其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: AmBisome Liposomal 50 mg Powder for dispersion for infusion (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Gilead Sciences Ltd has informed MHRA of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The affected batches of AmBisome Liposomal 50 mg Powder for dispersion for infusion (amphotericin B) include batch number of 019364D, D1900146D, 019545D, GAD221D, 020759D, 019547D, D2000038D, 020570D, GAD244D, 020595D, D2000066D, D2000049D.
The medical device is called Minisart Filter 16534-K. The device manufacturer has informed Gilead that the filter lots packaged with the AmBisome batches listed in this notification may be releasing fibres and particles, which may pose a risk to the patient. There is no quality issue associated with AmBisome product and due to supply considerations, the product is not being recalled. Gilead Sciences Ltd have confirmed that no further affected stock will be distributed, whilst they re-package packs with the correct filter. For packs already with wholesalers these will not be distributed onwards, until a replacement filter is provided by Gilead Sciences Ltd, to be provided with the impacted batches at the point of distribution.
Advice for healthcare professionals:
- Check the existing stock within your possession and identify if any of the AmBisome batches listed above are affected by this issue.
- Open the cartons and remove the defective Minisart filters and ensure you dispose of them appropriately. These filters should not be used.
- Other suitable 5 micron filters may be available in your hospital. Alternatively, as stated under section 6.6 of AmBisome Summary of Product Characteristics (SmPC): “An in-line membrane filter may be used for intravenous infusion of AmBisome. However, the mean pore diameter of the filter should not be less than 1.0 micron”.
- Filters from an alternative supplier are available from Gilead.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ambisome-liposomal-50-mg-powder-for-dispersion-for-infusion-pl-16807-slash-0001-el-21-a-slash-03
In Hong Kong, Ambisome For Inj 50mg (HK-43591) is a pharmaceutical product registered by Gilead Sciences Hong Kong Limited (Gilead), and is a prescription-only medicine. As confirmed with Gilead, the affected batches have not been imported into Hong Kong.
Ends/Tuesday, Feb 16, 2021
Issued at HKT 16:00
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