Health professional risk communication

Importation of UK-Authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion due to shortage of Canadian-authorized Potassium Chloride for Injection Concentrate

Last updated

Summary

Product
Potassium Chloride 15% w/v Concentrate for Solution for Infusion
Issue
Health products - Packaging
Health products - Product safety
Health products - Supply
What to do

See Key Messages below

Audience
Health professionals

Affected products

Product Name Dosage Form, Strength, Packaging Format, and Route of Administration Country of Origin and Identifying Code Manufacturer Importer and Supplier in Canada
Potassium Chloride 15% w/v Concentrate for Solution for Infusion Concentrate for Solution for Infusion, 150 mg/mL potassium chloride, 10 mL plastic ampoule, Intravenous use UK PL 24598/0003 Noridem Enterprises Ltd., Cyprus Juno Pharmaceuticals Corp.

Issue

There is a shortage of Potassium Chloride for Injection Concentrate in Canada due to disruptions in the manufacturing of the products. Given the medical necessity of this product and to help mitigate the shortage, Health Canada has permitted the exceptional, temporary importation and sale of UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion with English-only labels.

 

Audience

Healthcare professionals including hospital pharmacists, critical care physicians, emergency physicians, and hospital physicians.

 

Key Message

 

Background Information

In Canada, Potassium Chloride for Injection Concentrate (149 mg / mL) is indicated for the treatment of potassium deficiency states when oral replacement therapy is not feasible, for the treatment of hypokalemic-hypochloremic alkalosis, and for the prevention and treatment of hypokalemia which may occur secondary to diuretic or corticosteroid administration. It may also be used in the treatment of cardiac arrhythmias due to digitalis intoxication.

There is a shortage of Potassium Chloride for Injection Concentrate in Canada due to disruptions in manufacturing of the products. Health Canada is permitting the temporary importation of UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion to help mitigate the current market shortage in Canada.

 

Information for healthcare professionals

The UK-authorized product is available in 10 mL plastic ampoules and has the same active ingredient, concentration, excipients, and dosage form as the Canadian-authorized products. The UK-authorized and Canadian-authorized products are NOT for direct infusion and must be diluted prior to intravenous infusion.

Despite the same concentration, the strength per total volume is expressed slightly differently on the labels of the UK-authorized product (150 mg/mL) than on the labels of the Canadian-authorized products (149 mg/mL).

In addition to differences in indications (see Table 1), there are key differences in the packaging formats and related preparation instructions, and inner and outer labels.

 

Table 1: Tabular summary of the Canadian-authorized Potassium Chloride for Injection Concentrate (149 mg/mL) products in shortage and UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion (150 mg/mL) exceptionally imported*

    Canadian-authorized Potassium Chloride for Injection Concentrate (149 mg/mL) products – currently in shortage   UK-authorized Potassium Chloride
15% w/v Concentrate for Solution for Infusion
 

Pfizer Canada ULC

DIN 00037869

Omega Laboratories Limited

DIN 00402206
DIN 02480034

B. Braun Medical Inc.

DIN 02485699

 

 

Authorized Indication(s)

 

Treatment of potassium deficiency states when oral replacement therapy is not feasible.                              

 

 

Hypokalemic-hypochloremic alkalosis and for the prevention and treatment of hypokalemia which may occur secondary to diuretic or corticosteroid administration. It may be used in the treatment of cardiac arrhythmias due to digitalis intoxication.                                   

 

 

 

Treatment of potassium deficiency states when oral replacement therapy is not feasible.                        

 

 

The prevention and treatment of potassium deficiency when oral replacement therapy is not feasible.

 

 

 

Packaging
Format(s)†
10 mL and 20 mL single-use vials

10 mL and 20 mL single-use vials

100 mL pharmacy bulk vial
250 mL bag (pharmacy bulk package) 10 mL plastic ampoule

* The UK-authorized product is intended to support the shortage of comparable Canadian-authorized products highlighted in this table, regardless of differences in indication.

Due to the differences in packaging formats between the Canadian-authorized and UK-authorized products, the preparation instructions differ between the products.

 

Healthcare professionals are advised that:

Hospitals should also be aware that the UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion does not have a Drug Identification Number (DIN) or a barcode that scans in medication management systems in Canada. A facility-generated sticker could be helpful to enable barcode scanning and allow proper identification of the product being dispensed and administered.

 

Action taken by Health Canada

Given the medical necessity of Potassium Chloride for Injection Concentrate in Canada and to mitigate the shortage of this product, Health Canada has permitted the exceptional, temporary importation and distribution of UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion and has added this product to the List of Drugs for Exceptional Importation and Sale.

Health Canada has worked with Juno Pharmaceuticals Corp. to prepare this alert for Potassium Chloride 15% w/v Concentrate for Solution for Infusion. 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.

 

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Potassium Chloride 15% w/v Concentrate for Solution for Infusion should be reported to Juno Pharmaceuticals Corp. or Health Canada.

Juno Pharmaceuticals Corp.
2233 Argentia Road 402
Mississauga ON L5N2X7
1-855-819-0505

To correct your mailing address or fax number, contact Juno Pharmaceuticals Corp.

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:  hpce-cpsal@hc-sc.gc.ca
Telephone: 1-800-267-9675

 

Original signed by

Paul Varady 

 

Appendix 1 - Images of UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion with English-only labelling

Product Photos

Image of UK-authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion with English-only labelling

 

Vial label

Label of vial

POTASSIUM CHLORIDE
15% W/V CONCENTRATE FOR SOLUTION FOR INFUSION

For intravenous use
38246310-5
1.5 g in 10 ml.
Dilute before use
K
10mL contain 20mmol of K+, Cl- 
PL 24598/0003
PA 1122/3/1
 

Carton Label

Carton Front panel

Label of carton

POTASSIUM CHLORIDE 15% w/v
CONCENTRATE FOR SOLUTION FOR INFUSION

CONCENTRATE FOR SOLUTION FOR INFUSION
Potassium Chloride 150mg/ml

Dilute at least 50 times with suitable diluent. Mix thoroughly before slow intravenous infusion.
1,5g in 10ml
10ml contain 20mmol of K+, Cl-
Excipients: Water for Injections.
K
20 x 10ml ampoules
 

Carton Top Panel

Carton Top Panel

POTASSIUM CHLORIDE 15% w/v
CONCENTRATE FOR SOLUTION FOR INFUSION

Potassium Chloride
150mg/ml

5208063000233
20 x 10ml ampoules
K

Should be diluted before use
 

Back Carton Panel

Back Carton Panel

POTASSIUM CHLORIDE 15% w/v
CONCENTRATE FOR SOLUTION FOR INFUSION

For Intravenous Use.
Use only if the solutions is clear and free from particles.  Read the package leaflet before use.  Use as directed by a medical practitioner. Discard after first use.

K

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Marketing Authorisation Holder
noridem ENTERPRISES LIMITED
Evagorou & Makariou, Mitsi Building 3,
Office 115, 1065 Nicosia, Cyprus.

20 x 10 ml ampoules
 

Left Side Carton Panel

Left Side Carton Panel

POTASSIUM CHLORIDE 15% w/v
CONCENTRATE FOR SOLUTION FOR INFUSION

 Should be diluted before use

Potassium Chloride 150 mg/ml
After first opening:  From a microbiological point of view, the product should be used immediately.

5208063000233

K

 

POM
PL 24598/0003
PA 1122/3/1
20 x 10ml ampoules
 

Right Side Carton Panel

Image of right side carton panel

POTASSIUM CHLORIDE 15% w/v
CONCENTRATE FOR SOLUTION FOR INFUSION

Should be diluted before use
Potassium Chloride 150 mg/ml

 K

20 x 10ml ampoules
 

Additional information

Details
Original published date:
Alert / recall type
Health professional risk communication
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
Health professionals
Identification number
RA-74466

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