Nuhou Uea

ʻO Symbicort generic hou mua i ʻae ʻia e US FDA

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I kēia lā, ua ʻae ka US Food and Drug Administration i ka generic mua o Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol no ka mālama ʻana i ʻelua mau kūlana olakino maʻamau: hānō i nā maʻi ʻeono makahiki a ʻoi aku; a me ka mālama mālama ʻana i ke keakea o ka ea a me ka hoʻohaʻahaʻa ʻana i nā exacerbations no nā poʻe maʻi me ka maʻi obstructive pulmonary maʻi (COPD), me ka bronchitis mau a me / a i ʻole emphysema. ʻAʻole pono e hoʻohana ʻia kēia huahana hui pū ʻana o ka lāʻau lapaʻau maʻamau, ʻo ia ka mea inhaler me ka mika, no ka mālama ʻana i nā hōʻeha hānō.

"ʻO ka ʻae ʻana o kēia lā i ka generic mua no kekahi o nā huahana hui pū ʻana o nā lāʻau lapaʻau paʻakikī i kuhikuhi ʻia e mālama i ka hānō a me COPD kahi hana ʻē aʻe i mua o kā mākou kūpaʻa e lawe i nā kope generic o nā lāʻau paʻakikī i ka mākeke, hiki ke hoʻomaikaʻi i ka maikaʻi o ke ola. kōkua i ka hōʻemi ʻana i ke kumukūʻai o ka mālama ʻana, "wahi a Sally Choe, Ph.D., ka luna o ka Office of Generic Drugs ma ka FDA Center for Drug Evaluation and Research. "Ke hōʻike nei kēia i ka hoʻomau ʻana o ka FDA e hoʻonui i ka hoʻokūkū a me ka loaʻa ʻana o nā lāʻau lapaʻau maikaʻi, palekana, kūpono a kūpono hoʻi no nā maʻi a me nā mea kūʻai."

Hoʻopilikia ka Asthma i 25 miliona mau kānaka, ʻoi aku ma mua o ʻelima miliona o lākou he mau keiki, ʻoiai ʻo COPD e hoʻopilikia ai ma mua o 16 miliona, e like me ka National Heart, Lung, and Blood Institute. ʻO ka hānō he maʻi maʻi lōʻihi e pili ana i nā ea i loko o ka māmā, hiki ke hoʻonui ʻia e ka hoʻoikaika kino a hoʻomaka pinepine i ka wā kamaliʻi. Hiki iā ia ke hoʻoulu i ka uwē (he kani hāwī i ka hanu ʻana), pōkole o ka hanu, a me ka ʻaʻa. ʻO COPD, ʻo ia hoʻi ka emphysema a me ka maʻi bronchitis mau, he maʻi lōʻihi ia e hoʻopiʻi ai i ka ea a paʻakikī ke hanu.

ʻO kēia huahana hoʻohui lāʻau-lāʻau he mea inhaler metered-dose (MDI), i loaʻa nā budesonide (he corticosteroid e hoʻemi ana i ka mumū) a me ka formoterol (he bronchodilator hana lōʻihi e hoʻomaha ai i nā ʻiʻo o nā alaloa e hoʻomaikaʻi ai i ka hanu). ʻElua inhalations, ʻelua manawa i ka lā (ʻo ke kakahiaka a me ka pō, ma kahi o 12 mau hola ke kaʻawale), mālama i nā maʻi ʻelua ma ka pale ʻana i nā hōʻailona, ​​​​e like me ka wheezing no ka poʻe me ka hānō, a ma ke kōkua ʻana i ka hanu maikaʻi ʻana, no ka poʻe me COPD. Ua ʻae ʻia ka inhaler no ʻelua ikaika (160/4.5 mcg/actuation a me 80/4.5 mcg/actuation).

ʻO nā hopena ʻaoʻao maʻamau e pili ana me ka budesonide a me formoterol fumarate dihydrate oral inhalation aerosol no ka poʻe me ka hānō he nasopharyngitis (ka pehu ʻana o nā ʻaoʻao o ka ihu a me hope o ka ʻāʻī), ke poʻo, ka maʻi ʻeha o luna, ka ʻeha pharyngolaryngeal (ihu a me ka waha), ʻeha, sinusitis, influenza. , ka ʻeha hope, ka ihu ihu, ka ʻeha o ka ʻōpū, ka luaʻi, a me ka candidiasis waha (thrush). No ka poʻe me COPD, ʻo nā hopena ʻaoʻao maʻamau ka nasopharyngitis, candidiasis waha, bronchitis, sinusitis, a me ka maʻi o ka ʻōpū hanu luna.

Hana mau ka FDA i nā hana e kōkua i ke alakaʻi ʻana i ka ʻoihana ma o ka hoʻomohala ʻana i nā huahana lāʻau maʻamau, me nā huahana hui pū, e like me MDIs, i loaʻa i kahi lāʻau a me kahi mea hana. No ka hoʻomaʻamaʻa hou ʻana i ka hoʻomohala ʻana i ka lāʻau lapaʻau maʻamau, a no ke kōkua ʻana i ka ʻoihana lāʻau lapaʻau maʻamau i kēia kaʻina hana, hoʻopuka ka FDA i nā alakaʻi kikoʻī huahana (PSGs) e wehewehe ana i ka noʻonoʻo a me nā manaʻo o ke keʻena i kēia manawa e pili ana i ka hoʻomohala ʻana i nā huahana lāʻau lapaʻau maʻamau e like me ko lākou inoa inoa. nā hoa like. I Iune 2015, ua paʻi ka FDA i kahi PSG no ka budesonide a me formoterol fumarate dihydrate inhalation aerosol.

Pono ka FDA i nā mea kākoʻo e hoʻouna i ka ʻikepili kūpono a me ka ʻike e hōʻike ai i ka paʻakikī o nā huahana hui lāʻau-lāʻau paʻakikī e kū i nā kūlana ʻae koʻikoʻi o ke keʻena. ʻO kēia mau maʻamau e hōʻoia i ka palekana a me ka maikaʻi o nā huahana lāʻau maʻamau e like me ko lākou inoa inoa inoa a hoʻokō i nā kūlana kiʻekiʻe like.

ʻO nā huahana paʻakikī nā huahana lapaʻau kahi hiki ʻole i ka maopopo ʻole e pili ana i ke ala ʻae a i ʻole nā ​​ala ʻē aʻe i ka hoʻomohala ʻana i nā huahana hiki ke pōmaikaʻi mai ka hana ʻepekema mua, e like me nā huahana me nā mea hoʻoikaika paʻakikī a me nā huahana hui lāʻau. Ma muli o ka paʻakikī o ka hoʻomohala ʻana o nā huahana hui lāʻau-lāʻau, ʻoi aku ka liʻiliʻi o ka noho ʻana, e hopena i ka hoʻokūkū mākeke. ʻO ka hoʻoponopono ʻana i nā pilikia e pili ana i nā generics paʻakikī, a me ka hoʻolaha ʻana i ka hoʻokūkū maʻamau i kēia mau lāʻau, he ʻāpana koʻikoʻi ia o ka FDA's Drug Competition Action Plan, a me ka hoʻoikaika ʻana o ke keʻena e hāpai i ka loaʻa ʻana o nā mea maʻi a me nā lāʻau kūʻai aku.

Ua hāʻawi ka FDA i ka ʻae o kēia generic budesonide a me formoterol fumarate dihydrate inhalation aerosol iā Mylan Pharmaceuticals, Inc.

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