Indium In 111 Chloride Solution

Indium In 111 Chloride Solution

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Questions & Answers

Side Effects & Adverse Reactions

CONTENTS OF THE VIAL OF INDIUM In 111 CHLORIDE SOLUTION ARE INTENDED ONLY TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN VIVO DIAGNOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.

Legal Issues

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FDA Safety Alerts

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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

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product.

History

There is currently no drug history available for this drug.

Other Information

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint™ preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin™ preparations used for Radioimmunotherapy procedures. It is supplied as a sterile, non-pyrogenic solution of Indium In 111 Chloride in 0.05 molar hydrochloric acid. No carrier has been added to the solution. Each 0.5 milliliter of the solution contains 185 megabequerels (5 millicuries) of indium In 111 chloride at time of calibration (specific activity of >1.85 GBq/μg Indium; >50 mCi/μg Indium at this time of calibration). The solution pH is 1.1 to 1.4.

Radionuclidic Purity

Indium In 111 is cyclotron produced by the proton irradiation ((p,2n) reaction) of cadmium Cd 112 enriched target. At time of calibration, it contains not less than 99.925% indium In 111 and, not more than 0.075% indium In 114m and zinc Zn 65 combined. At the time of expiration, it contains not less than 99.85% indium 111 and not more than 0.15% indium In 114m and zinc Zn 65 combined. No carrier has been added.

Radiochemical Purity

At the time of calibration, the Indium In 111 Chloride Sterile Solution contains not less than 95% of the Indium present as ionic In3+.

Chemical Purity

Indium In 111 Chloride Sterile Solution is tested for the following metallic impurities: copper, iron, cadmium, lead, zinc, nickel, and mercury, and contains extremely low levels of these metals. The sum of the individual impurity ratios for the metals listed is not more than 0.60 ppm.

Physical Characteristics

Indium In 111 decays by electron capture to cadmium Cd 111 (stable) with a physical half-life of 67.32 hours (2.81 days) (see Table 2)1. Photons useful for detection and imaging are listed in Table 1.

Table 1. Principal Radiation Emission Data*
 Radiation  Mean Percent Per Disintegration  Mean Energy (keV)
 

*Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, 115 (1981).

 Gamma-2  90.2  171.3
 Gamma-3  94.0  245.4
1
From Radiopharmaceutical Internal Dosimetry Information Center, Oak Ridge Associated Universities, Oak Ridge, TN 37831-0117, February 1985.
External Radiation

The exposure rate constant for 37 MBq (1 mCi) of Indium In 111 is 8.3 x 10-4 C/kg/hr (3.21 R/hr) at 1 cm. The specific gamma ray constant for Indium In 111 is 3.21 R/hr-mCi @ 1 cm1. The first half-value thickness of lead (Pb) is 0.023 cm. 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 0.834 cm of Pb will decrease the external radiation exposure by a factor of about 1000.

Table 2. Indium In 111 Radiation Attenuation by Lead Shielding
 Shield Thickness (Pb) cm  Coefficient of Attenuation
 0.023  0.5
 0.203  10-1
 0.513  10-2
 0.834  10-3
 1.12  10-4

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely Indium In 114m.

To correct for physical decay of Indium In 111, the fractions that remain at selected intervals before and after calibration time are shown in Table 3.

Table 3. Indium In 111 Physical Decay Chart; Half-Life 67.32 hours (2.81 days)
 

*Calibration time

 Hours  Fraction Remaining  Hours  Fraction Remaining
 -72  2.10  0*  1.00
 -60  1.85  6  0.94
 -48  1.64  12  0.88
 -36  1.45  24  0.78
 -24  1.28  36  0.69
 -12  1.13  48  0.61
 -6  1.06  72  0.48

Indium In 111 Chloride Solution Manufacturers


  • Mallinckrodt Inc.
    Indium In 111 Chloride Solution [Mallinckrodt Inc.]

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