<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1679-4974</journal-id>
<journal-title><![CDATA[Epidemiologia e Serviços de Saúde]]></journal-title>
<abbrev-journal-title><![CDATA[Epidemiol. Serv. Saúde]]></abbrev-journal-title>
<issn>1679-4974</issn>
<publisher>
<publisher-name><![CDATA[Secretaria de Vigilância em Saúde e Ambiente - Ministério da Saúde do Brasil]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1679-49742017000300639</article-id>
<article-id pub-id-type="doi">10.5123/s1679-49742017000300021</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Perfil de segurança dos soros heterólogos produzidos pelo Instituto Butantan, São Paulo-SP, no período de 2012 a 2015]]></article-title>
<article-title xml:lang="en"><![CDATA[Safety profile of heterologous serum produced by the Butantan Institute, in São Paulo-SP, Brazil, from 2012 to 2015]]></article-title>
<article-title xml:lang="es"><![CDATA[Perfil de seguridad de los sueros heterólogos producidos por el Instituto Butantan, São Paulo-SP, Brasil, en el período de 2012 al 2015]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gattás]]></surname>
<given-names><![CDATA[Vera Lúcia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Braga]]></surname>
<given-names><![CDATA[Patrícia Emília]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Koike]]></surname>
<given-names><![CDATA[Marcelo Eiji]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lucchesi]]></surname>
<given-names><![CDATA[Maria Beatriz]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Precioso]]></surname>
<given-names><![CDATA[Alexander Roberto]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto Butantan Divisão de Ensaios Clínicos e Farmacovigilância ]]></institution>
<addr-line><![CDATA[São Paulo SP]]></addr-line>
<country>Brazil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2017</year>
</pub-date>
<volume>26</volume>
<numero>3</numero>
<fpage>639</fpage>
<lpage>647</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_arttext&amp;pid=S1679-49742017000300639&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_abstract&amp;pid=S1679-49742017000300639&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_pdf&amp;pid=S1679-49742017000300639&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Resumo  OBJETIVO: descrever o perfil de segurança dos soros heterólogos produzidos pelo Instituto Butantan (IB) de São Paulo-SP, Brasil.  MÉTODOS: estudo descritivo dos relatos de eventos adversos (EA) pós-exposição aos soros produzidos pelo IB, codificados pela terminologia do Dicionário Médico para Atividades Regulatórias (MedDRA), notificados espontaneamente ao IB entre 2012 e 2015.  RESULTADOS: foram notificados 52 usuários com algum evento adverso relacionado, principalmente, aos soros antibotrópico (n=11), antidiftérico (n=9) e antiofídico não especificado (n=9); observaram-se, em média, 3,2 EA por indivíduo; dos 173 EA notificados, 63,0% eram esperados por serem eventos descritos em bula; os EA mais notificados foram categorizados como afecções dos tecidos cutâneos e subcutâneos (30,6%); houve seis óbitos temporalmente relacionados ao uso de soros, porém essa associação foi descartada.  CONCLUSÃO: no período estudado, os soros produzidos pelo IB não apresentaram alteração em seu perfil de segurança, já que os EA relatados eram esperados conforme informação descrita em bula.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  OBJECTIVE: to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil.  METHODS: a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015.  RESULTS: 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.2 AEs per individual was observed; among the total of 173 AEs, 63.0% were expected considering that they were described in the package insert; most of them were classified as skin and subcutaneous tissue disorders (30.6%); there were six deaths temporally related to the use of serum, but this association was discarded.  CONCLUSION: in the studied period, the serum produced by the BI had no changes in their safety profiles, considering that the AEs were expected, according to the information previously described in the package insert.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  OBJETIVO: describir el perfil de seguridad de los sueros heterólogos producidos por el Instituto Butantan (IB) de São Paulo-SP, Brasil.  MÉTODOS: estudio descriptivo de los informes de eventos adversos (EAs) post-exposición a los sueros del IB y codificados según el Diccionario Médico para Actividades Regulatorias (MedDRA).  RESULTADOS: 52 usuarios presentaron EAs relacionados con los sueros antibotrópico (n=11), antidiftérico (n=9) y antiofídico no especificado (n=9); se observó, en los EAs, 3,2 de media por persona; de los 173 EAs reportados, 63,0% fueron &#8220;esperados&#8221;, ya que figuran descritos en la bula farmacológica; los EAs más reportados fueron los trastornos de piel y tejido subcutáneo (30,6%); hubo seis muertes, pero se descartó la asociación con el uso de suero.  CONCLUSIÓN: durante el período de estudio, los sueros del IB no mostraron ningún cambio en su perfil de seguridad, ya que los EAs reportados eran esperados conforme información descrita en la bula.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[Epidemiologia Descritiva]]></kwd>
<kwd lng="pt"><![CDATA[Imunoglobulinas]]></kwd>
<kwd lng="pt"><![CDATA[Imunização Passiva]]></kwd>
<kwd lng="pt"><![CDATA[Segurança]]></kwd>
<kwd lng="en"><![CDATA[Epidemiology, Descriptive]]></kwd>
<kwd lng="en"><![CDATA[Immunoglobulins]]></kwd>
<kwd lng="en"><![CDATA[Immunization, Passive]]></kwd>
<kwd lng="en"><![CDATA[Safety]]></kwd>
<kwd lng="es"><![CDATA[Epidemiología Descriptiva]]></kwd>
<kwd lng="es"><![CDATA[Inmunoglobulinas]]></kwd>
<kwd lng="es"><![CDATA[Inmunización Pasiva]]></kwd>
<kwd lng="es"><![CDATA[Seguridad]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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