Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · NexoBrid

NexoBrid 5 g powder and gel for gel · Abschnitt 4.8 · PDF-Seite 9

HOS-213904 · Präparat HOS-155226

Pyrexia/hyperthermia In pooled adult population from studies MW2004, MW2005, MW2008 and MW2010 with routine antibacterial soaking of the treatment area before and after this medicinal product application (see section 4.2), pyrexia hyperthermia and increased body temperature were reported in 13.3.% of the adult patients treated with this medicinal product vs. 9.7%, of the patients treated according to standard of care (SOC). In early studies without antibacterial soaking (Studies MW2001and MW2002), pyrexia or hyperthermia was reported in (this medicinal product vs. SOC): 35.1% vs. 8.6% of adult patients. In pooled paediatric population from studies MW2004, MW2008, and MW2012, with routine antibacterial soaking before and after treatment, fever-pyrexia or hyperthermia were reported in 16.9% of patients treated with this medicinal product vs. 9.3% of patients treated according to SOC.

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