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

A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of iodinated I 131 albumin in cisternography. Iodinated I 131 Albumin Injection is not approved for use in cisternography.

Although the immunological properties of albumin human are believed to be virtually unaltered by the iodination 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.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Pregnancy Category C

Animal reproduction studies have not been conducted with Iodinated I 131 Albumin Injection. It is also not known whether this agent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Iodinated I 131 Albumin Injection should be administered to a pregnant woman only if clearly needed.

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.

Since iodine 131 is excreted in human milk during lactation, formula feedings should be substituted for breast feedings.

Safety and effectiveness in children have not been established.