Diprivan® (Propofol) Injectable Emulsion, USP Now Available in 10 mL Vials

  Diprivan® (Propofol) Injectable Emulsion, USP Now Available in 10 mL Vials

New presentation developed in response to customer needs

Business Wire

LAKE ZURICH, Ill. -- August 11, 2014

Fresenius Kabi announced today it has introduced Diprivan® (propofol)
injectable emulsion in 10 mL single patient infusion vials. Diprivan is an
intravenous sedative-hypnotic agent for use in the induction and maintenance
of anesthesia or sedation and is one of the most widely used anesthesia
products in the United States. Fresenius Kabi is a global health care company
that specializes in life-saving medicines and technologies for infusion,
transfusion and clinical nutrition.

“The Diprivan 10 mL presentation is designed with consideration for common
dosing practices to support single patient use and reduce waste,” said John
Ducker, president and CEO of Fresenius Kabi USA. “This is particularly
important for outpatient surgery centers where lower doses are commonly
administered.”

During the U.S. propofol shortage from 2009 to 2013, clinicians reported
wasted product, particularly in shorter procedures often conducted in
outpatient settings. “Fresenius Kabi is committed to being a global leader in
the propofol segment by responding to unmet clinical needs,” Ducker said.
Fresenius Kabi received FDA approval for the exclusive 10 mL presentation in
June 2014.

Diprivan is now offered in 10 mL, 20 mL, 50 mL, and 100 mL presentations,
making Fresenius Kabi the only company to currently offer customers this range
of propofol doses.

Important Safety Information

DIPRIVAN Injectable Emulsion is contraindicated in patients with a known
hypersensitivity to DIPRIVAN Injectable Emulsion or any of its components, and
also in patients with allergies to eggs, egg products, soybeans or soy
products. Use of DIPRIVAN Injectable Emulsion has been associated with both
fatal and life-threatening anaphylactic and anaphylactoid reactions, as well
as Propofol Infusion Syndrome.

For general anesthesia or MAC sedation, DIPRIVAN Injectable Emulsion should be
administered only by persons trained in the administration of general
anesthesia and not involved in the conduct of the surgical/diagnostic
procedure. For sedation of intubated, mechanically ventilated patients in the
ICU, DIPRIVAN Injectable Emulsion should be administered only by persons
skilled in the management of critically ill patients and trained in
cardiovascular resuscitation and airway management. Sedated patients should be
continuously monitored.

Strict aseptic technique must always be maintained during handling. DIPRIVAN
Injectable Emulsion is a single access parenteral product. Failure to use
asceptic technique has been associated with microbial contamination of the
product, including fever, infection/sepsis, other life-threatening illness
and/or death. There have been reports, in the literature and other public
sources, of the transmission of bloodborne pathogens (such as Hepatitis B,
Hepatitis C, and HIV) from unsafe injection practices, and use of Propofol
vials intended for single use on multiple persons. DIPRIVAN Injectable
Emulsion vials are never to be accessed more than once or used on more than
one person.

Please see package insert for complete prescribing information.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that
specializes in medicines and technologies for infusion, transfusion and
clinical nutrition. The company’s products and services are used to help care
for critically and chronically ill patients. The company’s U.S. headquarters
is in Lake Zurich, Illinois. The company’s global headquarters is in Bad
Homburg, Germany. For more information about Fresenius Kabi worldwide, please
visit www.fresenius-kabi.com.

Contact:

Matt Kuhn
Fresenius Kabi
847-550-5751
matt.kuhn@fresenius-kabi.com
 
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