Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Soliris

Soliris 300 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-118089 · Präparat HOS-094753

Table 1 gives the adverse reactions observed from spontaneous reporting and in eculizumab completed clinical trials, including PNH, aHUS, refractory gMG and NMOSD studies. Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000) or not known (cannot be estimated from the available data) frequency with eculizumab, are listed by system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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