Label: ELECTROLYTE SOLUTION WITH DEXTROSE- dexolyte injection, solution

  • NDC Code(s): 65207-804-50, 65207-804-60
  • Packager: Nova-Tech, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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Drug Label Information

Updated February 24, 2023

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  • 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.

  • CONTRAINDICATIONS:

    Do not administer intraperitoneally to horses.

  • CAUTION:

    This product contains no preservatives.
    Use entire contents when first opened. Do not use if solution is not clear. Discard any unused solution.

  • DOSAGE & 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 Cattleand Horses - 1000 to 2000 mL
    Calves, Ponies&Foals - 500 to 1000 mL

    Adult SheepandSwine - 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.

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.
    Grand Island, NE 68801 USA

    18-804

    RMS 92-331

    NDC# 65207-805-60

    Nova-Tech®

    Animal Health

    I.V. Solution Injection

    Net Contents:

    1000 mL (33.81 fl oz)

    Assembled in USA

    Lot No.

    Exp. Date

  • VETERINARY INDICATIONS

    FOR ANIMAL USE ONLY

  • WARNINGS AND PRECAUTIONS

    KEEP OUT OF REACH OF CHILDREN

  • Caution:

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

  • COMPOSITION

    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

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    1000 mL Label1000 mL Label500 mL Label

  • INGREDIENTS AND APPEARANCE
    ELECTROLYTE SOLUTION WITH DEXTROSE 
    dexolyte injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-804
    Route of AdministrationINTRAVENOUS, INTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate12.50 g  in 500 mL
    Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R) Sorbitol12.50 g  in 500 mL
    Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37) Sodium Lactate3.95 g  in 500 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) 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:65207-804-50500 mL in 1 BOTTLE, PLASTIC
    2NDC:65207-804-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/16/2020
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)