The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product In-111 Dtpa (NDC 51808-125). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, characteristics, indications and usage, clinical pharmacology, contraindications, dosage and administration, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
In-111 DTPA is indicated for use in radionuclide cisternography
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
There are no known contraindications
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.
Store vial in its lead shield at a temperature of 5-30° C. Do not freeze
Figure 1
0e714ae6-figure-01 (0e714ae6 Figure 01)
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