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Iphilisi Lokulahlekelwa Isisindo Liphikisana: Amaqiniso ama-5 Asheshayo Okufanele Uwazi

iphilisi lokwehlisa isisindo

Lesi sidakamizwa esisha sokudla besilinde ukuvunywa kwe-FDA, kodwa inkampani eyenza imithi ngemuva kweContrave ayitholanga impendulo ebebeyifuna namuhla. Esikhundleni salokho, i-FDA yanquma ukuhlehlisa isinqumo ngezinyanga ezintathu kuze kube nguSepthemba 11, 2014. Nawa amaqiniso abalulekile mayelana ne-Contrave:

1. Yini Contrave?

amaphilisi okudla ayaphikisana

Contrave iphilisi lokwehlisa isisindo elenziwa yinkampani eyenza imithi Orexigen , okugxilwe kakhulu ekwelapheni ukukhuluphala. Igama layo lesikhashana yi-NB32 futhi liyinhlanganisela yezidakamizwa ezimbili esezivunyelwe kakade: i-Wellbutrin ne-Revia (Vivitrol, igama elijwayelekile elithi Naltrexone).

2. Contrave Kungenzeka Usize Abantu Lose 5-10% of Body Isisindo

Ukudla kwesisindo kwe-HCG

Umtholampilo izilingo ikhombise ukuthi abantu abathatha i-NB32 balahlekelwe ngamaphesenti ayi-5-10 esisindo somzimba wabo. Kumuntu ongamakhilogremu angama-200, lokho kungaba ngamakhilogremu ayi-10-20.

3. Ukuvunyelwa Kokuphikiswa Kwe-FDA ngonyaka we-2011

phula i-FDA

Ngo-2011, i-FDA yacela ukucwaningwa okwengeziwe ngezingozi zenhliziyo futhi ayizange ivume iphilisi lokulahlekelwa isisindo.

4. Izifundo Ezintsha Kubukeka Zikhombisa Ukushayisana / NB32 Kuphephile

iphilisi lokudla liphikisana

Ngenxa yomyalelo we-FDA ngo-2011, u-Orexigen ubelokhu enza ucwaningo oluqhubekayo lweziguli ezingama-8900 kwi-Contrave ezibizwa nge-Light Study. Ngenxa yemiphumela emihle evela ocwaningweni lwabo, baphinde bafaka isicelo sabo ku-FDA ngoDisemba ka-2013.

5. Contrave Kungasiza Futhi Ngokucindezeleka

iphilisi lokudangala

Phikisa iyinhlanganisela yemithi emibili esivele ikhona nesevunyiwe. Enye ye-anti-depressant Wellbutrin (bupropion) nayo esetshenziswa ngabantu ukuyeka ukubhema kanye neRevia, esetshenziselwa ukwelapha imilutha yotshwala nezidakamizwa. Izifundo zokuqala ikhombise ukuthi i-Contrave ibe nomthelela omuhle ezigulini ezicindezelekile.