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In-111 DTPA (AnazaoHealth Corporation)

Available Formats

Dosage Form Package Information Links
SOLUTION 1.5 mL in 1 VIAL (51808-125-01) Label Information

Complete In-111 DTPA Information

  • 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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-125
    Route of Administration INTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    INDIUM IN-111 PENTETATE DISODIUM (UNII: 7UIT3ZGC8E) (PENTETIC ACID - UNII:7A314HQM0I) INDIUM IN-111 PENTETATE DISODIUM 3.75 mCi  in 1.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-125-01 1.5 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/19/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE