Healthcare Professionals
Safety and manufacturing
Patient information
You can download the following files in PDF format :
Summary of Product Characteristics Prescribing Information Patient Information LeafletSafety concept
Products such as KOGENATE® Bayer derive the active ingredient from mammalian cell culture by recombinant technology. The development of such products set a new paradigm for the treatment of haemophilia.
High standards in viral safety are applied during the manufacturing process of KOGENATE® Bayer to reduce the theoretical risk of the transmission of
infectious agents. The Bayer concept behind the manufacturing of KOGENATE® Bayer is to achieve the highest level of safety, especially with regard to infectious risk, without sacrificing tolerability and efficacy.
Click here to find out about the high quality manufacturing process
A well documented safety record
Lowest published rate of inhibitor formation in PUPs/MTPs 1,2
Data from non-comparative studies
Confirmed cases of viral or prion transmission in 20 years and 10 billion units infused 3
Combined history of Kogenate® and KOGENATE® Bayer
References
1. Kreuz W et al. Thromb Haemost 2005;93:457-467
2. Courter GG and Bedrosian CL. Semin Hematol 2001;38(2)(Suppl 4):52-59
3. Data on file. KOGENATE® Bayer 0143 (Bayer HealthCare 2010)
Produced by Bayer. This website is intended for HealthCare professionals.
Date of preparation: December 2010
UK.PH.HN.KOG.2010.250.20.4