TECHNEGAS KIT

DistributionAfter inhalation, Technegas Aerosol is adsorbed on the walls of pulmonary bronchioles and alveoli. The distribution within the lungs is determined by the size and aerodynamic properties of the individual particles. Following inhalation, the particles are retained in the lung. The redistribution of Technegas Aerosol following inhalation to human subjects has been monitored for as long as 70 hours without evidence of particulate translocation.

EliminationThere is no intravascular cle...

The safety and effectiveness of Technegas Aerosol were evaluated in two studies.

Study 1(NCT03054870) was a single-arm, fixed-sequence, prospective study comparing Technegas Aerosol and xenon Xe 133 ventilation imaging in 200 patients undergoing ventilation scintigraphy. Xenon Xe 133 imaging was performed first, followed by Technegas Aerosol imaging. Mean patient age was 60 years (range: 20 years to 88 years) and 53% were male. Distribution by race was 89% White, 10% Black or African American, and 0.5% Asian; and distribution by ethnicity was 2% Hispanic/Latino and 98% non-Hispanic/Latino. Th...

The following clinically significant adverse reactions are described elsewhere in the labeling: Decreased Oxygen Saturation [see Warnings and Precautions (5.1)] The most common adverse reaction (≥ 1%) was hypoxia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cyclomedica Australia Pty Ltd at toll free phone number 1-888-8-586-4396 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse r...

None. None (4)

Decreased Oxygen Saturation: Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure. (5.1) Radiation Exposure Risk: Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure. (2.1, 5.2) 5.1 Decreased Oxygen Saturation Decrease in oxygen satura...