Label: VETERINARY LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution

  • NDC Code(s): 0338-0092-02
  • Packager: Baxter Healthcare Corporation
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

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Drug Label Information

Updated January 1, 2019

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  • DESCRIPTION

    Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for
    intravenous administration. It contains no antimicrobial agents. Discard unused portion. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

    Lactated Ringers Table 1

    The plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

  • CLINICAL PHARMACOLOGY

    Lactated Ringer’s Injection, USP has value as a source of water and
    electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

    Lactated Ringer’s Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

  • INDICATIONS & USAGE

    Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent.

  • CONTRAINDICATIONS

    None known

  • WARNINGS

    Lactated Ringer’s Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.


    Lactated Ringer’s Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.


    Lactated Ringer’s Injection, USP should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

    Lactated Ringer’s Injection, USP should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.


    The intravenous administration of Lactated Ringer’s Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum
    electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.


    In patients with diminished renal function, administration of Lactated Ringer’s Injection, USP may result in sodium or potassium retention.


    Lactated Ringer’s Injection, USP is not for use in the treatment of lactic acidosis.

  • ADVERSE REACTIONS

    Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

  • PRECAUTIONS

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.


    Lactated Ringer’s Injection, USP must be used with caution. Excess administration may result in metabolic alkalosis.


    Caution must be exercised in the administration of Lactated Ringer’s Injection, USP to patients receiving corticosteroids or corticotropin.


    Do not administer unless solution is clear and seal is intact.


    Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.


    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

  • DOSAGE & ADMINISTRATION

    As directed by a veterinarian. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.


    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.


    All injections in plastic containers are intended for intravenous administration using sterile equipment.


    Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

  • OVERDOSAGE

    In an event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings, Precautions and Adverse Events.

  • HOW SUPPLIED

    Lactated Ringer’s Injection, USP in plastic container is available as follows:
    Size (mL)         Code                    NDC
    5000             2B8219       NDC 0338-0092-02
    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

  • Directions for use of plastic container

    To Open


    Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

    Preparation for Administration

    1. Suspend container from eyelet support.
    2. Remove plastic protector from outlet port at bottom of container.
    3. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication


    WARNING: Additives may be incompatible.


    To add medication before solution administration

    1. Prepare medication site.
    2. Using syringe with 19 to 22 gauge needle, puncture medication port and inject.
    3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.


    To add medication during solution administration
    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 19 to 22 gauge needle, puncture resealable
    medication port and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in use position and continue administration.


    CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    For customer service call (800) 933-0303
    Printed in USA


    Baxter is a registered trademark of Baxter International, Inc.

    07-19-00-0639
    Rev. January 2019

  • PRINCIPAL DISPLAY PANEL

    Lactated Ringers - Representative Container Label

    Container Label

    Veterinary Lactated
    Ringer’s Injection USP

    5000 mL

    EACH 100 ML CONTAINS 600 MG SODIUM CHLORIDE USP
    310 MG SODIUM LACTATE 30 MG POTASSIUM CHLORIDE USP
    20 MG CALCIUM CHLORIDE USP PH 6.5 (6.0 TO 7.5) MEQ/L
    SODIUM 130 POTASSIUM 4 CALCIUM 2.7 CHLORIDE 109
    LACTATE 28 OSMOLARITY 273 MOSMOL/L (CALC)
    STERILE NONPYROGENIC SINGLE DOSE CONTAINER CONTAINS
    NO ANTIMICROBIALAGENTS USE SOLUTION PROMPTLY
    FOLLOWING INITIALENTRY NOT FOR USE INTHE TREATMENT
    OF LACTIC ACIDOSIS ADDITIVES MAY BE INCOMPATIBLE
    CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING
    ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DISCARD
    UNUSED PORTION DOSAGE INTRAVENOUSLY AS DIRECTED BY
    A VETERINARIAN SEE PACKAGE INSERT CAUTIONS SQUEEZE
    AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
    STERILITY DISCARD IF LEAKS ARE FOUND DO NOT ADMINISTER
    SIMULTANEOUSLY WITH BLOOD DO NOT USE UNLESS SOLUTION
    IS CLEAR AND SEALIS INTACT STORE UNIT IN MOISTURE
    BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F)
    UNTIL READY TO USE AVOID EXCESSIVE HEAT

    FOR ANIMAL USE ONLY
    CAUTION FEDERAL(USA) LAW RESTRICTS THIS DRUG TO USE BY
    OR ON THE ORDER OF A LICENSED VETERINARIAN
    BAXTER IS A REGISTERED TRADEMARK OF BAXTER INTERNATIONAL, INC.

    FOR CUSTOMER SERVICE CALL
    800 933 0303

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD, IL 60015 USA

    MADE IN USA

    NDC 0338-0092-02
    2B8219
    07-25-00-0419

    Baxter Logo

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  • INGREDIENTS AND APPEARANCE
    VETERINARY LACTATED RINGERS 
    sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0338-0092
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0092-022 in 1 CARTON
    15000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2019
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764analysis, label, manufacture, pack, sterilize, api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter, S.A. de C.V.810432484analysis, label, manufacture, pack, sterilize