Label: SODIUM BICARBONATE injection

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 22, 2019

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  • INDICATIONS:

    For treatment of metabolic acidosis. See package insert for specific indications.

  • COMPONENTS

    Each mL contains:

    Sodium Bicarbonate..........................84 mg

    (equal to 1 mEq/mL)

    Water for Injection...........................q.s.

  • Dosage and Administration:

    Administer intravenously. See package insert for complete directions for use and dosage information.

  • SPL UNCLASSIFIED SECTION

    RMS 92-307

    L814-100312

    Lot No.

    Exp. Date

    PhoenixTM

    Manufactured for:

    Clipper Distributing Company, LLC.

    St. Joseph, MO 64507

    Trademarks are the property of

    Clipper Distributing Company, LLC

    Take Time Observe Label Directions

    Manufactured by:

    Nova-Tech, Inc. Grand Island, NE 68801

    for Neogen Corporation.

  • STORAGE AND HANDLING

    Store at temperatures between 15°and 30°C (59°-86°F).

  • WARNINGS AND PRECAUTIONS

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

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

  • Warning:

    This is a sterile single dose vial. No preservatives have been added. Discard unused portion after use. Do not use if solution is hazy, cloudy, or contains a precipitate. The total osmolar concentration of this package is approximately 2000 mOsm/L.

  • Package Insert

    SODIUM BICARBONATE 8.4%

    STERILE NONPYROGENIC SOLUTION

    FOR VETERINARY USE ONLY

    DESCRIPTION: Sodium Bicarbonate 8.4% is a sterile
    nonpyrogenic preparation of sodium bicarbonate
    (NaHCO3) in Water for Injection. Each 100 mL contains
    8.4 grams of sodium bicarbonate (100 mEq/100 mL
    each of sodium and bicarbonate). This concentrated
    solution has an approximate pH of 7.8.

    ACTIONS: Sodium Bicarbonate is useful in the
    treatment of metabolic acidosis due to a wide variety of
    causes. Sodium Bicarbonate therapy increases plasma
    bicarbonate, buffers excess hydrogen ion concentration,
    raises blood pH and reverses the clinical manifestations
    of acidosis. Sodium Bicarbonate also alkalinizes the
    urine.

    INDICATIONS: Sodium Bicarbonate is indicated in the
    treatment of metabolic acidosis which may be due to
    severe renal disease, uncontrolled diabetes, circulatory
    insufficiency due to shock or severe dehydration,
    cardiac arrest and severe primary lactic acidosis.
    Sodium Bicarbonate is also indicated in severe diarrhea
    which is often accompanied by a significant loss of
    bicarbonate. Sodium Bicarbonate 8.4% is indicated in
    the treatment of metabolic acidosis in cattle, horses,
    sheep, swine and dogs depending upon causative
    factor.

    CONTRAINDICATIONS: Sodium Bicarbonate is contraindicated
    in animals losing chloride by vomiting and in
    animals receiving diuretics known to produce a
    hypochloremic alkalosis.

    PRECAUTIONS: Bicarbonate therapy is directed at
    producing a substantial correction of low total CO2
    content and blood pH, but risks of overdosage and
    alkalosis should be avoided. Repeated fractional doses
    and periodic monitoring by appropriate laboratory tests
    are therefore recommended to minimize the possibility
    of overdosage. Sodium Bicarbonate addition to
    parenteral solutions containing calcium should be
    avoided except where compatibility has been previously
    established. Precipitation or haze may result from
    sodium bicarbonate-calcium admixtures, and the
    resulting solution should not be administered.

    DOSAGE AND ADMINISTRATION: Sodium Bicarbonate
    8.4% is injected intravenously. Caution should be taken
    in emergencies where very rapid infusion of large
    quantities of bicarbonate is indicated, such as cardiac
    arrest. Sodium Bicarbonate solutions are hypertonic
    and may produce an undesirable rise in plasma sodium
    concentration during the process of correction of
    metabolic acidosis. During cardiac arrest, however, the
    risks from acidosis exceed those of hypernatremia. In
    cattle and horses, 200 to 300 mL of 8.4% solution may
    be given undiluted by rapid infusion using a needle and
    syringe.

    Sodium Bicarbonate 8.4% solution is often added to other
    intravenous fluids for the less urgent forms of metabolic
    acidosis. The amount of bicarbonate to be given over a
    4 to 8 hour period is approximately 2 to 5 mEq per kg of
    body weight (1-2.5 mL/lb body weight) depending upon
    the severity of the acidosis as judged by the lowering of
    total CO2 content, blood pH and clinical condition of the
    animal.

    Bicarbonate therapy should always be planned in
    stepwise fashion since the degree of response from a
    given dose is not precisely predictable. Initially, an
    infusion of 2 to 5 mEq per kg of body weight over a
    period of 4 to 8 hours will produce a measurable
    improvement in the abnormal acid-base status of the
    blood. Completion of therapy is dependent upon the
    clinical response of the animal. If severe symptoms
    have abated, then frequency of administration and size
    of the dose should be reduced.

    OVERDOSAGES: In case alkalosis occurs, the
    bicarbonate should be stopped and the animal
    managed according to the degree of alkalosis present.
    Sodium chloride injection (0.9%) may be given intravenously;
    potassium chloride also may be indicated if
    there is hypokalemia. Severe alkalosis may be accompanied
    by hyperirritability or tetany, and these
    symptoms may be controlled by calcium gluconate. An
    acidifying agent such as ammonium chloride may also
    be indicated in severe alkalosis.

    HOW SUPPLIED: Sodium Bicarbonate 8.4% is
    supplied in a 100 mL single dose vial.

    WARNING: This is a sterile single dose vial. No preservatives
    have been added. Discard unused portion after
    use. Do not use if solution is hazy, cloudy or contains a
    precipitate.

    Store at a temperature between 15°-30° C (59°-86° F).

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

    RMS# 92-516 NTI# 18-9078

    Neogen

    944 Nandino Blvd

    Lexington, KY 40511

    859-254-1221 or 800-525-2022

    inform@neogen.com

    www.neogen.com

    L1556-0316

  • Sodium Bicarbonate

    Sodium Bicarbonate

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-357
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE84 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-357-05100 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/20/2011
    Labeler - Phoenix (150711039)
    Registrant - Nova-Tech, Inc (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc196078976manufacture