Table 1 Single-dose pharmacokinetics of NovoEight in 20* adult and adolescent subjects with severe haemophilia A (FVIII 1%) ≤ Dose: 50 IU/kg turoctocog alfa (single i.v. dose) *Full analysis set adjusted for dose and product strength and excluding outliers; N=20 Abbreviations: Inc. recovery = incremental recovery; AUC = area under the plasma concentration-time curve; CL= clearance; t½ = plasma elimination half-life; Vss = steady date volume of distribution; Cmax = peak plasma concentration; MRT = mean residence time Pharmacokinetic data from single-dose administrations of NovoEight in 14 paediatric subjects below 6 years of age and in 14 paediatric subjects from 6 to below 12 years of age are listed in tables 2 and 3. Table 2 Single-dose pharmacokinetics of NovoEight in children with haemophilia A (1 − < 6 years) Dose: 50 IU/kg turoctocog alfa (single i.v. dose); N = 14 Table 3 Single-dose pharmacokinetics of NovoEight in children with haemophilia A (6 − < 12 years) Dose: 50 IU/kg turoctocog alfa (single i.v. dose); N = 14
Table 1 Single-dose pharmacokinetics of NovoEight in 20* adult and adolescent subjects with severe haemophilia A (FVIII ≤ 1%) Dose: 50 IU/kg turoctocog alfa (single i.v. dose) *Full analysis set adjusted for dose and product strength and excluding outliers; N=20 Abbreviations: Inc. recovery = incremental recovery; AUC = area under the plasma concentration-time curve; CL= clearance; t½ = plasma elimination half-life; Vss = steady date volume of distribution; Cmax = peak plasma concentration; MRT = mean residence time Pharmacokinetic data from single-dose administrations of NovoEight in 14 paediatric subjects below 6 years of age and in 14 paediatric subjects from 6 to below 12 years of age are listed in tables 2 and 3. Table 2 Single-dose pharmacokinetics of NovoEight in children with haemophilia A (1 − < 6 years) Dose: 50 IU/kg turoctocog alfa (single i.v. dose); N = 14 Table 3 Single-dose pharmacokinetics of NovoEight in children with haemophilia A (6 − < 12 years) Dose: 50 IU/kg turoctocog alfa (single i.v. dose); N = 14
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