Propofol

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Thursday, November 19, 2020 - 10:07pm

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Diprivan® (Propofol) Injectable Emulsion, USP is First Product Available in Fresenius Kabi +RFID™ Portfolio of Smart-Labeled Medications

Thursday, October 8, 2020 - 2:00pm

The first +RFID smart-labeled product, Diprivan (Propofol) 200 mg per 20 mL (10 mg per mL) Injectable Emulsion, USP, is now available in the United States.

Key Points: 
  • The first +RFID smart-labeled product, Diprivan (Propofol) 200 mg per 20 mL (10 mg per mL) Injectable Emulsion, USP, is now available in the United States.
  • View the full release here: https://www.businesswire.com/news/home/20201008005150/en/
    Fresenius Kabi introduced its first +RFID smart-labeled product - Diprivan (propofol) in a 20 mL vial.
  • In 2021, Fresenius Kabi expects to add more than 20 medicines to its +RFID portfolio in the United States.
  • This Important Safety Information does not include all the information needed to use DIPRIVAN (Propofol), Injectable Emulsion, USP safely and effectively.

New Blinded Observational Study Shows Greater Depth of Patient Sedation Than Intended During Procedural Colonoscopy

Monday, August 3, 2020 - 1:00pm

Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.

Key Points: 
  • Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.
  • Based on the study results, the researchers concluded, The depth of sedation achieved with anesthesia administered propofol for colonoscopy spans a continuum.
  • Although providers planned for moderate to deep sedation, processed EEG in this study revealed a substantially greater depth consistent with general anesthesia and even burst suppression.
  • Further research is required to establish the impact on patient outcomes of anesthetic practices resulting in intraprocedural burst suppression.

Premier Inc. ProvideGx™ Program Partners with Fresenius Kabi to Secure the Supply of Sedation Drug Essential for COVID-19 Care

Monday, July 13, 2020 - 12:00pm

(NASDAQ: PINC), through its ProvideGx program, has partnered with Fresenius Kabi to supply Diprivan (propofol) injectable emulsion, USP to healthcare providers, helping to stabilize the long-term supply of a medication vital for COVID-19 patient care.

Key Points: 
  • (NASDAQ: PINC), through its ProvideGx program, has partnered with Fresenius Kabi to supply Diprivan (propofol) injectable emulsion, USP to healthcare providers, helping to stabilize the long-term supply of a medication vital for COVID-19 patient care.
  • As a result, the product was added to the U.S. Food and Drug Administrations drug shortage list in the same month.
  • As such, Premier and Fresenius Kabi are partnering to take swift action to assure adequate supply and manage this surge.
  • Premiers ProvideGx program identifies safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list.

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

Monday, June 15, 2020 - 2:00pm

Fresenius Kabi announced today that following the recent U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), Fresenius Kabi Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL is now available in the U.S.

Key Points: 
  • Fresenius Kabi announced today that following the recent U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), Fresenius Kabi Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL is now available in the U.S.
  • View the full release here: https://www.businesswire.com/news/home/20200615005199/en/
    Fresenius Kabi received FDA Emergency Use Authorization for Propoven 2% (propofol 20 mg/mL) for mechanically ventilated COVID-19 patients.
  • The availability in the U.S. of Fresenius Kabi Propoven 2% under Emergency Use Authorization provides clinicians with another sedation option for their COVID-19 patients, said Seema Kumbhat, M.D., senior vice president and regional medical director at Fresenius Kabi USA.
  • Consistent with the EUA, Fresenius Kabi USA will offer the following presentation of Fresenius Kabi Propoven 2% (propofol 20 mg/mL) Emulsion:

DGAP-News: PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL

Tuesday, June 2, 2020 - 9:01am

PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred.

Key Points: 
  • PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred.
  • PAION will fulfill the request from the hospital and will deliver the material free of charge.
  • Remimazolam has received marketing authorization in Japan, and marketing approval applications have been submitted inter alia in the U.S. and in Europe.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Vizient’s Novaplus Enhanced Supply Program Enabled Access to 676,000 Additional Units of Propofol as COVID-19 Cases Surged

Monday, June 1, 2020 - 11:00am

Propofol was one of the first 11 drugs in the new Novaplus Enhanced Supply Program.

Key Points: 
  • Propofol was one of the first 11 drugs in the new Novaplus Enhanced Supply Program.
  • Because of our Novaplus Enhanced Supply contract for propofol, additional product was stocked in U.S. warehouses and ready to ship to hospitals.
  • Novaplus Enhanced Supply program contracted suppliers provide additional inventory of essential products to mitigate supply disruptions and demand surge.
  • By purchasing through Novaplus Enhanced Supply, health care facilities also receive expanded value and benefits built on the foundation of the industrys longest-run private label program.

Sommetrics and aerFree, LLC Contributing to Treatment of COVID-19

Wednesday, May 13, 2020 - 2:00pm

aerFree is a FDA cleared, single use product intended to maintain the patency of the upper airway during medical procedures utilizing non-propofol sedatives.

Key Points: 
  • aerFree is a FDA cleared, single use product intended to maintain the patency of the upper airway during medical procedures utilizing non-propofol sedatives.
  • Sommetrics also filed an Emergency Use Authorization request to use a modified aerSleep product to support patients with COVID-19 related respiratory impairment who are not candidates for mechanical ventilation.
  • Aer+ is the basis of Sommetrics Inc and aerFree LLC products and numerous issued and filed patents.
  • aerFree and aerSleep are registered trademarks of Sommetrics; aer+ is a trademark of Sommetrics.

Hikma responds to COVID-19 shortage with launch of Propofol Injectable Emulsion, USP

Tuesday, May 12, 2020 - 8:00am

For more information, please visit: www.hikma.com

Key Points: 
  • For more information, please visit: www.hikma.com
    Important Safety Information for Propofol Injectable Emulsion, USP
    Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of its components.
  • Propofol injectable emulsion is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.
  • Propofol injectable emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.
  • Propofol injectable emulsion vial is never to be accessed more than once or used on more than one person.

Hikma responds to COVID-19 shortage with launch of Propofol Injectable Emulsion, USP

Tuesday, May 12, 2020 - 8:00am

For more information, please visit: www.hikma.com

Key Points: 
  • For more information, please visit: www.hikma.com
    Important Safety Information for Propofol Injectable Emulsion, USP
    Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of its components.
  • Propofol injectable emulsion is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.
  • Propofol injectable emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.
  • Propofol injectable emulsion vial is never to be accessed more than once or used on more than one person.