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CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery
Date:3/15/2012

monary bypass surgery, the plasma concentration of fibrinogen has been reported to decrease by 34 to 42 percent, which can increase the risk of post-operative bleeding. During manufacture, CSL Behring's purified, pasteurized, fibrinogen concentrate undergoes multiple steps to remove potential pathogens, including being heated in aqueous solution at 60 degrees centigrade/140 degrees Fahrenheit for 20 hours. A publication by the World Federation of Hemophilia provides additional perspective on this matter. Fibrinogen concentrate is mostly tolerated without undesirable reactions. In rare cases allergoid-anaphylactoid reactions (like generalized urticaria, rash, fall in blood pressure, dyspnoea), and/or rise in temperature are observed. If allergoid-anaphylactoid reactions occur, the administration of fibrinogen concentrate has to be discontinued immediately (e.g. by interruption of the injection/infusion) and an appropriate treatment has to be initiated. The current medical standards for shock treatment are to be observed. There is a potential risk of thromboembolic episodes (including myocardial infarction and pulmonary embolism) following the administration of human plasma fibrinogen concentrate.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. Th
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