Label: 0.9% SODIUM CHLORIDE injection, solution

  • NDC Code(s): 44567-970-10, 44567-970-30, 44567-970-50
  • Packager: WG Critical Care, LLC
  • 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 January 27, 2020

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

  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Sterile - Nonpyrogenic Solution

  • DESCRIPTION

    0.9% Sodium Chlorideis a sterile, nonpyrogenic solution for fluid replenishment in single dose containers for intravenous administration. Discard unused portion. It contains no antimicrobial agents.

    COMPOSITION:

    Each 100 mL of sterile aqueous solution contains: Sodium Chloride 900 mg, Water for Injection 100 mL

    Milliequivalents per liter

    Cations: Sodium 154 mEq/L

    Anions: Chloride 154 mEq/L

    Total osmolarity is 308 milliosmoles per liter. pH 4.5 to 7.0.

  • INDICATIONS

    0.9% Sodium Chloride is indicated as a source of water and electrolytes.

  • WARNINGS

    0.9% Sodium Chloride, 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.

    The intravenous administration of 0.9% Sodium Chloride 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 0.9% Sodium Chloride may result in sodium retention.

  • 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.

    Caution must be exercised in the administration of 0.9% Sodium Chloride Intravenous Infusion to patients receiving corticosteroids or corticotrophin.

    Do not administer unless solution is clear and seal is 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 discolouration 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 judgement 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

    1000 mL bag with clear overwrap: NDC 44567-970-10

    3000 mL bag with clear overwrap: NDC 44567-970-30

    5000 mL bag with clear overwrap: NDC 44567-970-50

    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 0.63mm to 0.80mm 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 0.63mm to 0.80mm 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

    Manufactured by:

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

    Revised March 2016

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 44567-970-10

    0.9% Sodium Chloride

    1000 mL

    Sodium chloride 1000 mL bag label
  • INGREDIENTS AND APPEARANCE
    0.9% SODIUM CHLORIDE 
    0.9% sodium chloride injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:44567-970
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44567-970-101000 mL in 1 BAG
    2NDC:44567-970-303000 mL in 1 BAG
    3NDC:44567-970-505000 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