Label: DEXTROLYTE- electrolyte with dextrose injection, solution

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 22, 2011

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  • VETERINARY INDICATIONS

    For animal use only.  Keep out of reach of children and pets.

  • CAUTION:

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

  • INDICATIONS:

    For use in conditions associated with fluid and electrolyte loss, such as dehydration, shock, vomiting and diarrhea, particularly when an immediate source of energy is also indicated.

  • DOSAGE AND ADMINISTRATION:

    Warm solution to body temperature and administer slowly (10 to 30 mL per minute) by intravenous or intraperitoneal injection, using strict aseptic procedures.

    Adult Cattle and Horses: 1000 to 2000 mL

    Calves, Ponies and Foals: 500 to 1000 mL

    Adult Sheep and Swine: 500 to 1000 mL

    These are suggested dosages.  The actual amount and rate of fluid 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.

  • CONTRAINDICTIONS:

    Do not administer intraperitoneally to horses.

  • CONTAINS:

    Each 500 mL of sterile aqueous solution contains:

    Dextrose.H2O...................................................12.50 g

    Sorbitol............................................................12.50 g

    Sodium Lactate..................................................3.95 g

    Sodium Chloride.................................................2.40 g

    Potassium Chloride............................................0.37 g

    Magnesium Chloride.6H2O..................................0.21 g

    Calcium Chloride.2H2O.......................................0.19 g


    Milliequivalents per liter

    Cations
        Sodium.................................................. 153 mEq/L
        Potassium................................................. 9 mEq/L
        Calcium..................................................... 6 mEq/L
        Magnesium................................................ 4 mEq/L

    Anions
        Chloride.................................................. 101 mEq/L
        Lactate..................................................... 71 mEq/L
    Osmolarity (calc.): 602 mOsmol/L


  • CAUTION:

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

  • STORAGE:

    Store between 15 degree C-30 degree C (59 degree F-86 degree F).

  • PRINCIPAL DISPLAY PANEL

    Image of Container Label
  • INGREDIENTS AND APPEARANCE
    DEXTROLYTE 
    electrolyte with dextrose injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-804
    Route of AdministrationINTRAVENOUS, INTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2) Dextrose Monohydrate12.50 g  in 500 mL
    Sorbitol (UNII: 506T60A25R) (Sorbic acid - UNII:X045WJ989B) Sorbitol12.50 g  in 500 mL
    Sodium Lactate (UNII: TU7HW0W0QT) (Lactic acid - UNII:33X04XA5AT) Sodium Lactate3.95 g  in 500 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride2.40 g  in 500 mL
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride0.37 g  in 500 mL
    Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride0.21 g  in 500 mL
    Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride0.19 g  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-804-011000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/15/2011
    Labeler - MWI (VetOne) (019926120)
    Registrant - MWI (VetOne) (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture