Diprivan® (Propofol) Injectable Emulsion, USP Now Available in 10ml Vials
New presentation developed in response to customer needs
August 11, 2014
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.