Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bridion

Bridion 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-119627 · Präparat HOS-094981

8 Description of selected adverse reactions Drug hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below). In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown. These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex. Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal. In post-marketing reports, hypersensitivity has been observed for sugammadex as well as for sugammadex-rocuronium complex.

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