Nebenwirkungen · Tracleer
Tracleer 32 mg dispersible tablets · Abschnitt 4.8 · PDF-Seite 36
HOS-110007 · Präparat HOS-093279
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo). The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5–10.0 days) and 4.0 days (range 2.5–6.5 days). The most frequent adverse events in the bosentan- and placebo-treated patients were, respectively, anaemia or haemoglobin decrease (7 and 2 patients), generalised oedema (3 and 0 patients), and vomiting (2 and 0 patients).
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Version 2024-10-25T15:01:00Z · SHA-256 eddfcd40df26bd01c2c7847da53c544c94e0bafb8bcc62374b5c7788669470bc · Passage 0a01bbfff50b58a4f29e8cfebf834a47d951b05f31e1e1f79b53be81bb422fd3 · Zeichen 7576–8163 im Abschnitt