Nebenwirkungen · Synagis
Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection · Abschnitt 4.8 · PDF-Seite 4
HOS-090196 · Präparat HOS-084025
The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure. The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies. The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-10-11T08:14:00Z · SHA-256 80b341ab31afe95db5c42fa61205421fb02b06bd1c5fb252bf6a42f441c92dde · Passage 05a875339acb46d8c04d88b1b53eeef403761999ac61c2953169523a5f3db8e6 · Zeichen 630–1176 im Abschnitt