{"id":23772,"date":"2023-02-21T07:42:01","date_gmt":"2023-02-21T13:42:01","guid":{"rendered":"https:\/\/www.bbmnoticias.com\/labravaradiofm\/?p=23772"},"modified":"2023-02-21T07:42:02","modified_gmt":"2023-02-21T13:42:02","slug":"alerta-sanitaria-por-revocacion-del-registro-de-paracetamol-solucion-inyectable","status":"publish","type":"post","link":"https:\/\/www.bbmnoticias.com\/labravaradiofm\/2023\/02\/21\/alerta-sanitaria-por-revocacion-del-registro-de-paracetamol-solucion-inyectable\/","title":{"rendered":"Alerta Sanitaria por revocaci\u00f3n del Registro de paracetamol soluci\u00f3n inyectable"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>\n<ul class=\"wp-block-list\">\n<li><em>Piden que no se comercialice, distribuya ni administren el producto AXAPARA a pacientes<\/em><\/li>\n<\/ul>\n\n\n\n<p>Oaxaca de Ju\u00e1rez, Oax., 20 de febrero de 2023.- Los Servicios de Salud de Oaxaca (SSO) y la Comisi\u00f3n Federal para la Protecci\u00f3n Contra Riesgos Sanitarios (Cofepris) alertan a la poblaci\u00f3n en general y a profesionales de la salud, sobre la revocaci\u00f3n del registro sanitario del producto AXAPARA (paracetamol soluci\u00f3n inyectable 1000 mg\/100ml).<\/p>\n\n\n\n<p>Informaron que que durante 2022 fue revocado el registro sanitario No. 104M2019 SSA IV de este producto perteneciente a la raz\u00f3n social Integradora Nacional Cayena S. DE R.L. DE C.V.<\/p>\n\n\n\n<p>La alerta se emite derivado del an\u00e1lisis y la resoluci\u00f3n del proceso administrativo para el farmac\u00e9utico, al identificar irregularidades en piezas del producto, como: cambio de coloraci\u00f3n, presencia de part\u00edculas en la tapa y al interior del producto.<\/p>\n\n\n\n<p>Los resultados anal\u00edticos realizados concluyeron que se encontraba fuera de especificaci\u00f3n para las pruebas de esterilidad y hermeticidad, indicativo de fallas en el sistema contenedor-cierre (producto no herm\u00e9tico).<\/p>\n\n\n\n<p>Adem\u00e1s, a que las caracter\u00edsticas que presenta el envase primario no corresponden con las que fue evaluado y otorgado el Registro Sanitario, por lo que dichas modificaciones no garantizan las caracter\u00edsticas de identidad, pureza, seguridad, eficacia y calidad requeridas para su uso.<\/p>\n\n\n\n<p>Cabe mencionar que, las autoridades sanitarias no fueron notificadas del cambio a las condiciones de dise\u00f1o, desarrollo y validaci\u00f3n del proceso de fabricaci\u00f3n del producto mencionado, por lo que no se cuenta con la evaluaci\u00f3n y autorizaci\u00f3n correspondiente, impactando as\u00ed en la calidad del producto y convirti\u00e9ndolo en un riesgo sanitario para los pacientes a los que se les administre.<\/p>\n\n\n\n<p>Por lo anterior, ning\u00fan lote del producto AXAPARA (paracetamol soluci\u00f3n inyectable 100 mg\/100 mL), debe ser comercializado, distribuido, ni administrarse a pacientes.<\/p>\n\n\n\n<p>En ese sentido, se recomienda: en caso de estar utilizando este producto, suspenderlo y contactar de manera inmediata a su m\u00e9dico tratante.<\/p>\n\n\n\n<p>A las farmacias del Sistema Nacional de Salud P\u00fablico, Privado y distribuidores: en caso de identificar el producto, en cualquier presentaci\u00f3n y n\u00famero de lote, no adquirirlos y en caso de tener existencia en almac\u00e9n, inmovilizarlos y realizar la denuncia sanitaria a trav\u00e9s de la p\u00e1gina https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/denuncias- sanitarias.<\/p>\n\n\n\n<p>De encontrar a la venta el producto antes mencionado, realizar la denuncia sanitaria correspondiente a trav\u00e9s de la p\u00e1gina electr\u00f3nica: https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/denuncias-sanitarias.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Oaxaca de Ju\u00e1rez, Oax., 20 de febrero de 2023.- Los Servicios de Salud de Oaxaca (SSO) y la Comisi\u00f3n Federal para la Protecci\u00f3n Contra Riesgos Sanitarios (Cofepris) alertan a la poblaci\u00f3n en general y a profesionales de la salud, sobre la revocaci\u00f3n del registro sanitario del producto AXAPARA (paracetamol soluci\u00f3n inyectable 1000 mg\/100ml). Informaron que [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":23773,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":{"0":"post-23772","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sin-categoria"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Alerta Sanitaria por revocaci\u00f3n del Registro de paracetamol soluci\u00f3n inyectable - LA BRAVA RADIO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bbmnoticias.com\/labravaradiofm\/2023\/02\/21\/alerta-sanitaria-por-revocacion-del-registro-de-paracetamol-solucion-inyectable\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alerta Sanitaria por revocaci\u00f3n del Registro de paracetamol soluci\u00f3n inyectable - LA BRAVA RADIO\" \/>\n<meta property=\"og:description\" content=\"Oaxaca de Ju\u00e1rez, Oax., 20 de febrero de 2023.- Los Servicios de Salud de Oaxaca (SSO) y la Comisi\u00f3n Federal para la Protecci\u00f3n Contra Riesgos Sanitarios (Cofepris) alertan a la poblaci\u00f3n en general y a profesionales de la salud, sobre la revocaci\u00f3n del registro sanitario del producto AXAPARA (paracetamol soluci\u00f3n inyectable 1000 mg\/100ml). 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