Label: ULTIGENE- electrolyte solution withdextrose 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 9, 2019

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

  • Composition

    Each 500 mL of sterile aqueous solution contains:

    Dextrose.H2O                             12.50g

    Sorbitol                                      12.50g

    Sodium Lactate                            3.95g

    Sodium Chloride                           2.40g

    Potassium Chloride                       0.37g

    Magnesium Chloride.6H2O            0.21g

    Calcium Chloride.2H2O                 0.19g

    Milliequivalents per liter

    Cations                                      

    Sodium                                        153mEq/L

    Potassium                                        9mEq/L

    Calcium                                            6mEq/L

    Magnesium                                       4mEq/L

    Anions

    Chloride                                        101 mEq/L

    Lactate                                           71 mEq/L

    Osmolarity (calc.)                          602 mOsmol/L

  • Indications

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

  • Contradictions

    Do not administer intraperitoneally to horses

  • Dosage and Administration

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

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

    Adult Cattles 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

  • VETERINARY INDICATIONS

    FOR ANIMAL USE ONLY

  • Warning

    KEEP OUT OF REACH OF CHILDREN

  • CAUTION:

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

  • Storage

    Store between 15oC and 30oC (59oF - 86oF)

  • SAFE HANDLING WARNING

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  • Distributed By:

    VEDCO INC

    St. Joseph, MO, 64507

    Made in El Salvador

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  • Principal Display Panel

    NDC 50989-886-16

    ULTIGIENETM​ TERMINALLY STERILIZED

    ELECTROLYTE SOLUTION WITH DEXTROSE

    NET CONTENTS: 500 mL (16.9 fl. oz.)

    VEDCO

    Label

    NDC 50989-886-17

    ULTIGIENETM TERMINALLY STERILIZED

    ELECTROLYTE SOLUTION WITH DEXTROSE

    NET CONTENTS: 1000 mL (33.8 fl. oz.)

    VEDCO

    Label 1

  • INGREDIENTS AND APPEARANCE
    ULTIGENE 
    electrolyte solution withdextrose injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-886
    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:50989-886-16500 mL in 1 BOTTLE, PLASTIC
    2NDC:50989-886-171000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/05/2019
    Labeler - Vedco (021634266)
    Registrant - Vedco (021634266)