VOLUMEX Solution for injection Ref.[10323] Active ingredients: Iodine ¹³¹I human albumin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Volumex (Iodinated I 131 Albumin Injection) is a diagnostic radiopharmaceutical containing iodinated I 131 albumin for intravenous use. Each mL of sterile, nonpyrogenic, aqueous, colorless to very pale yellow solution provides approximately 10 mg protein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg monobasic sodium phosphate, not more, than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer acetyltryptophanate and sodium caprylate have a concentration of less than 0.0089M. The pH has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid.

Volumex was prepared from blood that was nonreactive when tested for hepatitis B surface antigen (HBsAg). The structure of the complex is unknown.

Physical Characteristics

Iodine 131 decays by beta and gamma emissions with a physical half-life of 8.08 days.1

Photons that are useful for detection and imaging studies are listed in Table 1.

Table 1. Principal Radiation Emission Data:

RadiationMean % per DisintegrationMean Energy (keV)
Beta-4 (average) 89.3 191.6
Gamma-1481.2364.5

1 Evaluated Nuclear Structure Data File of the Oak ridge Nuclear Data Project DOE (1985).

External Radiation

The specific gamma ray constant for iodine 131 is 2.2R/hour-millicurie at 1 cm. The first half-value layer is 0.24 cm lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that result from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from this radionuclide, the use of a 2.55 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding:

Shield Thickness (Pb) mmAttenuation Factor
0.240.5
0.8910-1
1.610-2
2.5510-3
3.710-4

To correct for physical decay of iodine 131, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart: I-131 half-life 8.08 days:

DaysFraction RemainingDaysFraction RemainingDaysFraction Remaining
0*1.00011.38821.164
1.9181235622.151
2.84213.32723.138
3.77314.30024.127
4.70915.27525.116
5.65116.25326.107
6.59717.23227.098
7.54818.21328.090
8.50319.19529.083
9.46120.17930.076
10.423    

* Calibration time

How Supplied

Volumex (Iodinated I 131 Albumin Injection USP) is available in single unit dose syringes containing 25 microcuries of activity in one milliliter per syringe on the date of calibration. Each single unit dose syringe is supplied with reference solution. Complete assay data for each single unit dose syringe and reference solution are provided on their respective containers. The maximum concentration of a single unit dose syringe of Volumex does not exceed 26.3 microcuries per milliliter at time of calibration.

This radiopharmaceutical is licensed by the Texas Department of Health, Bureau of Radiation Control for distribution to persons licensed pursuant to 41.26 (b) and Appendix 41-C, Group I and Group II, “Texas Regulations for Control of Radiation,” or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Manufactured for Daxor Corporation, 350 Fifth Avenue, Suite 7120 · New York, NY 10118 · 212-244-0804, by Iso-Tex Diagnostics, Inc., Friendswood, Texas 77546

Drugs

Drug Countries
VOLUMEX United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.