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I-FDA Ivumile Ukwethulwa Emakethe Yase-US kwe-Conceive Plus Fertility Personal Lubricant

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FDA Approves Conceive Plus Fertility Personal Lubricant for US Market Release - Conceive Plus® FDA Approves Conceive Plus Fertility Personal Lubricant for US Market Release - Conceive Plus®
I-Conceive Plus Fertility Lubricant Ivunywe yi-Federal Drug Administration Yabantu Abazama Ukukhulelwa Emaphutheni e-United States. CHICAGO, IL, Novemba 15, 2013 - I-Pew Research Center ibika ukuthi ngonyaka ka-2011, izinga lokuzalwa e-United States lehle ngo-8%. Lolo hlobo lwezibalo lukhombisa ukuthi ukukhulelwa akusekho lula njengakuqala. Kodwa-ke, umkhiqizi wemithi i-SASMAR uhlose ukuba phambili ekusizeni imibhangqwana iqale imindeni. I-FDA isivumile ngokusemthethweni i-lubricant yothando ye-OTC elungele isidoda, i-Conceive Plus, ukuthi ithengiswe emakethe yase-US. I-Conceive Plus Fertility Personal Lubricant iyi-lubricant yomuntu ye-isotonic enobungane ekukhulelweni esiza imibhangqwana ezama ukukhulelwa yandise amathuba okukhulelwa ngokwemvelo. Ifomula ye-Conceive Plus eselindelelwe ilungelo lobunikazi ilinganiselwe i-pH ukuze ifane namanzi okuzala kanye nesidoda, iqukethe ama-ion e-magnesium ne-calcium, nawo atholakala ngokwemvelo emzimbeni womuntu futhi abalulekile enqubweni yokufakelwa kwesidoda esibeleni. Izifundo zodokotela ezishicilelwe zikhombisa kakhulu ukuthi ama-lubricant afana ne-KY, Durex, Astroglide ne-Replens anomthelela ongemuhle ekunyakazeni kwesidoda (sperm motility) nasekuqinisweni kwe-sperm chromatin, okuvimba inqubo yokufakelwa kwesidoda kanye namathuba okukhulelwa. I-SASMAR isanda kuthola isaziso esidingekayo se-510(k) Premarket Notification futhi isenkambisweni yokuthola abasabalalisi beMkhiqizo Wemakethe yase-US. Abathengisi abakhulu nabasabalalisi e-U.S bebefuna ukunikeza i-lubricant enobungane esidodeni ekhiqizwa yi-SASMAR, lo mkhiqizi wemithi wamazwe ngamazwe ogxile ikakhulukazi emikhiqizweni ehlobene nokuzala, ukuhlela umndeni nempilo yabesifazane. I-Conceive Plus ithengiswa ngaphandle kwe-resiphi yamadokotela emazweni angaphezu kuka-60. I-Conceive Plus fertility personal lubricant inobungane esidodeni futhi ihloselwe ukusetshenziswa esithweni sowesilisa (penile) kanye/noma esithweni sowesifazane (vaginal). Ithambisa futhi i-lubricate, ukuze yandise ubulula nokunethezeka komsebenzi wocansi wosondelwano futhi ingeze ekuthambiseni kwemvelo komzimba ngaphandle kokulimaza inqubo yokufakelwa kwesidoda esibeleni. Iyahambisana nesidoda, ama-oocyte, nama-embryo, i-Conceive Plus ingasetshenziswa nasezinhlungwini zokwelapha ukungazali ukusiza ukungena kwemishini yokuxilonga neyokwelapha emgodini wesitho sangasese sowesifazane. I-Conceive Plus ivunywe yi-FDA ukuthi ingabekwa icala lokuthi iphephile ukusetshenziswa yimibhangqwana ezama ukukhipha ingane ngokwemvelo. Ukuze uthole ulwazi olwengeziwe vakashela www.conceiveplus.com noma xhumana no SASMAR ukuze ube ngumsasabalalisi.
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