In-111 DTPA

Generic Name: indium in-111 pentetate disodium
Dosage Form: intrathecal solution

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)

In-111 DTPA 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.

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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 for In-111 DTPA

In-111 DTPA is indicated for use in  radionuclide cisternography

In-111 DTPA - 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

In-111 DTPA 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

In-111 DTPA 
In-111 DTPA solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-125
Route of Administration INTRATHECAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDIUM IN-111 PENTETATE DISODIUM (PENTETIC ACID) INDIUM IN-111 PENTETATE DISODIUM 3.75 mCi  in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE  
Packaging
# Item Code Package Description
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 Operations
AnazaoHealth Corporation 011038762 MANUFACTURE
Revised: 06/2012
 
AnazaoHealth Corporation



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