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 |