Nebenwirkungen · Fabrazyme
Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5
HOS-109168 · Präparat HOS-093111
Adverse reactions reported from clinical trials with a total of 168 patients (154 males and 14 females) treated with Fabrazyme administered at a dose of 1 mg/kg every 2 weeks for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1,000 to < 1/100) in the table below. The occurrence of an adverse reaction in a single patient is defined as uncommon in light of the relatively small number of patients treated. Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data). Adverse reactions were mostly mild to moderate in severity:
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Version 2024-09-04T17:45:00Z · SHA-256 50723fc7f5ed616b813a9f05ffce97aba7e55f7a50650a9752044bdb78693681 · Passage 4a0044304d1b84d3a9e8bf780cff71864857c00893c18b61fb3648c816f6c74b · Zeichen 756–1525 im Abschnitt