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Enspryng · 4.8 · In the double-blinded treatment period, body weight increase ≥15% from baseline were observed in 3.8% of patie
Eintrag öffnenEnspryng · 4.8 · Injection-related reactions (IRRs)
Eintrag öffnenEnspryng · 4.8 · Laboratory abnormalities Neutrophils In the double-blinded treatment period, decreased neutrophils were observ
Eintrag öffnenEnspryng · 4.8 · Lipid parameters
Eintrag öffnenEnspryng · 4.8 · Liver enzymes In the double-blinded treatment period, elevations in ALT or AST occurred in 27.9% and 18.3% of
Eintrag öffnenEnspryng · 4.8 · Paediatric population
Eintrag öffnenEnspryng · 4.8 · Platelets In the double-blinded treatment period, decreases in platelet count (below 150 × 109/l) occurred in
Eintrag öffnenEnspryng · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenEnspryng · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEnspryng · 4.8 · Summary of the safety profile
Eintrag öffnenEnspryng · 4.8 · System Organ Class Frequency Very common Common Blood and lymphatic system disorders Hypofibrinogenaemia Metab
Eintrag öffnenEnspryng · 4.8 · Table 3 summarises the adverse reactions that have been reported in association with the use of satralizumab a
Eintrag öffnenEnspryng · 4.8 · Table 3: Adverse reactions
Eintrag öffnenEnspryng · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenEnspryng · 4.8 · The majority of the decreased platelets were transient and not below 75 × 109/l.
Eintrag öffnenEnspryng · 4.8 · The most frequently reported adverse reactions observed were: headache (19.2%), arthralgia (13.5%), white bloo
Eintrag öffnenEnspryng · 4.8 · The safety and efficacy of satralizumab have been studied in 9 children ≥12 years of age. Frequency, type and
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