC-65282-1510-1)

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  • STORAGE AND HANDLING

    Store at controlled room temperature 15-30 C (59-86 F). Avoid freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887
    By: KM. Pharm. Co., LTD.
    SM1500 Rev. B 12/00

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  • PRINCIPAL DISPLAY PANEL

    Sodium Chloride Inj USP 10mL

    Sodium Chloride Inj USP 10mL label

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A3419-20

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  • INGREDIENTS AND APPEARANCE
    A3419-20 SINGLE SHOT EPIDURAL 20G TUOHY 
    anesthesia conduction kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9345
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-9345-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 AMPULE 10 mL
    Part 1 of 1
    SODIUM CHLORIDE 
    sodium chloride solution
    Product Information
    Item Code (Source) NDC:65282-1510
    Route of Administration EPIDURAL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65282-1510-1 10 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/01/2000
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 06/16/2006
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Kwang Myung Pharm. Co., Ltd. 631099384 manufacture
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