Ukutholakala kocwaningo ngokubhekisana ne-FDA Labeling
Abesifazane abaningi bangase bakhethe ukusebenzisa i- Plan B One Step (amafomu awo ajwayelekile, i- My Way , I- Action , ne- Next Choice One Dose ) noma uhlobo olujwayelekile lwe-Plan B ( Okukhethwa Okulandelayo ), njengokukhulelwa okuphuthumayo ukuvimbela ukukhulelwa emva kokuhluleka kokulawula ukubeletha noma ukuziphatha okungavikelekile. Ngisho noma ukukhulelwa kwezimo eziphuthumayo kuphephile futhi kusebenza kahle, ukusetshenziswa kwePlani B kuyaqhubeka nokudala ukuphikisana . Iningi le mpikiswano ivela kuhlelo lweB B - ikakhulukazi ngokuqondene nokuthi noma yini iBulani B ivimbela amaqanda okukhulelwa ekufakweni. Kubuye kubonakale ukuthi isici esikhulu esibangela ukudideka mayelana nokuthi uhlelo lweB B lusebenza kanjani ukuthi ukubhaliswa kwe-FDA yalo mkhiqizo kusho into eyodwa, kodwa ucwaningo nolwazi aluqinisekisi amalebula ka-FDA.
Okushiwo yi-FDA Labeling
Ngokusho amalebula womkhiqizo, i-Plan B isebenza ngokuyinhloko ngokuvimbela / ukubambezela ukuvota noma ngokugwema ukukhulelwa (ngokushintsha ukuhamba kwesidoda kanye / noma iqanda). Le mpikiswano ivela engxenyeni elandelayo yelebula, ngaphansi kokuthi "indlela yokusebenza," ifundeka kanje:
"Ngaphezu kwalokho, [i-Plan B] ingavimbela ukufakelwa (ngokushintsha i-endometrium)."
Umphakathi wezokwelapha uchaza ukukhulelwa njengoba kusungulwa uma iqanda elikhulelwe lifakwe esibelethweni. Kodwa labo abanombono wokuthi ukukhulelwa kuqala ekukhuliseni bakholwa ukuthi uhlelo lweB b lufana nokukhipha isisu njengoba ukusetshenziswa kwalo kungavimbela ukutshalwa kweqanda. Lokhu kuthiwa, ucwaningo alusekeli le mbono mayelana nokuthi uhlelo lweB B lusebenza kanjani. Eqinisweni, ucwaningo lubonisa ukuthi uma kuthathwa ngemva kokuvuthwa, i-Plan B ayinciphisi izinga lokukhulelwa.
Yimiphi Imibukiso Yokucwaninga
- Idatha evela ezifundweni zamuva iqhubeka nokunikeza ubufakazi obunamandla bokuthi iSicwangciso B asivimbeli ukufakelwa (nalokhu kubonakala kuyiqiniso ku- Ella , okunye okukhethwa kukho okuphuthumayo kokukhulelwa). Iningi locwaningo luthi indlela eyinhloko ukuthi uhlelo lweB B lusebenza ngokuvimbela noma ukubambezela ukuvuthwa - uma isakhiwo B sithathwa ngaphambi kokuba kuqhume ukuvuthwa. Ngokungavumeli iqanda likhulule, akukho lutho olutholakalayo ukuze umdlwane ukhule, ngaleyo ndlela kuvimbele ukukhulelwa kungenzeki.
- Ucwaningo lubonisa nokuthi i- progestin (levonorgestrel) ku-Plan B ingasiza ekugwemeni ukukhulelwa ngokushintsha ukuhamba kwesidoda. Ucwaningo oluthile lubika ukuthi le progesin ingabangela ukukhwabanisa komlomo wesibeletho, ukuze kube nzima ukuba isidoda sifinyelele iqanda. Imibiko eyengeziwe yemininingwane yokuthi ukutholakala kwalesi progesin kungabangela isidoda ukuba singasebenzi noma "sidideke," ngaleyo ndlela sithinta isiqondiso esibhedayo.
- Ezingxenyeni eziningi zokucwaninga, abesifazane banikezwa uhlelo lweBhodi emva kokunquma (nge-test hormone) ababesifazane abaye bavotela futhi ababengekho. Imiphumela yonke yabonisa ukuthi akekho wabesifazane abathatha i-Plan B ngaphambi kokuvuna ukukhulelwa (le miphumela isiza ngempela ukugcizelela ukuthi uhlelo lweB B lusebenza kanjani ngokubambezela ukuvota). Ukukhulelwa kwenzakalo kwenzeka kuphela kwabesifazane abathatha uhlelo lweBhodi B emva noma emva kosuku lokuvuthwa, futhi laba besifazane bakhulelwa ngesilinganiso esifanayo njengabesifazane abangathathi iPulani B. Lezi ziphumo zenza abacwaningi uNoé, Croxatto, Salvatierra, noReyes (2011) ukuphetha ngokuthi uhlelo B
"Akuvimbeli ukufakelwa kombungu, ngakho-ke angeke kubhalwe ngokuthi yi-abortifacient."
- Ngo-2007, ucwaningo lubonise ubufakazi bokuthi iPlani B ayivimbeli ukunamathiswa kwemibungu yabantu emdongeni wesibeletho. Abacwaningi bathola amaqanda ahlwanyelwe amaqanda emitholampilo yokuzala. Ngemuva kokudalula la maqanda ku-progestin (etholakala ku-Plan B) endaweni evamile, imiphumela yabonisa ukuthi ukuba khona kwe-progestin akuzange kuvimbele amaqanda ukuba ahlangane namaseli ahambisana nesibindi.
Ngakho-ke, ucwaningo oluningi lwembula ukuthi ukusebenzisa i-Plan B akubanga neze ushintsho emgqeni wesibeletho (endometrium). Ngenxa yokuthi i-Plan B ayinayo impumelelo ku-endometrium, abacwaningi baphethe ngokuthi lokhu ukukhulelwa okuphuthumayo akukwazi ukuvimbela ukufakelwa kweqanda elikhulelwe. Abacwaningi abaningi baye bachaza umbono wokuthi i-Plan B ayikuvimbeli ukufakwa ekutheni kungenzeki mhlawumbe isizathu sokuthi ayikho i-100% ephumelelayo ekuvikeleni ukukhulelwa okungalindelekile - nokuthi kungani i-Plan B engasebenzi kahle uma ulinde ukuyisebenzisa.
Kungani ukufakwa kwe-FDA Kuhlanganisiwe kuLabel B Labels:
Kusukela ekuqaleni kwenqubo yokugunyazwa kwePlani B, umkhiqizi wayo ucele ukuthi i-FDA ingabandakanyi ukufakelwa kwemvelo njengenye yezindlela i-Plan B esebenza ngayo ebhokisini layo. Kodwa-ke kubonakala ukuthi phakathi nenqubo yokwamukelwa, iningi locwaningo olwenziwe kuPlani B liphenya ukuthi ngabe isithako sayo esisebenzayo, i-progestin levonorgestrel, singakwazi ukuvimbela ukukhulelwa ngokuphepha nangempumelelo. Lezi zifundo azihlolisanga ukuthi uhlelo lweB B lusebenza kanjani. Ngakho-ke, i-FDA kungenzeka inqume ukufaka ukufakwa kwesibalo kwi-Plan B yokubhalisa ngoba le ndlela ibonakala iyindlela yezindlela zokulawula amaphilisi okulawula ukubeletha (okuqukethe i-levonorgestrel kanye nemikhiqizo esebenzisa i-progesin ehlukile) - ngokushintsha umshini kwesibeletho. Ngakho-ke i-FDA kungenzeka ukuthi yanquma ukuthi ngoba iphilisi ingakwenza lokhu, ngakho-ke ungahlela B.
Kodwa kunezinto ezimbili okufanele uzikhumbule. Enye , ngisho noma iphilisi ingashintsha i-endometrium, izinguquko ezibangelwayo azizange zitholwe ukuthi zonakalisa ukufakelwa kweqanda elikhulelwe. Kodwa okubaluleke nakakhulu , ngamaphilisi okulawula ukubeletha, usakha ama-progestin amanani ngoba uthatha lawa maphilisi nsuku zonke. Ucwaningo lubonisa ukuthi umthamo owodwa we-levonorgestrel ku-Plan B awunawo amandla noma isikhathi sokwenza noma yiziphi izinguquko emgqeni wesibeletho.
Kodwa labo abathintekayo kuhlelo lwe-Plan B lokuvunywa kwenqubo ukuthi i-FDA yanquma ukufaka, kulebula lomkhiqizo, ukuthi kungenzeka ukuthi uhlelo lweB B lusebenza "ngokweqile ... ngokuphazamisa izinqubo eziningi zokuphila." I-FDA yabe isandiswa phezu kwalesi sitatimende ngokufaka uhlu lwazo zonke izindlela ezenzekayo ukuthi i-Plan B isebenza. Ngisho noma kwakungekho ubufakazi besayensi ukuthi iPulani B isebenza ngokuvimbela amaqanda ukuba angafaki, le nqubo yesenzo yayisakafakwa efayeleni lezidakamizwa.
Indlela Uhlelo B olusebenza ngayo - Isiphetho
Nakuba kungaziwa ukuthi i-FDA icubungula ukuthi ingabe ingavumelekile yini ukubuyekezwa kwelebula, u-Erica Jefferson, okhulumela i-FDA, wavuma, "Imininingwane evelayo kuPlani B ibonisa ukuthi ayivimbeli ukufakwa endaweni." Ucwaningo lubonisa ukuthi uhlelo B ngeke luphazamise ukukhulelwa okukhona, futhi lusebenza ngokuyinhloko ngokuvimbela ukuvota. Ngenxa yokuthi ucwaningo lubonisa ukuthi iPulani B ayivimbeli ukufakwa kweqanda elivundisiwe, umphakathi wocwaningo (kanye nabantu abaningi emphakathini wezokwelapha) unomuzwa wokuthi ulimi olunjalo mayelana nokufakelwa kufanele lukhishwe ku-label B ye-B.
Imithombo:
Durand M, del Carmen Cravioto M, uRaymond EG, Duran-Sanchez O, De La Luz Cruz-Hinojosa M, Castell-Rodriguez A, Schiavon R, Larrea F. Ngezinqubo Zokusebenza Zesikhathi Esifishane Sokulawulwa Kwezindlela Eziphuthumayo ze-Levonorgestrel. Ukwelashwa ngo- 2001; 64 (4): 227-234. Kufinyelelwe ngokubhalisa kwangasese.
Marions L, Hultenby K, Lindell I, Sun X, Stabi B, & Gemzell-Danielsson K. Ukukhulelwa Okuphuthumayo noMifepristone noLevionorgestrel: Indlela Yokusebenza. I-Obstetrics and Gynecology 2002; 100 (1): 65-71. Kufinyelelwe ngokubhalisa kwangasese.
I-Meng CX, i-Marions L, i-Bystrom B, ne-Gemzell-Danielsson K. Imiphumela yezokuLawulwa komlomo nezamaVaginal ye-Levonorgestrel Ukukhulelwa Kwesimo Esiphuthumayo Emakethe Wokutholwa Kwe-Endometrial. Ukukhiqizwa kwabantu ngo- 2010; 25 (4): 874-883. Kufinyelelwe ngokubhalisa kwangasese.
UNoé G, Croxatto HB, uSalvatierra AM, & Reyes R. Ukusebenza Kokuqapha Ukwelashwa Okuphuthumayo noLevionorgestrel Okunikezwe Ngaphambi Kokube Kwangemva Kokuvuthwa. Ukwelashwa 2011; 84 (5): 486-492. Kufinyelelwe ngokubhalisa kwangasese.
Ukwelashwa okuphuthumayo kwe-Prine L.: Izinkolelo namaqiniso. I-Obstet Gynecol Clin N Am .. 2007; 34: 127-136. Kufinyelelwe ngokubhalisa kwangasese.