JEANATOPE Solution for injection Ref.[10321] Active ingredients: Iodine ยนยฒโตI human albumin

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

Product description

Jeanatope 1-125 (Iodinated 1-125 Albumin Injection) is a sterile, nonpyrogenic, aqueous solution for intravenous use. Each milliliter provides approximately 10 mg protein (normal human serum albumin), 1.6 mg sodium phosphate, 16 mg sodium biphosphate, not more than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer aceryltryptophanate 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.

Jeanotope I-125 was prepared from the blood that was non-reactive when tested for hepatitis B surface antigen (HBsAg) and HIV antibody.

Physical Characteristics

Iodine 125 decays by electron capture with a physical half-life of 60.14 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)
Gamma-16.735.0
X-ray140.028.02

1 Dillman LT, Von der Lage FC; Radionuclide Deacy Schemes and Nuclear Parameters for Use in Radiation-Dose Estimation. MIRD Pamphlet No. 10 pg. 71 Soc Nucl Med, 1975.
2 Weighted mean energy

External Radiation

The specific gamma ray constant for I-125 is 1.5 R/millicurie-hour at 1 cm. The first half-value thickness of Pb for I-125 is .002 mm. 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 .02 min of Pb will decrease the external radiation exposure by a factor of 1,000.

Table 2. Radiation Attenuation by Lead Shielding:

Shield Thickness (Pb) mmAttenuation Factor
0.020.5
0.0610-1
0.1210-2
0.2010-3
0.3010-4
0.4010-5

To correct for physical decay of this radionuclide, 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-125 half-life 60.14 days:

DaysFraction RemainingDaysFraction RemainingDaysFraction Remaining
-141.17510.989180.813
-121.14820.977200.794
-101.12230.966220.776
-81.09640.955250.750
-71.08450.944300.708
-61.07260.933350.668
-51.06070.923400.631
-41.04780.912450.596
-31.035100.891500.562
-21.023120.871550.531
-11.012140.851600.501
0*1.000160.831750.422

* Calibration time

How Supplied

Jeanotope (Iodinated I-125 Albumin Injection USP) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 3.7 megabequerels/10.0 ml (100 microcuries/10.0 ml), 18.5 megabequerels/0.5 ml (500 microcuries/0.5 ml) and 37.0 megabequerels/1.0 ml (1.0 millicuries/1.0 ml). Complete assay data for each vial is provided on the container.

The maximum concentration of Iodinated I-125 Injection does not exceed one millicurie 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.

Iso-Tex Diagnostics, Inc., P.O. Box 909 . Friendswood, Texas 77549, USA
Phone: 281-482-1231 . Customer Service: 800-477-4839 . Fax: 281-482-1070

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JEANATOPE United States

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