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Eintrag öffnenEpysqli · 4.1 Therapeutic indications · 1
Eintrag öffnenEpysqli · 4.3 Contraindications · 1
Eintrag öffnenEpysqli · 4.3 · - with unresolved Neisseria meningitidis infection - who are not currently vaccinated against Neisseria mening
Eintrag öffnenEpysqli · 4.3 · 4 Hypersensitivity to the active substance, CHO cell products or to any of the excipients listed in section 6.
Eintrag öffnenEpysqli · 4.3 · Eculizumab therapy must not be initiated in patients (see section 4.4):
Eintrag öffnenEpysqli · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenEpysqli · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenEpysqli · 4.5 · Concomitant use of eculizumab with intravenous immunoglobulin (IVIg) may reduce effectiveness of eculizumab. C
Eintrag öffnenEpysqli · 4.5 · Concomitant use of eculizumab with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduc
Eintrag öffnenEpysqli · 4.5 · No interaction studies have been performed. Based on the potential inhibitory effect of eculizumab on compleme
Eintrag öffnenEpysqli · 4.5 · Plasma exchange (PE), plasmapheresis (PP), fresh frozen plasma infusion (PI) and intravenous immunoglobulin (I
Eintrag öffnenEpysqli · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenEpysqli · 4.8 Undesirable effects · 1
Eintrag öffnenEpysqli · 4.8 · 10 MedDRA system Very Common Uncommon Rare Not known organ class common (≥1/100 to (≥1/1 000 to <1/100) (≥1/10
Eintrag öffnenEpysqli · 4.8 · 11 In paediatric aHUS patients (aged 2 months to less than 18 years) included in the aHUS studies C08- 002, C0
Eintrag öffnenEpysqli · 4.8 · 9 MedDRA system Very Common Uncommon Rare Not known organ class common (≥1/100 to (≥1/1 000 to <1/100) (≥1/100
Eintrag öffnenEpysqli · 4.8 · Antibodies to eculizumab were detected in patients. As with all proteins there is a potential for immunogenici
Eintrag öffnenEpysqli · 4.8 · Cases of haemolysis have been reported in the setting of missed or delayed eculizumab dose in PNH clinical tri
Eintrag öffnenEpysqli · 4.8 · Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed eculiz
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