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FDA ivomereza mtundu woyamba wa Proventil HFA

FDA ivomereza mtundu woyamba wa Proventil HFANkhani

US Food and Drug Administration (FDA) inavomereza Cipla Limited kuti ipange mtundu woyamba wa Proventil HFA ( albuterol sulphate inhaler-dose inhaler, 90 mcg / inhalation.





Merck, wopanga ProAir, adatulutsa ProAir yovomerezeka mu Epulo 2019, yoperekedwa ndikugawidwa kudzera mwa imodzi Endo Mayiko makampani ogwira ntchito, Par Pharmaceuticals. Mtundu watsopanowu ndiye mtundu woyamba wamapangidwe oyamba, osapangidwa ndi Merck. Kutanthauza, ikuwonjezera mpikisano watsopano kumsika, womwe uyenera kuthandiza kutsika mtengo.



Kodi Proventil generic ndi chiyani?

Mtundu wa inhaler, womwe nthawi zina umatchedwa kuti inhaler, umapangidwa kuti ugwiritsidwe ntchito popewa kapena kuchiza bronchospasm mwa anthu azaka 4 kapena kupitilira apo omwe ali ndi matenda obwezeretsa m'mlengalenga. Ikhoza kugwiritsidwanso ntchito popewera bronchospasm yochita zolimbitsa thupi. Pafupifupi anthu 25 miliyoni , kuphatikiza ana pafupifupi 7 miliyoni, ku United States ali ndi mphumu, malinga ndi Centers for Disease Control and Prevention (CDC).

ProAir HFA (albuterol inhaler) ndi Proventil HFA (albuterol inhaler) ndi ena mwa ma albuterol sulphate omwe amagwiritsidwa ntchito mwachidule pamsika. Ena ndi awa Ventolin HFA (albuterol inhaler) ndi AccuNeb (albuterol nebulizer solution).

Kodi zotsatira zoyipa za Proventil HFA generic ndi ziti?

Zotsatira zoyipa kwambiri zamankhwala amtunduwu ndi monga rhinitis, nseru, kusanza, kugunda kwamtima mwachangu, kunjenjemera, mantha, komanso matenda am'mapapo am'mapapo, malinga ndi FDA.



Ubwino wa Proventil HFA generic

Chivomerezochi chimabwera patangotha ​​milungu ingapo FDA itavomereza mtundu wina wa albuterol inhaler. A FDA adavomereza kampani ya Perrigo Pharmaceutical kuti ayambe kupanga generic yoyamba ya ProAir HFA (albuterol sulphate) inhalation aerosol kumapeto kwa February .

Nthawi zambiri, kutulutsidwa kwa mtundu wina wa albuterol ndi nkhani yabwino kwa anthu omwe amafunikira mankhwala amtunduwu, malinga ndi zomwe ananena Aller Meadows, MD, Purezidenti wa American College of Allergy, Asthma and Immunology (ACAAI).

Zimakulitsa kupezeka ndikuchepetsa mtengo kwa ena, modzichepetsa, akutero Dr. Meadows.



Nthawi yowonjezera

Malinga ndi Commissioner wa FDA a Stephen M. Hahn, MD, pakadali pano kufunika kwa mtundu uwu wazogulitsa.

A FDA azindikira kuchuluka kwakufunika kwa mankhwala a albuterol munthawi ya mliri wa coronavirus, a Dr. Hahn adatero mu mawu kulengeza zavomerezo pa Epulo 8. Tili odzipereka kwambiri pakuwathandiza kupeza mwayi wazachipatala kuti zithandizire kuthana ndi zosowa zazikulu za anthu aku America.

Masabata angapo apitawa, ACAAI idatulutsa chikalata chovomereza kuchepa kwa ma inhalers a albuterol m'malo ena mdziko muno, chifukwa chakuchulukirachulukira kwa ogwiritsira ntchito inhalers kwa odwala omwe ali mchipatala. Matenda a COVID-19 . Zipatala zina zimachepetsa kugwiritsa ntchito ma nebulizers chifukwa chodandaula kuti amatha kufalitsa kachilomboka mumlengalenga.



Koma ACAAI idakumbutsa anthu kuti asachite mantha komanso kuti asadandaule za kuchuluka, popeza canister imodzi ya albuterol imayenera kukhala miyezi ingapo. Malinga ndi Dr. Meadows, inhaler imodzi yopulumutsa iyenera kukhala miyezi isanu ndi umodzi mpaka 18. Ngati mukugwiritsa ntchito chipulumutso chanu msanga, mwina simukhala kuwongolera mphumu yanu zokwanira. Zikatero, mungafunikire kukambirana ndi omwe amakuthandizani kuti musinthe kapena kusintha mankhwala omwe mukumwa.

Komabe, anthu ena amakhalabe ndi nkhawa zakusowa kwa ma albuterol yopulumutsa inhalers, chifukwa chake nkhani yina ya mankhwala otchedwa albuterol yomwe ikugunda pamsika ikhoza kuwalimbikitsa, atero Dr. Meadows.



Tiyenera kukhala ndi zambiri-osadandaula, akutero.

Kodi Proventil generic ipezeka liti?

Pakadali pano, sizikudziwika bwinobwino kuti generic yatsopanoyo idzafika pati kumsika wa U.S. Mawu omwe Cipra adatulutsa pa Epulo 9 adati, Tikukonzekera kutumiza modzidzimutsa. Tikuwonetsetsanso kuti tichita gawo lathu popereka mankhwalawa munthawi yofunikira.