其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Ennogen Pharma Limited has informed MHRA that the Patient Information Leaflets (PIL) within the packs for the following affected batches contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instructions for children under 6 years. The affected products are:
- Trimogal (trimethoprim) 100mg Tablets (batch number: 1402264, 1402265 and 1402266)
- Trimogal (trimethoprim) 200mg Tablets (batch number: 1402171, 1402262 and 1402263)
Correct information that should be in the PIL:
- Children under 6 years: This tablet form of Trimogal is not recommended for use in children under 6 years.
Healthcare professionals are advised that, when dispensing this medicine from the affected batches listed above, please ensure that the correct PIL (available from the electronic medicines compendium website or MHRA website) is issued.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ennogen-pharma-limited-trimogal-100mg-and-200mg-tablets-el-20-a-31
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Jul 21, 2020
Issued at HKT 15:00
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