Nebenwirkungen · Adynovi
ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 2 000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 3 000 IU / 5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8
HOS-136054 · Präparat HOS-097816
None of the subjects who participated in one or more of 6 completed clinical trials in PTPs developed persistent neutralizing (inhibitory) antibodies against factor VIII of ≥ 0.6 BU/ml (based on the Nijmegen modification of the Bethesda assay). One patient developed a transient factor VIII inhibitor at the lowest limit of positivity (0.6 BU) during personalized prophylaxis targeting a factor VIII level of 8-12%.
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Version 2026-07-09T17:45:00Z · SHA-256 49f6f4674dcaf56048931941828ba826f5d6f20055cfa2a957cf1788ccaf65f2 · Passage b7c82349157c07ff428cde2b1ab7af9e042c7a0e78005f5bae9563ca336e3eea · Zeichen 4225–4640 im Abschnitt