kit for the preparation of technetium Tc 99m albumin aggregated

FDA Drug Profile — Pulmotech MAA

Drug Details

Generic Name
kit for the preparation of technetium Tc 99m albumin aggregated
Brand Names
Pulmotech MAA
Application Number
BLA210089
Sponsor
Curium US LLC
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAPERITONEAL, INTRAVENOUS
Active Ingredients
ALBUMIN AGGREGATED

Indications and Usage

1 INDICATIONS AND USAGE DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients. DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. (1) Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. (1)