I-Neffy (i-epinephrine nasal spray) ivunyiwe yi- FDA kunyango olungxamisekileyo lwe-Type I reactions allergic reactions kubandakanya ubomi obusongela i-anaphylaxis. Oku kunika enye indlela yokulawula i-epinephrine kwabo (ingakumbi abantwana) abachasayo kwiinaliti kwaye bajongene nemeko esongela ubomi ye-anaphylaxis.
I-Epinephrine lolona nyango lusindisa ubomi lwe-anaphylaxis. Ifumaneka ukuza kuthi ga ngoku kuphela njengoko inaliti idla ngokusetyenziswa nge-intramuscular (IM) okanye nge-intravenous (IV) indlela. I-Neffy yimveliso yokuqala ye-epinephrine yonyango lwe-anaphylaxis engalawulwa ngenaliti.
Ukuvunywa kwesitshizi seempumlo kusekelwe kwiziphumo ezivela kwizifundo. Iindlela ezimbini ezizezi. Isitshizi seempumlo kunye nesitofu zibonise ugxininiso lwegazi lwe-epinephrine oluthelekisekayo olulandela ulawulo. Baphinde babonise ukunyuka okufanayo kwixinzelelo lwegazi kunye nesantya senhliziyo eziziphumo ezimbini ezibalulekileyo ze-epinephrine kunyango lwe-anaphylaxis.
I-Neffy sisitshizi seempumlo esinye sedosi esifakwe kwimpumlo enye. Idosi yesibini (ukusebenzisa isitshizi seempumlo esitsha kwimpumlo enye) inokunikwa ukuba akukho phuculo kwiimpawu okanye iimpawu eziya ziba mandundu. Izigulane zinokufuna uncedo lwezonyango olungxamisekileyo ukuze zibekwe iliso elisondeleyo.
Izithintelo ziimeko ezithile zempumlo, njengeepolyps zeempumlo okanye imbali yotyando lweempumlo olunokuthi luchaphazele ukufunxa, iimeko ezithile ezihlala zihleli kunye nokungaguquki komzimba okuhambelana nesulfite. Izigulane ezineemeko kufuneka ziqhagamshelane neengcali zempilo ukuba ziqwalasele ukusetyenziswa kwemveliso ye-epinephrine etofwayo. Iziphumo ebezingalindelekanga eziqhelekileyo ziquka ukurhawuzelelwa komqala, impumlo etshovayo (intranasal paresthesia), intloko ebuhlungu, ukungakhululeki kwempumlo, ukuziva jittery, ukurhawuzelela (paresthesia), ukudinwa, ukungcangcazela, impumlo ebalekayo (rhinorrhea), ukurhawuzelelwa ngaphakathi kwempumlo (impumlo yempumlo), ukuthimla, isisu. intlungu, intsini (gingival) intlungu, ukuba ndindisholo emlonyeni (hypoesthesia oral), ukuxinana kweempumlo, isiyezi, isicaphucaphu kunye nokugabha.
Ukunyanga Iimpendulo ziintshukumo ezingaqhelekanga zokhuselo lomzimba womntu kwinto eqhele ukubanga zimpawu.
I-Anaphylaxis ithathwa njengengxakeko yonyango. Sisenzo esiyingozi, esisongela ubomi esibandakanya amalungu amaninzi omzimba. Ukutya okuthile, amayeza kunye nokuluma kwezinambuzane zizinto eziqhelekileyo ezinokuthi zibangele i-anaphylaxis. Iimpawu zidla ngokuvela kwimizuzu nje yokuvezwa kwaye zibandakanya, kodwa azikhawulelwanga, ukudumba, ukurhawuzelelwa, ukugabha, ukuphefumla nzima kunye nokulahlekelwa zingqondo.
I-FDA inike imvume ye-Neffy kwi-ARS Pharmaceuticals.
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Iingxelo:
- I-FDA Yamkele Isitshizi sokuQala seempumlo kuNyango lwe-Anaphylaxis. Ithunyelwe nge-09 Agasti 2024. Iyafumaneka e https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis
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