其 他 安 全 警 示
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| Singapore: Soluvit N: Biotin interference with clinical laboratory tests resulting in incorrect laboratory values (English only) |
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Health Sciences Authority (HSA) announces that Fresenius Kabi (Singapore) Pte Ltd would like to inform healthcare professionals about Soluvit N on the potential interference of biotin with clinical laboratory tests that are based on biotin/streptavidin interaction. This may lead to incorrect laboratory values and healthcare professionals are advised to consider possible biotin interference when the laboratory test result does not match the clinical presentation of the patient. The package insert will be updated with the safety information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../soluvit-n-biotininterferencewithclinicallaboratorytestsresulting.html
In Hong Kong, Soluvit N Inj (HK-36207) is a biotin-containing pharmaceutical product registered by Fresenius Kabi Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Soluvit N or biotin. Related news on biotin interference with laboratory tests in patients taking biotin in dietary supplements was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 29 Nov 2017. Letters to inform local healthcare professionals were issued by the DH on the same day. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Tuesday, May 28, 2019
Issued at HKT 15:00
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