| Document Date: 2014-04-25 14:01:57
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Company MedImmune LLC / / Country Japan / United States / Australia / Israel / / Event FDA Phase / Product Issues / Product Recall / / IndustryTerm natural rubber latex / injection site / liquid solution / antigenic site / rubber stopper / sterile liquid solution / prevention of serious lower respiratory tract disease / healthcare / preservative-free liquid solution / treatment of RSV disease / drug products / / MedicalCondition bronchopulmonary dysplasia / RSV lower respiratory tract disease / severe RSV disease / anaphylactic shock / congenital heart disease / RSV infections / serious lung disease / Lymphatic System Disorders / coagulation disorder / RSV disease / hives / potential allergic reactions / Anaphylaxis / thrombocytopenia / heart disease / muscle weakness / dyspnea / respiratory failure / hemodynamically significant congenital heart disease / acute hypersensitivity / significant hypersensitivity / severe disease / pruritus / infectious agents / influenza / hypotension / premature birth / hepatitis viruses / General Disorders / pneumonia / severe allergic reaction / itching skin / CHD / serious lower respiratory tract disease / Coagulation Disorders / RSV infection / Carcinogenesis / fever / bronchiolitis / severe rash / urticaria / angioedema / allergic reactions / severe lung disease / hypotonia / mild hypersensitivity / Previous significant hypersensitivity / severe acute hypersensitivity / Fertility Carcinogenesis / rash / / MedicalTreatment open-heart surgery / surgery / bypass / / Organization Central Intelligence Agency / U.S. Food and Drug Administration / DOSAGE AND ADMINISTRATION / FDA / Administration of Synagis / / / Position pharmacist / General / using Fisher / / Product SYNAGIS / drug / epinephrine / glycine / dose / / ProvinceOrState Maryland / / PublishedMedium Microbiology / / Technology diagnostic tests / antibodies / Pharmacokinetics / recombinant DNA technology / / URL www.fda.gov/medwatch / www.synagis.com / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS. SYNAGIS® (palivizumab) injection, for