Public advisory - Incorrect dosing information on the "SAVE ME" instructional card in the Naloxone Take Home Kit by Canadian Hospital Specialties Ltd

OTTAWA, ON , July 26, 2024 /CNW/ - 

Summary

• Product: Naloxone Take Home Kits by Canadian Hospital Specialties Ltd.
• Issue: Health products – Product safety
• What to do: Check to see if your Naloxone Take Home Kit is impacted. If yes, contact the company or the store from which you obtained it to receive a new "SAVE ME" instructional card. If you need to administer a second dose of naloxone, you can safely do so two to three minutes after the first dose.

Issue

Naloxone Take Home Kits (NTH Kits) by Canadian Hospital Specialties Ltd. may contain incorrect naloxone dosing information on the "SAVE ME" instructional card, which could impact the efficacy of the treatment.

The product labelling for naloxone indicates that, if necessary, a second dose of the product can be administered two to three minutes after the first dose. The "SAVE ME" instructional card provided in the kit may recommend re-administration after three to five minutes. This is an error. Any "SAVE ME" instructional card that differs from the two to three-minute dosing re-administration recommendation that is found within the NTH Kits should be returned to the company or the store in order to obtain a corrected "SAVE ME" instructional card. Delaying the administration of an additional dose may result in permanent disability or death.

The NTH Kits contain naloxone either as a nasal spray, an ampule (injectable), or a vial (injectable). These products are used to reverse the effects of opioid overdose.

Anyone with an impacted NTH Kit should contact the company at [email protected] or the store where they obtained it to request a revised "SAVE ME" instructional card with the correct information.

It is important to note that these NTH Kits are not being removed from the Canadian market so as not to disrupt access to naloxone, a potentially life-saving drug.

Health Canada is monitoring the situation and if additional safety information is identified, it will take appropriate action and inform Canadians, as needed.

What you should do

• If you need to administer a second dose of naloxone, you can safely do so two to three minutes after the first dose.
• Check to see if your NTH Kit is impacted. If yes, contact the company at [email protected] or the store from which you obtained it to receive a new "SAVE ME" instructional card.
• Report any health product-related side effects or complaints to Health Canada.

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SOURCE Health Canada (HC)

Media Enquiries: Health Canada: [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]