Agenția Europeană pentru Medicamente (EMA) și Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR), compania AstraZeneca AB dorește să vă informeze următoarele
- COVID-19 Vaccine AstraZeneca: beneficiile depășesc riscurile, cu toate că o posibilă legătură cu cazuri foarte rare de cheaguri sanguine asociate cu număr scăzut de trombocite nu poate fi exclusă.
- După vaccinarea cu COVID-19 Vaccine AstraZeneca, a fost observată foarte rar, o asociere de tromboză cu trombocitopenie, în unele cazuri însoțite de sângerare.
- Profesioniștii din domeniul sănătății trebuie să fie atenți la semnele și simptomele tromboembolismului și ale
- Persoanele vaccinate trebuie instruite să solicite asistență medicală imediată în cazul în care, după vaccinare, prezintă simptome precum: dificultăți de respirație, dureri toracice, tumefiere la nivelul membrelor inferioare, dureri abdominale persistente. De asemenea, orice persoană care, după vaccinare, prezintă simptome neurologice, inclusiv cefalee severă sau persistentă sau vedere încețoșată, sau care prezintă echimoze (peteșii) în afara locului de administrare a vaccinului după câteva zile, trebuie să solicite imediat asistență medicală.
Informaţii suplimentare referitoare la problema de siguranţă
COVID-19 Vaccine AstraZeneca este indicat pentru imunizarea activă a persoanelor cu vârsta de 18 ani și peste, pentru prevenirea COVID 19 cauzată de SARS-CoV-2.
Au fost raportate cazuri de evenimente tromboembolice după administrarea COVID-19 Vaccine AstraZeneca în mai multe țări din Spațiul Economic European, unele ducând la suspendarea locală a unor loturi specifice sau a utilizării vaccinului în sine.
O asociere de tromboză cu trombocitopenie, în unele cazuri însoțită de sângerare, a fost observată foarte rar după vaccinarea cu COVID-19 Vaccine AstraZeneca. Aceasta include cazuri severe care se prezintă cu tromboză venoasă, inclusiv cu localizări neobișnuite, cum ar fi tromboza de sinus venos cerebral, tromboza de venă mezenterică, precum și tromboză arterială, concomitent cu trombocitopenie. Majoritatea acestor cazuri au apărut în primele șapte până la paisprezece zile de la vaccinare, la femei cu vârsta sub 55 de ani, însă acest lucru poate reflecta utilizarea crescută a vaccinului la această populație. Unele cazuri au avut evoluție fatală.
Pe baza acestor evenimente, Comitetul EMA pentru evaluarea riscurilor în materie de farmacovigilență (Pharmacovigilance Risk Assessment Committee – PRAC) a declanșat procedura de evaluare a semnalului de siguranță, pentru a analiza în continuare această situație.
Comitetul PRAC a efectuat o evaluare completă în cadrul unui calendar accelerat, incluzând o revizuire atentă a rapoartelor de reacții adverse din EudraVigilance, rapoarte referitoare la apariția de cheaguri de sânge și trombocitopenie, la persoane care au primit vaccinul, acordând o atenție specială informațiilor privind sexul, vârsta, factorii de risc, diagnosticul de COVID- 19 (dacă a fost disponibil), intervalul de timp până la debutul reacției adverse, finalitatea reacției adverse și starea clinică.
Investigația a inclus, de asemenea, o evaluare a datelor relevante din literatură, precum și o analiză a datelor observate și așteptate, analiză condusă pe baza rapoartelor de caz din EudraVigilance [și anume, prin includerea următorilor termeni preferați în limba engleză (Preferred Terms): tromboză de sinus venos (cerebral) – (cerebral) venous sinus thrombosis, coagulare intravasculară diseminată – disseminated intravascular coagulation și purpură trombotică trombocitopenică – thrombotic thrombocytopenic purpura].
În timp ce sunt colectate dovezi suplimentare, comitetul PRAC a recomandat o actualizare a informațiilor despre produs referitoare la vaccinul COVID-19 Vaccine AstraZeneca suspensie injectabilă, pentru a reflecta cunoștințele actuale privind această problemă de siguranță.
Apel la raportarea reacțiilor adverse
Este important să raportaţi orice reacţie adversă suspectată, asociată cu administrarea vaccinului COVID-19 Vaccine AstraZeneca către Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale din România, în conformitate cu sistemul naţional de raportare spontană, utilizând sistemul online (https://covid19.anm.ro) disponibil pe pagina web a Agenţiei Naţionale a Medicamentului şi a Dispozitivelor Medicale din România (www.anm.ro). www.anm.ro
Raportare online la adresa: https://covid19.anm.ro
E-mail: [email protected]
Totodată, reacțiile adverse suspectate se pot raporta și către reprezentanța locală a deţinătorului autorizaţiei de punere pe piaţă, la următoarele date de contact:
AstraZeneca România
Adresă: Str. Menuetului, Nr. 12, Bucharest Business Park, , clădirea D, etaj 1, Sector 1, Bucuresti, România
Telefon: +4 021 317 60 41
Fax: +4 021 317 60 53
Nr. Telefon dedicat COVID-19 Vaccine AstraZeneca: 031 630 03 18
Website dedicat COVID-19 Vaccine AstraZeneca: https://www.azcovid-19.com
Pentru a avea sub control trasabilitatea medicamentelor biologice, numele și numărul lotului medicamentului administrat trebuie înregistrate cu atenție.
Vaccinul COVID-19 Vaccine AstraZeneca face obiectul unei monitorizări suplimentare. Acest lucru va permite identificarea rapidă de noi informații referitoare la siguranță.
Sursa :A gentia Nationala a Medicamentului si a Dispozitivelor Medicale
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