Label: NEOGENVET SODIUM BICARBONATE- sodium bicarbonate injection

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

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Drug Label Information

Updated September 1, 2015

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  • USE IN SPECIFIC POPULATIONS

    ​FOR ANIMAL USE ONLY

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  • ​Each mL contains:

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

    (equal to 1 mEq/mL)

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

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  • STORAGE AND HANDLING

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

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  • SPL UNCLASSIFIED SECTION

    Item No. 09078

    RMS 92-305

    Made in USA

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  • USER SAFETY WARNINGS

    ​KEEP OUT OF REACH OF CHILDREN

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  • ​Indications:

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

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  • ​Dosage:

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

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  • ​Warnings:

    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.

    ​Read entire package insert before use.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Nova-TEch, Grand Island, NE 68801 for Neogen Corporation Lexingtn, KY 40511 • 859.254-1221

    L568-103013

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  • ​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 (NaHCO​3​) in Water for Injection. Each 100 mL contains 8.4 grams of sodium bicarbonate (100 mEq/100mL 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 CO​2​ 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 the total CO​2​ 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 room temperature 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.

    ​NEOGEN®​CORPORATION

    944 Nandino Blvd · Lexington, KY 40511

    859/254-1221 or 800/525-2022 · inform@neogen.com

    L1556-0214

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  • ​Principal Display Panel

    NDC: 59051-9078-5

    ​Sodium Bicarbonate 8.4%

    ​STERILE SOLUTION

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

    ​NEOGEN®Vet

    ​Net Contents: 100 mL

    NeogenVet Sodium Bicarbonate 8.4% Label

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  • INGREDIENTS AND APPEARANCE
    NEOGENVET SODIUM BICARBONATE 
    sodium bicarbonate injection
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59051-9078
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 84 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9078-5 100 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/10/2012
    Labeler - Neogen Corporation (042125879)
    Establishment
    Name Address ID/FEI Business Operations
    Nova-Tech, Inc 196078976 analysis, manufacture, sterilize
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