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[title] => Britanski regulator izdao upozorenje o anafilaksiji na Pfizerovo cjepivo: Svi koji su imali povijest značajnih alergijskih reakcija neka ga ne uzimaju
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Britanski regulator za lijekove priopćio je da se svatko tko je imao anafilaksiju na lijek ili hranu ne smije cijepiti Pfizer/BioNTechovim cjepivom za covid-19, dajući potpunije smjernice vezano za ranije upozorenje o alergiji na cjepivo.
Počevši od starijih osoba i radnika na prvim linijama obrane protiv koronavirusa, Velika Britanija u utorak je započela masovno cijepljenje stanovništva, kao dio globalnog pokreta koji predstavlja jedan od najvećih logističkih izazova u mirnodopskoj povijesti.
Regulatorna agencija za lijekove i zdravstvene proizvode (MHRA) priopćila je da postoje dva izvještaja o anafilaksiji i jedno o mogućoj alergijskoj reakciji od početka uvođenja cijepljenja.
"Svaka osoba koja ima povijest anafilaksije na cjepivo, lijek ili hranu ne bi smjela primiti Pfizer/BioNTechovo cjepivo", priopćila je izvršna direktorica MHRA-e June Raine.
Dodala je da većina ljudi neće imati anafilaksiju te da koristi zaštite ljudi od covida-19 nadilaze rizike.
"Možete biti potpuno sigurni da je ovo cjepivo zadovoljilo MHRA-ine robusne standarde sigurnosti, kvalitete i učinkovitosti", poručila je Raine.
Raine je istaknula kako takve alergijske reakcije nisu bile dio Pfizerovih kliničkih ispitivanja. Međutim, alergijske reakcije možda je uzrokovala komponenta Pfizerovog cjepiva nazvana polietilen glikol ili PEG, koja pomaže stabilizirati cjepivo, a nije u drugim vrstama cjepiva.
Anafilaksija je pretjerana reakcija imunološkog sustava, a Nacionalna zdravstvena služba opisuje ju kao ozbiljnu reakciju i ponekad opasnu po život.
Potpunije smjernice koje pojašnjavaju da glavni rizik predstavlja konkretno anafilaksa, izdane su nakon savjetovanja sa stručnjacima za alergije. MHRA je u početku savjetovala svima koji su imali povijest "značajnih alergijskih reakcija" da ne uzimaju to cjepivo.
Pfizer i BioNTech rekli su da podržavaju istragu MHRA-e.
Prošli tjedan, britanska MHRA prva je na svijetu odobrila cjepivo koje su razvili njemački BioNTech i Pfizer, dok američka Uprava za hranu i lijekove (FDA) i Europska agencija za lijekove (EMA) nastavljaju s analizom podataka.
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Britanski regulator za lijekove priopćio je da se svatko tko je imao anafilaksiju na lijek ili hranu ne smije cijepiti Pfizer/BioNTechovim cjepivom za covid-19, dajući potpunije smjernice vezano za ranije upozorenje o alergiji na cjepivo.
Počevši od starijih osoba i radnika na prvim linijama obrane protiv koronavirusa, Velika Britanija u utorak je započela masovno cijepljenje stanovništva, kao dio globalnog pokreta koji predstavlja jedan od najvećih logističkih izazova u mirnodopskoj povijesti.
Regulatorna agencija za lijekove i zdravstvene proizvode (MHRA) priopćila je da postoje dva izvještaja o anafilaksiji i jedno o mogućoj alergijskoj reakciji od početka uvođenja cijepljenja.
"Svaka osoba koja ima povijest anafilaksije na cjepivo, lijek ili hranu ne bi smjela primiti Pfizer/BioNTechovo cjepivo", priopćila je izvršna direktorica MHRA-e June Raine.
Dodala je da većina ljudi neće imati anafilaksiju te da koristi zaštite ljudi od covida-19 nadilaze rizike.
"Možete biti potpuno sigurni da je ovo cjepivo zadovoljilo MHRA-ine robusne standarde sigurnosti, kvalitete i učinkovitosti", poručila je Raine.
Raine je istaknula kako takve alergijske reakcije nisu bile dio Pfizerovih kliničkih ispitivanja. Međutim, alergijske reakcije možda je uzrokovala komponenta Pfizerovog cjepiva nazvana polietilen glikol ili PEG, koja pomaže stabilizirati cjepivo, a nije u drugim vrstama cjepiva.
Anafilaksija je pretjerana reakcija imunološkog sustava, a Nacionalna zdravstvena služba opisuje ju kao ozbiljnu reakciju i ponekad opasnu po život.
Potpunije smjernice koje pojašnjavaju da glavni rizik predstavlja konkretno anafilaksa, izdane su nakon savjetovanja sa stručnjacima za alergije. MHRA je u početku savjetovala svima koji su imali povijest "značajnih alergijskih reakcija" da ne uzimaju to cjepivo.
Pfizer i BioNTech rekli su da podržavaju istragu MHRA-e.
Prošli tjedan, britanska MHRA prva je na svijetu odobrila cjepivo koje su razvili njemački BioNTech i Pfizer, dok američka Uprava za hranu i lijekove (FDA) i Europska agencija za lijekove (EMA) nastavljaju s analizom podataka.
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Frank Augstein
A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London, on December 8, 2020. - Britain on December 8 hailed a turning point in the fight against the coronavirus pandemic, as it begins the biggest vaccination programme in the country's history with a new Covid-19 jab. (Photo by Frank Augstein/POOL/AFP)
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13. svibanj 2024 09:29
