Kukho ukuphikisana okuninzi malunga nokuba i-generic kunye negama legama elichasene ne-epileptic medication yiloo nto ebizwa ngokuba "ngolo hlobo lwezokwelapha." Ngamanye amazwi, kukho umbuzo othile nokuba ngaba amayeza asebenzayo kunye kunye namaqabane akwixabiso elibi kakhulu. Ukuba ucinga ukutshintshwa kwilisi yegama lomtshini kwiyeza elidala le-anticonvulsant, okanye nokuba ucinga ukutshintshwa kwimiyeza ethile yonyango, kufuneka ufunde kakuhle le ngxaki ukuze wenze isigqibo esinolwazi.
Ngokuqinisekileyo, uya kufuna ukuqiniseka kwaye uxoxe ngale sigqibo ngogqirha wakho.
Indlela Amachiza Ovelisayo Aza Kuqala Ukudlala
Xa inkampani yezobisi ivelisa isilya esitsha, ihlala igalela izigidi zeedola ekuphandeni. Le nkqubo inendleko iyanceda ukuqinisekisa ukuba imyeza iyahlangabezana nemigangatho eyamkelekileyo yokhuseleko kunye nokusebenza. Ikhamphani yeziyobisi isenokuthi ihlawulise imali eninzi ngegama elitsha lomhlaza. Phantse iminyaka engama-20 emva kokuba i-patent yokuqala ifakwe, inkampani yezobisi ilahlekelwa ilungelo lokusabalalisa kuphela loo mayeza. Ngamanye amazwi, ezinye iinkampani zinokunikela inguqulo yesiqhelo yonyango ngexabiso eliphantsi.
Uvavanyo lwe-United States lokutya kunye noLawulo lweeDrug yonke imimiselo eyenziwa ngama-antiepileptics ukuqinisekisa ukuba amayeza ayatshintshaniswa nemveliso yelwimi. Nangona kunjalo, uphando lwamagqirha kunye neengxelo zeengxelo zibonisa ukuba kukho iingxaki ezibalulekileyo xa usuka kwi-anti -pile drug name to generics.
Ukuba i-FDA ibaluleke kakhulu ekuhlolweni, ingaba njani ukuba amaninzi amaninzi kunye nezigulana zibonisa ukukhathazeka?
Ukuxhalabisa ekutshintsheni
I-FDA ibona isichengisi sohlobo lokuba "ulingane ngonyango" kwisigama segama logqirha ukuba linomlinganiselo ofanayo nesithako esisebenzayo, kwaye ihlangabezana nemigangatho yamandla, umgangatho, ubumsulwa kunye nobunikazi.
Iinkalo ezimbini zihlolwe ngokukodwa:
- Indawo-phantsi kwe-curve (AUC)
- Uxinzelelo oluphezulu lwe-plasma (Cmax).
Ezi zixhobo zilinganisela ukuba unyango olunjani luya kufakwa kwigazi. I-FDA idinga ukuba i-AUC kunye neCmax yemithi yokufaka endaweni yamachiza ibe ngama-80 ekhulwini ukuya kuma-125 ekhulwini lamanyathelo egama-magama kunye neentembelelo ezingama-90. Oku kubonakala ngathi kuluhlu oluhle kakhulu, ingakumbi ukuba isilwanyana esibuzwayo sinomncinci "wefestile yezilwanyana" - umahluko phakathi kwesifo semithi esisebenzayo kunye nesifo semithi esenza iziphumo ezingamkelekanga.
Ukongezelela, iimvavanyo zokuqinisekisa ukuba izidakamizwa eziqhelekileyo zidibana nalo mgangatho ziqhelekileyo zenziwa ngabantu abangaba ngu-35. Lo mgangatho ohluke kakhulu kunamaxesha amaninzi abantu abavavanyelwe igama lonyango.
Yintoni i-FDA State malunga nokuTshintshela kwiMicropyic Medication?
I-FDA ithe akukho bungqina obuqinileyo bokuthi kukho izingozi ezingakumbi zokutshintshela kwi-generics. Abanye abaxhasi beli gama bakhombisa ukuba impembelelo engabonakali inokudlala indima kwiingxaki ezichazwe zizigulane emva kokutshintsha. Nangona impembelelo ye-placebo iquka iimpawu zezilwanyana eziphuculweyo emva kokufumana into engasebenzi (njengepilisi yeshukela) ngenxa yokuba isigulane siyakholelwa ukuba loo nto iya kubanceda, isiphumo sengqondo sichaphazela iimpawu zegulane ziba zibi nakakhulu kuba zicinga ukuba imithi esebenzayo ayiyi kunceda.
Konke kunzima ukukusho-mhlawumbi uxinzelelo kunye nokuxhalabisa okuhambisana nokutshintshela kwi-generic trigger ukutshatyalaliswa kwabanye abantu abanesithuthwane.
Ukujonga ngokugqithiseleyo kwi-Generic Anti-Epileptics
Nangona kunjalo, ukuba ukungabikho komsebenzi kuhambelana nokuxinzelela kokuguqula imishanguzo, akuqhelekanga ukuba iziphumo ezifanayo azibonakali kwezinye iintlobo zamachiza ezinjengeentlungu zamachiza . Kutheni le nto ingaba yinkinga enkulu kwizigulane ezithatha imishanguzo yokuhluthwa? Kungenzeka ukuba i-anti-epileptics idinga ukutsalwa kwe-dose ngokufutshane kwaye ukuba iipameters ezisungulwe yi-FDA azisebenzi kakuhle kunye namayeza kunye neefestile ezincinci zokwelapha.
Kule meko, ingxaki engaphantsi kokutshintshwa kwigama lesigqirha ukuya kumachiza oveliso, kodwa ingaba nayo xa usuka kwimoya yesiqhelo ukuya kwelinye, njengoko loo mayeza ayenokuthi ahluke. Ngokomzekelo, ukuba omnye unyango lwe-generic unama-125 ekhulwini le-dose ephumelelayo efunyenwe kwigama elingenayo isisindo, kwaye ushintshela kumachiza onama-80 ekhulwini le dose, i-dose yakho yokwenene imithi iye yawa kakhulu.
Ingozi
Ubungozi bokutshintshwa kwigama lesigqirha ukuya kwi-generic okanye phakathi kwama-generics kuya kuxhomekeka kwinqanaba elithathayo. Izigulane zisebenzisa i-Keppra (levetiracetam), uLamictal (lamotrigine) okanye i-Divalproex kakhulu inokuthi ibuyele kwimveliso yegama lonyango, ngokuphindaphindiweyo ukwenzela ukunyuka kwamathambo okanye ukuguquka kwezimpendulo zonyango ezingalunganga. Ukulumkisa okuthe xa kuthiwa xa ukuxhwaba kunokuba yingozi kakhulu, njengabantu abaqhuba umqhubi, abakhulelweyo, okanye abaye babandezeleka kakhulu ngenxa yokubanjelwa kwabo kwixesha elidlulileyo.
Okukwintsusa
Iingxaki ezixeliweyo ngokutshintshwa kwegama lomenzi we-antiepileptic mayeza akuthethi ukuba zonke izigulana ezikhuselekileyo zonyango kufuneka ziphetshwe. Njengawo nawaphi na amanye amayeza, kukho amathuba kunye neenzuzo zokutshintshela kwii-generics. Ezi ngozi kunye nezibonelelo kufuneka ziqondwe kakuhle ngaphambi kokwenza isigqibo sokutshintsha. Imali iya kugcinwa, kodwa kunokubakho iingxaki ezifunekayo ukuba uziqaphele okanye ulungelelanise umthamo oza kufuneka wenze. Kubalulekile ukuqaphela ukuba kunokwenzeka ukuba uxinzeleleke xa usuqulela phakathi kwemichiza enomdla kwaye uxoxe ngazo zonke iinketho zakho kunye nokukhathazeka ngogqirha wakho.
Imithombo:
I-American Epilepsy Society (AES) Intlanganiso ye-65 yonyaka: i-FDA yeehholo zedolophu. I-Disemba 2, 2011.
Gidal, BE (2012). Izidakamizwa ze-antiepileptic eziqhelekileyo: Zihle kangakanani ngokukhawuleza? Izifo ze-Epilepsy, 12 (1): 32-34.
UHenney, JE. (1999). Ukususela kokutya nokusetyenziswa kweziyobisi. JAMA, 282 1995.
Kramer, G., Steinhoff, BJ, Feucht, M., Pfafflin, M., & May, TW (2007). Amava kunye neziyobisi eziqhelekileyo kwizigulane zokuhluthwa: ukuhlolwa kwe-elektroniki kwamalungu aseJamani, ase-Austrian naseSwitzerland amagatsha e-ILAE. I-Epilepsia , 48 (3): 609-611
Krauss, GJ, Caffo, B., Chang, Y.-T., Hendrix, CW, & Chuang, K. (2011). Ukuvavanya i-bioequivalence yezilwanyana ezikhuselekileyo. Ama-Annal of Neurology , 70: 221-228. i-doi: 10.1002 / ana.22452
INKCAZELO: Ulwazi olukule ndawo lusezinjongo zemfundo kuphela. Akufanele isetyenziswe njengendawo yokunyamekelwa ngumntu ogqirha. Nceda ubone ugqirha wakho ukuze ufumane unyango kunye nonyango malunga nayiphi na impawu okanye imeko yonyango .