{"id":4118,"date":"2019-03-09T21:52:53","date_gmt":"2019-03-09T14:52:53","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4118"},"modified":"2019-03-09T21:52:53","modified_gmt":"2019-03-09T14:52:53","slug":"ema-cac-khuyen-cao-noi-bat-tu-prac-thang-3-2018-lien-quan-den-zinbryta-daclizumab-beta-xofigo-abiraterone-acetate-va-lay-y-kien-cong-khai-ve-cac-khang-sinh-quinolone-va-fluoroquinolone","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/ema-cac-khuyen-cao-noi-bat-tu-prac-thang-3-2018-lien-quan-den-zinbryta-daclizumab-beta-xofigo-abiraterone-acetate-va-lay-y-kien-cong-khai-ve-cac-khang-sinh-quinolone-va-fluoroquinolone\/","title":{"rendered":"EMA: C\u00e1c khuy\u1ebfn c\u00e1o n\u1ed5i b\u1eadt t\u1eeb PRAC th\u00e1ng 3\/2018 li\u00ean quan \u0111\u1ebfn Zinbryta (daclizumab beta), Xofigo (abiraterone acetate) v\u00e0 l\u1ea5y \u00fd ki\u1ebfn c\u00f4ng khai v\u1ec1 c\u00e1c kh\u00e1ng sinh quinolone v\u00e0 fluoroquinolone"},"content":{"rendered":"<h2>L\u1eadp t\u1ee9c ng\u1eebng l\u01b0u h\u00e0nh v\u00e0 thu h\u1ed3i thu\u1ed1c \u0111i\u1ec1u tr\u1ecb x\u01a1 c\u1ee9ng \u0111a \u1ed5 Zinbryta<\/h2>\n<p>V\u00e0o ng\u00e0y 02\/03, PRAC \u0111\u00e3 ti\u1ebfn h\u00e0nh t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u kh\u1ea9n c\u1ea5p v\u1ec1 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb x\u01a1 c\u1ee9ng \u0111a \u1ed5 Zinbryta (daclizumab beta). Trong bu\u1ed5i h\u1ecdp tu\u1ea7n qua, U\u1ef7 ban n\u00e0y \u0111\u00e3 khuy\u1ebfn c\u00e1o l\u1eadp t\u1ee9c ng\u1eebng l\u01b0u h\u00e0nh v\u00e0 thu h\u1ed3i thu\u1ed1c n\u00f3i tr\u00ean, sau khi c\u00f3 12 b\u00e1o c\u00e1o tr\u00ean to\u00e0n c\u1ea7u v\u1ec1 t\u1ed5n th\u01b0\u01a1ng vi\u00eam \u1edf n\u00e3o nghi\u00eam tr\u1ecdng, trong \u0111\u00f3 c\u00f3 vi\u00eam n\u00e3o v\u00e0 vi\u00eam n\u00e3o &#8211; m\u00e0ng n\u00e3o.<br \/>\nKhuy\u1ebfn c\u00e1o n\u00e0y \u0111ang \u0111\u01b0\u1ee3c g\u1eedi t\u1edbi U\u1ef7 ban ch\u00e2u \u00c2u \u0111\u1ec3 \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh qui ph\u1ea1m ph\u00e1p l\u00ed cu\u1ed1i c\u00f9ng. Song song v\u1edbi \u0111\u00f3, C\u01a1 quan qu\u1ea3n l\u00ed d\u01b0\u1ee3c ch\u00e2u \u00c2u s\u1ebd ti\u1ebfp t\u1ee5c t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u chuy\u00ean s\u00e2u v\u00e0 c\u00f4ng b\u1ed1 k\u1ebft qu\u1ea3 cu\u1ed1i c\u00f9ng.<\/p>\n<p>Xem th\u00eam th\u00f4ng tin t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/zinbryta\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/zinbryta<\/a><\/p>\n<h2>Khuy\u1ebfn c\u00e1o ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh d\u00e0nh cho thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0 ti\u1ec1n li\u1ec7t tuy\u1ebfn Xofigo<\/h2>\n<p>Trong bu\u1ed5i h\u1ecdp th\u00e1ng 3, \u1ee6y ban \u0111\u00e1nh gi\u00e1 nguy c\u01a1 c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c (PRAC) \u0111\u00e3 \u0111\u01b0a ra khuy\u1ebfn c\u00e1o ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0 ti\u1ec1n li\u1ec7t tuy\u1ebfn Xofigo (radium-223 dichloride) c\u00f9ng v\u1edbi Zytiga (abiraterone acetate) v\u00e0 prednisone\/prednisolone, t\u1eeb c\u00e1c k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng s\u01a1 b\u1ed9 cho th\u1ea5y gia t\u0103ng nguy c\u01a1 t\u1eed vong v\u00e0 g\u00e3y x\u01b0\u01a1ng khi s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p c\u00e1c thu\u1ed1c tr\u00ean.<br \/>\nKhuy\u1ebfn c\u00e1o n\u00e0y \u0111ang \u0111\u01b0\u1ee3c g\u1eedi t\u1edbi U\u1ef7 ban ch\u00e2u \u00c2u \u0111\u1ec3 c\u00f3 quy\u1ebft \u0111\u1ecbnh qui ph\u1ea1m ph\u00e1p l\u00ed cu\u1ed1i c\u00f9ng. \u0110\u00e2y l\u00e0 bi\u1ec7n ph\u00e1p t\u1ea1m th\u1eddi trong th\u1eddi gian ch\u1edd ho\u00e0n thi\u1ec7n t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u chuy\u00ean s\u00e2u v\u1ec1 l\u1ee3i \u00edch v\u00e0 nguy c\u01a1 c\u1ee7a Xofigo.<\/p>\n<p>Xem th\u00eam th\u00f4ng tin t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/xofigo\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/xofigo<\/a><\/p>\n<h2>T\u1ed5 ch\u1ee9c thu th\u1eadp \u00fd ki\u1ebfn c\u00f4ng khai v\u1ec1 c\u00e1c kh\u00e1ng sinh quinolone v\u00e0 fluoroquinolone<\/h2>\n<p>PRAC \u0111\u00e3 quy\u1ebft \u0111\u1ecbnh t\u1ed5 ch\u1ee9c thu th\u1eadp \u00fd ki\u1ebfn c\u00f4ng khai nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a vi\u1ec7c t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u v\u1ec1 c\u00e1c kh\u00e1ng sinh quinolone v\u00e0 fluoroquinolone, \u0111\u1ec3 tr\u1ef1c ti\u1ebfp l\u1eafng nghe kinh nghi\u1ec7m c\u1ee7a c\u00e1c b\u00ean c\u00f3 li\u00ean quan t\u1edbi c\u00e1c thu\u1ed1c n\u00e0y, t\u1eeb \u0111\u00f3 xem x\u00e9t \u0111\u01b0a v\u00e0o khuy\u1ebfn c\u00e1o c\u1ee7a U\u1ef7 ban.<\/p>\n<p>V\u00e0o th\u00e1ng 12\/2017, PRAC \u0111\u00e3 b\u1eaft \u0111\u1ea7u t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u v\u1ec1 c\u00e1c kh\u00e1ng sinh quinolone v\u00e0 fluoroquinolone \u0111\u01b0\u1eddng u\u1ed1ng, ti\u00eam v\u00e0 h\u00edt nh\u1eb1m \u0111\u00e1nh gi\u00e1 m\u1ee9c \u0111\u1ed9 dai d\u1eb3ng c\u1ee7a c\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n nghi\u00eam tr\u1ecdng \u1ea3nh h\u01b0\u1edfng ch\u1ee7 y\u1ebfu tr\u00ean c\u01a1, kh\u1edbp v\u00e0 h\u1ec7 th\u1ea7n kinh, m\u1ed9t s\u1ed1 t\u00e1c d\u1ee5ng trong s\u1ed1 n\u00e0y c\u00f3 th\u1ec3 k\u00e9o d\u00e0i. Trong qu\u00e1 tr\u00ecnh t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u, EMA nh\u1eadn th\u1ea5y c\u1ed9ng \u0111\u1ed3ng ng\u00e0y c\u00e0ng quan t\u00e2m \u0111\u1ebfn t\u00ednh an to\u00e0n c\u1ee7a c\u00e1c thu\u1ed1c n\u00e0y. PRAC \u0111\u00e3 xem x\u00e9t m\u1ed1i quan t\u00e2m n\u00f3i tr\u00ean v\u00e0 cho r\u1eb1ng s\u1ebd c\u00f3 \u00edch khi t\u1ed5 ch\u1ee9c thu th\u1eadp \u00fd ki\u1ebfn \u0111\u1ec3 th\u1ea5u hi\u1ec3u h\u01a1n quan \u0111i\u1ec3m c\u1ee7a c\u1ed9ng \u0111\u1ed3ng v\u1ec1 nguy c\u01a1 \u0111i k\u00e8m c\u00e1c kh\u00e1ng sinh quinolone v\u00e0 t\u00ednh kh\u1ea3 thi c\u1ee7a m\u1ed9t s\u1ed1 bi\u1ec7n ph\u00e1p nh\u1eb1m t\u1ed1i \u01b0u h\u00f3a vi\u1ec7c s\u1eed d\u1ee5ng an to\u00e0n c\u00e1c kh\u00e1ng sinh n\u00e0y.<\/p>\n<p>Vi\u1ec7c thu th\u1eadp \u00fd ki\u1ebfn c\u00f4ng khai s\u1ebd \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh trong l\u1ea7n h\u1ecdp v\u00e0o th\u00e1ng 06\/2018 c\u1ee7a \u1ee6y ban. Th\u00f4ng tin th\u00eam v\u1ec1 vi\u1ec7c l\u1ea5y \u00fd ki\u1ebfn, bao g\u1ed3m t\u00f3m t\u1eaft c\u00e1c m\u1ed1i quan t\u00e2m v\u1ec1 an to\u00e0n, danh m\u1ee5c c\u00e2u h\u1ecfi c\u1ee5 th\u1ec3 cho c\u00e1c th\u00f4ng tin \u0111i\u1ec1u tra trong c\u1ed9ng \u0111\u1ed3ng, c\u0169ng nh\u01b0 c\u00e1c th\u00f4ng tin h\u1eefu d\u1ee5ng v\u1ec1 c\u00e1ch th\u1ee9c tham gia v\u00e0 m\u1eabu \u0111\u0103ng k\u00ed l\u1ea5y \u00fd ki\u1ebfn s\u1ebd s\u1edbm \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i tr\u00ean trang web c\u1ee7a EMA.<\/p>\n<p>\u0110\u00e2y l\u00e0 l\u1ea7n th\u1ee9 hai PRAC t\u1ed5 ch\u1ee9c l\u1ea5y \u00fd ki\u1ebfn c\u00f4ng khai trong qu\u00e1 tr\u00ecnh t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u v\u1ec1 thu\u1ed1c, sau l\u1ea7n \u0111\u1ea7u \u0111\u01b0\u1ee3c t\u1ed5 ch\u1ee9c v\u00e0o th\u00e1ng 09\/2017 \u0111\u1ec3 th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u li\u00ean quan \u0111\u1ebfn valproate &#8211; thu\u1ed1c d\u00f9ng trong \u0111i\u1ec1u tr\u1ecb \u0111\u1ed9ng kinh, r\u1ed1i lo\u1ea1n c\u1ea3m x\u00fac l\u01b0\u1ee1ng c\u1ef1c v\u00e0 \u0111au n\u1eeda \u0111\u1ea7u.<\/p>\n<p>Ngu\u1ed3n:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-march-2018\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-march-2018<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u1eadp t\u1ee9c ng\u1eebng l\u01b0u h\u00e0nh v\u00e0 thu h\u1ed3i thu\u1ed1c \u0111i\u1ec1u tr\u1ecb x\u01a1 c\u1ee9ng \u0111a \u1ed5 Zinbryta V\u00e0o ng\u00e0y 02\/03, PRAC \u0111\u00e3 ti\u1ebfn h\u00e0nh t\u1ed5ng h\u1ee3p d\u1eef li\u1ec7u kh\u1ea9n c\u1ea5p v\u1ec1 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb x\u01a1 c\u1ee9ng \u0111a \u1ed5 Zinbryta (daclizumab beta). Trong bu\u1ed5i h\u1ecdp tu\u1ea7n qua, U\u1ef7 ban n\u00e0y \u0111\u00e3 khuy\u1ebfn c\u00e1o l\u1eadp t\u1ee9c ng\u1eebng l\u01b0u [&#8230;]\n","protected":false},"author":1,"featured_media":4123,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4118","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4118","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=4118"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4118\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4123"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}