<?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>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942025000300265</article-id>
<article-id pub-id-type="doi">10.30827/ars.v66i3.32021</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Seguridad de Inmunoglobulina G (Gammaraas®) en Pacientes atendidos en una Clínica de Alta Complejidad: Estudio Descriptivo]]></article-title>
<article-title xml:lang="en"><![CDATA[Safety of Immunoglobulin G (Gammaraas®) in Patients Treated at a High-Complexity Clinic: A Descriptive Study]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-Ruiz]]></surname>
<given-names><![CDATA[Alfredo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Herrera-Vargas]]></surname>
<given-names><![CDATA[Jhojan Sebastián]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vasco-Correa]]></surname>
<given-names><![CDATA[Laura Victoria]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-Valdivieso]]></surname>
<given-names><![CDATA[Mónica Rocío]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Angarita-Galvis]]></surname>
<given-names><![CDATA[María Cristina]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Grupo de Investigación Clínica Somer Unidad de Investigación y Docencia ]]></institution>
<addr-line><![CDATA[Rionegro ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2025</year>
</pub-date>
<volume>66</volume>
<numero>3</numero>
<fpage>265</fpage>
<lpage>275</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942025000300265&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942025000300265&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942025000300265&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción: En los últimos años, se ha incrementado el uso de la inmunoglobulina intravenosa (IGIV) para tratar inmunodeficiencias y trastornos inmunomoduladores. A pesar de ser generalmente segura, puede causar eventos adversos leves a graves. Este estudio describió los aspectos de seguridad de Gammaraas® 5 % en pacientes de una clínica de alta complejidad entre 2020 y 2022.  Método:  Se realizó un estudio observacional retrospectivo en una clínica de alta complejidad entre 2000 y 2022, de pacientes tratados con inmunoglobulina G intravenosa. Se analizaron las historias clínicas para recopilar información demográfica, indicación, dosis y eventos adversos. Los datos se presentaron como frecuencias absolutas y relativas para variables cualitativas y como medidas de tendencia central para las variables cuantitativas. Se siguieron los lineamientos éticos de la declaración de Helsinki, y el estudio fue aprobado por el comité de ética institucional.  Resultados:  Durante el período estudiado, 49 pacientes recibieron la inmunoglobulina G intravenosa en estudio. Predominando el sexo masculino con 27 (55,1 %), distribuidos equitativamente entre adultos y pediátricos, con una mediana de edad de 17,2 años (IQR: 3,7 - 48,2), los cuales recibieron 98 infusiones. Cinco pacientes (10,2 %), presentaron reacciones adversas, la mayoría de estas clasificadas como leves. Las principales indicaciones fueron: Púrpura trombocitopénica idiopática, miopatía inflamatoria, síndrome de Guillain-Barré y el síndrome mucocutáneo linfonodular &#8220;Kawasaki&#8221;. Dos pacientes presentaron reacciones severas las cuales finalmente fueron clasificadas como no relacionadas con la inmunoglobulina G intravenosa.  Conclusiones:  La aplicación de Gammaraas® 5 % intravenosa, fue segura en el 90 % de los casos. Las reacciones documentadas fueron leves, lo cual está en concordancia con lo expresado en la literatura.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction:  Recent years have seen an increase in the use of intravenous immunoglobulin (IVIG) for treating primary and secondary immunodeficiencies, as well as immune modulation. Despite being generally safe, IVIG can cause mild to severe adverse events. This study aimed to describe safety aspects of Gammaraas® 5 % in high-complexity clinic patients between 2020 and 2022.  Method:  A retrospective observational study conducted at a high-complexity clinic between 2000 and 2022, involving patients treated with intravenous immunoglobulin G. Medical records were analyzed to collect demographic information, indication, medication dosage, and adverse events. Data were presented as absolute and relative frequencies for qualitative variables and measures of central tendency for quantitative variables. The ethical guidelines of the Helsinki Declaration were followed, and the study was approved by the institutional ethics committee.  Results:  During the study period, 49 patients received the intravenous immunoglobulin G under the study. Males predominated with 27 (55.1 %), equally distributed between adults and pediatrics, with a median age of 17.2 years (IQR: 3.7-48.2), who received 98 infusions. Five patients (10.2 %) experienced adverse reactions, most of them classified as mild.The main indications were: idiopathic thrombocytopenic purpura, inflammatory myopathy, Guillain-Barre syndrome and &#8220;Kawasaki&#8221; lymphonodular mucocutaneous syndrome. Two patients experienced severe reactions wich were finally classified as not related to intravenous immunoglobulin G.  Conclusions: The intravenous administration of Gammaraas® 5 % was safe in 90 % of cases. The documented reactions were mild, which is consistent with the literature.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Eventos adversos]]></kwd>
<kwd lng="es"><![CDATA[inmunoglobulina intravenosa]]></kwd>
<kwd lng="es"><![CDATA[farmacovigilancia]]></kwd>
<kwd lng="es"><![CDATA[usos terapéuticos, estudios retrospectivos]]></kwd>
<kwd lng="en"><![CDATA[Adverse effects]]></kwd>
<kwd lng="en"><![CDATA[intravenous immunoglobulins]]></kwd>
<kwd lng="en"><![CDATA[pharmacovigilance]]></kwd>
<kwd lng="en"><![CDATA[therapeutic uses]]></kwd>
<kwd lng="en"><![CDATA[retrospective studies]]></kwd>
</kwd-group>
</article-meta>
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