Nebenwirkungen · Elaprase
Elaprase 2 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6
HOS-116002 · Präparat HOS-094403
Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age. During the 53-week study, 67.9% (19 of 28) of patients had at least one blood sample that tested positive for anti-idursulfase antibodies, and 57.1% (16 of 28) tested positive for antibodies on at least three consecutive study visits. Fifty-four percent of patients tested positive for neutralizing antibodies at least once and half of the patients tested positive for neutralizing antibodies on at least three consecutive study visits.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-15T13:25:00Z · SHA-256 151f04884a4bfff5e3e2f2bc4504b34bd66d141a52fe7850322837f067df0dbd · Passage 0c4d8098f8d3e2dec4c334367dd9276cba0d275db06e38f97d45c2bd15dfd512 · Zeichen 6055–6586 im Abschnitt