Jeanatope
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Questions & Answers
Side Effects & Adverse Reactions
Radiopharmaceuticals should not be administered to patients who are pregnant
or to nursing mothers unless the expected benefit to be gained outweighs
the potential hazards.
Since I-125 is excreted in human milk during lactation, formula-feedings
should be substituted for breast-feedings.
Ideally, examinations using radiopharmaceuticats, especially those elective in
nature, of a woman of childbearing capability should be performed during the
first few (approximately 10) days following the onset of menses.
A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation
have been reported with the use of this product in cisternography. This material
is not approved for use in cisternography.
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
Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Jeanatope Manufacturers
-
Iso-tex Diagnostics, Inc.
![Jeanatope (Iodinated I-125 Albumin) Injection, Solution [Iso-tex Diagnostics, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Jeanatope | Iso-tex Diagnostics, Inc.
Radioiodinated serum albumin is administered intravenously. When a
procedure such as a blood volume determination is to be repeated, the total
dosage administered in any one week should not exceed 7.4 megabecquerels
(200 microcuries).
To minimise the uptake of radioactive iodine by the thyroid, prior
administration of Lugol's Solution (Strong Iodine Solution USP) may be used.
Ten drops of Lugol's Solution three times a daily, beginning at least 24 hours
before administration of Iodinated Serum Albumin I-125 and continuing for one
or two weeks thereafter, is a suitable dose.
Complete assay data for each vial are provided on the container.
Note: The expiration date given on the container pertains to the biologic
properties of the material and not to the radioactivity label, it is important to
make certain that the radioactivity in the dose at the time of administration is
sufficient for the intended use.
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