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 5-30 C. Do not freeze
Package Label.principal Display Panel ⮝
Figure 1
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 Revised: 6/2012 Document Id: 0e714ae6-396c-4488-868e-bfe5fd446f3f Set id: aa3bd304-ff60-48a1-8576-be99de02e5f6 Version: 1 Effective Time: 20120619 AnazaoHealth Corporation
