Nebenwirkungen · Vimizim
Vimizim 1 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5
HOS-129617 · Präparat HOS-096765
The majority of adverse reactions in clinical studies were IRs, which are defined as reactions occurring after initiation of infusion until the end of the day following the infusion. Serious IRs were observed in clinical studies and included anaphylaxis, hypersensitivity and vomiting. The most common symptoms of IRs (occurring in ≥ 10% of patients treated with Vimizim and ≥ 5% more when compared to placebo) were headache, nausea, vomiting, pyrexia, chills and abdominal pain. IRs were generally mild or moderate, and the frequency was higher during the first 12 weeks of treatment and tended to occur less frequently with time.
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Version 2019-02-08T17:23:00Z · SHA-256 8c938b69406aaaf758f53467f97dad48c9cd424d8131a769814c28e28374beb2 · Passage ef67c9ce1af1e3cfe751d6a4f011fdc3c9fb5881956adbeaf517e678b6381b8c · Zeichen 322–953 im Abschnitt