Label: ACD-A- anticoagulant citrate dextrose solution a solution

  • NDC Code(s): 53157-796-08
  • Packager: Haemonetics Manufacturing Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 9, 2015

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  • DESCRIPTION

    Re-Order Product Code: 796-08

    750 mL volume. Single use container.

    Sterile, nonpyrogenic fluid path. Sterilized by steam.

    Store at room temperature.

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  • INDICATIONS AND USAGE

    For use with automated pheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for pheresis only.

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  • CONTRAINDICATIONS

    Not for direct intravenous infusion.

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  • WARNINGS

    Avoid excessive heat. Protect from freezing.

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  • PRECAUTIONS

    Do not use unless solution is clear and no leaks detected.

    General

    Rx only. Discard unused portion.

    Recommended Storage: Store at room temperature (25°C / 77°F).

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  • HOW SUPPLIED

    750 mL volume bag.

    Each 100 ml contains:

    0.73 g citric acid (anhydrous), USP

    2.20 g sodium citrate (dihydrate), USP

    2.45 g dextrose (monohydrate), USP

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Hot Stamped Bag

    796-08 Hot Stamped Bag

    Envelope Label

    796-08 Envelope Label
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  • References

    HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

    Manufactured for:

    Haemonetics Corporation

    400 Wood Road

    Braintree, MA 02184, USA

    By: Haemonetics Manufacturing Inc.

    1630 Industrial Park Street

    Covina, CA 91722, USA

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  • INGREDIENTS AND APPEARANCE
    ACD-A 
    anticoagulant citrate dextrose solution a solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-796
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 2.45 g  in 100 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE 2.20 g  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.73 g  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53157-796-08 12 in 1 CARTON
    1 750 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA710497 11/06/1987
    Labeler - Haemonetics Manufacturing Inc (078598396)
    Registrant - Haemonetics Manufacturing Inc (078598396)
    Establishment
    Name Address ID/FEI Business Operations
    Haemonetics Manufacturing Inc 078598396 MANUFACTURE(53157-796)
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