其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: SmofKabiven Extra Nitrogen Electrolyte Free (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Fresenius Kabi Ltd & Calea UK Ltd has informed MHRA of an error on the bag labels for SmofKabiven Extra Nitrogen Electrolyte Free, Emulsion for Infusion (batch number: 10NI3300 and 10PB8836). A sentence has been inadvertently included stating “with electrolytes” on an electrolyte free product. The outer cartons and leaflets have been checked and these are all in compliance. The bag label should state “1. Amino acid solution”.
Healthcare professionals are advised that there are no concerns with the product quality, safety or efficacy and therefore the product is not being recalled. Healthcare professionals should be aware that there is a product available with electrolytes and caution should be exercised when dispensing and administering this product.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-smofkabiven-extra-nitrogen-electrolyte-free-el-20-a-39-pl-08828-0269
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Aug 14, 2020
Issued at HKT 15:00
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