Nebenwirkungen · Adempas
Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.8 · PDF-Seite 34
HOS-129102 · Präparat HOS-096659
The safety of riociguat has been investigated in 24 paediatric patients aged 6 to less than 18 years over 24 weeks in a open-label uncontrolled trial (PATENT-CHILD) consisting of an individual dose titration phase starting with 1 mg (body weight adjusted) for 8 weeks and a maintenance phase for up to 16 weeks (see section 4.2), followed by an optional long-term extension phase. Most common adverse reactions including the long-term extension phase were hypotension and headache occurring in 4/24, and 2/24 patients, respectively.
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