Iodinated I-131 Albumin

FDA Drug Profile — Volumex, Megatope

Drug Details

Generic Name
Iodinated I-131 Albumin
Brand Names
Volumex, Megatope
Application Number
BLA017837
Sponsor
Iso-Tex Diagnostics, Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
HUMAN SERUM ALBUMIN I-131

Indications and Usage

INDICATIONS AND USAGE MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.

Warnings

WARNINGS Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use.