Nebenwirkungen · Cubicin
Cubicin 350 mg powder for solution for injection or infusion Cubicin 500 mg powder for solution for injection or infusion · Abschnitt 4.8 · PDF-Seite 9
HOS-114908 · Präparat HOS-094185
Summary of the safety profile In clinical studies, 2,011 adult subjects received Cubicin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers. In paediatric studies, 372 patients received Cubicin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg). Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for Cubicin and comparator regimens.
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