Examinando por Autor "Fayad Pinedo, Sara Silvana"

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    Farmacovigilancia activa del producto farmacéutico Neo BB® solución gotas pediátricas en establecimientos farmacéuticos de Lima Metropolitana, 2019
    (Universidad Privada Norbert Wiener, 2019-11-28) Fayad Pinedo, Sara Silvana; Castillo Soto, Pedro Félix
    Objectives: The main objective of this research was to determine the safety profile of the product NEO-BB® Pediatric Drops Solution to ensure its proper use, as well as to determine the frequency of adverse reactions and identify predisposing factors associated with the reported adverse reactions. Methods: First-hand information was obtained through questionnaires applied to a parent or legal guardian of children aged 1 to 3, who were enrolled in various pharmaceutical establishments in metropolitan Lima from February to July 2019. Results: During the follow-up of the 186 enrolled patients, seven individual case reports were filed, which included a total of seven suspected non-serious ADRs (3.76%). No suspected serious ADRs were reported. The reported suspected ADRs corresponded to reactions listed in the NEO-BB® Pediatric Drops Solution product insert. The suspected ADRs were managed by suspension (n=4, 2.15%), reduction of the daily dose (n=1, 0.54%), or continuation of the treatment with no changes (n=2, 1.08%), and no specific treatment was indicated for the ADR. Conclusion: The information obtained allows us to establish that the product's safety profile remains consistent with the authorized information in the insert and provides no reason for an insert update. The benefit-risk profile of NEO-BB® Pediatric Drops Solution remains unchanged and favorable.