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Riximyo · 4.8 · Neurologic events Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencep
Eintrag öffnenRiximyo · 4.8 · Neurologic events Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencep
Eintrag öffnenRiximyo · 4.8 · Neutropenia Events of neutropenia were observed with rituximab treatment, the majority of which were transient
Eintrag öffnenRiximyo · 4.8 · Neutropenia In GPA/MPA Study 1, 24% of patients in the rituximab group (single course) and 23% of patients in
Eintrag öffnenRiximyo · 4.8 · Other serious adverse reactions reported include hepatitis B reactivation and PML (see section 4.4.)
Eintrag öffnenRiximyo · 4.8 · Paediatric population An open-label, single arm study was conducted in 25 paediatric patients with severe, act
Eintrag öffnenRiximyo · 4.8 · Patient subpopulations – rituximab combination therapy
Eintrag öffnenRiximyo · 4.8 · Patient subpopulations – rituximab monotherapy
Eintrag öffnenRiximyo · 4.8 · Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate
Eintrag öffnenRiximyo · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenRiximyo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenRiximyo · 4.8 · Respiratory system Cases of interstitial lung disease, some with fatal outcome have been reported.
Eintrag öffnenRiximyo · 4.8 · Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in cl
Eintrag öffnenRiximyo · 4.8 · Skin and subcutaneous tissue disorders Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrom
Eintrag öffnenRiximyo · 4.8 · Skin and subcutaneous tissue disorders Toxic Epidermal Necrolysis (Lyell’s syndrome) and Stevens-Johnson syndr
Eintrag öffnenRiximyo · 4.8 · Summary of the safety profile
Eintrag öffnenRiximyo · 4.8 · Summary of the safety profile in PV Study 1 (Study ML22196) and PV Study 2 (Study WA29330)
Eintrag öffnenRiximyo · 4.8 · Table 4 Summary of adverse reactions reported in clinical trials or during post-marketing surveillance occurri
Eintrag öffnenRiximyo · 4.8 · Table 5 Adverse reactions occurring at 6 months in ≥ 5% of adult patients receiving rituximab in GPA/MPA Study
Eintrag öffnenRiximyo · 4.8 · Table 6 Adverse reactions occurring in ≥ 5% of adult patients receiving rituximab in GPA/MPA Study 2 (Rituxima
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