In-111 DTPA by AnazaoHealth Corporation IN-111 DTPA solution

In-111 DTPA by

Drug Labeling and Warnings

In-111 DTPA by is a Prescription medication manufactured, distributed, or labeled by AnazaoHealth Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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