FDA records indicate that there are no current recalls for this drug.
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Indium Dtpa In 111 Recall
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Questions & Answers
Side Effects & Adverse Reactions
The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.
Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
History
There is currently no drug history available for this drug.
Other Information
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 µg 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-)-111In-[N,N-bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [N,N-bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-)111In.
Molecular formula: C14H18O10N3 111In Na2
Molecular weight: 545.29
Structural formula:
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.
Radiation | Mean %/Disintegration | Mean Energy (keV) |
---|---|---|
|
||
Gamma-2 | 90.2 | 171.3 |
Gamma-3 | 94.0 | 245.4 |
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 will attenuate the radiation emitted by a factor of about 1,000.
Shield Thickness (Pb) cm |
Coefficient of Attenuation |
---|---|
To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3. | |
0.021 | 0.5 |
0.19 | 10-1 |
0.49 | 10-2 |
0.80 | 10-3 |
1.1 | 10-4 |
Hours | Fraction Remaining | Hours | Fraction Remaining |
---|---|---|---|
|
|||
0* | 1.000 | 84 | 0.424 |
12 | 0.885 | 96 | 0.375 |
24 | 0.783 | 108 | 0.332 |
36 | 0.693 | 120 | 0.294 |
48 | 0.613 | 132 | 0.260 |
60 | 0.542 | 144 | 0.230 |
72 | 0.480 | 168 | 0.180 |
Sources
Indium Dtpa In 111 Manufacturers
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Ge Healthcare, Medi-physics, Inc.
Indium Dtpa In 111 | Ge Healthcare, Medi-physics, Inc.
Extreme care must be exercised to assure aseptic conditions in intrathecal injections.
The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 µCi. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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