其 他 安 全 警 示
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| Singapore: Defective Sartorius 5μm Filters present in cartons of AmBisome® Liposomal Amphotericin B 50mg Lyophilisate for Dispersion for Infusion Batch: 019545D (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Gilead to inform healthcare professionals of a potential quality issue in relation to specific lots of 5μm sterile filters, which are co‐packed in cartons of the AmBisome® product batch number: 019545D. This defective filter may be releasing fibres and particles, which may pose a risk to the patient. Healthcare professionals are advised to remove and not use the defective filter from the affected batch. Suitable filters may already be available in hospitals or Gilead will provide replacement filters.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/defective-sartorius-5%ce%bcm-filters-present-in-cartons-of-ambisome-liposomal-amphotericin-b-50mg-lyophilisate-for-dispersion-for-infusion-batch-019545d
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 batch has not been imported into Hong Kong. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 16 Feb 2021.
Ends/Thursday, Feb 25, 2021
Issued at HKT 15:00
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