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

  • NDC Code(s): 72483-202-01, 72483-202-05, 72483-202-10, 72483-202-24
  • Packager: Laboratorios Alfa SRL
  • 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 February 17, 2020

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

  • DESCRIPTION

    Veterinary Lactated Ringers Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment

    in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents. 

    Table 1.Veterinary Lactated Ringers Injection, USP 
     Size mL Composition (g/100 mL)  Osmolarity
    (mOsmol/L)
    Calculated 
     pH  Ionic Concentration (mEq/L)    Caloric
    Content
    (Kcal/L)  
     Sodium Chloride
    USP
     Sodium Lactate Potassium
    Chloride
    USP
     Calcium
    Chloride
    USP
     Sodium PotasiumCalcium  ChlorideLactate 
    100     0.6                  0.31    0.03  0.02      274  6-7.5      130.50    4.0    2.70    109.80   27.69     9
    250 
    500
    1000 

    No venting is necessary during infusion.

  • CLINICAL PHARMACOLOGY

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

    Veterinary 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 cautions.

  • INDICATIONS AND USAGE

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

  • CONTRAINDICATIONS

    Veterinary Lactated Ringer’s Injection, USP is contraindicated in patients with a known hypersensitivity to sodium lactate.

  • WARNINGS

    Veterinary 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.

    Veterinary 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.

    Veterinary 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.

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

    The container label for these injections bears the statement: Do not administer simultaneously with blood.

    The intravenous administration of Veterinary Lactated Ringer’s Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary edema.

    The risk of dilutive states is inversely proportional to the electrolyte concentration 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 Veterinary Lactated Ringer’s Injection, USP may result in sodium retention proportional to the electrolyte concentrations of the injections.

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

    Keep out of the reach of children.

  • 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 veterinary Lactated Ringer’s Injection, USP to patients receiving corticosteroids or corticotrophin.
    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.

    Do not administer unless solution is clear and both seal and container are intact.

  • DOSAGE AND 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 discolorations 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. Discard unused portion.

  • OVERDOSAGE

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

  • STORAGE

    Store below 30ºC (86ºF).

  • PRECAUTION OF USE OF THE BOTTLE

    This is a single dose container and does not contain preservatives.

    Use the solution immediately after the bottle is opened, discard the remaining one.
    Squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles.

    Do not administer simultaneously with blood.
    Do not use it unless solution is clear and seal is intact, the solution containing dextrose may be contraindicated in patients with a known allergy to corn or corn products.

    DIRECTIONS FOR USE PLASTIC CONTAINER:

    Preparation and administration
    1. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
    2. Suspend container from eyelet support.
    3. Remove Plastic protector from ports area at the bottom of container.
    4. Hold the bottle in vertical position and inset pyrogen free IV administration set in the outlet port. Use aseptic Technique

    To Add Medication
    WARNING: Additives may be incompatible.
    To add medication before solution administration
    1. Prepare medication site.
    2. Using syringe with 18 to 21 gauge needle, puncture inlet 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 18 to 21 gauge needle, puncture inlet port and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Mix solution and medication thoroughly.
    6. Return container to in use position and continue administration.

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

  • Package Insert 

    For animal use only.

    Lactated Ringer_Insert_Page_1

    Lactated Ringer_Insert_Page_2

    Lactated Ringer_Insert_Page_3

    Lactated Ringer_Insert_Page_4

  • PRINCIPAL DISPLAY PANEL

    LACTATED RINGER’S INJECTION , USP

    Veterinary Use

    Sterile and NonProgenic Solution

    Keep out of reach of Children.

    For Animal Use Only.

    Take Time - Observe label directions

    Manufactured by:

    Laboratorios Alfa, SRL

    Santo Domingo

    Domincan Republic

    www.laboratoriosalfa.com

    +1-809-544-0222

    Ringer package label 100 mL

    Ringer package label 250 mL

    Ringer package label 500 mL

    Ringer package label 1000 mL

  • INGREDIENTS AND APPEARANCE
    ALFA VETERINARY LACTATED RINGERS 
    lactated ringers sodium chloride,sodium lactate, potassium chloride,calcium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:72483-202
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE20 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72483-202-101000 mL in 1 BOTTLE, PLASTIC
    2NDC:72483-202-05500 mL in 1 BOTTLE, PLASTIC
    3NDC:72483-202-24250 mL in 1 BOTTLE, PLASTIC
    4NDC:72483-202-01100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/29/2019
    Labeler - Laboratorios Alfa SRL (815941244)