Table 2.
Prolastin | Zemaira/Respreeza | |
---|---|---|
Origin * | Human donor plasma | Human donor plasma |
Presentations * | 1 gr + 40 mL solvent (25 mg/mL) | 1 gr + 20 mL solvent (50 mg/mL) 4 gr + 76 mL solvent (50 mg/mL) 5 gr + 95 mL solvent (50 mg/mL) |
Excipients * | Powder: Sodium chloride Sodium dihydrogen phosphate Solvent: Water for injections |
Powder: Sodium chloride Sodium dihydrogen phosphate monohydrate Mannitol Solvent: Water for injections |
Purity (AAT/proteins) [49] | 76.9% | 97.4% |
Specific activity (active AAT/proteins) [49] | 64% | 86.2% |
Infusion velocity * | 0.08 mL/kg/min | 0.08 mL/kg/min |
Time of infusion 60 mg/kg dose † | 30 min | 15 min |
Time of infusion 120 mg/kg dose ‡ | 60 min | 30 min |
Lung density decline reduction [4,25] | Versus basal: −1.73 g/L/year Versus placebo: 1.01 g/L/year |
Versus basal: −1.45 g/L/year Versus placebo: 0.74 g/L/year |
*, Obtained from the technical leaflet; †, At a dose of 60 mg/kg/wk for a 75 kg patient; ‡, At a dose of 120 mg/kg/2 wk for a 75 kg patient.