其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid® FlexTouch® 100 units/ml, Saxenda® FlexTouch® 6mg/ml (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Novo Nordisk Limited identifies a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the United Kingdom. The affected products are:
- NovoRapid® FlexTouch® 100 units/ml solution for injection in pre-filled pen (insulin aspart) (batch number: MZF0M05, MZF1H04)
- Saxenda® FlexTouch® 6mg/ml solution for injection in pre-filled pen (liraglutide) (batch number: LZFW572, LZF0H19, LZF0D36, LZF0D41, LZFW142, LZFW571, LZFY408, LZFY613, MZF0V95, MZF1B51)
The defect results in a non-functioning device where it is not possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose. A very small number of pens are affected – the average number of affected products is 2-3 pens per million pens. Based on the critical need for the products, they are not being recalled.
This information relates to both NovoRapid and Saxenda FlexTouch pens. If the pen is faulty, it will not be possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose therefore the fault will be noticeable to the patient. If a patient returns a faulty pen from these batches to their pharmacy or other healthcare professional, Novo Nordisk request that the healthcare professional follows the usual safety and complaints process whereby they provide the patient with a replacement pen.
Patients are advised to always carry a spare pen to avoid any doses being missed. The pens with the affected defect are not being recalled. Patients can continue to use pens from these batches if not affected by the defect.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-novo-nordisk-limited-novorapid-r-flextouch-r-100-units-slash-ml-saxenda-r-flextouch-r-liraglutide-6mg-slash-ml-el-22-a-slash-33
In Hong Kong, the following pharmaceutical products are registered by Novo Nordisk Hong Kong Ltd. (Novo Nordisk):
- NovoRapid Penfill Inj 100U/ml (HK-46862)
- NovoRapid Flexpen Inj 100U/ml (HK-55341)
- NovoRapid Flexpen Inj 100U/ml (Brazil) (HK-60321)
- NovoRapid Penfill Solution For Injection 100U/ml (HK-60462)
- Saxenda Solution For Injection In Pre-filled Pen 18mg/3ml (HK-65010)
The four NovoRapid products are pharmacy-only medicines and Saxenda is a prescription-only medicine. As confirmed by Novo Nordisk, the four NovoRapid products registered in Hong Kong are not “FlexTouch”. For Saxenda, the affected batches in the United Kingdom have not been imported into Hong Kong.
Ends/Friday, Jul 22, 2022
Issued at HKT 15:30
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