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Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com.
Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) severe acute hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.
In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.
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