Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information (Caution in Use): Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Drug Alert for Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase).
Boehringer Ingelheim Limited has received an increased number of complaints relating to the rubber stoppers being pushed into the vial during reconstitution using the supplied transfer cannula. This renders the vial unusable. Boehringer Ingelheim Limited have provided guidance to Healthcare Professionals on the handling of the transfer cannula.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-caution-in-use-actilyse-20mg-and-50mg-powder-and-solvent-for-solution-for-injection-and-infusion-alteplase#advice-for-healthcare-professionals
In Hong Kong, Actilyse Lyophilised Pdr for IV Inf 50mg (HK-30511) and Actilyse Lyophilised Pdr for IV Inj 20mg (HK-37894) are pharmaceutical products registered by Boehringer Ingelheim (HK) Ltd (BI), and are prescription only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction report related to the products. According to BI, only Actilyse 50mg is marketed in Hong Kong which the clients are hospital pharmacies, while Actilyse 20mg has not been marketed. With regard to precautionary measure, BI updated DH that they are going to issue letters to alert hospital pharmacies to the incident. DH will remain vigilant on the safety of the products.
Ends/ Thursday, August 25, 2016
Issued at HKT 17:00
On 26 August 2016, BI has disseminated letter to hospital pharmacies regarding the issue, together with handling instructions of the transfer set. DH will remain vigilant on any further update from BI.
Content last updated: Monday, August 29, 2016
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