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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 1, 2012

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  • 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:

  • 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

  • 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

  • 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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

    29c1fd45-figure-01
  • INGREDIENTS AND APPEARANCE
    DEXTRAN 75 
    dextran 75 injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-210
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 75 (UNII: JY83SHX053) (DEXTRAN 75 - UNII:JY83SHX053) DEXTRAN 7510 mg
    Inactive Ingredients
    Ingredient NameStrength
    STANNOUS CHLORIDE (UNII: 1BQV3749L5) 0.3 mg
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 1 mg
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.73 mg
    Product Characteristics
    Color    Scoreno score
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-210-011 in 1 KIT
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other07/01/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    NameAddressID/FEIBusiness Operations
    AnazaoHealth Corporation011038762MANUFACTURE(51808-210)
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