Nebenwirkungen · Talmanco (previously Tadalafil Generics)
Talmanco 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-137565 · Präparat HOS-098059
A total of 51 paediatric patients aged from 2.5 to 17 years with PAH were treated with tadalafil in clinical trials (H6D-MC-LVHV, H6D-MC-LVIG). A total of 391 paediatric patients with PAH, from new-born to < 18 years, were treated with tadalafil in an observational post-marketing study (H6D-JETD01). Following tadalafil administration, the frequency, type and severity of adverse reactions in children and adolescents were similar to that seen for adults. Due to differences in study design, sample size, gender, age range, and doses, safety findings from these trials are detailed separately below.
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