Label: 5% DEXTROSE injection, solution

  • NDC Code(s): 44567-980-05, 44567-980-10, 44567-980-30, 44567-980-50
  • Packager: WG Critical Care, LLC
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 5, 2018

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  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Sterile - Nonpyrogenic Solution

  • DESCRIPTION

    5% Dextrose Injection is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents.

    COMPOSITION:

    Each 100 mL contains:

    Dextrose Monohydrate 5000 mg; Water for Injection q.s.

    278 mOsmol/liter

    Energy value: (200 Kcal/l)

    pH 3.5 - 6.5

  • CLINICAL PHARMACOLOGY

    5% Dextrose Injection has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

  • INDICATIONS AND USAGE

    5% Dextrose Injection is indicated as a source of water and calories.

  • WARNINGS

    5% Dextrose Injection should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

    The intravenous administration of 5% Dextrose Injection 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 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.

    Excessive administration of dextrose injections may result in significant hypokalemia.

  • ADVERSE REACTIONS

    Reactions which may occur because of the injection 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.

    5% Dextrose Injection should be used with caution in patients with overt or subclinical diabetes mellitus.

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

    This is a hypotonic solution and as such should not be used for resuscitation.

  • 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.

  • 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 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 veterinarian, 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.

  • PACKAGING

    500 mL bag with clear overwrap: NDC 44567-980-05

    1000 mL bag with clear overwrap: NDC 44567-980-10

    3000 mL bag with clear overwrap: NDC 44567-980-30

    5000 mL bag with clear overwrap: NDC 44567-980-50

    STORAGE:

    Store below 25°C (77°F).

    Keep out of reach of children.

    Directions for Use of Plastic Container:

    To Open

    Tear overwrap at slit and remove solution container. 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 solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below:

    Preparation for Administration

    (Use Aseptic Technique)

    1. Close flow control clamp of administration set.

    2. Twist off the protector cap from the administration port of the bags.

    Bag image

    3. Insert the spike, a slight resistance should be felt as the port membrane is broken.

    Use a twisting motion during insertion. Insert the spike until the shoulder of the spike is level with the port.

    NOTE: See full directions on administration set packaging.

    4. Suspend container from hanger.

    5. Squeeze and release drip chamber to establish proper fluid level in chamber.

    6. Open flow control clamp and clear air from set. Close clamp.

    7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

    8. Regulate rate of administration with flow control clamp.

    WARNING: Do not use flexible container in series connections.

    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 the clamp on the administration set.

    2. Prepare medication site.

    3. Using syringe with 19 to 22 gauge needle, puncture 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 law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

    Manufactured for:

    WG Critical Care,LLC

    Paramus, NJ 07652

    Manfactured by:

    INFOMED FLUIDS S.R.L., Bucharest, Romania

    Revised March 2016

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 44567-980-05

    5% Dextrose Injection

    500 mL

    5% Dextrose Injection Bag label 500 mL
  • INGREDIENTS AND APPEARANCE
    5% DEXTROSE 
    5% dextrose injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:44567-980
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44567-980-05500 mL in 1 BAG
    2NDC:44567-980-101000 mL in 1 BAG
    3NDC:44567-980-303000 mL in 1 BAG
    4NDC:44567-980-505000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/05/2018
    Labeler - WG Critical Care, LLC (829274633)
    Registrant - WG Critical Care, LLC (829274633)
    Establishment
    NameAddressID/FEIBusiness Operations
    Infomed Fluids SRL681561866MANUFACTURE