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Table 3 Pharmacovigilance data for some of the commercially available PCCs

From: Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

Brand name (manufacturer) Dates of survey Amount produced to date Estimated number of applications Number of cases of proven infection transmission Number of cases of HIT type II Number of cases of proven thromboembolism
Beriplex P/N (CSL Behring, Germany) 1996 to 2004 >400 million units >200,000 (average dose 2,000 units) 0 0 0 (two cases were reported but PCC not established as the cause)
Cofact (Sanquin, The Netherlands) 1997 to 2006 ~97 million units ~64,000 to 82,500 (average dose 20 to 50 ml) 0 0 0
Uman Complex D.I. (Kedrion, Italy) 2005 to 2007 ~31.5 million units ~16,000 (average dose 2,000 units) 0 0 0
  1. Pharmacovigilance data for some of the commercially available prothrombin complex concentrates (PCCs) listed in the World Federation of Hemophilia register of clotting factor concentrates, excluding those for national markets only [54]. HIT, heparin-induced thrombocytopaenia.