Le document pr\u00e9sente l\u2019\u00e9valuation europ\u00e9enne du m\u00e9dicament Zarzio dans le cadre de l\u2019European public assessment report (EPAR). Zarzio est un m\u00e9dicament de type biosimilaire, contenant comme substance active le filgrastim (30 ou 48 millions d\u2019unit\u00e9s), autoris\u00e9 dans l\u2019Union europ\u00e9enne et administr\u00e9 en solution injectable ou en perfusion \u00e0 partir de seringues pr\u00e9remplies. Le m\u00e9dicament est comparable au m\u00e9dicament de r\u00e9f\u00e9rence Neupogen, auquel il est similaire sur le plan biologique et par la substance active.<\/p>\n
Zarzio est indiqu\u00e9 pour stimuler la production de globules blancs (neutrophiles) dans plusieurs situations cliniques. Il est utilis\u00e9 pour r\u00e9duire la dur\u00e9e de la neutrop\u00e9nie et la fr\u00e9quence des neutrop\u00e9nies f\u00e9briles chez des patients recevant une chimioth\u00e9rapie cytotoxique anticanc\u00e9reuse. Il est \u00e9galement indiqu\u00e9 pour r\u00e9duire la dur\u00e9e d\u2019une neutrop\u00e9nie chez des patients b\u00e9n\u00e9ficiant d\u2019un traitement pr\u00e9alable \u00e0 une greffe de moelle osseuse, lorsque ces patients pr\u00e9sentent un risque de neutrop\u00e9nie s\u00e9v\u00e8re et prolong\u00e9e. Par ailleurs, Zarzio est utilis\u00e9 pour augmenter le taux de neutrophiles et r\u00e9duire le risque d\u2019infections chez des patients neutrop\u00e9niques ayant des ant\u00e9c\u00e9dents d\u2019infections s\u00e9v\u00e8res et r\u00e9p\u00e9t\u00e9es, ainsi que dans le traitement de la neutrop\u00e9nie persistante chez des patients pr\u00e9sentant une infection \u00e0 VIH \u00e0 un stade avanc\u00e9, afin de diminuer le risque d\u2019infections bact\u00e9riennes lorsque d\u2019autres traitements ne sont pas appropri\u00e9s. Le m\u00e9dicament peut aussi \u00eatre utilis\u00e9 chez des personnes saines donnant des cellules souches sanguines pour une greffe, afin de favoriser la mobilisation de ces cellules depuis la moelle osseuse vers le sang.<\/p>\n
Le m\u00e9dicament ne peut \u00eatre obtenu que sur prescription m\u00e9dicale. Il est administr\u00e9 par injection sous-cutan\u00e9e ou par perfusion intraveineuse, la posologie, le mode d\u2019administration et la dur\u00e9e du traitement d\u00e9pendant de l\u2019indication, du poids corporel du patient et de la r\u00e9ponse au traitement. Le traitement est en principe r\u00e9alis\u00e9 dans un centre sp\u00e9cialis\u00e9, mais une auto-injection sous-cutan\u00e9e est possible apr\u00e8s formation adapt\u00e9e du patient. Les informations plus d\u00e9taill\u00e9es sur les modalit\u00e9s de prise en charge et les pr\u00e9cautions figurent dans la notice destin\u00e9e au patient, qui fait partie de l\u2019EPAR.<\/p>\n
Le filgrastim contenu dans Zarzio est une forme recombinante du facteur de croissance des colonies de granulocytes (G-CSF) humain, produite par technologie ADN recombinante \u00e0 partir de bact\u00e9ries modifi\u00e9es. Il agit de la m\u00eame fa\u00e7on que le G-CSF naturel en stimulant la moelle osseuse \u00e0 produire davantage de globules blancs. L\u2019\u00e9valuation scientifique de ce biosimilaire et la formulation des recommandations d\u2019utilisation ont \u00e9t\u00e9 r\u00e9alis\u00e9es par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments. Les \u00e9l\u00e9ments plus techniques sous-tendant ces recommandations figurent dans la discussion scientifique de l\u2019EPAR, destin\u00e9e aux professionnels de sant\u00e9 et aux personnes souhaitant approfondir les bases de l\u2019avis du CHMP. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente l\u2019\u00e9valuation europ\u00e9enne du m\u00e9dicament Zarzio dans le cadre de l\u2019European public assessment report (EPAR). Zarzio est un m\u00e9dicament de type biosimilaire, contenant comme substance active le filgrastim […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21888","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21888","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21888"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21888\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21888"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21888"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21888"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}