Nebenwirkungen · Tracleer
Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-109955 · Präparat HOS-093279
The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%). This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks). The most frequent adverse events were upper respiratory tract infections (25%), pulmonary (arterial) hypertension (20%), nasopharyngitis (17%), pyrexia (15%), vomiting (13%), bronchitis (10%), abdominal pain (10%), and diarrhoea (10%). There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age. Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
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