Articles with "package insert" as a keyword



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Detection of vaccine adverse events before package insert revisions using a Japanese spontaneous reporting system.

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Published in 2023 at "Journal of clinical pharmacology"

DOI: 10.1002/jcph.2243

Abstract: The usefulness of disproportionality analysis for the pharmacovigilance of vaccines in Japanese Adverse Drug Event Report (JADER) database is yet to be proven. This study aimed to verify whether significant disproportionality could be detected before… read more here.

Keywords: jader; vaccine adverse; package; insert revisions ... See more keywords
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Response to: Eculizumab package insert recommendations for meningococcal vaccinations: call for clarity and a targeted approach for use of the drug in neuromyelitis optica spectrum disorder

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Published in 2020 at "CNS Spectrums"

DOI: 10.1017/s1092852920001625

Abstract: Dear Editor, We thank Avasarala et al. for their editorial on meningococcal infection prevention in patients with neuromyelitis optica spectrum disorder (NMOSD) receiving eculizumab. While we appreciate the authors’ concerns and agree that its manufacturers… read more here.

Keywords: vaccination recommendations; vaccine; package insert; neuromyelitis optica ... See more keywords