Product information for ACTILYSE 50 mg :
At the end of 2021, the use of latex (rubber) stopper on vials of Actilyse® was discontinued in EU and a latex-free material was introduced instead. In addition, in 2022, BI implemented an improved manufacturing process for the active ingredient alteplase in EU which made it free of gentamicin. As a result of these two changes, the previously included warnings on hypersensitivity to latex and gentamicin have been removed from the Product Information of Actilyse®.
BI is still producing Actilyse® vials containing latex stoppers and traces of gentamicin for other countries. So as part of broader efforts to tackle global supply constraints of Lytics medicines, the competent National authorities issued an exemption allowing production of specific batches of Actilyse® 50 mg with stoppers containing latex and potential traces of gentamicin. These batches will be supplied in Belgium, Finland, Luxembourg, Netherlands, Norway and Sweden alongside vials containing latex-free stoppers and free of gentamicin.
English
The corresponding product information and information letter for hospitals and HCPs are available for download here.
Belgium/Luxembourg
De bijbehorende productinformatie en Informatiebrief voor ziekenhuizen en zorgverleners kunt u hier downloaden.
Les informations produit correspondantes et la lettre d'information pour les hôpitaux et les professionnels de la santé peuvent être téléchargées ici.
Die entsprechenden Produktinformationen kann hier heruntergeladen werden.
Netherlands
De overeenkomstige productinformatie en informatiebrief voor ziekenhuizen en zorgverleners zijn hier beschikbaar voor download.
Sweden
Dispensbeslut, informationsbrev till vården och ett dokument som visar på skillnaderna i bipacksedeln kan laddas ned här.
Norway
Unntaksvedtak, informasjonsbrev til sykehus og helsepersonell og et dokument som viser forskjellene i pakningsvedlegget kan lastes ned her.