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.
There is currently no manufacturer warning information available for this drug.
Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume.
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.