Technetium Tc-99m

FDA Drug Profile — Ultra-Technekow V4

Drug Details

Generic Name
Technetium Tc-99m
Brand Names
Ultra-Technekow V4
Application Number
NDA017243
Sponsor
Curium US LLC
NDC Codes
13
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TECHNETIUM TC-99M SODIUM PERTECHNETATE

Indications and Usage

1 INDICATIONS AND USAGE Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 1.1 Leukocyte Labeled Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. 1.2 Cerebral Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke.