Table I.
Main characteristics of the prothrombin complex concentrates available in Italy*
| Brand (Company) | Purification | Viral inactivation | Clotting factors (U/mL) | Anticoagulant proteins (U/mL) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| II | VII | IX | X | PC | PS | AT | Heparin | |||
| Uman Complex D.I. (Kedrion) | Ion-exchange chromatography | Solvent/detergent + 100°C for 30 min | 25 | - | 25 | 20 | - | - | NQ | NQ |
| Prothromplex TIM 3 (Baxter) | Ion-exchange chromatography | Vapour heat 60°C for 10 h, 80°C for 1 h | 30 | - | 30 | 30 | - | - | - | 0.5 |
| Confidex (CSL Behring) | Ion-exchange chromatography | Pasteurization 60°C for 10 h + nanofiltration (75 nm-35 nm) | 20–48 | 10–25 | 20–31 | 22–60 | 15–45 | 13–38 | 0.6 | 0.5 |
Abbreviations: PC, protein C; PS, protein S; AT, antithrombin; NQ, not quantified.
*
In Europe, ranges are usually given on the product label, in accordance with the European Pharmacopoeia; single values are generally from older, national registrations.