INDIUM DTPA IN 111- indium in-111 pentetate disodium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Indium In-111 Pentetate Disodium (UNII: 7UIT3ZGC8E) (Indium Cation In-111 - UNII:WJZ06C0H8L)

Available from:

Medi-Physics, Inc. dba GE Healthcare

INN (International Name):

Indium In-111 Pentetate Disodium

Composition:

Indium Cation In-111 1 mCi in 1 mL

Administration route:

INTRATHECAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography. None known.

Product summary:

Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of 55.5 MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers. NDC 17156-251-08 Store vial in its lead shield at a temperature of 5°-30°C (41°-86°F). Do not freeze. The residual materials may be discarded in ordinary trash provided the vials and syringes read no greater than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding. This radiopharmaceutical is licensed by Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 III. Adm. Code 330.260(a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State.

Authorization status:

New Drug Application

Summary of Product characteristics

INDIUM DTPA IN 111- INDIUM IN-111 PENTETATE DISODIUM SOLUTION
MEDI-PHYSICS, INC. DBA GE HEALTHCARE
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INDIUM DTPA IN 111
PENTETATE INDIUM DISODIUM IN 111
R ONLY
DESCRIPTION
GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic
drug for
intrathecal use. It is available as a sterile, pyrogen-free, isotonic,
aqueous solution,
buffered to pH 7 to 8. At calibration time, each milliliter contains
37 MBq, 1 mCi of
Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 _µ_g of
pentetic acid, and
sodium bicarbonate for pH adjustment. _THE DRUG IS TO BE DISCARDED
AFTER SINGLE_
_USE._ Radionuclidic purity at calibration time is at least 99.88%
with less than 0.06%
Indium In 114m and 0.06% Zinc Zn 65. The concentration of each
radionuclidic
contaminant changes with time. Graph 1 shows maximum concentration of
each
radionuclidic impurity as a function of time.
GRAPH 1 - RADIONUCLIDIC IMPURITIES
The chemical names are 1. Indate(2-)-
_In_-[_N,N_-bis[2-[bis-
(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium
[_N,N_-bis[2-
(carboxymethyl)amino]glycinato(5-)]-indate (2-)
In.
Molecular formula: C
H
O
N
In Na
X
111
111
14
18
10
3
111
2
Molecular weight: 545.29
Structural formula:
PHYSICAL CHARACTERISTICS
Indium 111 decays by electron capture with a physical half-life of
67.9 hours.
The
energies of the photons that are useful for detection and imaging
studies are listed in
Table 1.
TABLE 1. PRINCIPAL RADIATION EMISSION DATA
RADIATION
MEAN
%/DISINTEGRATION
MEAN ENERGY
(KEV)
*
Gamma-2
90.2
171.3
Gamma-3
94.0
245.4
EXTERNAL RADIATION
The specific gamma ray constant for Indium In 111 is 3.3 R/hr-mCi at 1
cm. The half-
value thickness of lead (Pb) for Indium In 111 is 0.021 cm. To
facilitate control of the
radiation exposure from millicurie amounts of this radionuclide, a
range of values for the
relative attenuation of the radiation emitted by this radionuclide
that results from
interposition of various thicknesses of Pb is shown in Table 2. For
example, the use of a
0.8 cm thickness of Pb