Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Datroway

Datroway 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-153449 · Präparat HOS-100992

Ocular surface undesirable effects occurred in 46.3% of the pool of patients treated with Datroway, of which 29.1% were Grade 1, 13.2% were Grade 2, 3.6% were Grade 3 and 0.36% were Grade 4. Keratitis occurred in 16.6% of the pool of patients treated with Datroway, of which 10.7% were Grade 1, 4.2% were Grade 2, 1.7% were Grade 3 and 0.1% were Grade 4. The median time to onset was 4.4 months (range: 0.3 to 24). Keratitis resolved in 50% of patients, with a median duration of 2.3 months (range: 0.2 to 15.9). Discontinuation due to keratitis occurred in 0.5% of patients.

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