Importation of Fresenius Propoven 2% due to Shortage of Canadian Labelled Propofol Injection 1% Products

Starting date:

May 19, 2020

Posting date:

May 19, 2020

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Supply, Product Safety

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-73071

Last updated: 2020-05-19

• Issue
• Who is affected
• Report health or safety concerns
• Images

Audiences

Healthcare professionals including intensivists, anesthesiologists, anesthesiology nurses, pharmacists, dental surgeons, gastroenterologists, chiefs of medicine in hospitals, Intensive Care Unit (ICU) and Emergency Room (ER) medical staff.

Key messages

• There is an unprecedented demand and shortage of propofol injection in Canada as a result of the COVID-19 pandemic.
• Propofol is a general anaesthetic agent. Given the medical necessity of this product in Canada, Health Canada has added Fresenius Propoven 2% (propofol 20 mg/mL) in 100 mL vials to the List of Drugs for Exceptional Importation and Sale.
• Special attention is required to ensure correct patient dosing. Fresenius Propoven 2% (propofol 20 mg/mL) contains twice the concentration of propofol compared to ALL currently authorized and marketed propofol injection products (propofol 1%, 10 mg/mL) in Canada.
• Healthcare professionals are advised that:
  • Dosing calculations need to be modified to reflect the propofol concentration (20 mg/mL)
  • This new concentration should be added to infusion pump libraries, drug databases, and other relevant systems
  • Propoven 2% (propofol 20 mg/mL), 100 mL, is in a single use vial format and it does NOT contain preservatives
  • Reconstitution and dilution recommendations for Propoven 2% may differ from other propofol injection products; the package insert should be consulted prior to administration

         

Issue

Increased demand for propofol injection due to the COVID-19 pandemic has led to reported shortages and limited supply of this product in Canada. Given the medical necessity of propofol injection and increased demand to manage critically ill patients needing ventilation support, Health Canada has added Propoven 2% (propofol 20 mg/mL), 100 mL Emulsion for injection or infusion to the List of Drugs for Exceptional Importation and Sale, as an interim measure to help mitigate the shortage.

Products affected

Propoven 2%: propofol 20 mg/mL in 100 mL vials manufactured by Fresenius Kabi Austria GmbH. 

Background information

In Canada, Propofol Injection 1% is indicated in adults for:

• Induction and maintenance of general anesthesia
• Conscious sedation for surgical and diagnostic procedures
• Sedation during intensive care

Propofol injection is only indicated for anesthesia in children 3 years of age and older.

Increased demand for propofol injection due to the COVID-19 pandemic has led to reported shortages and limited supply of this product in Canada. The temporary importation of Propoven 2% will maximize the amount of propofol injection available to COVID-19 patients in Canada who require mechanical ventilation and also help mitigate the current market shortage.

Fresenius Propoven 2% (propofol 20 mg/mL), 100 mL contains double the concentration of active ingredient compared to ALL propofol injection products (propofol 1%, 10 mg/mL) currently authorized and marketed in Canada.
 

Who is affected

Information for healthcare professionals

Healthcare professionals are advised that:

• The key formulation and labelling characteristics of Propoven 2%, 100 mL are indicated in the table below.

  Product Name	Fresenius Propoven 2% (Propofol 20 mg/mL) Emulsion for Injection or Infusion
  Active Substance	Propofol
  Propofol Concentration	20 mg per mL*
  Source/Type of Oil	soybean oil, refined; medium-chain triglycerides
  Fill Volume	100 mL
  Format	Single Use Vial
  Manufacturer	Fresenius Kabi Austria GmbH

• Propoven 2%, 100 mL (propofol 20 mg/mL) has double the concentration of propofol compared to ALL propofol injection products (propofol  1%, 10 mg/mL) currently authorized and marketed in Canada, therefore:
  • Dosing calculations need to be modified to reflect the propofol concentration (20 mg/mL)
  • This new concentration should be added to infusion pump libraries, drug databases, and other relevant systems
• Institutions should confirm that barcode systems provide correct information when the product is scanned. The barcode used on Propoven 2% is an international pharmaceutical manufacturing code and may not be appropriately recognized by scanning systems used in Canada.
• Institutions should take extra care in the preparation and administration as:
  • The label on the vials of Propoven 2% may display the strength differently or it may appear in a different location than is usual for Canadian products.
  • Reconstitution and dilution recommendations for Propoven 2% may differ from other propofol injection products available on the Canadian market.
• Propoven 2%, 100 mL, does NOT contain preservative and comes in a single use vial format.
• Fresenius Propoven 2% Emulsion for Injection or Infusion package insert should be used for full prescribing information.

Action taken by Health Canada

The Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. Drugs included on the List of Drugs for Exceptional Importation and Sale referenced in the Interim Order are eligible for the exceptional importation and sale provisions provided for in the Interim Order. Health Canada has added propofol to this list, which permits the importation and sale of Propoven 2%.

Health Canada has worked with Fresenius Kabi Canada Ltd. to prepare this alert for Propoven 2%. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any adverse reaction in patients receiving Propoven 2% should be reported to Fresenius Kabi Canada Ltd. or Health Canada.

Fresenius Kabi Canada Ltd.
E-mail: Canada_Vigilance@fresenius-kabi.com
Telephone: 1-877-779-7760

To correct your mailing address or fax number, contact Fresenius Kabi Canada Ltd.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Enforcement Branch
E-mail: hc.hpce-cpsal.sc@canada.ca

Original signed by

Jo-anne Soltesz
Associate Director, Regulatory Affairs and Vigilance
Fresenius Kabi Canada Ltd.

Images

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