Label: SYKES CALCIUM GLUCONATE 23%- calcium gluconate solution

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

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Drug Label Information

Updated December 19, 2017

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  • GENERAL PRECAUTIONS

    STERILE NONPYROGENIC SOLUTION
    For Animal Use Only

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INFORMATION FOR OWNERS/CAREGIVERS

    500 mL

  • Each 100mL contains:

    CALCIUM GLUCONATE (PROVIDES 2.14 grams OF CALCIUM) 23 grams
    WATER FOR INJECTION q.s.
    BORIC ACID (AS A SOLUBILIZING AGENT) 3.5 grams

    mEq/L CALCIUM 1069, HYPERTONIC, pH: 2.5 to 4.5, OSMOLARITY: 6,782 mOsmol/L (calc)

  • INDICATIONS

    FOR USE IN CATTLE AS AN AID IN TREATING UNCOMPLICATED MILK FEVER (PARTURIENT PARESIS).

  • DOSAGE AND ADMINISTRATION

    FOR INTRAVENOUS ADMINISTRATION ONLY.
    CATTLE 250 – 500 mL
    DOSAGE MAY BE REPEATED AT 8 TO 12 HOUR INTERVALS IF REQUIRED.

  • CAUTION

    SOLUTION SHOULD BE WARMED TO BODY TEMPERATURE AND ADMINISTERED SLOWLY. ENTIRE CONTENTS SHOULD BE USED UPON ENTERING, AS THIS PRODUCT CONTAINS NO PRESERVATIVE. DISCARD ANY UNUSED PORTION. DO NOT USE IF SOLUTION IS CLOUDY OR CONTAINS PRECIPITATE. MONITOR ANIMAL’S CONDITION CLOSELY. RE-TREATMENT MAY BE NECESSARY. IF THERE IS NO NOTICEABLE IMPROVEMENT WITHIN 24 HOURS FOLLOWING TREATMENT, CONSULT YOUR VETERINARIAN. ASEPTIC PRECAUTIONS SHOULD BE OBSERVED.

  • STORAGE

    STORE BETWEEN 59°F-86°F/15°C-30°C IN BARRIER OVER-POUCH UNTIL READY FOR USE. PROTECT FROM FREEZING.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Made in Australia

    MANUFACTURED AND DISTRIBUTED BY: SYPHARMA PTY LTD, 27 HEALEY ROAD, DANDENONG VICTORIA 3175 AUSTRALIA.

    FOR CUSTOMER SERVICE EMAIL: CUSTOMERSERVICE@SYPHARMA.COM.AU

    NDC NUMBER: 86043-1004-2    BARCODE: 9317643192506

    BATCH NUMBER:

    EXPIRY:

  • 500mL Sykes Calcium Gluconate 23% Solution

    CalciumGluconate23CalciumGluconate23

  • INGREDIENTS AND APPEARANCE
    SYKES CALCIUM GLUCONATE 23% 
    calcium gluconate solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86043-1004
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM GLUCONATE23 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86043-1004-2500 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/22/2016
    Labeler - Sypharma Pty Ltd (753786292)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sypharma Pty Ltd753786292manufacture, pack, sterilize
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