Other safety alerts
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| Canada: Missing French label information regarding hypersensitivity to egg-, soya- or peanut protein for Intralipid 10%, 20% and 30% Fat Emulsion for Intravenous Infusion |
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Fresinius Kabi AB, in collaboration with Health Canada, informed healthcare professionals and the public about important missing information on the French label regarding "Contraindications" and "Warnings" in the Product Information Leaflet and "Cautions" on the pouch label for Intralipid 10%, 20% and 30% Fat Emulsion for intravenous infusion indicated for nutritional supplementation.
Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients is contraindicated for the use of Intralipid. 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 potential cross reactions between peanuts and soybeans). Allergic reactions such as anaphylaxis can be serious and require immediate medical attention.
The English copy is complete. This discrepancy impacts the French labelling only. Healthcare Professionals should ask patients or guardians about a history of allergic reactions to egg-, soya-, or peanut protein prior to starting Intralipid therapy. Healthcare Professionals should also notify affiliated staff administering this product in a homecare setting.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../33987a-eng.php
In Hong Kong, there are two Intralipid products registered by Fresenius Kabi Hong Kong Ltd, namely Intralipid Emulsion 10% For IV Use (HK-35420) and Intralipid Inj 20% (HK-35421). The approved package inserts of the products in Hong Kong have included the relevant safety information regarding hypersensitivity to egg-, soya- or peanut protein.
Ends/ Tuesday, June 11, 2013
Issued at HKT 12:00
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