Label: HYPERTONIC SALINE injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 4, 2014

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  • INDICATIONS:

    For use in replacement therapy of sodium, chloride and water which may become depleted in many diseases.

  • DOSAGE AND ADMINISTRATION:

    Horses/Cattle: 50 to 100 mL per 100 lb bodyweight. Warm to body temperature and administer slowly by intravenous or subcutaneous injection. The amount and rate of administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Distributed by: MWI
    Boise, ID 83705
    (888) 694-8381
    www.vetone.net

    Manufactured by: Nova-Tech, Inc.
    Grand Island, NE 68801

    Rev. 03/12

    Solution, USP

    Sterile-Preservative Free

    V1 501031

    Net Contents: 1000 mL

    RMS 92-1005        18-806-60

    LOT NO.:         EXP. DATE:

  • WARNINGS AND PRECAUTIONS

    Keep out of reach of children.

  • VETERINARY INDICATIONS

    For animal use only.

  • CAUTION:

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • COMPOSITION:

    Each 100 mL of sterile aqueous solution contains:
    Sodium Chloride........................7.2 g
    Milliequivalents per liter
    Cations:
    Sodium.................................1232 mEq/L
    Anions:
    Chloride................................1232 mWq/L
    Total osmolarity is 2464 millosmoles per liter.

  • CAUTION:

    This product contains no preservatives. Use entire contents when opened. Discard any unused solution.

  • STORAGE:

    Store at controlled room temperature between 15 degrees and 30 degrees C (59 degrees - 86 degrees F).

  • PRINCIPAL DISPLAY PANEL

    92-1005 Container Label

  • INGREDIENTS AND APPEARANCE
    HYPERTONIC SALINE 
    hypertonic saline injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-806
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE7.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-806-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2012
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture
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