Label: SODIUM CHROMATE 51 solution

  • 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 June 19, 2012

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  • Per your order, we have compounded Chromium 51 as a sterile intravenous injectable dispensed as 1 mL in a 5 mL vial. The characteristics of this preparation are described below

  • DESCRIPTION

    AnazaoHealth’s compounded Cr-51 vial is a sterile, non-pyrogenic diagnostic radiopharmaceutical that consists up to 1 mCi of Cr-51 (precalibrated) in a volume up to 5 mL normal saline and 6 mg/mL benzyl alcohol.

  • INDICATIONS AND USAGE

    Cr51 is indicated for use in determining red blood cell volume or mass, studying red blood cell survival time (in conditions such as hemolytic anemia), and evaluating blood loss

    Mechanism of Action

    The chromium in this agent is present as the dianionic chromate ion in which form it appears to bind to the red blood cell in two steps, initially by a rapid but reversible attachment to the cell membrane followed by a slower nearly irreversible binding to intracellular hemoglobin and reduction to the anionic state. It has been suggested that the slow rate of uptake is dependent on the rate at which chromate can penetrate the cell membrane. Binding is maintained until the red blood cells are sequestered by the spleen or until elution of the chromium occurs into the plasma. The chromium is then readily excreted mainly in the urine. Once liberated by elution or erythrocyte senescence, chromium 51 is not available for relabeling of red cells.

    In normal individuals the erythrocyte survival half-time T ½  as measured by the chromium 51 "random labeling" technique, generally ranges between 25 and 35 days. This apparent short survival time, when compared to the 120 day life span of the red blood cells, is due to the elution of chromium from the cells and to cell damage that probably occurs during the process of withdrawing them from the body and labeling. Subnormal T ½ may be indicative of blood toss, sequestration of red blood cells by the  spleen, or shortened cell viability, as occurs In hemolytic anemia

  • CONTRAINDICATIONS

    There are no known contraindications for this preparation

  • DOSAGE AND ADMINISTRATION

    • The suggested dose range in the average patient (70kg) is:
      Determination of red blood cell volume or mass-0.37 to 1.11 megabecquerels (10 to 30 microcuries).
    • Study of red blood cell survival time-5.55 megabecquerels (150 microcuries).
    • Evaluation of blood loss-7.40 megabecquerels (200 microcuries)
  • Figure 1

    C:\Users\achai\Desktop\NDC Project-AC 2012\Cr51\Chart.JPG
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 2

    40ecc37d-figure-02
  • INGREDIENTS AND APPEARANCE
    SODIUM CHROMATE 51 
    sodium chromate 51 solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-101
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHROMIUM CR-51 (UNII: 9QAU17N705) (CHROMIUM CR-51 - UNII:9QAU17N705) CHROMIUM CR-511 mCi  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 30 mg  in 5 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-101-025 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/19/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    NameAddressID/FEIBusiness Operations
    AnazaoHealth Corporation011038762MANUFACTURE(51808-101)