Other safety alerts
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| Singapore: SIMPONI (golimumab) 50 mg and 100 mg: Important changes to the patient information leaflet for the SmartJect pre-filled pen |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte. Ltd. to inform healthcare professionals of the important changes to the patient information leaflet (PIL) for the SIMPONI SmartJect pre-filled pen.
This followed identified safety issues such as accidental needle stick injuries from skin pinching when administering the injection and failure of the device to actuate from prematurely pressing the button. Healthcare professionals are advised to inform all patients and caregivers on the proper use of the SmartJect pre-filled pen, in accordance with the revised PIL.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/simponi-(golimumab)-50-mg-and-100-mg-important-changes-to-the-patient-information-leaflet-(pil)-for-the-smartject-(pre-filled-pen)
In Hong Kong, Simponi Pre-filled Smartject Autoinjector 50mg/0.5ml (HK-59900), Simponi Pre-filled Smartject Autoinjector 100mg/1ml (HK-64295) and Simponi Pre-filled Smartject Autoinjector 50mg/0.5ml (HK-66453) are pharmaceutical products registered by Johnson & Johnson (Hong Kong) Ltd. All products are prescription-only medicines. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to golimumab, but these cases were not related to accidental needle stick injuries or failure of the device to actuate. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Feb 24, 2023
Issued at HKT 15:00
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