\nConform sursei citate, sunt vizate medicamentele Debridat 24 mg\/5 ml granule pentru suspensie oral\u0103 x 125 ml \u015fi Debridat 24 mg\/5 ml granule pentru suspensie oral\u0103 x 250 ml.<\/p>\n
\n\u201eIncidentul a avut loc pe linia de umplere la locul de fabrica\u0163ie din Fran\u0163a. DAPP a luat m\u0103sur\u0103 retragerii din re\u0163eaua de distribu\u0163ie a tuturor seriilor fabricate \u00een perioada scurs\u0103 \u00eentre dou\u0103 verific\u0103ri ale echipamentului de umplere. Cu toate acestea, \u00een urm\u0103 testelor repetate f\u0103cute de produc\u0103tor, s-a ajuns la concluzia c\u0103 probabilitatea c\u0103 un corp str\u0103in metalic s\u0103 ajung\u0103 \u00een flacon este foarte redus\u0103, dar nu poate fi exclus\u0103. \u00cen plus, reconstituirea produsului \u00een concordan\u0163\u0103 cu instruc\u0163iunile din prospectul produsului face detectabil\u0103 prezen\u0163a unui corp metalic \u00een flacon, at\u00e2t auditiv (prin agitarea flaconului dup\u0103 reconstituire), c\u00e2t \u015fi vizual, la umplerea m\u0103surii dozatoare cu suspensia oral\u0103 (pentru form\u0103 de 250 ml), neput\u00e2nd fi extras din flacon la folosirea seringii dozatoare (pentru form\u0103 de 125 ml). De asemenea, produsul reconstituit nu are propriet\u0103\u0163i chimice care s\u0103 poat\u0103 determina degradarea sau coroziunea o\u0163elului inoxidabil\u201d, men\u0163ioneaz\u0103 sursa citat\u0103.<\/p>\n
\n\u00cen acest context, ANM a decis retragerea de la v\u00e2nzare a urm\u0103toarelor serii de medicamente: Debridat 24 mg\/5 ml granule pentru suspensie oral\u0103 x 125 ml seriile: 3830 (exp. 07.2021), 3847 (exp. 09.2021), 3855 (exp. 10.2021), 3862 (exp. 01.2022), 3874 (exp. 04.2022) \u015fi Debridat 24 mg\/5 ml granule pentru suspensie oral\u0103 x 250 ml seriile: 3804 (exp. 04.2021), 3805, 3806, 3807, 3808, 3809, 3810, 3811(exp. 05.2021), 3812, 3813 (exp. 06.2021), 3835(exp. 07.2021), 3836, 3837, 3838, 3839, 3840, 3841, 3842 (exp. 08.2021), 3843, 3849, 3850, (exp. 09.2021), 3864 (exp. 01.2022), 3865, 3868, 3869, 3870 (exp. 02.2022), 3871, 3872, 3873 (exp. 03.2022) 3877 (exp. 04.2022).<\/p>\n
\n\u201eDup\u0103 finalizarea opera\u0163iei de retragere din re\u0163eaua de distribu\u0163ie (depozite \u015fi farmacii), ANMDMR- Direc\u0163ia General\u0103 Inspec\u0163ie Farmaceutic\u0103 va primi documentele care s\u0103 ateste \u00eencheierea acestei opera\u0163ii, cantit\u0103\u0163ile din fiecare serie din produsele men\u0163ionate retrase de la fiecare beneficiar, precum \u015fi dovad\u0103 distrugerii acestora\u201d, conchide sursa citat\u0103.<\/p>\n
\nPotrivit prospectului, Debridat este folosit pentru tratamentul simptomatic al tulbur\u0103rilor func\u0163ionale gastrointestinale \u015fi biliare, \u00een special \u00een cazul durerilor \u015fi crampelor abdominale, spasmelor digestive, excesului de gaze intestinale, diareei \u015fi\/sau constipa\u0163iei.<\/p>\n","protected":false},"excerpt":{"rendered":"
Mai multe serii ale medicamentului Debridat sunt retrase de pe pia\u0163a din Rom\u00e2nia, dup\u0103 ce firma produc\u0103toare a anun\u0163at c\u0103 \u00eentr-un flacon ar putea exista un corp str\u0103in metalic, anun\u0163\u0103, miercuri, Agen\u0163ia Na\u0163ional\u0103 a Medicamentului \u015fi a Dispozitivelor Medicale din Rom\u00e2nia (ANMDMR).<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[510],"tags":[325,45774,32260],"class_list":["post-178297","post","type-post","status-publish","format-standard","hentry","category-actualitate","tag-anm","tag-debridat","tag-medicament"],"_links":{"self":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/178297","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=178297"}],"version-history":[{"count":0,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/178297\/revisions"}],"wp:attachment":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=178297"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=178297"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=178297"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}