Nebenwirkungen · NexoBrid
NexoBrid 5 g powder and gel for gel · Abschnitt 4.8 · PDF-Seite 10
HOS-213911 · Präparat HOS-155226
Clinical trial experience in paediatric patients (newborn up to 18 years of age) includes use of this medicinal product in a dedicated SOC-controlled study (MW2012), in which 69 patients were exposed to this medicinal product (age range new born-18 years; see section 5.1 for age distribution) and use in paediatric patients in studies MW2004 and MW2008, which included 17 and 3 paediatric patients, respectively (age range 4-17 years). Overall, the safety profile in paediatric patients is similar to the safety profile in adults. Due to the low numbers of adverse reactions reported in each age group, it is not possible to draw valid conclusions regarding potential age-related differences in the safety profile.
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