Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol

FDA Drug Profile — TECHNEGAS

Drug Details

Generic Name
Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol
Brand Names
TECHNEGAS
Application Number
NDA022335
Sponsor
Cyclomedica Australia Pty Limited
NDC Codes
3
Dosage Forms
AEROSOL, KIT
Routes
N/A
Active Ingredients
GRAPHITE

Indications and Usage

1 INDICATIONS AND USAGE TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), for use in adults and pediatric patients aged 6 years and older for: • visualization of pulmonary ventilation • evaluation of pulmonary embolism when paired with perfusion imaging TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), a radioactive diagnostic agent for use in adults and pediatric patients aged 6 years and older for: • visualizationofpulmonaryventilation • evaluationofpulmonaryembolismwhenpairedwithperfusion imaging (1)