Namuhla, i Ukuphathwa Kwezokudla Nezidakamizwa e-US (FDA) ikhiphe isigunyazo sokusebenzisa izimo eziphuthumayo (i-EUA) ye PfizerI-Paxlovid (amaphilisi e-nirmatrelvir kanye namaphilisi e-ritonavir, ahlanganiswe ukuze asetshenziswe ngomlomo) ukuze ekwelaphe isifo se-coronavirus (COVID-19) kubantu abadala nasezigulini zezingane (ezineminyaka eyi-12 nangaphezulu ezinesisindo esingamakhilogremu angama-40 okungenani. noma cishe amaphawundi angama-88) anemiphumela emihle yokuhlolwa okuqondile kwe-SARS-CoV-2, futhi abasengozini enkulu yokudlulela ku-COVID-19 enzima, okuhlanganisa ukulaliswa esibhedlela noma ukufa.
I-Paxlovid itholakala ngencwadi kadokotela kuphela futhi kufanele iqalwe ngokushesha ngangokunokwenzeka ngemva kokuxilongwa kwe-COVID-19 futhi zingakapheli izinsuku ezinhlanu izimpawu ziqale.
"Ukugunyazwa kwanamuhla kwethula ukwelashwa kokuqala kwe-COVID-19 okuyindlela yephilisi eliphuzwa ngomlomo - okuyisinyathelo esikhulu ekulweni nalolu bhubhane lomhlaba wonke," kusho uPatrizia Cavazzoni, MD, umqondisi wenhlangano. FDA's Center for Drug Evaluation and Research. "Lesi sigunyazo sihlinzeka ngethuluzi elisha lokulwa ne-COVID-19 ngesikhathi esibalulekile kulolu bhubhane njengoba kuvela izinhlobo ezintsha futhi sithembisa ukwenza ukwelashwa ngezidambisigciwane kufinyeleleke kalula ezigulini ezisengozini enkulu yokudlulela ku-COVID-19 enzima."
PfizerI-Paxlovid ka-Paxlovid ayigunyaziwe ekuvimbeleni ukuchayeka ngaphambi kwesikhathi noma ekuvimbeleni ukuchayeka ngemva kwe-COVID-19 noma ukuqalisa ukwelashwa kulabo abadinga ukulaliswa esibhedlela ngenxa ye-COVID-19 enzima noma ebucayi. I-Paxlovid ayithathi indawo yokugoma kubantu okunconyelwe ukugonyelwa i-COVID-19 kanye nethamo elikhuthazayo. I-FDA igunyaze umuthi wokugoma owodwa futhi yagunyaza eminye ukuthi ivimbele i-COVID-19 kanye nemiphumela yomtholampilo ebucayi ehlobene nokutheleleka nge-COVID-19, okuhlanganisa ukulaliswa esibhedlela nokufa. I FDA inxusa umphakathi ukuthi ugonywe futhi uthole i-booster uma kufanele.
I-Paxlovid iqukethe i-nirmatrelvir, evimbela iphrotheni yakwa-SARS-CoV-2 ukumisa leli gciwane ukuthi lingaziphindaphinda, kanye ne-ritonavir, ebambezela ukuwohloka kwe-nirmatrelvir ukuyisiza ukuthi ihlale emzimbeni isikhathi eside ezindaweni eziphakeme. I-Paxlovid isetshenziswa njengamaphilisi amathathu (amaphilisi amabili e-nirmatrelvir nephilisi elilodwa le-ritonavir) athathwe ndawonye ngomlomo kabili ngosuku izinsuku ezinhlanu, ingqikithi yamaphilisi angama-30. I-Paxlovid ayigunyaziwe ukuthi isetshenziswe isikhathi esingaphezu kwezinsuku ezinhlanu zilandelana.
