{"id":6770,"date":"2019-04-09T15:24:15","date_gmt":"2019-04-09T08:24:15","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=6770"},"modified":"2019-04-11T15:31:37","modified_gmt":"2019-04-11T08:31:37","slug":"thu-hoi-lo-san-pham-pw00369-cua-vien-nen-bao-phim-losartan-accord-50mg-tai-phap","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/thu-hoi-lo-san-pham-pw00369-cua-vien-nen-bao-phim-losartan-accord-50mg-tai-phap\/","title":{"rendered":"Thu h\u1ed3i l\u00f4 s\u1ea3n ph\u1ea9m PW00369 c\u1ee7a vi\u00ean n\u00e9n bao phim Losartan Accord 50mg t\u1ea1i Ph\u00e1p"},"content":{"rendered":"<h2>ANSM (Ph\u00e1p) th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c thu h\u1ed3i l\u00f4 s\u1ea3n ph\u1ea9m PW00369 c\u1ee7a vi\u00ean n\u00e9n bao phim Losartan Accord 50mg t\u1ea1i Ph\u00e1p<\/h2>\n<p>\u0110\u00e2y l\u00e0 h\u1ec7 qu\u1ea3 c\u1ee7a c\u00e1c cu\u1ed9c \u0111i\u1ec1u tra \u0111ang di\u1ec5n ra t\u1ea1i Ph\u00e1p \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 sai s\u00f3t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng c\u00e1c <strong>sartans.<\/strong> ANSM \u0111\u00e3 \u0111\u01b0\u1ee3c C\u00f4ng ty Accord th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c ph\u00e1t hi\u1ec7n t\u1ea1p ch\u1ea5t N-Nitroso-N-methyl-4-aminobutyric acid (vi\u1ebft t\u1eaft NMBA) trong c\u00e1c s\u1ea3n ph\u1ea9m m\u00e0 c\u00f4ng ty n\u00e0y ph\u00e2n ph\u1ed1i, t\u1ea1p ch\u1ea5t n\u00e0y ch\u01b0a bao gi\u1edd \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n trong c\u00e1c l\u00f4 sartans \u0111ang \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i Ph\u00e1p tr\u01b0\u1edbc \u0111\u00f3.<\/p>\n<p>\u0110\u00e2y l\u00e0 h\u1ec7 qu\u1ea3 c\u1ee7a c\u00e1c cu\u1ed9c \u0111i\u1ec1u tra \u0111ang di\u1ec5n ra t\u1ea1i Ph\u00e1p \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 sai s\u00f3t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng c\u00e1c sartans. ANSM \u0111\u00e3 \u0111\u01b0\u1ee3c C\u00f4ng ty Accord th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c ph\u00e1t hi\u1ec7n t\u1ea1p ch\u1ea5t N-Nitroso-N-methyl-4-aminobutyric acid (vi\u1ebft t\u1eaft NMBA) trong c\u00e1c s\u1ea3n ph\u1ea9m m\u00e0 c\u00f4ng ty n\u00e0y ph\u00e2n ph\u1ed1i, t\u1ea1p ch\u1ea5t n\u00e0y ch\u01b0a bao gi\u1edd \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n trong c\u00e1c l\u00f4 sartans \u0111ang \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i Ph\u00e1p tr\u01b0\u1edbc \u0111\u00f3.<\/p>\n<p>Do ph\u00e1t hi\u1ec7n t\u1ea1p ch\u1ea5t, l\u00f4 vi\u00ean n\u00e9n bao phim Losartan Accord 50mg (m\u00e3 PW00369)\u0111\u00e3 b\u1ecb thu h\u1ed3i. C\u00e1c lo\u1ea1i thu\u1ed1c kh\u00e1c ch\u1ee9a losartan c\u00f3 th\u1ec3 ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng.<\/p>\n<p>K\u1ec3 t\u1eeb th\u00e1ng 7 n\u0103m 2018, c\u00e1c x\u00e9t nghi\u1ec7m tr\u00ean c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 ngu\u1ed3n g\u1ed1c sartans cho th\u1ea5y s\u1ef1 xu\u1ea5t hi\u1ec7n t\u1eadp ch\u1ea5t c\u1ee7a nh\u00f3m nitrosamins cao h\u01a1n gi\u1edbi h\u1ea1n cho ph\u00e9p c\u1ee7a c\u01a1 quan y t\u1ebf, c\u00e1c \u0111\u1ee3t thu h\u1ed3i \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n t\u1ea1i m\u1ed9t s\u1ed1 qu\u1ed1c gia v\u00e0 v\u00f9ng l\u00e3nh th\u1ed5 trong \u0111\u00f3 c\u00f3 ch\u00e2u \u00c2u v\u00e0 Hoa K\u1ef3.<\/p>\n<p>ANSM nh\u1ea5n m\u1ea1nh r\u1eb1ng ch\u1ec9 c\u00f3 l\u00f4 PW00369 c\u00f3 li\u00ean quan c\u1ee7a t\u1ea1p ch\u1ea5t NMBA c\u00f3 ngu\u1ed3n g\u1ed1c nitrosamin. Trong th\u1ef1c t\u1ebf, nhi\u1ec1u l\u00f4 losartan kh\u00e1c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng c\u00f3 quy tr\u00ecnh s\u1ea3n xu\u1ea5t kh\u00e1c nhau n\u00ean m\u1ee9c \u0111\u1ed9 nhi\u1ec5m t\u1ea1p ch\u1ea5t c\u0169ng kh\u00e1c nhau. Do \u0111\u00f3, b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng c\u00e1c lo\u1ea1i thu\u1ed1c losartan kh\u00e1c c\u00f3 th\u1ec3 ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng ch\u00fang.<\/p>\n<p>ANSM nh\u1eafc nh\u1edf r\u1eb1ng t\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1edfi sartans kh\u00f4ng n\u00ean ng\u1eebng \u0111i\u1ec1u tr\u1ecb m\u00e0 kh\u00f4ng c\u1ea7n \u00fd ki\u1ebfn b\u00e1c s\u0129. Nguy c\u01a1 \u0111\u1ed1i v\u1edbi s\u1ee9c kh\u1ecfe khi ng\u1eebng \u0111\u1ed9t ng\u1ed9t c\u00e1c thu\u1ed1c nh\u00f3m sartans c\u00f3 th\u1ec3 l\u00e0 t\u0103ng huy\u1ebft \u00e1p, m\u1ea5t b\u00f9 tim v\u00e0 tai n\u1ea1n li\u00ean quan \u0111\u1ebfn th\u1ea7n kinh.<\/p>\n<p>N\u1ebfu c\u1ea7n thi\u1ebft, c\u00e1c sartans kh\u00e1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi v\u1edbi c\u00e1c thu\u1ed1c h\u1ea1 huy\u1ebft \u00e1p kh\u00e1c (thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n, thu\u1ed1c l\u1ee3i ti\u1ec3u, thu\u1ed1c ch\u1eb9n k\u00eanh canxi, ch\u1eb9n k\u00eanh beta, v.v).<\/p>\n<p>H\u00e0ng th\u00e1ng, ANSM c\u1eadp nh\u1eadt tr\u00ean trang web c\u1ee7a m\u00ecnh nh\u1eefng th\u00f4ng tin li\u00ean quan \u0111\u1ebfn d\u1ef1 b\u00e1o nhu c\u1ea7u c\u1ee7a valsartan v\u00e0 c\u00e1c sartans kh\u00e1c t\u1ea1i Ph\u00e1p.<\/p>\n<p>T\u00f3m t\u1eaft l\u1ea1i m\u1ed9t s\u1ed1 ho\u1ea1t \u0111\u1ed9ng \u0111\u01b0\u1ee3c ANSM \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n t\u1eeb m\u00f9a h\u00e8 n\u0103m 2018 \u0111\u1ec3 ki\u1ec3m so\u00e1t c\u00e1c thu\u1ed1c nh\u00f3m sartan b\u1ecb nhi\u1ec5m t\u1ea1p ch\u1ea5t:<\/p>\n<p>Ph\u00e2n t\u00edch c\u00e1c thu\u1ed1c c\u00f3 ngu\u1ed3n g\u1ed1c sartans l\u01b0u h\u00e0nh t\u1ea1i Ph\u00e1p v\u00e0 c\u00f3 c\u1ea5u tr\u00fac h\u00f3a h\u1ecdc (nh\u00e2n tetrazol) c\u00f3 kh\u1ea3 n\u0103ng t\u1ed5ng h\u1ee3p d\u1eabn \u0111\u1ebfn s\u1ef1 h\u00ecnh th\u00e0nh c\u00e1c t\u1ea1p ch\u1ea5t: valsartan, irbesartan, candesartan, losartan v\u00e0 olmesartan.<br \/>\nTh\u00f4ng b\u00e1o th\u01b0\u1eddng xuy\u00ean cho c\u00e1c chuy\u00ean gia y t\u1ebf v\u00e0 b\u1ec7nh nh\u00e2n c\u00f3 li\u00ean quan v\u1ec1 c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u00e3 th\u1ef1c hi\u1ec7n.<br \/>\nGi\u00e1m s\u00e1t c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t, ph\u00e2n ph\u1ed1i v\u00e0 ti\u1ebfp th\u1ecb sartans ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m thay th\u1ebf \u0111\u1ec3 \u0111\u00e1p \u1ee9ng \u0111\u1ee7 nhu c\u1ea7u c\u1ee7a b\u1ec7nh nh\u00e2n t\u1ea1i Ph\u00e1p.<br \/>\nANSM s\u1ebd ti\u1ebfp t\u1ee5c th\u00f4ng b\u00e1o cho b\u1ec7nh nh\u00e2n v\u00e0 c\u00e1c chuy\u00ean gia ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe khi c\u00f3 nh\u1eefng d\u1eef li\u1ec7u c\u1eadp nh\u1eadt.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/ansm.sante.fr\/S-informer\/Actualite\/Rappel-d-un-lot-de-Losartan-Accord-50-mg-comprime-pellicule-secable-lot-PW00369-Point-d-information\" rel=\"noopener\">https:\/\/ansm.sante.fr\/S-informer\/Actualite\/Rappel-d-un-lot-de-Losartan-Accord-50-mg-comprime-pellicule-secable-lot-PW00369-Point-d-information<\/a><\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: V\u0169 \u0110\u1ee9c Ho\u00e0n \u2013 Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay<\/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>ANSM (Ph\u00e1p) th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c thu h\u1ed3i l\u00f4 s\u1ea3n ph\u1ea9m PW00369 c\u1ee7a vi\u00ean n\u00e9n bao phim Losartan Accord 50mg t\u1ea1i Ph\u00e1p \u0110\u00e2y l\u00e0 h\u1ec7 qu\u1ea3 c\u1ee7a c\u00e1c cu\u1ed9c \u0111i\u1ec1u tra \u0111ang di\u1ec5n ra t\u1ea1i Ph\u00e1p \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 sai s\u00f3t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng c\u00e1c sartans. ANSM \u0111\u00e3 \u0111\u01b0\u1ee3c C\u00f4ng ty Accord th\u00f4ng b\u00e1o v\u1ec1 [&#8230;]\n","protected":false},"author":1,"featured_media":6771,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6770","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\/6770","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=6770"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/6770\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/6771"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=6770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=6770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=6770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}