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Ilaris · 4.8 · 11 Asymptomatic and mild elevations of serum bilirubin have been observed in CAPS patients treated with canaki
Eintrag öffnenIlaris · 4.8 · 12 treated with triamcinolone acetonide (2.5% for both AST and ALT) compared with canakinumab- treated patient
Eintrag öffnenIlaris · 4.8 · A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 y
Eintrag öffnenIlaris · 4.8 · ALT/AST In the overall SJIA programme, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in
Eintrag öffnenIlaris · 4.8 · ALT/AST Mean and median increases in alanine transaminase (ALT) of 3.0 U/l and 2.0 U/l, respectively, and in a
Eintrag öffnenIlaris · 4.8 · Additionally, 6 paediatric patients under the age of 2 years were evaluated in a small open-label clinical stu
Eintrag öffnenIlaris · 4.8 · Adverse reactions are listed according to MedDRA system organ class. Within each system organ class, the adver
Eintrag öffnenIlaris · 4.8 · Description of selected adverse reactions
Eintrag öffnenIlaris · 4.8 · Elderly population
Eintrag öffnenIlaris · 4.8 · Elevations of transaminases have been observed rarely in CAPS patients.
Eintrag öffnenIlaris · 4.8 · Hypersensitivity reactions have been reported in patients treated with canakinumab (see sections 4.3 and 4.4).
Eintrag öffnenIlaris · 4.8 · In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory
Eintrag öffnenIlaris · 4.8 · In the overall SJIA programme, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l w
Eintrag öffnenIlaris · 4.8 · In the overall SJIA programme, transient decreases in platelet counts (< LLN) were observed in 19 patients (9.
Eintrag öffnenIlaris · 4.8 · Laboratory abnormalities in SJIA patients Haematology In the overall SJIA programme, transient decreased white
Eintrag öffnenIlaris · 4.8 · Laboratory abnormalities in TRAPS, HIDS/MKD and FMF patients Neutrophils Although ≥ Grade 2 reductions in neut
Eintrag öffnenIlaris · 4.8 · Laboratory abnormalities in gouty arthritis patients Haematology Decreased white blood cell counts (WBC) ≤ 0.8
Eintrag öffnenIlaris · 4.8 · Long term data from observational study
Eintrag öffnenIlaris · 4.8 · Long-term data and laboratory abnormalities in CAPS patients During clinical trials with canakinumab in CAPS p
Eintrag öffnenIlaris · 4.8 · MedDRA Indications: System Organ CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis Class Infections and infest
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