Other safety alerts
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| The United Kingdom: Parents and carers advised to inspect Buccolam oral syringes before use |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that, in an alert issued last year, healthcare professionals were asked to speak to parents and carers about carefully inspecting Buccolam pre-filled plastic syringes before giving the medicine.
Buccolam is an epilepsy medicine, which is available as pre-filled oral syringes. A defect with some syringes has been reported. In a small number of cases, the translucent (white) tip-cap can sometimes remain attached to the syringe after the red cap has been taken off, this is a choking hazard. Buccolam remains safe to use if the patient/carer instructions are followed. Carefully check the syringe before giving the medicine and remove the translucent tip-cap manually if it is still on the syringe after the red cap has been pulled off.
This is not a new issue, MHRA previously issued this alert in Dec 2017 on Buccolam (midazolam) 2.5mg, 5mg, 7.5mg and 10mg Oromucosal Solution Pre-filled Syringes. However, MHRA is now aware of a few rare reports in Europe of a child breathing in or swallowing the tip-cap and the European Medicines Ageney (EMA) has added guidance on its website.
MHRA wants to make sure parents and carers of children who are using Buccolam are aware of the practical steps to take should they need to dispense this medicine. Pharmacists who prescribe and dispense Buccolam have also been asked to share this information with parents and caregivers. The manufacturer is working to resolve this issue for new syringes.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/news/parents-and-carers-advised-to-inspect-buccolam-oral-syringes-before-use
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by MHRA and EMA, and was posted on the Drug Office website on 8 Dec 2017 and 16 Jan 2018.
Ends/Thursday, Jan 18, 2018
Issued at HKT 16:00
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