JEANATOPE Solution for injection Ref.[10321] Active ingredients: Iodine ¹²⁵I human albumin

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 radiopharmaceuticals, 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.

Although the immunological properties of serum albumin are believed to be virtually unaltered by the iodinated process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.

In the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and occupational workers consistent with proper patient management.