Label: CAL-DEX CMPK- cmpk injection, solution

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

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Drug Label Information

Updated March 17, 2020

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  • COMPOSITION:

    Each 500 mL of sterile aqueous solution contains.
    Calcium (as calcium borogluconate, equivalent to calcium gluconate 23.2%) .............. 10.8 g
    Potassium (as potassium chloride) ........................................................................  8.0 g
    Phosphorus (as sodium hypophosphite • H2O) .......................................................... 2.5 g
    Magnesium (as magnesium borogluconate) ............................................................ 1.6 g
    Dextrose • H2O .................................................................................................... 75.0 g
    MILLIEQUIVALENTS PER LITER

    Cations
      Calcium ................ 1,080 mEq/L
      Potassium ............... 410 mEq/L
      Magnesium ............. 261 mEq/L
      Sodium .................. 161 mEq/L

    Anions
      Borogluconate ....... 1,341 mEq/L
      Chloride .................. 410 mEq/L
      Hypophosphite ......... 161 mEq/L

  • INDICATIONS:

    For use as an aid in the treatment of hypocalcemia (parturient paresis, milk
    fever), hypomagnesemia (grass tetany), and other conditions associated with calcium,
    magnesium, phosphorus and potassium deficiencies in cattle.

  • CONTRAINDICATIONS:

    Do not administer this product to animals showing signs of cardiac
    distress.

  • PRECAUTIONS:

    Administration should be made slowly and with care to avoid adverse
    effects such as heart block or shock. Perivascular or subcutaneous deposition of hypertonic
    solutions may result in severe inflammation at the injection site.

  • CAUTION:

    This product contains no preservatives. Use entire contents when first opened.
    Discard any unused solution.

  • DOSAGE AND ADMINISTRATION:

    Warm solution to body temperature. The usual
    intravenous dose in cattle is 500 mL per 800 to 1,000 pounds of body weight.

  • STORAGE AND HANDLING

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

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

    Keep Out of Reach of Children

  • VETERINARY INDICATIONS

    For Animal Use Only

  • CAUTION:

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    NDC: 11695-6412-5

    For treatment of milk fever in cattle

    Volume: 16.907 fl oz (500 mL)

    Questions? (855) 724-3461

    Reorder #069177

    18-805

    RMS 92-1177

    AH-069177-01

    REV: 0719

    Lot No.

    Exp. Date

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Manufactued by:

    Nova-Tech, Inc.

    Grand Island, NE 68801

    Assembled in USA

  • PRINCIPAL DISPLAY PANEL

    500 ml500 ml

  • INGREDIENTS AND APPEARANCE
    CAL-DEX CMPK 
    cmpk injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-6412
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose monohydrate75.0 g  in 500 mL
    Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION8.0 g  in 500 mL
    Calcium Gluconate Monohydrate (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Gluconate Monohydrate10.8 g  in 500 mL
    Phosphorus (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) Phosphorus2.5 g  in 500 mL
    Magnesium Gluconate (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Gluconate1.6 g  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-6412-5500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/17/2020
    Labeler - Covetrus (603750329)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture
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