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Doctors can
recommend the use of propofol 20mg/mL injectable emulsion only in emergency,
ventilated COVID-19 patients.
Propofol 20mg/mL emulsion will be hereon allowed to be used
as Emergency Use Authorization (EUA) in patients’ ≥16 years old that need
mechanical ventilation in intensive care unit (ICU) during the COVID-19
pandemic, informed FDA. As this emulsion is not an approved product but it contains
2X concentration of the FDA-approved propofol 10mg/mL injection emulsion
and poses to be at a risk of unintended overdose. Certain points to be kept in
mind in accordance with the EUA of this emulsion are:
The EUA of this emulsion is based on the agency’s evaluation of available evidence regarding the efficacy of this drug in this situation.
A multinational pharmaceutical company has also broadcasted the availability of Propofol Injectable Emulsion in 20mL, 50mL, and 100mL vials formulation in the US after approval of its additional Abbreviated New Drug Application.
FDA
FDA Issues EUA for Critical Med Needed for Ventilating COVID-19 Patients
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