Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Technegas Aerosol was evaluated in 291 patients undergoing ventilation studies with prospective data collection.
Patients received an amount of Technegas Aerosol to achieve 1,500 cps to 2,500 cps by oral inhalation.
The mean age of patients was 60 years (range:18 to 95 years);
distribution by race was 92 % White, 7% Black or African American, 0.3 % Asian, and 0.3 % unreported;
and distribution by ethnicity was 4% Hispanic/Latino and 96 % non-Hispanic/Latino.
Adverse reactions were reported in 10 patients (3.4%).
The adverse reaction occurring at ≥ 1% in patients receiving Technegas Aerosol was hypoxia (1%).
5 WARNINGS AND PRECAUTIONS 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 saturation may occur during or after the inhalation of Technegas Aerosol.
Oxygen saturation nadirs as low as 60% have been reported in a published study [see Adverse Reactions (6.1)].
Like all medications, Technegas can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: