Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Replagal

Replagal 1 mg/ml concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 5

HOS-109146 · Präparat HOS-093103

Table 1 lists adverse reactions reported for the 344 patients treated with Replagal in clinical trials, including 21 patients with history of end stage renal disease, 30 paediatric patients (≤ 18 years of age) and 98 female patients, and from post-marketing spontaneous reports. Information is presented by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1 000 to < 1/100). The adverse reactions categorized as incidence “not known (cannot be estimated from the available data)” are derived from post-marketing spontaneous reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The occurrence of an event in a single patient is defined as uncommon in view of the number of patients treated. A single patient could be affected by several adverse reactions.

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