Label: IN-111 DTPA solution

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

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Drug Label Information

Updated June 19, 2012

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  • DESCRIPTION

    In-111 DTPA is supplied as a sterile, pyrogen-free, isotonic, aqueous solution that is  buffered to pH 7 to 8. At calibration time, each milliliter contains 2.5 mCi of Pentetate Indium Disodium In-111 (no carrier-added) and sodium bicarbonate for pH adjustment.

  • CHARACTERISTICS

    Indium 111 decays by electron capture with a physical half-life of 67.9 hour. The energies of the photons that are useful for detection and imaging studies are:

    Radiation Mean % Disintegration Mean Energy (keV)

    Gamma-2 90.2 171.3

    Gamma-3 94.0 245.4

  • INDICATIONS AND USAGE

    In-111 DTPA is indicated for use in  radionuclide cisternography

  • CLINICAL PHARMACOLOGY

    After intrathecal administration, the In-111 DTPA is absorbed from the subarachnoid space and the remainder flows superiorly to the basal cisterns within 2 to 4 hours and subsequently will be apparent in the Sylvian cisterns, the interhemispheric cisterns, and over the cerebral convexities. In normal individuals, the it  will have ascended to the parasagittal region within 24 hours with simultaneous partial or complete clearance of activity from the basal cisterns and Sylvian regions. In contrast to air, In-111 DTPA does not normally enter the cerebral ventricles

  • CONTRAINDICATIONS

    There are no known contraindications

  • DOSAGE AND ADMINISTRATION

    Extreme care must be exercised to assure aseptic conditions in intrathecal injections. The maximum recommended intrathecal dose in the average patient (70kg) is 18.5 megabecquerels (500 microcuries). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    Storage and Handling

    Store vial in its lead shield at a temperature of 5-30º C. Do not freeze

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

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  • INGREDIENTS AND APPEARANCE
    IN-111 DTPA 
    in-111 dtpa solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-125
    Route of AdministrationINTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INDIUM IN-111 PENTETATE DISODIUM (UNII: 7UIT3ZGC8E) (PENTETIC ACID - UNII:7A314HQM0I) INDIUM IN-111 PENTETATE DISODIUM3.75 mCi  in 1.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-125-011.5 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