USKORO POČINJE CIJEPLJENJE U HRVATSKOJ: ‘Prve doze stižu 26. prosinca, a idućeg dana počinje kampanja. Moguće su ove nuspojave…’

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‘Prve doze doći će u manjim količinama, bit će to inicijalne količine. Kasnije će dolaziti nove doze’, kazao je ravnatelj Agencije za lijekove i medicinske proizvode Siniša Tomić

Nakon sastanka s premijerom Andrejom Plenkovićem, ravnatelj Hrvatske agencije za lijekove i medicinske proizvode (HALMED) Siniša Tomić izjavio je da je dolazak prvih doza cjepiva planiran 26. prosinca.

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</span> <p>“Sutra je predviđena sjednica Europske agencije za lijekove, odnosno njezina povjerenstva za humane lijekove koja bi trebala donijeti pozitivno mišljenje o cjepivu. Nakon toga slijedi odobrenje Europske komisije koje će vrijediti za sve države članice Europske unije pa tako i za Hrvatsku”, rekao je Tomić dodavši da se ovih dana očekuju detaljnije informacije o lijeku poput uputa za pacijente i sažetka opisa svojstva lijeka za zdravstvene radnike.</p> <div class="responsive-ad-container-v2"> <div id="div-gpt-ad-1645699903930-0" class="div-gpt"> <script> googletag.cmd.push(function() { googletag.display('div-gpt-ad-1645699903930-0'); }); </script> </div> </div> <h3>Uputa o lijeku bit će pisana razumljivim jezikom</h3> <p>Što se tiče doza cjepiva i plana cijepljenja, Tomić je kazao kako je za to nadležan HZJZ. <p>“Sve to bit će definirano Vladinom nacionalnom strategijom o cijepljenju protiv COVID-a. Naš dio je onaj koji se odnosi na odobravanja samog proizvoda”, kazao je ravnatelj HALMED-a.</p> <p>Kazao je kako su sve regulatorne informacije zabilježene u opisu proizvoda.</p> <p>“To su stručne informacije koje sve detaljno opisuju, a namijenjene su zdravstvenim radnicima. To će biti dostupno i u našoj bazi lijekova, kao i na linku Europske komisije. To je temeljni dokument. Uključivat će kontraindikacije, indikacije i nuspojave. Iz toga se radi uputa o lijeku koja je pisana jezikom prilagođenom pacijentu, a koja će sadržavati sve nužne upute potrebne pacijentu”, napomenuo je Tomić.</p> <h3>Prve, manje količine cjepiva stižu 26. prosinca</h3> <p>Prema Tomićevim riječima, dolazak cjepiva predviđen je 26. prosinca.</p><div id="midasWidget__10643"></div><script async src="https://cdn2.midas-network.com/Scripts/midasWidget-11-673-10643.js"></script> <p>“Nakon dobivanja odobrenja potrebno je provesti posebnu provjeru kakvoće koje radi država članica na čijem se teritoriju lijek pušta. HALMED nakon toga mora dati svoju suglasnost. To je postupak uzajamnog priznavanja, ali mi moramo dati nacionalnu suglasnost temeljem važećih dokumenata”, objasnio je.</p> <p>Kampanja cijepljenja započet će odmah nakon što 26. prosinca pristignu prve, manje količine doza cjepiva.</p> <p>“Kampanja je predviđena 27., 28., i 29. prosinca. Cijepljenje će sigurno biti rasprostranjeno, a to ovisi o Vladinoj nacionalnoj strategiji cijepljenja. Prve doze doći će u manjim količinama, bit će to inicijalne količine. Kasnije će dolaziti nove doze”, rekao je Tomić.</p> <h3>Minimum učinkovitosti cjepiva – 95 posto</h3> <p>Tomić jr naglasio da cjepiva moraju zadovoljiti kriterije kakvoće, sigurnosti i djelotvornosti.</p> <p>“To je regulator provjerio u svim postupcima koji su bili detaljni i robusni. Nakon toga se uspostavlja sustav praćenja cjepiva. Efikasnost se gleda kroz klinička ispitivanja i svako cjepivo mora zadovoljiti određene uvjete učinkovitosti. Minimum je oko 95 posto. U svakom slučaju, sva cjepiva koja zadovolje kriterije, a efikasnost nije jedini kriterij, ući će u konačnu ocjenu”, objasnio je Tomić.</p> <p>Što se tiče eventualnih nuspojava, obavijesti o njima primat će HALMED i HZJZ, a usto će međusobno razmjenjivati informacije, kao i s Europskom unijom.</p> <p>“EU ima vrlo rigorozan sustav praćenja, informacije se brzo razmjenjuju, a tu su i baze podataka. Moguće nuspojave su glavobolja, umor, bol na mjestu uboda, povišena temperatura”, naveo je Tomić.</p> <p>Inače, Hrvatska je ukupno naručila 5,7 milijuna doza cjepiva od više proizvođača, a prvo stiže ono Pfizerovo.</p> <p>Danas.hr/Net.hr</p> <div class="responsive-ad-container-v3"> <div id="div-gpt-ad-1645699951870-0" class="div-gpt"> <script> googletag.cmd.push(function() { googletag.display('div-gpt-ad-1645699951870-0'); }); </script> </div> </div> <div class="post-tags"><div><a href="https://riportal.net.hr/tag/agencija-za-lijekove-i-medicinske-proizvode/">Agencija za lijekove i medicinske proizvode</a></div><div><a href="https://riportal.net.hr/tag/cjepivo/">cjepivo</a></div><div><a href="https://riportal.net.hr/tag/halmed/">HALMED</a></div><div><a href="https://riportal.net.hr/tag/ravnatelj/">ravnatelj</a></div><div><a href="https://riportal.net.hr/tag/sinisa-tomic/">Siniša Tomić</a></div></div> <div class="share-meta-container"><div class="article-meta"> <div class="editor"><span><svg xmlns="http://www.w3.org/2000/svg" xml:space="preserve" style="enable-background:new 0 0 640 512" viewBox="0 0 640 512"><path d="M224 256c70.7 0 128-57.3 128-128S294.7 0 224 0 96 57.3 96 128s57.3 128 128 128zm-45.7 48C79.8 304 0 383.8 0 482.3 0 498.7 13.3 512 29.7 512h293.1c-3.1-8.8-3.7-18.4-1.4-27.8l15-60.1c2.8-11.3 8.6-21.5 16.8-29.7l40.3-40.3c-32.1-31-75.7-50.1-123.9-50.1h-91.3zm435.5-68.3c-15.6-15.6-40.9-15.6-56.6 0l-29.4 29.4 71 71 29.4-29.4c15.6-15.6 15.6-40.9 0-56.6l-14.4-14.4zM375.9 417c-4.1 4.1-7 9.2-8.4 14.9l-15 60.1c-1.4 5.5.2 11.2 4.2 15.2s9.7 5.6 15.2 4.2l60.1-15c5.6-1.4 10.8-4.3 14.9-8.4l129.2-129.3-71-71L375.9 417z" class="meta-icon"/></svg></span><a href="https://riportal.net.hr/autor/robert/" title="Objave od: R.Z." rel="author">R.Z.</a></div> <div class="column-date"><span><svg xmlns="http://www.w3.org/2000/svg" xml:space="preserve" style="enable-background:new 0 0 448 512" viewBox="0 0 448 512"><path d="M96 32v32H48C21.5 64 0 85.5 0 112v48h448v-48c0-26.5-21.5-48-48-48h-48V32c0-17.7-14.3-32-32-32s-32 14.3-32 32v32H160V32c0-17.7-14.3-32-32-32S96 14.3 96 32zm352 160H0v272c0 26.5 21.5 48 48 48h352c26.5 0 48-21.5 48-48V192z" class="meta-icon"/></svg></span>20.12.2020.</div> <div class="column-time"><span><svg xmlns="http://www.w3.org/2000/svg" xml:space="preserve" style="enable-background:new 0 0 512 512" viewBox="0 0 512 512"><path d="M256 512C114.6 512 0 397.4 0 256S114.6 0 256 0s256 114.6 256 256-114.6 256-256 256zm-24-392v136c0 8 4 15.5 10.7 20l96 64c11 7.4 25.9 4.4 33.3-6.7s4.4-25.9-6.7-33.3L280 243.2V120c0-13.3-10.7-24-24-24s-24 10.7-24 24z" class="meta-icon"/></svg></span>19:07</div> </div> <div class="share-buttons"> <div class="facebook"><a onclick="window.open('https://www.facebook.com/sharer.php?u=https://riportal.net.hr/vijesti/uskoro-pocinje-cijepljenje-u-hrvatskoj-prve-doze-stizu-26-prosinca-a-iduceg-dana-pocinje-kampanja-moguce-su-ove-nuspojave/214698/','Facebook','width=600,height=300,left='+(screen.availWidth/2-300)+',top='+(screen.availHeight/2-150)+''); return false;" href="http://www.facebook.com/sharer.php?u=https://riportal.net.hr/vijesti/uskoro-pocinje-cijepljenje-u-hrvatskoj-prve-doze-stizu-26-prosinca-a-iduceg-dana-pocinje-kampanja-moguce-su-ove-nuspojave/214698/" title="Podijeli na Facebooku"></a></div> <div class="twitter"><a target="_blank" href="https://twitter.com/intent/tweet?text=Trenutno čitam USKORO POČINJE CIJEPLJENJE U HRVATSKOJ: ‘Prve doze stižu 26. prosinca, a idućeg dana počinje kampanja. 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