Patients can reconstitute ADVATE using the BAXJECT III system. The easy, one-step activation eliminates the need to disinfect, as vials are already assembled in the system housing. 1. For complete Instructions for Use, see the ADVATE Prescribing Information here.

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: ADVATE is not indicated for the treatment …

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LEXINGTON, Mass. – Aug. 1, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has approved the BAXJECT III reconstitution system for ADYNOVATE [Antihemophilic Factor, (Recombinant), PEGylated].

Aug 2, 2016 · Shire recently announced that the U.S. Food and Drug Administration (FDA) has approved its Baxject III reconstitution system for Adynovate, an approved treatment for …

Oct 31, 2006 · BAXJECT II is the newest convenience feature to be added to ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin- Free Method], the only factor VIII therapy free of blood-based additives. Unlike other devices, BAXJECT II is compatible with existing injection ports and butterfly sets.

Aug 2, 2016 · The FDA approved Irish biopharma Shire’s ($SHPG) Baxject III reconstitution system for Adynovate, which reduces the number of steps in the reconstitution process for hemophilia A patients and...

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Aug 17, 2023 · Takeda has decided to voluntarily replace BAXJECT II and BAXJECT II Hi-Flow reconstitution devices produced at Takeda’s contract device manufacturer between October 2021 and January 2022. This is a precautionary measure and is due to the potential presence of particulate matter in the luer port of the device.