Safety Advisory


HPS Pharmacies wish to advise that Boehringer Ingelheim, in consultation with the Therapeutic Goods Administration (TGA), is investigating a safety issue concerning:

Actilyse® 50mg Vial
Alteplase Powder for Injection
ARTG 17905

The TGA is investigating reports of the rubber stopper being pushed into the vial during reconstitution; rendering the product unusable. The cause of this issue has not been identified at this stage, and no product is being recalled.

While the number of reports received has been small, the serious nature of the conditions for which Actilyse® is used demands caution to be exercised. Staff should familiarise themselves with the handling instructions contained within the product information before attempting reconstitution of the powder for injection. Strict adherence to these instructions may help to prevent these issues from occurring.

Retain this notice in a prominent position, including in other related business units. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Boehringer Ingelheim on (02) 8875 8800.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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