{"id":3675,"date":"2020-01-21T23:02:33","date_gmt":"2020-01-21T23:02:33","guid":{"rendered":"https:\/\/malmed.gov.mk\/?p=3675"},"modified":"2020-01-21T23:02:34","modified_gmt":"2020-01-21T23:02:34","slug":"%d0%b4%d0%b5%d1%84%d0%b8%d0%bd%d0%b8%d1%86%d0%b8%d0%b8","status":"publish","type":"post","link":"https:\/\/malmed.gov.mk\/sq\/%d0%b4%d0%b5%d1%84%d0%b8%d0%bd%d0%b8%d1%86%d0%b8%d0%b8\/","title":{"rendered":"Definicionet"},"content":{"rendered":"<p><strong>Farmakovigjilenca&nbsp;<\/strong>p\u00ebrfaq\u00ebson shkenc\u00eb dhe p\u00ebrmbledhje t\u00eb aktiviteteve q\u00eb lidhen me zbulimin, vler\u00ebsimin, kuptimin, parandalimin dhe trajtimin n\u00eb rast t\u00eb reaksioneve t\u00eb pad\u00ebshiruara prej barnave si dhe informacione t\u00eb reja p\u00ebr rreziqet prej p\u00ebrdorimit t\u00eb barnave.<\/p>\n\n\n\n<p><strong>Farmakovigjilenca e vaksinave<\/strong>&nbsp;\u00ebsht\u00eb shkenc\u00eb dhe t\u00ebr\u00ebsi e aktiviteteve q\u00eb lidhen me zbulimin, vler\u00ebsimin, kuptimin dhe komunikimin n\u00eb rast t\u00eb ngjarjeve t\u00eb paq\u00ebllimshme q\u00eb ndodhin pas imunizimit dhe \u00e7\u00ebshtje t\u00eb tjera t\u00eb lidhura me vaksinat ose imunizimin, dhe parandalimin e reaksioneve t\u00eb pad\u00ebshiruara  nga vaksinat ose imunizimet, (CIOMS-WHO16).<\/p>\n\n\n\n<p><strong>Ngjarje e pad\u00ebshiruar&nbsp;<\/strong><strong>(Adverse Event)&nbsp;<\/strong>\u00ebsht\u00eb paraqitje e pad\u00ebshiruar, siptom\u00eb ose s\u00ebmundje ((p\u00ebrfshir\u00eb devijimin n\u00eb testet laboratorike) t\u00eb cilat lidhen p\u00ebrkoh\u00ebsisht me p\u00ebrdorimin e barnave dhe p\u00ebr t\u00eb cilat lidhja shkak-pasoj\u00eb me p\u00ebrdorimin e barnave nuk ka pse t\u00eb v\u00ebrtetohet<\/p>\n\n\n\n<p><strong>Ngjarje serioze e pad\u00ebshiruar&nbsp;<\/strong><strong>(Serious Adverse Event SAE)&nbsp;<\/strong>\u00ebsht\u00eb \u00e7do ngjarje e papritur q\u00eb si pasoj\u00eb sjell vdekjen, k\u00ebrc\u00ebnim p\u00ebr jet\u00ebn, mbajtja e pacientit n\u00eb spital ose vazhdimi i q\u00ebndrimit n\u00eb spital, i p\u00ebrhersh\u00ebm dhe \/ ose t\u00eb meta \/ t\u00eb meta t\u00eb konsiderueshme ose anomali kongjenitale \/ defekt kongjenital q\u00eb shoq\u00ebrohet p\u00ebrkoh\u00ebsisht me p\u00ebrdorimin e barnave dhe p\u00ebr t\u00eb cilin lidhja shkak-pasoj\u00eb me p\u00ebrdorimin e barnave nuk ka pse t\u00eb v\u00ebrtetohet.<\/p>\n\n\n\n<p><strong>Reaksioni i pad\u00ebshiruar&nbsp;<\/strong>i barnave \u00ebsht\u00eb \u00e7do reaksion i pad\u00ebshiruar dhe i d\u00ebmsh\u00ebm ndaj barnave q\u00eb shfaqen gjat\u00eb p\u00ebrdorimit t\u00eb tij.<\/p>\n\n\n\n<p><strong>Papritur reaksion i pad\u00ebshiruar<\/strong><strong>Unexpected Adverse Reaction)&nbsp;<\/strong>\u00ebsht\u00eb \u00e7do reaksion i papritur dhe i pad\u00ebshiruar, natyra e t\u00eb cilit, pesha dhe rezultati nuk \u00ebsht\u00eb n\u00eb p\u00ebrputhje me raportin p\u00ebrmblbedh\u00ebs t\u00eb vetive t\u00eb barnave ose nuk \u00ebsht\u00eb p\u00ebrshkruar n\u00eb broshur\u00ebn e ekzeminuesit.<\/p>\n\n\n\n<p><strong>Reaksion serioz i pad\u00ebshiruar&nbsp;<\/strong><strong>(Serious Adverse Reaction SAR)&nbsp;<\/strong>\u00ebsht\u00eb \u00e7do ngjarje e papritur q\u00eb si pasoj\u00eb sjell vdekjen, k\u00ebrc\u00ebnim p\u00ebr jet\u00ebn, mbajtja e pacientit n\u00eb spital ose vazhdimi i q\u00ebndrimit n\u00eb spital, i p\u00ebrhersh\u00ebm ose e met\u00eb dometh\u00ebn\u00ebse \/paaft\u00ebsia ose anomali kongjenitale \/e met\u00eb e  lindur.<\/p>\n\n\n\n<p><strong>P\u00ebrdorimi i paautorizuar i barnave (Off<\/strong><strong>-label use)<\/strong>&nbsp;\u00ebsht\u00eb p\u00ebrdorimi i q\u00ebllimsh\u00ebm i barnave p\u00ebr q\u00ebllime mjek\u00ebsore i cili nuk \u00ebsht\u00eb n\u00eb p\u00ebrputhje me SmPc dhe PIL t\u00eb aprovuar p\u00ebr barnat n\u00eb Republik\u00ebn e Maqedonis\u00eb s\u00eb Veriut, P\u00ebrdorimi i paautorizuar i barnave p\u00ebrfshin gjithashtu p\u00ebrdorimin e tyre n\u00eb kategori pediatrike t\u00eb papranuara.<\/p>\n\n\n\n<p><strong>Fjalori mjek\u00ebsor p\u00ebr aktivitetet rregullatore (Medical Dictionary for Regulatory Activities, MedDRA)&nbsp;<\/strong>\u00ebsht\u00eb terminologji mjek\u00ebsore nd\u00ebrkomb\u00ebtare e vlefshme klinike e p\u00ebrdorur nga autoritetet rregullatore dhe industria biofarmaceutike.<\/p>\n\n\n\n<p>Terminologjia zbatohet gjat\u00eb gjith\u00eb procesit rregullator, p\u00ebrpara dhe pas miratimit p\u00ebr p\u00ebrdorimin e barnave n\u00eb qarkullim si dhe m\u00ebnyr\u00ebn e thjesht\u00eb t\u00eb futjes s\u00eb t\u00eb dh\u00ebnave, \nk\u00ebrkimin, analiz\u00ebn dhe shfaqjen.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>\u0424\u0430\u0440\u043c\u0430\u043a\u043e\u0432\u0438\u0433\u0438\u043b\u0430\u043d\u0446\u0430&nbsp;\u0435 \u043d\u0430\u0443\u043a\u0430 \u0438 \u0437\u0431\u0438\u0440 \u043d\u0430 \u0430\u043a\u0442\u0438\u0432\u043d\u043e\u0441\u0442\u0438 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[&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3675","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/3675","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=3675"}],"version-history":[{"count":0,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/3675\/revisions"}],"wp:attachment":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/media?parent=3675"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/categories?post=3675"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/tags?post=3675"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}