Label: DEXTRAN 75 - dextran 75 injection, powder, lyophilized, for solution 

  • NDC Code(s): 51808-210-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 07/12

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  • SPL UNCLASSIFIED SECTION

    Dear Medical Professional,

    Per your order, we have compounded Dextran 75 as a lyophilized powder for injection. The characteristics of this preparation are as follows:

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  • DESCRIPTION

    AnazaoHealth supplies compounded Dextran 75 for the preparation of Tc-99m Dextran 75. Each reaction vial contains 10 mg of Dextran 75, 0.30mg of stannous chloride, 0.73 mg Sodium Citrate and 1 mg of dextrose (lyophilized mixture, under nitrogen atmosphere), per unit dose vial.

    Mechanism of Action

    Dextran, when labeled with technetium Tc99m and given intravenously, is distributed throughout the body in much the same way as the patient’s serum, and serves as a suitable tracer with which to transiently image the vascular compartment

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  • INDICATIONS AND USAGE

    Technetium Tc99m Dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or GI Bleed

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  • DOSAGE AND ADMINISTRATION

    To prepare injection, up to 40 mCi of an oxidant-free sodium pertechnetate Tc 99m solution is aseptically injected into the vial, minimum volume 1ml, mix gently and let Dextran dissolve completely for 10 minutes

    Storage and Handling

    Injection should be administered within 6 hours after preparation. Before and after reconstitution- Store at room temperature

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

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  • INGREDIENTS AND APPEARANCE
    DEXTRAN 75 
    dextran 75 injection, powder, lyophilized, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-210
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTRAN 75 (DEXTRAN 75) DEXTRAN 75 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STANNOUS CHLORIDE 0.3 mg
    ANHYDROUS DEXTROSE 1 mg
    SODIUM CITRATE 0.73 mg
    Product Characteristics
    Color      Score no score
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-210-01 1 in 1 KIT
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 07/01/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE(51808-210)
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