Label: ACD SOLUTION MODIFIED - acd solution modified solution

  • NDC Code(s): 51808-201-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 23, 2012

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  • SPL UNCLASSIFIED SECTION

    Per your order, we have compounded ACD Solution Modified as a  solution of 10 mL in a 100 mL vial.  The characteristics of this compounded preparation are as follows

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  • DESCRIPTION

    Each 100 mL vial contains 80 mg citric acid, 224 mg sodium citrate anhydrous, and 120 mg dextrose anhydrous in a sterile, non-pyrogenic solution of 10 mL. The pH of the solution has been adjusted to be between 4.5 to 5.5

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  • CLINICAL PHARMACOLOGY

    In vitro, citrate ions combine with ionic calcium in the blood and the resulting

    lack of ionic calcium prevents coagulation. Blood that has been treated with citrate anticoagulants is nontoxic to the body when injected in small amounts intravenously. After injection, citrate ions are rapidly removed from the blood by the liver, polymerized into glucose, and then metabolized in the usual manner

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  • INDICATIONS AND USAGE

    ACD solution modified is to be used in the labeling of red blood cells for intravenous administration with Cr-51 Sodium Chromate.

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  • CONTRAINDICATIONS

    There are no known contraindications.

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  • DOSAGE AND ADMINISTRATION

    Red Blood Cell Labeling Procedure

    1. Labeling may be performed without washing or centrifugation steps directly in the reaction vial.
    2. A 30 to 50 mL sample of whole blood is withdrawn from the patient and added aseptically to a vial of ACD Solution Modified.
    3. 50 to 150 microcuries of Sodium Chromate 51 is then injected into the reaction vial using a shielded syringe. The amount of radioactivity added to the vial will

      depend on the intended use of the labeled red blood cells.

    4. The suspension is incubated for 30 to 60 minutes at room temperature with frequent, gentle agitation.
    5. After incubation, 100 mg Ascorbic Acid Injection is injected into the vial. The ascorbic acid reduces any remaining unbound dianionic chromium 51 to the anionic state which does not penetrate red blood cells; thus in vivo labeling of red blood cells is prevented.

    Storage and Handling

    Store the product at room temperature

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

    C:\Users\achai\Desktop\NDC Project-AC 2012\ACD\ACD Label.JPG
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  • INGREDIENTS AND APPEARANCE
    ACD SOLUTION MODIFIED 
    acd solution modified solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-201
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 22.4 mg  in 1 mL
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 12 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-201-01 10 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/23/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE
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