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Eintrag öffnenEnspryng · 4.1 Therapeutic indications · 1
Eintrag öffnenEnspryng · 4.3 Contraindications · 1
Eintrag öffnenEnspryng · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenEnspryng · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenEnspryng · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenEnspryng · 4.5 · Both in vitro and in vivo studies have shown that the expression of specific hepatic CYP450 enzymes (CYP1A2, C
Eintrag öffnenEnspryng · 4.5 · Given the prolonged terminal half-life of satralizumab, the effect of satralizumab may persist for several wee
Eintrag öffnenEnspryng · 4.5 · No interaction studies have been performed.
Eintrag öffnenEnspryng · 4.5 · Population pharmacokinetic (PK) analyses did not detect any effect of azathioprine (AZA), oral corticosteroids
Eintrag öffnenEnspryng · 4.5 · Therefore caution should be exercised when starting or discontinuing satralizumab treatment in patients also r
Eintrag öffnenEnspryng · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenEnspryng · 4.8 Undesirable effects · 1
Eintrag öffnenEnspryng · 4.8 · 9.6% of patients receiving satralizumab had neutrophils below 1 x 109/L, compared with 5.4% receiving placebo
Eintrag öffnenEnspryng · 4.8 · Adverse reactions from clinical trials (Table 3) are listed by MedDRA system organ class. Adverse reactions ar
Eintrag öffnenEnspryng · 4.8 · Description of selected adverse reactions
Eintrag öffnenEnspryng · 4.8 · Elevations in ALT or AST >3 x ULN occurred in 2.9% and 1.9% of patients treated with satralizumab (monotherapy
Eintrag öffnenEnspryng · 4.8 · Elevations of ALT above 5 x ULN were observed 4 weeks after initiation of therapy in one (1%) patient receivin
Eintrag öffnenEnspryng · 4.8 · IRRs reported in patients treated with satralizumab were predominantly mild to moderate, and most occurred wit
Eintrag öffnenEnspryng · 4.8 · In the double-blinded treatment period, 10.6% of patients receiving satralizumab (monotherapy or in combinatio
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