kit for the preparation of technetium tc 99m pentetate

FDA Drug Profile — Kit for the Preparation of Technetium Tc 99m Pentetate

Drug Details

Generic Name
kit for the preparation of technetium tc 99m pentetate
Brand Names
Kit for the Preparation of Technetium Tc 99m Pentetate
Application Number
ANDA215146
Sponsor
Curium US LLC
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS, RESPIRATORY (INHALATION)
Active Ingredients
PENTETIC ACID

Indications and Usage

1 INDICATIONS AND USAGE DRAXIMAGE ® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults ( 1.1 ). Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients ( 1.2 ). Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients ( 1.3 ). 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration. 1.3 Lung Ventilation Imaging Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.