Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Fresenius Kabi Limited has identified an error on the infusion bag packaged in 6 batches of Kabiven Emulsion for Infusion (4 x 2053 ml 3-chamber infusion bag) (batch number: 10PC9374, 10PE3357, 10PM9641, 10QA1922, 10QD5451, 10QH8524). In the list of ingredients section printed onto the bag, the amount of Glucose 19 %: Glucose (monohydrate) has been incorrectly declared as 110 g, the actual amount is 220 g.
The correct amount of carbohydrates (as glucose anhydrous) is correctly declared on the infusion bag within the energy content section as 200 g. The correct amounts are also stated on the outer carton and in the Summary of Product Characteristics (SmPC).
All other Kabiven bag sizes state the correct amount of glucose in both monohydrate and anhydrous form.
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when administering this product particularly when calculating patient nutritional requirements.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-kabiven-emulsion-for-infusion-el-22-a-slash-02
In Hong Kong, Kabiven Emulsion For Infusion (HK-49268) is a pharmaceutical product registered by Fresenius Kabi Hong Kong Limited (Fresenius Kabi). The product is a prescription-only medicine. As confirmed with Fresenius Kabi, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Jan 26, 2022
Issued at HKT 14:30
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