Aventis Behring anticipates the market introduction of Helixate FS
in the third quarter, 2000.
5 billion units infused to date, Helixate FS
has been shown to be safe and effective in clinical studies as well as in post marketing use in the hemophilia community.
Aventis Behring issues its version of Kogenate FS under the name Helixate FS
, but it is the same product and manufactured by Bayer.
This new indication was granted by the FDA after determining Helixate FS
is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
ZLB Behring announced today that Helixate FS
has received approval to be stored at room temperature (up to 25(degree) C, 77(degree) F) for three months.
A scientific innovator, CSL Behring Canada markets HELIXATE FS
, Antihemophilic Factor [Recombinant] and Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, the only factor concentrate for von Willebrand disease, and is also the only company in Canada to offer two modes of human immunoglobulin (Ig) administration, including Vivaglobin, Immune Globulin Subcutaneous (Human), the first subcutaneous Ig (SCIg) replacement therapy approved in Canada.
This has also impacted Aventis-Behring's ability to ship its product Helixate FS
, as it is manufactured under an arrangement with Bayer Corporation.
The system allows for a comprehensive view of a patient's progress, with young patients relaying information about bleeding events and their use of Helixate FS
to their hemophilia treatment center via the handheld device between office visits.
For patients requiring high doses of Helixate FS
, the 2000 IU vial size reduces reconstitution time by eliminating the need to mix and pool multiple vials.
For more information about Helixate FS
, please see the full prescribing information at http://www.