其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Aspen Pharma Trading Limited, Co-trimoxazole 80mg/400mg per 5ml adult suspension (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet (PIL) of Co-trimoxazole (trimethoprim/sulfamethoxazole) 80mg/400mg per 5ml adult suspension. For details of the affected batch numbers, please refer to the website in Health Canada.
The error is in the section, ‘What co-trimoxazole looks like and contents of the pack’. The PIL states ‘4001mg sulfamethoxazole’ instead of ‘400 mg sulfamethoxazole’. The other sections of the PIL and product information state the correct strength.
Healthcare professionals are advised to continue to use the product as normal but be aware of the typographical error highlighted above.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-aspen-pharma-trading-limited-co-trimoxazole-80mg-slash-400mg-per-5ml-adult-suspension-el-24-a-slash-32#contents
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jul 26, 2024
Issued at HKT 16:00
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