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Bekemv
Eintrag öffnenBekemv · 4.1 Therapeutic indications · 1
Eintrag öffnenBekemv · 4.3 Contraindications · 1
Eintrag öffnenBekemv · 4.3 · BEKEMV is contraindicated in babies and children below 2 years of age since they may not yet be diagnosed with
Eintrag öffnenBekemv · 4.3 · BEKEMV is contraindicated in subjects with hereditary fructose intolerance (HFI). Prior to initiating treatmen
Eintrag öffnenBekemv · 4.3 · BEKEMV therapy must not be initiated in patients (see section 4.4): - with unresolved Neisseria meningitidis i
Eintrag öffnenBekemv · 4.3 · Hypersensitivity to eculizumab or to any of the excipients listed in section 6.1.
Eintrag öffnenBekemv · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBekemv · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBekemv · 4.5 · No interaction studies have been performed. Based on the potential inhibitory effect of eculizumab on compleme
Eintrag öffnenBekemv · 4.5 · Plasma exchange (PE), plasmapheresis (PP) and fresh frozen plasma infusion (PI) have been shown to reduce ecul
Eintrag öffnenBekemv · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBekemv · 4.8 Undesirable effects · 1
Eintrag öffnenBekemv · 4.8 · 10 MedDRA Very Common Uncommon Rare Not known system organ common (≥ 1/100 to (≥ 1/1 000 to (≥ 1/10 000 to (ca
Eintrag öffnenBekemv · 4.8 · 11 MedDRA Very Common Uncommon Rare Not known system organ common (≥ 1/100 to (≥ 1/1 000 to (≥ 1/10 000 to (ca
Eintrag öffnenBekemv · 4.8 · 12 In paediatric aHUS patients (aged 2 months to less than 18 years) included in the aHUS studies C08- 002, C0
Eintrag öffnenBekemv · 4.8 · Antibodies to eculizumab were detected in patients with PNH and aHUS. As with all proteins there is a potentia
Eintrag öffnenBekemv · 4.8 · Cases of haemolysis have been reported in the setting of missed or delayed eculizumab dose in PNH clinical tri
Eintrag öffnenBekemv · 4.8 · Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed eculiz
Eintrag öffnenBekemv · 4.8 · Description of selected adverse reactions
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