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Ultomiris
Eintrag öffnenUltomiris · 4.1 Therapeutic indications · 1
Eintrag öffnenUltomiris · 4.3 Contraindications · 1
Eintrag öffnenUltomiris · 4.3 · • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients with
Eintrag öffnenUltomiris · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenUltomiris · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenUltomiris · 4.5 · Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc recepto
Eintrag öffnenUltomiris · 4.5 · No interaction studies have been performed. Based on the potential inhibitory effect of ravulizumab on complem
Eintrag öffnenUltomiris · 4.5 · See section 4.2 for guidance in case of concomitant PE, PP, or IVIg treatment.
Eintrag öffnenUltomiris · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenUltomiris · 4.8 Undesirable effects · 1
Eintrag öffnenUltomiris · 4.8 · 10 Table 7: Adverse Drug reactions from clinical trials and postmarketing experience MedDRA System Organ Very
Eintrag öffnenUltomiris · 4.8 · 11 Immunogenicity In adult PNH patient studies (N = 475), a paediatric PNH study (N = 13), aHUS studies (N = 8
Eintrag öffnenUltomiris · 4.8 · Atypical haemolytic uremic syndrome (aHUS) In paediatric patients with evidence of aHUS (N= 34, aged 10 months
Eintrag öffnenUltomiris · 4.8 · Description of selected adverse reactions
Eintrag öffnenUltomiris · 4.8 · Gastrointestinal Diarrhoea, Vomiting, disorders Nausea, Dyspepsia Abdominal pain Skin and subcutaneous Urticar
Eintrag öffnenUltomiris · 4.8 · Generalised Myasthenia Gravis (gMG) Ravulizumab has not been studied in paediatric patients with gMG.
Eintrag öffnenUltomiris · 4.8 · Infusion-related reactions In clinical trials, infusion-related reactions were common (≥1%). These events, whi
Eintrag öffnenUltomiris · 4.8 · Meningococcal infection/sepsis/encephalitis Vaccination reduces, but does not eliminate, the risk of meningoco
Eintrag öffnenUltomiris · 4.8 · Nervous system Dizziness, Headache disorders
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