SUMMARY  

• In clinical trials, the use of closed system transfer devices (CSTDs) was permitted for administration of TALVEY.¹
  • For syringe volumes less than 1 mL, CSTDs must not be used for dose preparation or administration.¹
  • For syringe volumes ≥1mL, commercially available CSTDs could be used in the preparation and administration of TALVEY provided the guidelines below are followed¹:
    • The hold up volumes of the CSTD components (e.g., vial spike and syringe adapter) must be accounted for when drawing up the dose as this may impact the number of TALVEY vials required to prepare the dose.
    • For CSTDs applied at the time of dose administration: hold up volumes of the CSTD components must be accounted for during the preparation of the syringe(s) to ensure that the exact dose volume is in the syringe after priming the CSTD.

Literature Search

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 18 July 2024.