IN-111 DTPA - in-111 dtpa solution 
AnazaoHealth Corporation

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.

----------

In-111 DTPA (In-111 Pentetate Disodium)

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

0e714ae6-figure-01
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

Revised: 6/2012
Document Id: 0e714ae6-396c-4488-868e-bfe5fd446f3f
Set id: aa3bd304-ff60-48a1-8576-be99de02e5f6
Version: 1
Effective Time: 20120619
 
AnazaoHealth Corporation