其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg／ml Oral Solution BP Sugar Free and Methadone Mixture 1mg／ml (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Thornton & Ross Ltd has informed MHRA that specific batches of Methadone 1mg/ml Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml have been packaged with the incorrect Product Information Leaflet (PIL). The incorrect PIL is missing important safety information. For details of the affected batch numbers, please refer to the website in MHRA.
Healthcare professionals are advised that there is no risk to product quality as a result of this issue and the affected batches on the market are not being recalled. For dispensing of products from all affected batches, healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL, where appropriate. The missing information in the PIL provides additional safety information related to dependency, addiction and withdrawal reactions; potential effects on hormones; safety information about pregnancy and breastfeeding; and potential interactions with other medicines.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-thornton-and-ross-ltd-methadone-1mg-slash-ml-oral-solution-bp-sugar-free-methadone-mixture-1mg-slash-ml-el-23-a-slash-07
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Mar 8, 2023
Issued at HKT 14:00
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