Nebenwirkungen · Arixtra
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe. · Abschnitt 4.8 · PDF-Seite 46
HOS-110183 · Präparat HOS-093307
Paediatric population The safety of fondaparinux in paediatric patients has not been established. In an open-label, single-arm retrospective, non-randomized, single-centre clinical study with 366 paediatric VTE patients treated with fondaparinux, the safety profile was as follows: Major bleeding events as per ISTH definition (n=7; 1.9%): 1 patient (0.3%) had clinically overt bleeding, 3 patients (0.8%) had major bleeding, and 3 patients (0.8%) had major bleeding that required surgical intervention. Major bleeding events resulted in the interruption of fondaparinux treatment for 4 patients and the discontinuation of fondaparinux for 3 patients.
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