Label: QUABIC-100- hemodialysis grade sodium bicarbonate solution solution, concentrate

  • NDC Code(s): 81943-503-01
  • Packager: AQUA MEDICA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

    This solution already diluted 1:27:57 with purified wather (standard 13959:2014), provides:

    Sodium: 35.0 mEq/l

    Each 1000 mL of this solution contains:

    Sodium bicarbonate USP, hemodialysis grade: 84.0 g

    Purified water (standard ISO 13959:2014), csp: 1000 mL

  • ACTIVE INGREDIENT

    Sodium Bicarbonate: Antiseptic

  • PURPOSE

    For use only with 3-pump hemodialysis machines.

  • INDICATIONS & USAGE

    Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1.

  • WARNINGS

    This solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

  • DOSAGE & ADMINISTRATION

    For use only with 3-pump hemodialysis machines, together wit acid conentrate for hemodialysis, diluting with purified water.

  • DO NOT USE

    If cloudy or with broken seal.

  • WHEN USING

    If not all the contents are used, discard the excess.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Keep at room temperature.

  • INACTIVE INGREDIENT

    Purified water (standard ISO 13959:2014)

  • PRINCIPAL DISPLAY PANEL

    3785 mL Label3785 mL NDC: 81943-503-01

  • INGREDIENTS AND APPEARANCE
    QUABIC-100 
    hemodialysis grade sodium bicarbonate solution solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-503
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE8.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-503-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-503)
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