Sedative that Received FDA Emergency Use Authorization Now Available from Fresenius Kabi for use in Mechanically Ventilated COVID-19 patients

*NOTE: This propofol 20 mg per mL product contains DOUBLE THE CONCENTRATION OF PROPOFOL compared to the FDA-approved and marketed Diprivan^® (propofol) Injectable Emulsion, USP 10 mg/mL product.

The Fresenius Kabi Propoven 2% Emulsion 100mL product will be manufactured by Fresenius Kabi AG in the same FDA-inspected facilities as Diprivan^® and other Propoven 2% fill sizes.

ADVERSE EVENT REPORTING

Adverse events or quality problems experienced with the use of this product should be reported to the FDA or Fresenius Kabi. Health care facilities and prescribing health care providers or their designees receiving Fresenius Kabi Propoven 2% Emulsion will track all medication errors associated with the use of and all serious adverse events that are considered to be potentially attributable to Fresenius Kabi Propoven 2% Emulsion use and must report these to FDA using one of the following methods:

• Complete and submit a MedWatch form online (www.fda.gov/medwatch/report.htm)
• Complete and submit FDA Form 3500 (health professional) by fax (1-800-FDA-0178) (this form can be found via link above).

Call 1-800-FDA-1088 for questions. Submitted reports should state, "use of Fresenius Kabi Propoven 2% Emulsion was under an EUA" at the beginning of the question "Describe Event" for further analysis.

To report adverse events to Fresenius Kabi, contact the Vigilance department at Fresenius Kabi USA by calling 1-800‐551‐7176, option 5 or by email adverse.events.USA@Fresenius Kabi-kabi.com.

To report a product complaint to Fresenius Kabi, contact the Medical Affairs Department at Fresenius Kabi USA by calling 1-800-551-7176, option 1 or by email productcomplaint.USA@Fresenius Kabi-kabi.com.

To ask questions about the safety, efficacy or use of a Fresenius Kabi product, contact the Medical Affairs Department at Fresenius Kabi USA by calling 1-800-551-7176, option 3, or by email [email protected].

To ask about Fresenius Kabi pharmaceutical product availability and ordering, contact Fresenius Kabi USA Customer Service by calling 1-888-386-1300 or by email [email protected].

Fresenius Kabi USA Vigilance, Medical Affairs and Customer Service are available Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST).