Intralipid - Missing French Label Information Regarding Allergic Reactions to Egg-, Soya- or Peanut Protein - For the Public

Starting date:

June 10, 2013

Posting date:

June 10, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Allergy Information, Labelling and Packaging

Audience:

General Public

Identification number:

RA-33993

This is duplicated text of a letter from Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Intralipid

June 10, 2013

Dear Customer,

Subject: Missing French label information, regarding allergic reactions to egg-, soya- or peanut protein for Intralipid 10%, 20% and 30% Fat Emulsion for Intravenous Infusion (IV)

Fresenius Kabi AB, in collaboration with Health Canada, would like to inform you about important missing information about allergic reactions on the French versions of the label in the Product Information Leaflet and on the pouch label for Intralipid 10%, 20% and 30% Purified Lipids (Fat) for IV nutrition.

It is not recommended to use Intralipid if you have an allergy to egg-, soya- or peanut protein or to any of the active substances or inactive ingredients. Since Intralipid contains soybean oil and egg phospholipids, there is a risk of allergic reaction in patients with egg-, soya- or peanut protein allergies (the latter due to possible cross-reactions between peanuts and soybeans). Some allergic reactions can be serious and require immediate medical attention.

• Important labelling information about allergic reactions is missing from the French version of the Product Information Leaflet and the pouch label.
• It is not recommended to use Intralipid if you have an allergy to egg-, soya- or peanut protein or to any of the active or inactive ingredients.
• Patients or guardians should inform Health Care Professionals if they have a history of allergic reactions to egg-, soya-, or peanut protein prior to starting Intralipid therapy.

Specifically, there is a printing discrepancy between the English and French copy in the Product Information Leaflet that accompanies Intralipid and the Intralipid pouch label.  The sentences that are missing in the French copy of the Product Information Leaflet refer to the following:

Contraindications

Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients is also contra-indicated.

French Text for Above: / Version française de l'anglais ci-dessus :

Contre-indications

Il est également contre-indiqué dans les cas d'hypersensibilité aux protéines d'œuf, de soya ou d'arachides, à l'une des substances actives ou à l'un des excipients de ce produit.

Warnings:

Use in pregnancy

This medicinal product contains soya-bean oil and egg phospholipids which may rarely cause allergic reactions. Cross allergic reactions have been observed between soybean and peanut.

French Text for Above: / Version française de l'anglais ci-dessus :

Mise en garde:

Utilisation Durant la grossesse

Ce produit contient des phospholipides d'huile de soya et d'œuf, lesquels peuvent parfois provoquer des réactions allergiques. Des cas de réactions allergiques croisées entre le soya et les arachides ont été observés.

On the pouch label, the following information is missing:

Caution:

Contains soya-bean oil and egg phospholipid which may rarely cause allergic reactions. Cross allergic reactions have been observed between soybean and peanut.

French Text for Above: / Version française de l'anglais ci-dessus :

Précaution:

Contient des phospholipides d'huile de soya et d'œuf qui peuvent parfois provoquer des réactions allergiques. Des cas de réactions allergiques croisées entre le soya et les arachides ont été observés.

The English copy is complete. This discrepancy impacts the French labelling only.

The French product information leaflet is being revised and will be used in new production batches starting in June 2013. The pouch label will be revised by July 2013.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious allergic reaction or other serious or unexpected side effects in patients receiving Intralipid should be reported to Baxter Corporation or Health Canada.

Baxter Corporation

7125 Mississauga Rd.

Mississauga, Ontario

L5N 0C2

Canada

1-888-719-9955 between 7:00 am and 7:00 pm Eastern Time, Monday through Friday or email: hospitalcare@baxter.com

You can report any suspected side effect 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, please contact Health Canada at:

Health Product and Food Branch Inspectorate

E-mail: DCVIU_UVECM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 613-946-5636

Sincerely,

original signed by

Alexander Stoll

Qualified Person

Fresenius Kabi, Plant Uppsala