Label: VETALYTE PLUS injection, solution

  • NDC Code(s): 46066-804-50, 46066-804-60
  • Packager: Aspen Veterinary
  • 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 April 26, 2017

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

  • 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 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 andHorses - 1000 to 2000 mL
    Calves, Ponies andFoals - 500 to 1000 mLAdult Sheep andSwine - 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

    RMS# 92-501
    18-804

    Manufactured for:
    Aspen Veterinary Resources®, Ltd.Liberty, MO 64068, USA              A287NT          Rev. 09/15
    www.aspenveterinaryresources.com

    I.V. Solution Injection
    Electrolytes - Dextrose

    NET CONTENTS:1000 mL (33.81 fl oz) 

    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 gSorbitol...................................12.50 gSodium Lactate.........................3.95 gSodium Chloride........................2.40 gPotassium Chloride....................0.37 gMagnesium Chloride•6H2O.........0.21 gCalcium Chloride•2H2O..............0.19 g

    Milliequivalents per liter

    CationsSodium...................................153 mEq/LPotassium..................................9 mEq/LCalcium.....................................6 mEq/LMagnesium................................4 mEq/L

    AnionsChloride..................................101 mEq/LLactate.....................................71 mEq/LOsmolarity (calc.) 602 mOsmol/L

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    1000 ml container label500 ml container label

  • INGREDIENTS AND APPEARANCE
    VETALYTE PLUS 
    vetalyte plus injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-804
    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 1000 mL
    Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R) Sorbitol12.50   in 1000 mL
    Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37) Sodium Lactate3.95   in 1000 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride2.40   in 1000 mL
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride0.37   in 1000 mL
    Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride0.21   in 1000 mL
    Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride0.19   in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-804-601000 mL in 1 BOTTLE, PLASTIC
    2NDC:46066-804-50500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2017
    Labeler - Aspen Veterinary (627265361)
    Registrant - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture