Nebenwirkungen · Ocrevus
Ocrevus 300 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 17
HOS-134125 · Präparat HOS-097528
In a randomised, double-blind, active comparator-controlled trial of flexible duration (at least 24 weeks; median treatment duration 76.7 weeks), paediatric patients with RRMS aged 10 to less than 18 years (n=14 aged 11 to less than 14 years and n=79 aged 14 to less than 18 years; total n=93 in the ocrelizumab arm) were treated with intravenous ocrelizumab 600 mg every 24 weeks (administered as two 300 mg intravenous infusions 2 weeks apart for Dose 1, followed by single 600 mg intravenous infusions for subsequent doses) (see section 5.1). The overall safety profile in paediatric patients was generally consistent with that observed in adult patients.
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