Megatope
Generic: IODINATED I-131 ALBUMIN
Basic Information
Manufacturer
Iso-Tex Diagnostics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
62ca4278-8cc9-46b7-8f3c-303ce6a9c155
Indications & 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.
The safety and effectiveness of MEGATOPE for cisternography have not been established.
MEGATOPE is not approved for this use.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified with the use of radioiodinated albumin products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity