{"id":2770,"date":"2018-07-13T14:59:28","date_gmt":"2018-07-13T14:59:28","guid":{"rendered":"https:\/\/malmed.gov.mk\/?p=2770"},"modified":"2018-07-17T13:01:53","modified_gmt":"2018-07-17T13:01:53","slug":"%d0%b8%d0%b7%d0%b2%d0%b5%d1%81%d1%82%d1%83%d0%b2%d0%b0%d1%9a%d0%b5-%d0%b7%d0%b0-%d0%b1%d0%b5%d0%b7%d0%b1%d0%b5%d0%b4%d0%bd%d0%be%d1%81%d0%bd%d0%b0-%d0%b8%d0%bd%d1%84%d0%be%d1%80%d0%bc%d0%b0%d1%86","status":"publish","type":"post","link":"https:\/\/malmed.gov.mk\/sq\/%d0%b8%d0%b7%d0%b2%d0%b5%d1%81%d1%82%d1%83%d0%b2%d0%b0%d1%9a%d0%b5-%d0%b7%d0%b0-%d0%b1%d0%b5%d0%b7%d0%b1%d0%b5%d0%b4%d0%bd%d0%be%d1%81%d0%bd%d0%b0-%d0%b8%d0%bd%d1%84%d0%be%d1%80%d0%bc%d0%b0%d1%86\/","title":{"rendered":"Njoftim p\u00ebr informacion t\u00eb sigurt t\u00eb barnave t\u00eb cilat p\u00ebrmbajn\u00eb valsartan si substanc\u00eb aktive prej serive individuale t\u00eb barit t\u00eb kontaminuar me N-nitrosodimetilamin (NDMA)"},"content":{"rendered":"

M\u00eb 5 korrik t\u00eb vitit 2018 Agjencia Evropiane e Barnave (EMA) ka rishikuar barnat t\u00eb cilat n\u00eb p\u00ebrb\u00ebrje kan\u00eb substanc\u00eb aktive valsartan, q\u00eb \u00ebsht\u00eb prodhuar n\u00eb kompanin\u00eb Zhejiang Huahai Pharmaceuticals , Linhai, Kin\u00eb. Revizioni \u00ebsht\u00eb nxitur pasi q\u00eb kompania ka zbuluar ndotje me N-nitrosodimetilamin (NDMA) t\u00eb substanc\u00ebs aktive valsartan, me t\u00eb cil\u00ebn kompania i furnizon disa nga prodhuesit e barnave q\u00eb p\u00ebrmbajn\u00eb substanc\u00eb aktive valsartan, nd\u00ebrsa jan\u00eb t\u00eb pranishme n\u00eb Bashkimin Europian.<\/p>\n

 <\/p>\n

N\u00eb baz\u00eb t\u00eb rezultateve t\u00eb testeve laboratorike, NDMA \u00ebsht\u00eb klasifikuar si kancerogjen i mundsh\u00ebm njer\u00ebzor (substanc\u00eb q\u00eb mund t\u00eb shkaktoj\u00eb kancer). Prania e NDMA-s\u00eb ishte e papritur dhe vler\u00ebsohet se ka lidhje me ndryshimin e m\u00ebnyr\u00ebs s\u00eb prodhimit t\u00eb substanc\u00ebs aktive.<\/p>\n

P\u00ebrderisa revizioni \u00ebsht\u00eb n\u00eb vijim, autoritetet nacionale n\u00eb BE t\u00ebrheqin barnat q\u00eb p\u00ebrmbajn\u00eb valsartan, substanc\u00eb aktive e s\u00eb cil\u00ebs \u00ebsht\u00eb e prodhuar nga Zhejiang Huahai Pharmaceuticals, Linhai, Kin\u00eb.<\/p>\n

 <\/p>\n

N\u00eb k\u00ebt\u00eb drejtim, Agjencia e Barnave dhe e Pajisjeve Mjek\u00ebsore njofton se barnat t\u00eb cilat p\u00ebrmbajn\u00eb valsartan si substanc\u00eb aktive, q\u00eb \u00ebsh\u00eb prodhuar nga kompania Zhejiang Huahai Pharmaceuticals, Linhai, Kin\u00eb, <\/strong>Republik\u00ebn e Maqedonis\u00eb<\/strong> jan\u00eb regjistruar n\u00eb format dhe doza farmaceutike nga poseduesit n\u00eb vijim:<\/p>\n

 <\/p>\n

    \n
  1. Lek \u2013Shkup Lek sh.i. SHPKNJP Lubljana<\/strong><\/li>\n<\/ol>\n

    \u2013 ANGINORM \u2013 LEK 40 mg tablet\u00eb e veshur me film<\/p>\n

    \u2013 ANGINORM \u2013 LEK 80 mg tablet\u00eb e veshur me film<\/p>\n

    \u2013 ANGINORM \u2013 LEK 160 mg tablet\u00eb e veshur me film<\/p>\n

     <\/p>\n

      \n
    1. SANOVEL ILA\u00c7 SANAJI VE TIXHARET ANONIM SHIRKETI, P\u00ebrfaq\u00ebsia<\/strong> Shkup<\/strong><\/li>\n<\/ol>\n

      \u2013 CARDOPAN SANOVEL 80 mg tablet\u00eb e veshur me film<\/p>\n

      \u2013 CARDOPAN SANOVEL 160 mg tablet\u00eb e veshur me film<\/p>\n

      \u2013 CARDOPAN SANOVEL 320 mg tablet\u00eb e veshur me film<\/p>\n

       <\/p>\n

        \n
      1. P\u00ebrfaq\u00ebsia BOSNJALEK D.D.<\/strong><\/li>\n<\/ol>\n

        -TENVAL 80 mg tablet\u00eb e veshur me film<\/p>\n

        -TENVAL 160 mg tablet\u00eb e veshur me film<\/p>\n

        -TENVAL DUO 80mg\/12,5 mg tablet\u00eb e veshur me film<\/p>\n

        -TENVAL DUO 160mg\/12,5 mg tablet\u00eb e veshur me film<\/p>\n

        \u00a0<\/strong><\/p>\n

          \n
        1. PLIVA SHPK-SHKUP<\/strong><\/li>\n<\/ol>\n

          \u2013 VALTENSIN tablet\u00eb e veshur me film 40 mg<\/p>\n

          \u2013 VALTENSIN tablet\u00eb e veshur me film 80 mg<\/p>\n

          \u2013 VALTENSIN tablet\u00eb e veshur me film 160 mg<\/p>\n

          \u2013 VALTENSIN PLUS tablet\u00eb e veshur me film 160mg\/12,5 mg<\/p>\n

          \u2013 VALTENSIN PLUS tablet\u00eb e veshur me film 80mg\/12,5 mg<\/p>\n

          \u2013 VALTENSIN PLUS tablet\u00eb e veshur me film 160mg\/25 mg<\/p>\n

           <\/p>\n

          P\u00ebr momentin n\u00eb bot\u00eb rekomandohet t\u00ebrheqja e t\u00eb gjitha serive t\u00eb barnave t\u00eb cilat p\u00ebrmbajn\u00eb valsartan si substanc\u00eb aktive q\u00eb \u00ebsht\u00eb e prodhuar nga kompania Zhejiang Huahai Pharmaceuticals, Linhai, Kin\u00eb.<\/p>\n

          N\u00eb pajtim me at\u00eb q\u00eb u p\u00ebrmend m\u00eb lart, Komisioni i Siguris\u00eb dhe i Shpalljeve n\u00eb Agjencin\u00eb e Barnave dhe t\u00eb Pajisjeve Mjek\u00ebsore miratoi konkluzion q\u00eb barnat e lartp\u00ebrmendura t\u00eb t\u00ebrhiqen nga qarkullimi p\u00ebr shkaqe sigurie.<\/p>\n

           <\/p>\n

          MALMED-i me kujdes do t\u00eb v\u00ebzhgoj\u00eb t\u00eb gjitha masat e nd\u00ebrmarra dhe procesin e zbatimit t\u00eb aktiviteteve t\u00eb propozuara parandaluese.<\/p>\n

           <\/p>\n

          Nj\u00ebkoh\u00ebsisht Ju informojm\u00eb se n\u00eb Republik\u00ebn e Maqedonis\u00eb jan\u00eb regjistruar edhe barna t\u00eb tjera t\u00eb cilat n\u00eb p\u00ebrb\u00ebrjen e tyre p\u00ebrmbajn\u00eb substanc\u00eb aktive valsartan, q\u00eb nuk \u00ebsht\u00eb prodhuar nga kompania Zhejiang Huahai Pharmaceuticals, Linhai, Kin\u00eb dhe t\u00eb njejtat jan\u00eb t\u00eb pranishme n\u00eb tregun e Republik\u00ebs s\u00eb Maqedonis\u00eb. <\/strong>Republik\u00ebn e Maqedonis\u00eb jan\u00eb regjistruar edhe barna t\u00eb tjera <\/strong>t\u00eb cilat n\u00eb p\u00ebrb\u00ebrjen e tyre p\u00ebrmbajn\u00eb substanc\u00eb aktive valsartan<\/strong> q\u00eb nuk \u00ebsht\u00eb prodhuar nga kompania Zhejiang Huahai Pharmaceuticals, Linhai, Kin\u00eb<\/strong>dhe<\/strong> \u0438 <\/strong>t\u00eb njejtat <\/strong>jan\u00eb t\u00eb pranishme n\u00eb tregun e Republik\u00ebs s\u00eb Maqedonis\u00eb.<\/strong><\/p>\n

          N\u00eb shtojc\u00eb Ju dor\u00ebzojm\u00eb dokumentin e p\u00ebrkthyer t\u00eb shpallur n\u00eb ueb faqen e Agjencis\u00eb Evropiane t\u00eb Barnave (EMA), t\u00eb cilin mund ta shkarkoni k\u00ebtu<\/a>.<\/strong><\/span><\/p>\n

           <\/p>\n

           <\/p>\n

           <\/p>","protected":false},"excerpt":{"rendered":"

          \u041d\u0430 05 \u0458\u0443\u043b\u0438 2018 \u0433\u043e\u0434\u0438\u043d\u0430 \u0415\u0432\u0440\u043e\u043f\u0441\u043a\u0430\u0442\u0430 \u0410\u0433\u0435\u043d\u0446\u0438\u0458\u0430 \u0437\u0430 \u043b\u0435\u043a\u043e\u0432\u0438 (EMA) \u0433\u0438 \u0440\u0435\u0432\u0438\u0434\u0438\u0440\u0430 \u043b\u0435\u043a\u043e\u0432\u0438\u0442\u0435 \u043a\u043e\u0438 \u0432\u043e \u0441\u0432\u043e\u0458\u043e\u0442 \u0441\u043e\u0441\u0442\u0430\u0432 \u0441\u043e\u0434\u0440\u0436\u0430\u0442 \u0430\u043a\u0442\u0438\u0432\u043d\u0430 \u0441\u0443\u043f\u0441\u0442\u0430\u043d\u0446\u0438\u0458\u0430 \u0432\u0430\u043b\u0441\u0430\u0440\u0442\u0430\u043d, \u043a\u043e\u0458\u0430 \u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u0435\u0434\u0435\u043d\u0430 \u043e\u0434 \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0458\u0430\u0442\u0430 Zhejiang Huahai Pharmaceuticals, \u041b\u0438\u043d\u0445\u0430\u0438, \u041a\u0438\u043d\u0430. \u0420\u0435\u0432\u0438\u0437\u0438\u0458\u0430\u0442\u0430\u00a0 \u0435 \u043f\u043e\u0442\u0442\u0438\u043a\u043d\u0430\u0442\u0430 \u043e\u0442\u043a\u0430\u043a\u043e \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0458\u0430\u0442\u0430 \u0433\u043e \u043e\u0442\u043a\u0440\u0438\u043b\u0430 \u043e\u043d\u0435\u0447\u0438\u0441\u0442\u0443\u0432\u0430\u045a\u0435\u0442\u043e \u0441\u043e N-\u043d\u0438\u0442\u0440\u043e\u0441\u043e\u0434\u0438\u043c\u0435\u0442\u0438\u043b\u0430\u043c\u0438\u043d (NDMA) \u0432\u043e \u0430\u043a\u0442\u0438\u0432\u043d\u0430\u0442\u0430 \u0441\u0443\u043f\u0441\u0442\u0430\u043d\u0446\u0438\u0458\u0430 \u0432\u0430\u043b\u0441\u0430\u0440\u0442\u0430\u043d, \u0441\u043e \u043a\u043e\u0458\u0430 \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0458\u0430\u0442\u0430 \u0433\u0438 \u0441\u043d\u0430\u0431\u0434\u0443\u0432\u0430\u00a0 \u043d\u0435\u043a\u043e\u0438 \u043e\u0434 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u0438\u0442\u0435 \u043d\u0430 […]<\/p>","protected":false},"author":2,"featured_media":1503,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[44,42,16,10],"tags":[],"class_list":["post-2770","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nositeli","category-pacienti","category-16","category-10"],"_links":{"self":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/2770","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/comments?post=2770"}],"version-history":[{"count":0,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/2770\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/media\/1503"}],"wp:attachment":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/media?parent=2770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/categories?post=2770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/tags?post=2770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}