UTri-Lo-Estarylla

UTri-Lo-Estarylla

Igama lesiqhelo: norgestimate kunye ne-ethinyl estradiol
Ifomu yesisindo: iipilisi
Udidi lweziyobisi: Izinto zokuthintela ukukhulelwa

By Uhlaziyo lweMedia; Ukuhlaziywa ngu-Varixcare.cz. Igqityelwe ukuhlaziywa ngo-Agasti 23, 2021.



Kweli Phepha
Yandisa ISILUMKISO: UKUTSHAYA CIGARETTE NEZIGANEKO EZINZIMA ZE-CARDIOVASCULAR

Ukutshaya icuba kukonyusa umngcipheko weziganeko ezinesifo sentliziyo ngokudityaniswa komlomo (COC). Lo mngcipheko unyuka kunye nobudala, ngakumbi kwabasetyhini abangaphezulu kweminyaka engama-35 ubudala, kunye nenani lecuba elitshaywayo. Ngesi sizathu, ii-COCs ziyaphikiswa kwabasetyhini abangaphezulu kweminyaka engama-35 ubudala kwaye bayatshaya IMIQATHANGO (4) ].



Iimpawu kunye nokusetyenziswa kweTri-Lo-Estarylla

Ukuthintela ukukhulelwa ngomlomo

UTri-Lo-EstaryllaTM(iipilisi ze-norgestimate kunye ne-ethinyl estradiol) zibonisiwe ukuba zisetyenziswe ngabasetyhini abanamandla okuzala ukukhusela ukukhulelwa [jonga IZIFUNDO ZEZIKONZO (14) ].

Isisombululo se-Tri-Lo-Estarylla kunye noLawulo

Uyiqala njani iTri-Lo-Estarylla TM

UTri-Lo-EstaryllaTMikhutshwe kwipakethe yeblister [jonga INDLELA YOKUXHASWA / UKUGCINWA NOKUPHATHWA (16) ]. UTri-Lo-EstaryllaTMingaqalwa ngokusebenzisa uSuku 1 ukuqala okanye ukuqala kweCawa (yabona Itheyibhile 1 ). Kumjikelo wokuqala werejimeni yokuQala kweCawa, indlela eyongezelelweyo yokuthintela ukukhulelwa kufuneka isetyenziswe kude kube semva kweentsuku ezisi-7 zokuqala zolawulo.



Uyithatha njani iTri-Lo-Estarylla TM

Itheyibhile 1: Imiyalelo yoLawulo lweTri-Lo-EstaryllaTM

Ukuqala kwee-COC kwabasetyhini abangazisebenzisi izinto zokuthintela ukukhulelwa kwehomoni (Usuku lokuqala 1 okanye ukuqala kweCawa)
Kubalulekile:
Qwalasela ukubakho kwe-ovulation kunye nokukhulelwa ngaphambi kokuqala kwale mveliso.
Umbala wethebhulethi:

UTri-Lo-EstaryllaTMIipilisi ezisebenzayo zimhlophe (Usuku 1 ukuya kuSuku 7), ukukhanya okuluhlaza okwesibhakabhaka (Usuku lwe-8 ukuya kuSuku lwe-14) noluhlaza okwesibhakabhaka (Usuku lwe-15 ukuya kuSuku lwama-21).
UTri-Lo-EstaryllaTMiipilisi ezingasebenziyo zeziluhlaza(Usuku lwe-22 ukuya kwi-Day 28).

Umhla woku-1 wokuqala:

Thatha ipilisi yokuqala esebenzayo ngaphandle kokutya kusuku lokuqala lwe-mens.
Thatha iipilisi ezisebenzayo kanye yonke imihla ngexesha elifanayo yonke imihla imihla engama-21.
Thatha ipilisi enye eluhlaza engasebenziyo yonke imihla kangangeentsuku ezisixhenxe kwaye kwangaxeshanye kusenziwa iipilisi ezisebenzayo.
Qalisa ipakethe nganye elandelayo kwangolo suku lweveki njengepakethi yomjikelo wokuqala (okt, ngemini emva kokuthatha ithebhulethi yokugqibela engasebenziyo)

Ukuqala kweCawa:



Thatha ithebhulethi yokuqala esebenzayo ngaphandle kokutya ngeCawa yokuqala emva kokuqala kwemens.Ngenxa yokuba semngciphekweni wokukhulelwa, sebenzisa ezongezwayo zokuthintela ukukhulelwa ezingezizo iihomoni (ezinje ngeekhondom kunye nokubulala amadlozi) kwiintsuku ezisixhenxe zokuqala kumjikelo wokuqala wesigulana seTri-Lo-EstaryllaTM.
Thatha iipilisi ezisebenzayo kanye yonke imihla ngexesha elifanayo yonke imihla imihla engama-21.
Thatha ithebhulethi enye eluhlaza engasebenziyo yonke imihla kwezi ntsuku zisixhenxe zilandelayo kwaye ngaxeshanye nosuku kuthathwe iipilisi ezisebenzayo.
Qalisa ipakethe nganye elandelayo kwangolo suku lweveki njengepakethi yokuqala yomjikelo (okt ngeCawa emva kokuthatha ithebhulethi yokugqibela engasebenziyo) kunye nothintelo lokuthintela ukungakhethi ihomoni aludingeki.

Ukutshintshela kwi-Tri-Lo-EstaryllaTMukusuka kolunye ucwangciso lomlomo

Qala kwangolo suku bekuya kuqala ngalo ipakethe entsha yendlela yokucwangcisa yomlomo.

Ukutshintsha kwenye indlela yothintelo kukhulelwa kwi-Tri-Lo-EstaryllaTM

Qalisa iTri-Lo-EstaryllaTM:

Isikhutshana seTransdermal
Ngomhla wokufakwa kwesicelo okulandelayo
Isangqa sangasese
Ngomhla xa ukufakwa okulandelayo bekuya kucwangciswa
Inaliti
Ngomhla wokucwangciswa kwenaliti elandelayo
Izinto zokuthintela ukukhulelwa ngaphakathi
Ngomhla wokususwa
Ukuba i-IUD ayisuswanga kusuku lokuqala lomjikelo wokuya exesheni kwesigulana, izinto ezongezelelweyo zokuthintela ukukhulelwa ezingezizo ezomzimba (ezinjengeekhondom kunye nokubulala amadlozi) ziyafuneka kwiintsuku ezisixhenxe zokuqala zepakethe yomjikelo wokuqala.
Ukufakelwa
Ngomhla wokususwa

Gqibezela imiyalelo yokuququzelela isiluleko sesigulana ekusebenziseni kakuhle iithebhulethi ezikwi-FDA-Approved Patient Labeling.

Ukuqala kwe-Tri-Lo-EstaryllaTMemva kokuKhupha isisu okanye ukukhupha isisu

Ikota yokuqala

Emva kokuphuma kwesisu okanye ukuphuma kwesisu, iTri-Lo-EstaryllaTMingaqalwa kwangoko. Indlela eyongezelelweyo yokuthintela ukukhulelwa ayifuneki ukuba iTri-Lo-EstaryllaTMiqalwa ngoko nangoko.
Ukuba iTri-Lo-EstaryllaTMayiqaliswanga kwisithuba seentsuku ezi-5 emva kokupheliswa kokukhulelwa, isiguli kufuneka sisebenzise izinto ezongezelelweyo zokuthintela ukukhulelwa ezingezizo iihomoni (ezinje ngeekhondom kunye nokubulala amadlozi) kwiintsuku ezisixhenxe zokuqala kumjikelo wokuqala womjikelo weTri-Lo-EstaryllaTM.

Ikota yesibini

Ungaqali de kube ziiveki ezi-4 emva kokukhulelwa kwesisu okanye ukuphuma kwesisu, ngenxa yomngcipheko wesifo se-thromboembolic. Qalisa iTri-Lo-EstaryllaTM, ukulandela imiyalelo kwiTheyibhile 1 yoSuku 1 okanye ukuqala kweCawa, njengoko unqwenela njalo. Ukuba usebenzisa ukuqala kwangeCawa, sebenzisa ezinye izinto zokuthintela ukukhulelwa ezingezizo iihomoni (ezinjengeekhondom kunye nokubulala amadlozi) kwiintsuku ezisixhenxe zokuqala kumjikelo wokuqala wesigulana seTri-Lo-EstaryllaTM. [Yabona IMIQATHANGO (4) , Izilumkiso kunye namanyathelo (5.1) , kunye I-FDA-YAMKELWE UKUFAKANWA KWEZIGULO .]

Ukuqala kwe-Tri-Lo-EstaryllaTMemva kokubeleka

Musa ukuqala de kube ziiveki ezi-4 emva kokubeleka, ngenxa yengozi yesifo se-thromboembolic. Qalisa unyango lokucwangcisa ngeTri-Lo-EstaryllaTMukulandela imiyalelo kwiTheyibhile 1 yabasetyhini abangasebenzisi zindlela zokuthintela ukukhulelwa kwehomoni.
UTri-Lo-EstaryllaTMayikhuthazwa ukuba isetyenziswe kubafazi abancancisayo [jonga UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.3) ].
Ukuba owasetyhini akakabinalo ixesha lasemva kokubeleka, qaphela ukubakho kwe-ovulation kunye nokukhulelwa okwenzeka ngaphambi kokusetyenziswa kwe-Tri-Lo-EstaryllaTM. [Yabona IMIQATHANGO (4) , Izilumkiso kunye namanyathelo (5.1) , UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.1 kwaye 8.3) , kunye Ukuphawulwa kweelensi ezivunyiweyo ze-FDA ].

NGAPHAMBI kokuba uqale ukuthatha iipilisi zakho

1.
GQIBA NGELIPHI IXESHA LOMNTU OFUNA UKUTHATHA IPHilisi YAKHO.
Kubalulekile ukuyithatha malunga nexesha elifanayo yonke imihla.
2.
Ipakethe yeepilisi ezingama-28 ineepilisi ezingama-21 ezimhlophe, eziluhlaza okwesibhakabhaka, kunye neblue 'esebenzayo' (ezinamahomoni) onokuzithatha iiveki ezintathu. Oku kulandelwa yiveki e-1 yeepilisi 'zokukhumbuza' eziluhlaza (ngaphandle kwamahomoni).
3.
FUMANA:
1)
apho kwipakethe ukuqala ukuthatha iipilisi,
2)
ukuze uthathe iipilisi (landela iintolo),
3)
Amanani eveki njengoko kubonisiwe kumzobo ongezantsi.

Zine.
QINISEKA UKUBA UKULUNGELE NGALO LONKE IXESHA:
OLUNYE UHLOBO LOLAWULO LOKUZALWA (njengeikhondom okanye ukubulala amadlozi) ukuze ulusebenzise xa usiya kuphoswa ziipilisi.
UKONGEZA, IPEKILEYO EPHELELEYO.

Amacwecwe aphosiweyo

Itheyibhile 2: Imiyalelo ye-Tri-Lo-Estarylla ephosiweyoTMAmacwecwe

Ukuba ipilisi enye esebenzayo ayiphoswanga kwiiveki 1, 2, okanye 3

Thatha ithebhulethi ngokukhawuleza. Qhubeka uthatha ithebhulethi enye ngosuku de ipakethi igqitywe.

Ukuba iipilisi ezimbini ezisebenzayo zilahlekile kwiVeki yoku-1 okanye kwiVeki yesi-2

Thatha iipilisi ezimbini ezilahlekileyo ngokukhawuleza kunye neepilisi ezimbini ezizayo ngosuku olulandelayo. Qhubeka uthatha ithebhulethi enye ngosuku de ipakethi igqitywe.Ukongezwa kokuthintela ukukhulelwa okungenayo i-hormonal (njengeikhondom kunye ne-spermicide) kufuneka isetyenziswe njenge-back-up ukuba isiguli senza isondo kwiintsuku ezili-7 emva kokulahleka kwamacwecwe.

Ukuba iipilisi ezimbini ezisebenzayo ziphosiwe kwiveki yesithathu okanye iipilisi ezintathu nangaphezulu ezisebenzayo ziphoswe ngokulandelelana kwiVeki yoku-1, yesi-2, okanye yesi-3

Ukuqala kosuku 1: Phonsa yonke ipakethi uze uqalise ipakethe entsha kwangolo suku.
Ukuqala kweCawa: Qhubeka uthatha ithebhulethi enye ngosuku kude kube yiCawa, emva koko ulahle yonke ipakethi kwaye uqalise ipakethe entsha kwangolo suku lunye.Ukongezwa kokuthintela ukukhulelwa okungenayo i-hormonal (njengeikhondom kunye ne-spermicide) kufuneka isetyenziswe njenge-back-up ukuba isiguli senza isondo kwiintsuku ezili-7 emva kokulahleka kwamacwecwe.

Ndingayithatha ibuprofen ngegabapentin

Ingcebiso Kwimeko yokuphazamiseka kwamathumbu

Kwimeko yokugabha kakhulu okanye urhudo, ukufunxwa akunakuba kugqityiwe kwaye kufuneka kuthathwe amanyathelo okhuseleko. Ukuba ukugabha okanye urhudo kwenzeka ngaphakathi kweeyure ezi-3 ukuya kwezi-4 emva kokuba uthathe ipilisi, yiphathe njengethebhulethi ephosiweyo Ukuphawulwa kweelensi ezivunyiweyo ze-FDA ].

Iifom zedosi kunye namandla

UTri-Lo-EstaryllaTMiipilisi zifumaneka kwikhadi le-blister. Ikhadi ngalinye le-blister lineepilisi ezingama-28 ngolu hlobo lulandelayo:

Amacwecwe amhlophe ayi-7 amhlophe, ajikeleziweyo, abhalwe 'SZ' kwelinye icala kwaye 'T5' kwelinye icala iqulethe i-0.18 mg norgestimate kunye ne-0.025 mg ethinyl estradiol.
I-7 ukukhanya okuluhlaza okwesibhakabhaka, ukujikeleza, amacwecwe agqityiweyo abhalwe 'SZ' kwelinye icala kwaye 'T6' kwelinye icala iqulethe i-0.215 mg norgestimate kunye ne-0.025 mg ethinyl estradiol.
I-7 eluhlaza okwesibhakabhaka, erhangqwe ngamacwecwe agutyungelweyo abhalwe 'SZ' kwelinye icala kwaye 'T7' kwelinye icala iqulethe i-0.25 mg norgestimate kunye ne-0.025 mg ethinyl estradiol.
Iipilisi ezi-7 eziluhlaza, ezijikelezileyo, ezifakwe umbala zishicilelwe 'SZ' kwelinye icala kwaye 'J1' kwelinye icala iqulethe izithako ezingenanto.

Ukungqinelana

Musa ukumisela i-norgestimate kunye ne-ethinyl estradiol kwabasetyhini abaziwa ukuba banezi meko zilandelayo:

Umngcipheko ophezulu wezifo zemithambo-luvo okanye imithambo-luvo. Imizekelo ibandakanya abasetyhini abaziwa ukuba:
Umsi, ukuba ungaphezulu kweminyaka yobudala engama-35 [bona ISILUMKISO ESIFUTSHANE kwaye Izilumkiso kunye namanyathelo (5.1) ]
Yiba ne-vein thrombosis enzulu okanye i-pulmonary embolism, ngoku okanye ngaphambili [jonga Izilumkiso kunye namanyathelo (5.1) ]
Ndizuze njengelifa okanye ndafumana i-hypercoagulopathies [jonga Izilumkiso kunye namanyathelo (5.1) ]
Yiba nesifo se-cerebrovascular [jonga Izilumkiso kunye namanyathelo (5.1) ]
Unesifo semithambo yegazi [jonga Izilumkiso kunye namanyathelo (5.1) ]
Ngaba une-thrombogenic valvular okanye i-thrombogenic rhythm izifo zentliziyo (umzekelo, subacute bacterial endocarditis nesifo se-valvular, okanye i-atrial fibrillation) [jonga Izilumkiso kunye namanyathelo (5.1) ]
Ukuba noxinzelelo lwegazi olungalawulekiyo [jonga Izilumkiso kunye namanyathelo (5.4) ]
Unesifo seswekile nesifo semithambo [bona Izilumkiso kunye namanyathelo (5.6) ]
Yiba nentloko eneempawu ezijolise kwimithambo-luvo okanye yintloko ye-migraine ene-aura [jonga Izilumkiso kunye namanyathelo (5.7) ]
Abasetyhini abangaphezulu kweminyaka yobudala be-35 ngayo nayiphi na intloko ebuhlungu ye-migraine [jonga Izilumkiso kunye namanyathelo (5.7) ]
Izidumba zesibindi, ezinobungozi okanye ezinobungozi, okanye isifo sesibindi [jonga Izilumkiso kunye namanyathelo (5.2) ]
Ukopha kwesibeleko ngokungaqhelekanga okuchongiweyo [jonga Izilumkiso kunye namanyathelo (5.8) ]
Ukukhulelwa, kuba akukho sizathu sokusebenzisa ii-COCs ngexesha lokukhulelwa [jonga Izilumkiso kunye namanyathelo (5.9) kwaye UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.1) ]
Umhlaza webele okanye omnye umhlaza onobuzaza be-estrogen- okanye iprogestin, ngoku okanye ngaphambili [jonga Izilumkiso kunye namanyathelo (5.11) ]
Ukusetyenziswa kwendibaniselwano yeziyobisi zeHepatitis C equlathe i-ombitasvir / paritaprevir / ritonavir, kunye okanye ngaphandle kwe-dasabuvir, ngenxa yokuphakama kwe-ALT [jonga Izilumkiso kunye namanyathelo (5.3) ]

Izilumkiso kunye nokuQapha

Ukuphazamiseka eTromboembolic kunye nezinye iingxaki zeVascular

Misa i-estradiol ye-norgestimate kunye ne-ethinyl ukuba kwenzeka isiganeko se-thrombotic okanye i-venous thrombotic (VTE).
Misa i-norgestimate kunye ne-ethinyl estradiol ukuba kukho ilahleko engachazekiyo yombono, iproptosis, idiplopia, ipapilledema, okanye izilonda zemithambo. Vavanya i-retina vein thrombosis kwangoko [jonga IZIPHUMO EZIPHAMBILI (6.2) ].
Ukuba kunokwenzeka, yeka i-norgestimate kunye ne-ethinyl estradiol ubuncinci iiveki ezi-4 ngaphambi nasemva kweeveki ezi-2 emva kotyando olukhulu okanye olunye utyando olwaziwa ngokuba nomngcipheko ophakamileyo we-VTE kunye nangexesha kunye nokulandela ukungasebenzi kakuhle ixesha elide.
Qalisa i-norgestimate kunye ne-ethinyl estradiol hayi ngaphambi kweeveki ezi-4 emva kokubeleka, kwabasetyhini abangancancisi. Umngcipheko we-postpartum VTE uyehla emva kweveki yesithathu emva kokubeleka, ngelixa umngcipheko we-ovulation unyuka emva kweveki yesithathu emva kokubeleka.
Ukusetyenziswa kwee-COCs kunyusa umngcipheko we-VTE. Nangona kunjalo, ukukhulelwa kwonyusa umngcipheko we-VTE ngokungaphezulu okanye ngaphezulu kokusebenzisa ii-COC. Umngcipheko we-VTE kwabasetyhini abasebenzisa ii-COCs ziimeko ezi-3 ukuya kwezi-9 nge-10,000 leminyaka yabasetyhini. Umngcipheko we-VTE uphezulu kunyaka wokuqala wokusetyenziswa kwee-COC naxa uqala kwakhona ukukhulelwa kwehomoni emva kwekhefu leeveki ezi-4 okanye ngaphezulu. Umngcipheko wesifo se-thromboembolic ngenxa ye-COCs uyanyamalala ngokuthe ngcembe emva kokusetyenziswa.
Ukusetyenziswa kwee-COCs kukonyusa umngcipheko we-arterial thromboses ezinje ngemivumbo kunye ne-myocardial infarction, ngakumbi kubafazi abanezinye izinto ezinobungozi kwezi ziganeko. Ii-COC zibonisiwe ukuba zikhulisa ubungozi obunokubakho kunye neziganeko ezinokubakho zeziganeko ze-cerebrovascular (thrombotic and hemorrhagic strokes). Lo mngcipheko unyuka ngokuhamba kweminyaka, ngakumbi kwabasetyhini abangaphezulu kweminyaka engama-35 ubudala abatshayayo.
Sebenzisa ii-COC ngononophelo kwabasetyhini abanesifo sentliziyo.

Isifo sesibindi

Umsebenzi wokungasebenzi kakuhle kwesibindi

Sukusebenzisa i-norgestimate kunye ne-ethinyl estradiol kubafazi abanesifo sesibindi, njenge-hepatitis yentsholongwane ebukhali okanye ukuqina kwesibindi (jonga) IMIQATHANGO (4) ].Ukuphazamiseka okuthe gca okanye okungapheliyo kokusebenza kwesibindi kunokubangela ukuba kuyekwe ukusetyenziswa kwe-COC de kube kumakishe ukusebenza kwesibindi kubuyela esiqhelweni kwaye i-COC causation ayifakwanga. Yeka i-norgestimate kunye ne-ethinyl estradiol ukuba i-jaundice iyakhula.

Ukudumba kwesibindi

I-Norgestimate kunye ne-ethinyl estradiol iyaphikiswa kwabasetyhini abanesifo esibi kunye nesifo esibi sesibindi. IMIQATHANGO (4) ].I-hepatic adenomas inxulunyaniswa nokusetyenziswa kweCOC. Uqikelelo lomngcipheko obangelwa ziimeko ezi-3.3 / 100,000 yabasebenzisi beCOC. Ukuqhekeka kwe-adenomas ye-hepatic kunokubangela ukufa ngokuphuma kwesisu esiswini.

Izifundo zibonise umngcipheko okhulayo wokuba ne-hepatocellular carcinoma kwixesha elide (> iminyaka esi-8) abasebenzisi beCOC. Nangona kunjalo, umngcipheko wesifo somhlaza wesibindi kubasebenzisi beCOC ungaphantsi kwetyala elinye kwisigidi sabasebenzisi.

Umngcipheko weeNzyme zesibindi kunye nonyango oluhambelana neHepatitis C

Ngexesha lovavanyo lweklinikhi kunye nerejimeni yokudibanisa iHepatitis C equlathe i-ombitasvir / paritaprevir / ritonavir, kunye okanye ngaphandle kwe-dasabuvir, ukuphakama kwe-ALT okungaphezulu kwamaxesha ama-5 umda ophezulu wesiqhelo (i-ULN), kubandakanya amanye amatyala angaphezulu kwama-20 amaxesha e-ULN, zazibaluleke kakhulu rhoqo kubasetyhini abasebenzisa amayeza ane-ethinyl estradiol, anje ngeeCOC. Yeka i-norgestimate kunye ne-ethinyl estradiol ngaphambi kokuba uqalise ngonyango ngokudibanisa ichiza irejimeni ombitasvir / paritaprevir / ritonavir, kunye okanye ngaphandle kwe-dasabuvir [jonga IMIQATHANGO (4) ]. I-Norgestimate kunye ne-ethinyl estradiol inokuphinda iqaliswe malunga neeveki ezi-2 emva kokugqitywa konyango kunye nerejimeni yokudibanisa iHepatitis C.

Igazi elonyukayo

I-Norgestimate kunye ne-ethinyl estradiol iyaphikiswa kwabasetyhini abanesifo segazi esingalawulekiyo okanye uxinzelelo lwegazi olunesifo semithambo [jonga IMIQATHANGO (4) ]. Kwabasetyhini abanoxinzelelo lwexinzelelo lwegazi, jonga uxinzelelo lwegazi kwaye uyeke i-norgestimate kunye ne-ethinyl estradiol ukuba uxinzelelo lwegazi lonyuka ngokubonakalayo.

Ukonyuka koxinzelelo lwegazi kuye kwaxelwa kwabasetyhini abathatha ii-COCs, kwaye oku kunyuka kunokwenzeka ngakumbi kubantu basetyhini abadala kunye nexesha elongezelelekileyo lokusetyenziswa. Imeko yoxinzelelo lwegazi inyuka ngokunyuka koxinzelelo lweprogestin.

Isifo seGallbladder

Izifundo ziphakamisa umngcipheko omncinci okhulayo wokuhlaselwa sisifo se-gallbladder phakathi kwabasebenzisi beCOC. Ukusetyenziswa kwee-COCs kunokuzenza mandundu izifo ezikhoyo zenyongo. Imbali edlulileyo ye-COC enxulumene ne-cholestasis iqikelela umngcipheko okhulayo ngokusetyenziswa kwe-COC elandelayo. Abasetyhini abanembali yecholestasis enxulumene nokukhulelwa banokuba semngciphekweni owandayo weCOC cholestasis.

Iicarbohydrate kunye neLipid Iziphumo zeMetabolic

Qaphela ngononophelo abafazi abanesifo seswekile kunye nabaneswekile abathatha i-norgestimate kunye ne-ethinyl estradiol. Ii-COCs zinokunciphisa ukunyamezelana kweswekile.

Cinga ngezinye iindlela zokuthintela ukukhulelwa kwabasetyhini abane-dyslipidemia engalawulekiyo. Inani elincinci labasetyhini liya kuba neenguqu ezimbi ze-lipid ngelixa zikwi-COCs.

Abasetyhini abane-hypertriglyceridemia, okanye imbali yosapho emva koko, banokuba semngciphekweni wokwanda kwepancreatitis xa usebenzisa ii-COCs.

Intloko ebuhlungu

Ukuba owasetyhini othatha i-norgestimate kunye ne-ethinyl estradiol ikhula iintloko ezintsha eziphindaphindayo, ezingapheliyo, okanye ezinzima, vavanya unobangela kwaye uyeke i-norgestimate kunye ne-ethinyl estradiol ukuba ibonakalisiwe.

Cinga ukuyekiswa kwe-norgestimate kunye ne-ethinyl estradiol kwimeko yokunyuka kwesantya okanye ubukrakra be-migraine ngexesha lokusetyenziswa kwe-COC (enokuthi ibe yinto ebambekayo kwisigulo se-cerebrovascular).

Ukuphalaza izitenxo kunye ne-Amenorrhea

Ukopha okungacwangciswanga kunye nokuBala

Ukungacwangciswanga (ukuphumelela okanye ukungena ngaphakathi) ukuphuma kwegazi kunye nokubona ngamanye amaxesha kwenzeka kwizigulana ezikwii-COC, ngakumbi kwiinyanga ezintathu zokuqala zokusetyenziswa. Ukuba ukuphuma kwegazi kuyaqhubeka okanye kwenzeka emva kwemijikelezo yesiqhelo yangaphambili, jonga izizathu ezinjengokukhulelwa okanye ubundlobongela. Ukuba isifo kunye nokukhulelwa kungafakwanga, izitenxo zokopha zingasombulula ngokuhamba kwexesha okanye ngenguqu kwimveliso yento ethile yothintelo.

Kuvavanyo lweklinikhi lwe-norgestimate kunye ne-ethinyl estradiol, ubude kunye nexesha lokuphuma kwegazi okungacwangciswanga kunye / okanye ukubonwa kwavavanywa kwabasetyhini be-1,673 (i-11,015 yokujikeleza okujikelezayo). Inani elipheleleyo le-3 (0.2%) yabasetyhini abayeke i-norgestimate kunye ne-ethinyl estradiol, ubuncinci kwinxalenye, ngenxa yokopha okanye ukubona. Ngokusekwe kwidatha evela kuvavanyo lweklinikhi, i-7 ukuya kwi-17% yabasetyhini abasebenzisa i-norgestimate kunye ne-ethinyl estradiol bafumana ukopha okungacwangciswanga kumjikelo ngamnye kunyaka wokuqala. Ipesenti yabasetyhini abafumana ukopha okungacwangciswanga kuye kwancipha ngokuhamba kwexesha.

Amenorrhea kunye ne-Oligomenorrhea

Abasetyhini abasebenzisa i-norgestimate kunye ne-ethinyl estradiol banokufumana i-amenorrhea. Abanye abantu basetyhini banokufumana i-amenorrhea okanye i-oligomenorrhea emva kokupheliswa kwee-COCs, ngakumbi xa imeko enjalo ibikhona ngaphambili.

Ukuba kucwangcisiwe (ukurhoxa) ukuphuma kwegazi akwenzeki, cinga malunga nokukhulelwa. Ukuba isigulana asikhange sihambisane neshedyuli emiselweyo (siphoswe ipilisi enye okanye ezingaphezulu okanye siqale ukusithatha ngosuku emva kwexesha ebesinalo) . Ukuba isigulana sinamathele kwirejimeni emiselweyo kwaye saphoswa ngamaxesha amabini alandelelanayo, thintela ukukhulelwa.

Ukusetyenziswa kweCOC ngaphambi okanye ngexesha lokukhulelwa kwangoko

Izifundo ezongezelelekileyo zesifo esivelisayo azibonisanga bungozi bokwanda kweziphene zokuzalwa kwabasetyhini abaye basebenzisa izinto zokucwangcisa ngomlomo ngaphambi kokukhulelwa. Izifundo zikwacebisa ukuba nefuthe le-teratogenic, ngakumbi ukuza kuthi ga ngoku xa kukho ukungahambi kakuhle kwentliziyo kunye neziphene zokunciphisa amalungu, xa izinto zokucwangcisa ngomlomo zithathwa ngokungazi ngexesha lokukhulelwa kwasekuqaleni. Yeka ukusetyenziswa kwe-norgestimate kunye ne-ethinyl estradiol ukuba ukukhulelwa kuqinisekisiwe.

Ulawulo lweeCOCs ukukhuthaza ukuphuma kwegazi akufuneki lusetyenziswe njengovavanyo lokukhulelwa [jonga UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.1) ].

Uxinzelelo

Qaphela ngononophelo abasetyhini abanembali yoxinzelelo kwaye bayeke i-norgestimate kunye ne-ethinyl estradiol ukuba ukudakumba kubuyela kwinqanaba elibi.

ICarcinoma yebele kunye noMlomo weSibeleko

I-Norgestimate kunye ne-ethinyl estradiol iyaphikiswa kwabasetyhini okwangoku abanomhlaza wamabele ngenxa yokuba umhlaza webele unokuba novakalelo lwehomoni. IMIQATHANGO (4) ].
Kukho ubungqina obuninzi bokuba ii-COCs azinyusi izehlo zomhlaza wamabele. Nangona olunye uphando oludlulileyo lucebise ukuba ii-COCs zinokunyusa imeko yomhlaza wamabele, uphononongo lwamva nje aluzange lukuqinisekise oko kufunyanisiweyo.
Olunye uphononongo lubonisa ukuba ukusetyenziswa kwe-COC kunxulunyaniswa nokwanda komngcipheko womhlaza womlomo wesibeleko okanye i-intraepithelial neoplasia. Nangona kunjalo, kusaqhubeka impikiswano malunga nokuba ezi ziphumo zinokubangelwa yintoni umahluko kwindlela yokuziphatha ngokwesondo kunye nezinye izinto.

Iziphumo zokuBopha iiglobulin

Icandelo le-estrogen lee-COCs linokuphakamisa ukugxila kwe-serum ye-globulin ebopha i-thyroxine, isondo elibopha i-hormone eglobulin, kunye ne-cortisol-binding globulin. Idosi yokutshintsha i-hormone ye-thyroid okanye unyango lwe-cortisol kunokufuna ukonyuswa.

Ukubeka iliso

Umfazi othatha ii-COCs kufuneka atyelele unyaka nonyaka kunye nomboneleli wakhe wezempilo ukujonga uxinzelelo lwegazi kunye nolunye unyango olubonisiweyo.

I-Angioedema yelifa

Kwabasetyhini abane-angioedema yelifa, ii-estrogens zangaphandle zinokubangela okanye zonyuse iimpawu ze-angioedema.

Chloasma

I-Chloasma inokuthi yenzeke ngamanye amaxesha, ngakumbi kubafazi abanembali ye-chloasma gravidarum. Abasetyhini abanotyekelo lwe-chloasma kufuneka bakuphephe ukubekwa elangeni okanye kwimitha ye-ultraviolet ngelixa bethatha i-norgestimate kunye ne-ethinyl estradiol.

Iziphumo ezingalunganga

Ezi mpendulo zibi zilandelayo nokusetyenziswa kwee-COCs ziyaxoxwa kwenye indawo ekubhaleni:

Iziganeko ezinzulu zentliziyo kunye nokubetha [jonga ISILUMKISO ESIFUTSHANE kwaye Izilumkiso kunye namanyathelo (5.1) ]
Iziganeko zeVascular [bona Izilumkiso kunye namanyathelo (5.1) ]
Isifo sesibindi [jonga Izilumkiso kunye namanyathelo (5.2) ]

Iziphumo ezibi ezixelwa rhoqo ngabasebenzisi beCOC zezi:

Ukuphuma gwenxa kwesibeleko
Isicaphucaphu
Ukuthamba kwebele
Intloko ebuhlungu

Amava ovavanyo lwezonyango

Kuba ulingo lweklinikhi luqhutywa phantsi kweemeko ezahluka-hlukeneyo, amaqondo okusabela okungalunganga aqwalaselweyo kuvavanyo lweklinikhi lwesiyobisi alunakuthelekiswa ngokuthe ngqo namaxabiso kuvavanyo lweklinikhi lelinye ichiza kwaye ayinakubonakalisa amaxabiso abonwe kunyango lweklinikhi.

Ukhuseleko lwe-norgestimate kunye ne-ethinyl estradiol yavavanywa kwizifundo ze-1,723 ezithathe inxaxheba kwilingo elingenamkhethe, elingaboniyo, elininzi, elilawulwa ngokukuko lonyango lwe-norgestimate kunye ne-ethinyl estradiol yokuthintela ukukhulelwa. Olu vavanyo luvavanye abasempilweni, abangakhulelwanga, amavolontiya aneminyaka eyi-18 ukuya kwi-45 (engatshayi ukuba uneminyaka engama-35 ukuya kwengama-45 ubudala), ababesabelana ngesondo kunye necoitus eqhelekileyo. Izifundo zilandelwe ukuya kuthi ga kwi-13 yeentsuku ezingama-28 zemihla.

Ukuphendula gwenxa okuqhelekileyo (≧ 2% yezifundo)

Ezona mpendulo zixhaphakileyo zixelwe ubuncinci yi-2% yabasetyhini abayi-1,723 abasebenzisa irejimeni yeentsuku ezingama-28 bezi zilandelayo ukuze kunciphe izehlo: intloko ebuhlungu / migraine (30.5%), isicaphucaphu / ukugabha (16.3%); Imiba yebele (kubandakanya ukuthamba, iintlungu, ukwanda, ukudumba, ukukhupha, ukungonwabi, i-cyst, kunye nentlungu yengono) (10.3%), iintlungu zesisu (9.2%), ukuphazamiseka kokuya exesheni (kubandakanya idysmenorrhea, ukungahambi exesheni, ukuphazamiseka kokuya exesheni) (9.2%) , ukuphazamiseka kwemood (kubandakanya ukudakumba, ukutshintsha kwemozulu, ukutshintsha kweemvakalelo kunye nokudakumba) (7.6%); induna (5.1%), usuleleko lobufazi (3.5%), isisu esisisi (2.8%), ubunzima bonyukile (2.4%), ukudinwa (2.1%).

Ukuphendula gwenxa okukhokelela ekuyekisweni kwesifundo

Kuvavanyo lweklinikhi lwe-norgestimate kunye ne-ethinyl estradiol 4% yezifundo ziyekile ukulingwa ngenxa yokuphendula gwenxa. Ezona mpawu zixhaphakileyo zikhokelela ekuphelisweni ziintloko / i-migraine (i-1.2%), isicaphucaphu / ukugabha (i-0.7%), idysplasia yomlomo wesibeleko (i-0.7%), iintlungu zesisu (0.4%), i-ovarian cyst (0.3%), i-acne (0.2% ), Ukuqunjelwa (0.2%) kunye noxinzelelo (0.2%).

Iziphumo ezibi kakhulu

ICarcinoma yomlomo wesibeleko in situ (1 isifundo) kunye nedysplasia yomlomo wesibeleko (isifundo esi-1).

Amava entengiso

Ezi zinto zilandelayo zingezizo ezichaseneyo neziyobisi zichaziweyo ukusuka kumava okuthengisa emva kwehlabathi kunye ne-norgestimate / ethinyl estradiol. Ngenxa yokuba ezi mpendulo zichazwa ngokuzithandela ukusuka kubungakanani besayizi engaqinisekanga, akusoloko kunokwenzeka ukuba uqikelele ngokuthembekileyo ukuhamba kwabo rhoqo okanye ukuseka ubudlelwane obunobangela wokuvezwa kweziyobisi.

Usulelo kunye nosulelo:Usulelo lwe-Urinary tract

I-Neoplasms Benign, enobungozi kwaye engachazwanga (kubandakanya iiCyst kunye neePolyps):Umhlaza webele, i-neoplasm yebele enobungozi, i-adenoma ye-hepatic, i-focal nodular hyperplasia, i-cyst yebele

Ukuphazamiseka kwenkqubo yomzimba:Hypersensitivity

Ukuphazamiseka kwimetabolism kunye nesondlo:Idyslipidemia

Ukuphazamiseka kwengqondo:Ixhala, ukulala

Ukuphazamiseka kwenkqubo:Syncope, ukuxhuzula, paresthesia, isiyezi

Ukuphazamiseka kwamehlo:Ukungaboni kakuhle, iliso elomileyo, ukunganyamezelani kwelensi

Ukuphazamiseka kwindlebe kunye neLabyrinth:Vertigo

Ukuphazamiseka kwentliziyo:Tachycardia, ukubetha kwentliziyo

Iziganeko zeVascular:I-vein thrombosis enzulu, i-pulmonary embolism, i-retinal vascular thrombosis, ishushu eshushu

Imicimbi yeArterial:I-Arterial thromboembolism, i-myocardial infarction, ingozi ye-cerebrovascular

Ukuphefumla, ukuphazamiseka kwethambo kunye nokuphazamiseka kwangaphakathi:IDyspnea

Iingxaki zesisu:Pancreatitis, distension esiswini, urhudo, ukuqhina

Ukuphazamiseka kwiHepatobiliary:Hepatitis

Ulusu kunye nokuphazamiseka kwethishu engaphantsi:I-angioedema, i-erythema nodosum, i-hirsutism, ukubila ebusuku, i-hyperhidrosis, ukusabela kwe-photosensitivity, urticaria, pruritus, acne

Imisipha, izihlunu eziDibeneyo, kunye nokuphazamiseka kwethambo:Ukudumba kwemisipha, iintlungu ezisekupheleni, i-myalgia, iintlungu zomqolo

Inkqubo yokuzala kunye nokuphazamiseka kwebele:Umhlaza we-Ovarian cyst, ukucinezelwa kwe-lactation, ukoma kwe-vulvovaginal

Ukuphazamiseka ngokubanzi kunye neMeko zoLawulo lweSiza:Intlungu yesifuba, iimeko ze-asthenic.

Ukusebenzisana kweziyobisi

Qhagamshelana nelebheli yeziyobisi ezisetyenziswa ngaxeshanye ukufumana ulwazi oluthe kratya malunga nokunxibelelana nezinto zokuthintela ukukhulelwa kwehomoni okanye ukubakho kweenguqulelo ze-enzyme.

Akukho zifundo zokunxibelelana neziyobisi ezenziwa nge-norgestimate kunye ne-ethinyl estradiol.

Iziphumo zezinye iziyobisi kuthintelo lokuthintela ukukhulelwa

Izinto ezinciphisa ukuqaqamba kwePlasma yeeCOC

Iziyobisi okanye iimveliso zemveliso ezenza ii-enzymes ezithile, kubandakanya i-cytochrome P450 3A4 (CYP3A4), inokunciphisa ukubonwa kwe-COCs kwiplasma kwaye inokunciphisa ukusebenza kwe-COCs okanye yonyuse ukuphuma kwegazi. Amanye amachiza okanye iimveliso zamayeza ezinokunciphisa ukusebenza kwe-COCs zibandakanya i-phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant kunye neemveliso eziqulathe iSt. Ukusebenzisana phakathi kwee-COCs kunye nezinye iziyobisi kunokukhokelela ekuphumeni kokuphuma kwegazi kunye / okanye ukungaphumeleli kokukhulelwa. Cebisa abasetyhini ukuba basebenzise enye indlela yokuthintela ukukhulelwa okanye indlela yokubuyela umva xa kusetyenziswa i-enzyme inducers kunye nee-COCs, kunye nokuqhubeka nokuthintela inzalo kwiintsuku ezingama-28 emva kokuyeka inducer ye-enzyme ukuqinisekisa ukuthembakala kokuthintela ukukhulelwa.

Colesevelam

I-Colesevelam, i-bile acid sequestrant, enikezwe kunye ne-COC, ibonakalisiwe ukunciphisa kakhulu i-AUC ye-ethinyl estradiol (EE). Ukudibana kweziyobisi phakathi kokuthintela inzala kunye ne-colesevelam kuncitshisiwe xa iimveliso ezimbini zamachiza zanikwa iiyure ezi-4 ngokwahlukeneyo.

Izinto ezonyusa ukujongwa kwePlasma kweeCOC

Ukulawulwa ngokudibeneyo kwe-atorvastatin okanye i-rosuvastatin kunye nee-COCs ezithile ezine-EE zonyusa amaxabiso e-AUC e-EE malunga nama-20 ukuya kuma-25%. I-Ascorbic acid kunye ne-acetaminophen inokunyusa ukugxila kwe-EE yeplasma, ngokunokwenzeka ngokuthintela ukudibana. I-CYP3A4 inhibitors ezinje nge-itraconazole, i-voriconazole, i-fluconazole, ijusi ye-grapefruit, okanye i-ketoconazole inokunyusa ukugxila kwe-plasma.

Intsholongwane kaGawulayo (i-HIV) / iHepatitis C Virus (HCV) Protease Inhibitors kunye ne-Non-nucleoside Reverse Transcriptase Inhibitors

Utshintsho olubalulekileyo (ukwanda okanye ukuncipha) kwizinga leplasma ye-estrogen kunye / okanye iprogestin kuye kwaphawulwa kwezinye iimeko zolawulo-kunye ne-HIV protease inhibitors (ukunciphisa [umz., Nelfinavir, ritonavir, darunavir / ritonavir, (fos) amprenavir / ritonavir , lopinavir / ritonavir, kunye ne-tipranavir / ritonavir] okanye ukwanda [umz., indinavir kunye ne-atazanavir / ritonavir]) / HCV protease inhibitors (ukunciphisa [umz., boceprevir kunye ne-telaprevir]) okanye nge-non-nucleoside reverse transcriptase inhibitors (nciphisa [umz., nevirapine ] okanye ukwanda [umz., etravirine]).

Iziphumo zokuthintela ukukhulelwa komlomo ngokudibeneyo kwezinye iziyobisi

Ii-COCs ezine-EE zinokuthintela imetabolism yezinye iikhompawundi (umz.
Ii-COC zibonisiwe ukunciphisa i-plasma ye-acetaminophen, i-clofibric acid, i-morphine, i-salicylic acid, i-temazepam kunye ne-lamotrigine. Ukwehla okuphawulekayo koxinzelelo lweplasma ye-lamotrigine kubonisiwe, ngokunokwenzeka ngenxa yokungeniswa kwe-lamotrigine glucuronidation. Oku kunganciphisa ulawulo lokuhlutha; Ke ngoko, ulungelelwaniso lomthamo we-lamotrigine lunokufuneka.
Abasetyhini kunyango lwehomoni yonyango yokutshintsha kunokufuna iidosi ezonyukayo zehomoni ye-thyroid kuba uxinzelelo lwe-serum ye-globulin ebopha i-thyroid inyuka ngokusetyenziswa kwe-COCs.

Ungenelelo kuvavanyo lweLebhu

Ukusetyenziswa kwe-steroids yokuthintela ukukhulelwa kunokuba nefuthe kwiziphumo zovavanyo oluthile lwelabhoratri, ezinje ngezinto ezixineneyo, i-lipids, ukunyamezelana kweswekile, kunye neeproteni ezibophayo.

Ukusetyenziswa ngokuhambisanayo kunye ne-HCV yoNyango lweNyango-isibindi se-Enzyme Elevation

Sukulawula ngokudibeneyo kunye ne-ethinyl estradiol ngokudityaniswa kweziyobisi ze-HCV eziqukethe i-ombitasvir / paritaprevir / ritonavir, kunye okanye ngaphandle kwe-dasabuvir, ngenxa yokuphakama kwe-ALT [jonga Izilumkiso kunye namanyathelo (5.3) ]

UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO

Ukukhulelwa

Kukho umngcipheko omncinci okanye ongekhoyo wokukhubazeka kwabasetyhini abasebenzisa iiCOC ngokungazi ngexesha lokukhulelwa kwangaphambili. Izifundo ze-Epidemiologic kunye nohlalutyo lwe-meta alufumananga umngcipheko okhulayo wokuzala okanye ukungabikho kwamalungu okuzala (kubandakanya ukungahambi kakuhle kwentliziyo kunye neziphene zokunciphisa amalungu) emva kokuvezwa kwii-COCs zangaphambi kokukhulelwa okanye ngexesha lokukhulelwa kwangoko.

Sukuyilawula i-COCs ukuba inyanzelise ukuphuma kwegazi njengovavanyo lokukhulelwa. Sukusebenzisa ii-COCs ngexesha lokukhulelwa ukunyanga isisu esisisongelo okanye esiqhelekileyo.

Oomama Abongikazi

Cebisa umama ongumongikazi ukuba asebenzise ezinye iindlela zokuthintela ukukhulelwa, xa kunokwenzeka, ade amlumle umntwana wakhe. Ii-COCs zinokunciphisa ukuveliswa kobisi koomama abancancisayo. Oku kunqabile ukuba kwenzeke xa ukuncancisa kusekwe kakuhle; Nangona kunjalo, inokwenzeka nangaliphi na ixesha kubafazi abathile. Inani elincinci le-steroids yomlomo yokukhulelwa kunye / okanye i-metabolites zikhona kubisi lwebele.

Ukusetyenziswa kwabantwana

Ukhuseleko kunye nokusebenza kwe-norgestimate kunye ne-ethinyl estradiol sele isekiwe kubafazi abakwiminyaka yokuzala. Ukusebenza kulindeleke ukuba kube yinto efanayo kulutsha lwasemva kokubeleka nolungaphantsi kweminyaka eli-18 nakubasebenzisi abaneminyaka eli-18 nangaphezulu. Ukusetyenziswa kwale mveliso ngaphambi kokuya exesheni.

Ukusetyenziswa kweGeriatric

I-Norgestimate kunye ne-ethinyl estradiol khange ifundwe kubafazi be-postmenopausal kwaye ayiboniswanga kuluntu.

Ukonakala kweHepatic

I-pharmacokinetics ye-norgestimate kunye ne-ethinyl estradiol khange ifundwe kwizifundo ezinokukhubazeka kwe-hepatic. Nangona kunjalo, iihomoni ze-steroid zinokungasebenzi kakuhle kwizigulana ezinokukhubazeka kwe-hepatic. Ukuphazamiseka okuthe gca okanye okungapheliyo kokusebenza kwesibindi kunokubangela ukuba kuyekwe ukusetyenziswa kwe-COC de kube kumakishe ukusebenza kwesibindi kubuyela esiqhelweni kwaye i-COC causation ayifakwanga. [Yabona IMIQATHANGO (4) kwaye Izilumkiso kunye namanyathelo (5.2) .]

Ukuphazamiseka kwentliziyo

I-pharmacokinetics ye-norgestimate kunye ne-ethinyl estradiol khange ifundwe kwabasetyhini abanokukhubazeka kwezintso.

Ukugqithisa

Khange kubekho ngxelo malunga neziphumo ezibi ezibi zokuba ngaphezulu komthamo wezinto zokucwangcisa zomlomo, kubandakanya nokufakwa kwabantwana. Ukugqithisa okungaphezulu kunokubangela ukuyeka ukopha kubantu ababhinqileyo kunye nesicaphucaphu.

Inkcazo yeTri-Lo-Estarylla

UTri-Lo-EstaryllaTM. I-Norgestimate ikhethwe njenge- (18,19-Dinor-17-pregnancy-4-en-20-yn-3-one, 17- (acetyloxy) -13-ethyl-, oxime, (17cy) - (+) -) kunye i-ethinyl estradiol yonyulwe njenge (19-nor-17α-pregna, 1,3,5 (10) -trien-20-yne-3,17-diol).

Ithebhulethi nganye emhlophe esebenzayo ine-0.18 mg ye-norgestimate kunye ne-0.025 mg ye-ethinyl estradiol. Izithako ezingasebenziyo zibandakanya i-crospovidone, i-lactose anhydrous, i-magnesium stearate, i-polyethylene glycol, i-polyvinyl yotywala, i-pregelatinised starch, i-talc kunye ne-titanium dioxide.
Ithebhulethi nganye ekhanyayo eluhlaza equkethe i-0.215 mg ye-norgestimate kunye ne-0.025 mg ye-ethinyl estradiol. Izinto ezingasebenziyo zibandakanya i-crospovidone, i-FD & C Blue No. , kunye ne-titanium dioxide.
Ithebhulethi nganye esebenzayo eluhlaza okwesibhakabhaka iqulethe i-0.25 mg ye-norgestimate kunye ne-0.025 mg ye-ethinyl estradiol. Izinto ezingasebenziyo zibandakanya i-crospovidone, i-FD & C Blue No. , talc, kunye ne-titanium dioxide.
Ithebhulethi nganye ye-placebo eluhlaza inezithako ze-inert kuphela, ngolu hlobo lulandelayo: i-crospovidone, i-FD & C Blue No. 2 indigo carmine aluminium echibini, i-FD & C Yellow No.5 tartrazine aluminium echibini, i-lactose anhydrous, lecithin (soya), i-magnesium stearate, i-polyethylene glycol, i-polyvinyl yotywala, isitatshi esandulelweyo, i-talc, kunye ne-titanium dioxide.

I-Tri-Lo-Estarylla-Clinical Pharmacology

Indlela yokuSebenza

Ii-COCs zehlisa umngcipheko wokukhulelwa ikakhulu ngokucinezela i-ovulation. Ezinye iindlela ezinokubakho zinokubandakanya utshintsho lwencindi yomlomo wesibeleko ethintela ukungena kwesidoda kunye notshintsho lwe-endometriamu elinciphisa ukubakho kokumiliselwa.

Pharmacodynamics

Akukho zifundo zenziweyo ze-pharmacodynamic ezenziwa nge-norgestimate kunye ne-ethinyl estradiol.

Pharmacokinetics

Ukufunxa

I-Norgestimate (NGM) kunye ne-EE zithathwa ngokukhawuleza emva kolawulo lomlomo. I-NGM ikhawuleze kwaye igqityiwe ngokupheleleyo ngokudlula kokuqala (amathumbu kunye / okanye i-hepatic) kwiindlela ze-norelgestromin (NGMN) kunye ne-norgestrel (NG), ezizezona ziyimetabolites eziphambili ze-NGM. Kuthetha iiparameterokinetic parameter ze-NGMN, NG kunye ne-EE ngexesha lemijikelezo emithathu yolawulo lwe-norgestimate kunye ne-ethinyl estradiol ishwankathelweItheyibhile 3.

Ukugxilwa kwe-serum ye-NGMN kunye ne-EE ngokubanzi kwafikelelwa ngeyure ezi-2 emva kolawulo lwe-norgestimate kunye ne-ethinyl estradiol. Ukuqokelelwa kulandela idosi eninzi ye-0.180 mg NGM / 0.025 mg EE idosi imalunga ne-1.5 ukuya kwi-2 ephindwe kabini ye-NGMN kunye ne-1.5 ephindwe kabini ye-EE xa kuthelekiswa nolawulo lwedosi enye, ngokuvumelana noko kwaxelwa kwangaphambili ngokusekwe kumgca we-kinetics we-NGMN kunye ne-EE. I-pharmacokinetics ye-NGMN yidosi ngokulingana kwiidosi ze-NGM ze-0.180 ukuya kwi-0.250 mg. Isimo esime bume se-NGMN kulandela idosi nganye ye-NGM kunye ne-EE zafezekiswa ngexesha lesifundo semijikelezo emithathu. Ukuqokelelwa okungahambelaniyo nomgama (4.5-14.5 fold) ye-NG yaqwalaselwa njengesiphumo sokubophelela okuphezulu kwi-SHBG, ethintela umda ekusebenzeni kwayo.

Itheyibhile 3Isishwankathelo se-NGMN, NG kunye ne-EE yeparacokinetic parameter.

Itheyibhile 3: Ithetha (i-SD) ye-Pharmacokinetic Parameters ye-Norgestimate kunye ne-Ethinyl Estradiol ngexesha loFundo lwemijikelezo emithathu.

Hlaziya1 Umjikelo Usuku Cubuninzi tubuninzi(h) I-AUC0–24h t1/2(h)

I-NGMN (2, 3, 4)

1

1

0.91 (0.27)

I-1.8 (1)

Izimvo eziyi-5.86 (1.54)

I-NC

3

7

1.42 (0.43)

1.8 (0.7)

11.3 (3.2)

I-NC

14

1.57 (0.39)

1.8 (0.7)

Umanqaku 13.9 (3.7)

I-NC

amashumi amabini ananye

1.82 (0.54)

1.5 (0.7)

16.1 (4.8)

28.1 (10.6)

NG (2, 3, 4)

1

1

0.32 (0.14)

2 (1.1)

2.44 (2.04)

I-NC

3

7

1.64 (0.89)

1.9 (0.9)

isetyenziselwa ntoni iprotonix

27.9 (18.1)

I-NC

14

2.11 (1.13)

Isi-4 (6.3)

40.7 (24.8)

I-NC

amashumi amabini ananye

2.79 (1.42)

1.7 (1.2)

49.9 (27.6)

36.4 (10.2)

I-EE (2, 3, 5)

1

1

Ngama-55.6 (18.1)

1.7 (0.5)

421 (118)

I-NC

3

7

91.1 (36.7)

1.3 (0.3)

782 (329)

I-NC

14

96.9 (38.5)

1.3 (0.3)

796 (273)

I-NC

amashumi amabini ananye

95.9 (38.9)

1.3 (0.6)

771 (303)

17.7 (4.4) usetyenziso lweWindows kwi- Ivenkile yeWindows

1NGMN = Norelgestromin, NG = norgestrel, EE = ethinyl estradiol

2Cubuninzi= incopho yoxinaniso lwe-serum, tubuninzi= ixesha lokufikelela koxinzelelo lwe-serum, AUC0–24h= indawo ephantsi koxinaniso lwe-serum vs. ijika lexesha ukusuka kwi-0 ukuya kwiiyure ezingama-24, t1/2= Ukuphelisa isiqingatha sobomi.

3iiyunithi zazo zonke ii-analytics; h = iiyure

4iiyunithi ze-NGMN kunye ne-NG-Cubuninzi= ng / ml, AUC0–24h= h • ng / ml

5iiyunithi ze-EE kuphela-Cubuninzi= ipg / mL, i-AUC0–24h= h • iphe / ml

I-NC = ayibalwanga

Iziphumo zokutya

Iziphumo zokutya kwi-pharmacokinetics ye-norgestimate kunye ne-ethinyl estradiol khange ifundwe.

Ukuhanjiswa

I-NGMN kunye ne-NG ziboshwe kakhulu (> 97%) kwiiproteni ze-serum. I-NGMN ibotshelelwe kwi-albhamuin hayi kwi-SHBG, ngelixa i-NG ibotshelelwe ikakhulu kwi-SHBG. I-EE iboshwe kakhulu (> 97%) kwi-albhamu ye-serum kwaye inyusa ukonyuka koxinaniso lwe-serum ye-SHBG.

Imetabolism

I-NGM idweliswe kakhulu ngeendlela zokupasa zokuqala kwithumbu kunye / okanye isibindi. Eyona nto iphambili esebenzayo ye-NGM yi-NGMN. Imetabolism ye-hepatic elandelayo ye-NGMN yenzeka kwaye i-metabolites ibandakanya i-NG, ekwangayo esebenzayo kunye ne-hydroxylated kunye ne-conjugated metabolites. Nangona i-NGMN kunye nee-metabolites zayo zithintela iintlobo ezahlukeneyo ze-P450 enzymes kwii-microsomes zesibindi somntu, phantsi kwerejimeni yencindi yokucebisa,kwi vivoUkugxilwa kwe-NGMN kunye ne-metabolites yayo, nkqu kwinqanaba le-serum ephezulu, iphantsi ngokuthelekiswa ne-inhibitory rhoqo (Ki). I-EE ikwadityaniswa kwimveliso eyahlukeneyo yehydroxylated kunye ne-glucuronide kunye ne-sulfate conjugates.

Ukutsalwa

ubuthatha njani ubushushu ngomlomo

Ukulandela imijikelezo emi-3 yolawulo lwe-norgestimate kunye ne-ethinyl estradiol, intsingiselo (± SD) yokuphelisa amaxabiso obomi besiqingatha, kwindawo ezinzileyo, ye-NGMN, NG kunye ne-EE yayiziiyure ezingama-28.1 (± 10.6), iiyure ezingama-36.4 (± 10.2) kunye nee-17.7 (± 4.4) iiyure, ngokwahlukeneyo (Itheyibhile 2). Iimetabolites ze-NGMN kunye ne-EE ziyasuswa ziindlela ze-renal kunye ne-fecal.

Sebenzisa kubemi abathile

Iziphumo zobunzima bomzimba, indawo engaphezulu komzimba kunye nobudala

Iziphumo zobunzima bomzimba, umphezulu womzimba, ubudala kunye nohlanga kwi-pharmacokinetics ye-NGMN, NG kunye ne-EE zavavanywa kwabasetyhini abasempilweni abasebenzisa idatha edityanisiweyo kulandela ukulawulwa kwethamo elinye le-NGM 0.180 okanye i-0.250 mg / EE i-0.025 yeepilisi yeepilisi kwizifundo ezine ze-pharmacokinetic . Ukonyusa ubunzima bomzimba kunye nomphezulu womzimba nganye inxulunyaniswa nokwehla kweCubuninzikunye ne-AUC0–24hIxabiso le-NGMN kunye ne-EE kunye nokunyuka kwi-CL / F (ukucoca ngomlomo) kwi-EE. Ukunyusa ubunzima bomzimba nge-10 kg kuqikelelwe ukunciphisa ezi paramitha zilandelayo: NGMN Cubuninzinge-9% kunye ne-AUC0–24hnge-19%, KWI-Cubuninzinge-12% kunye ne-AUC0–24hngama-46%, EE C.ubuninzinge-13% kunye ne-AUC0–24hnge-12%. Olu tshintsho lwalubalulekile ngokwezibalo. Ukwanda kweminyaka kwakudityaniswa nokuncipha okuncinci (iipesenti ezi-6 kunye nobudala obandayo ngeminyaka emi-5) kwi-Cubuninzikunye ne-AUC0–24hye-NGMN kwaye ibalulekile ngokwezibalo, kodwa kwakungekho siphumo sibalulekileyo kwi-NG okanye kwi-EE. Liqhezu elincinci ukuya kumodareyitha (5 ukuya kuma-40%) lokwahluka ngokubanzi kwi-pharmacokinetics ye-NGMN kunye ne-EE kulandela iipilisi ze-norgestimate kunye ne-ethinyl estradiol ezinokuchazwa yiyo nayiphi na okanye kuzo zonke ezi paramitha zingasentla.

Unclinical Toxicology

ICarcinogenesis, iMutagenesis, ukungasebenzi kakuhle kokuchuma

[Yabona Izilumkiso kunye namanyathelo (5.2 , 5.11 )kwaye UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.1) .]

Izifundo zonyango

Kuvavanyo olusebenzayo lweklinikhi olusebenzayo oluhlala iinyanga ezili-12, abafazi abayi-1,673, abaneminyaka eli-18 ukuya kwengama-45 ubudala bagqiba imijikelezo eyi-11,003 yokusetyenziswa kwe-norgestimate kunye ne-ethinyl estradiol kunye nokukhulelwa okungama-20 kubikwa kubasebenzisi be-norgestimate kunye ne-ethinyl estradiol. Idemokhrasi yabantu abo baphathwa nge-norgestimate kunye ne-ethinyl estradiol yayi: Caucasian (86%), African-American (6%), Asia (2%), kunye nezinye (6%). Kwakungekho ngaphandle ngenxa yesisindo; Uluhlu lobunzima babafazi abaphathwayo lwaluyi-90 ukuya kwi-240 lbs, enobunzima obumalunga ne-142 lbs. Izinga lokukhulelwa kwabasetyhini abaneminyaka eli-18 ukuya kwengama-35 ubudala lalimalunga ne-2.6 yokukhulelwa kwi-100 yeminyaka yokusebenzisa abafazi.

Unikezo / ugcino kunye nokusingathwa

Unikwa njani

UTri-Lo-EstaryllaTM(iipilisi ze-norgestimate kunye ne-ethinyl estradiol, i-USP) ziyafumaneka kwikhadi le-blister:

Ikhadi ngalinye le-blister (iipilisi ezingama-28) ziqulathe ngolu hlobo lulandelayo:

Amacwecwe amhlophe ayi-7 amhlophe, ajikeleziweyo, abhalwe 'SZ' kwelinye icala kwaye 'T5' kwelinye icala iqulethe i-0.18 mg ye-progestational compound, norgestimate, kunye ne-0.025 mg ye-estrogenic compound, ethinyl estradiol.
I-7 ukukhanya okuluhlaza okwesibhakabhaka, ukujikeleza, amacwecwe agqityiweyo abhalwe 'SZ' kwelinye icala kwaye 'T6' kwelinye icala iqulethe i-0.215 mg ye-progestational compound, norgestimate, kunye ne-0.025 mg ye-estrogenic compound, ethinyl estradiol.
I-7 eluhlaza okwesibhakabhaka, erhangqwe ngamacwecwe agutyungelweyo abhalwe 'SZ' kwelinye icala kwaye 'T7' kwelinye icala iqulethe i-0.25 mg ye-progestational compound, norgestimate, kunye ne-0.025 mg ye-estrogenic compound, ethinyl estradiol.
Iipilisi ezi-7 eziluhlaza, ezijikelezileyo, ezifakwe umbala zishicilelwe 'SZ' kwelinye icala kwaye 'J1' kwelinye icala iqulethe izithako ezingenanto.

I-NDC 70700-120-84, ibhokisi enye equlathe ibhokisi yeeyunithi ezi-1
I-NDC 70700-120-85, ibhokisi enye equlathe iibhokisi zeyunithi ezi-3

Imiqathango yoGcino

Gcina kuma-20 ° ukuya kuma-25 ° C (68 ° ukuya kuma-77 ° F) [jonga i-USP yamaGumbi amaBushushu aLawulwayo].
Khusela ekukhanyeni.
Gcina kude nokufikelela kwabantwana.

Ulwazi ngeNgcebiso ngezigulana

Yabona Ilebheli yesigulana evunyiweyo yi-FDA (Ulwazi loMonde kwaye Imiyalelo yokuSebenzisa) .

Cebisa abaguli malunga nale ngcaciso ilandelayo:

Ukutshaya imidiza kwandisa umngcipheko weziganeko ezinzulu zentliziyo ezisetyenziswa yi-COC, kwaye nabasetyhini abangaphezulu kweminyaka engama-35 ubudala nabatshayayo akufuneki basebenzise ii-COCs [jonga Ibhokisi Isilumkiso ].
Umngcipheko owandileyo we-VTE xa kuthelekiswa nabangengabo abasebenzisi be-COCs ngowona mkhulu emva kokuqala iCOC okanye ukuqala kwakhona (kulandela i-4-iveki okanye ixesha elikhulu elingenazipilisi) ngokufanayo okanye kwi-COC eyahlukileyo [jonga Izilumkiso kunye namanyathelo (5.1) ].
UTri-Lo-EstaryllaTMayikhuseli kusulelo lwe-HIV (i-AIDS) kunye nezinye izifo ezosulela ngokwabelana ngesondo.
UTri-Lo-EstaryllaTMayimele isetyenziswe ngexesha lokukhulelwa; ukuba ukukhulelwa kwenzeka ngexesha lokusetyenziswa kweTri-Lo-EstaryllaTMuyalele isigulana ukuba siyeke ukusebenzisa ngakumbi [bona Izilumkiso kunye namanyathelo (5.9) ].
Thatha ipilisi enye imihla ngemihla ngomlomo ngexesha elifanayo yonke imihla. Yalela izigulana ukuba zenze ntoni kumacwecwe omsitho aphosiweyo [jonga IDOSI NOLAWULO (2.2) ].
Sebenzisa i-back-up okanye enye indlela yokuthintela ukukhulelwa xa kusetyenziswa i-enzyme inducers nge-Tri-Lo-EstaryllaTM[Bona UKUSETYENZISWA KWEZIYOBISI (7.1) ].
Ii-COCs zinokunciphisa ukuveliswa kobisi lwebele, oku kunqabile ukuba kwenzeke ukuba ukuncancisa kuzinzile [jonga UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO (8.3) ].
Abasetyhini abaqala ii-COCs emva kokubeleka; kwaye abangekabinalo ixesha, kufuneka basebenzise enye indlela eyongezelelweyo yokuthintela ukukhulelwa bade bathathe icwecwe elimhlophe kangangeentsuku ezisixhenxe ezilandelelanayo [jonga IDOSI NOLAWULO (2.2) ].
Amenorrhea kunokwenzeka. Cinga ukukhulelwa kwimeko ye-amenorrhea ngexesha lokuqala lokuphosa. Khupha ukukhulelwa kwimeko ye-amenorrhea kwimijikelo emibini okanye nangaphezulu elandelelanayo [jonga Izilumkiso kunye namanyathelo (5.8) ].

Yenziwe yiLabatorios Leon Farma S.A., Spain

yeXiromed LLC. IFlorham Park, NJ 07932

Imveliso yaseSpain

ISityhi sikaJanuwari 2018

Ulwazi loMonde

UTri-Lo-EstaryllaTM
(iipilisi ze-norgestimate kunye ne-ethinyl estradiol, i-USP)

(okanye u-YES-ti-mate, i-ETH-i-nil es-tra-DYE-ol)

Loluphi ulwazi olubaluleke kakhulu endimele ndilwazi malunga neTri-Lo-EstaryllaTM?

Sukusebenzisa iTri-Lo-EstaryllaTMukuba uyatshaya kwaye ungaphezulu kweminyaka engama-35 ubudala.Ukutshaya kwandisa umngcipheko weziphumo ezibi zentliziyo kunye neepilisi zokulawula ukuzalwa kwehomoni, kubandakanya nokusweleka kwintliziyo, amahlwili egazi okanye ukubetha. Lo mngcipheko unyuka ngokuhamba kweminyaka kunye nenani leesigarethi ozitshayayo.

Yintoni iTri-Lo-EstaryllaTM?

UTri-Lo-EstaryllaTMyipilisi yolawulo lokuzalwa (izinto zokucwangcisa ngomlomo) ezisetyenziswa ngabafazi ukuthintela ukukhulelwa.

Kwenzeka njani ukuba iTri-Lo-EstaryllaTMukusebenzela ukuthintela ukukhulelwa?

Ithuba lakho lokukhulelwa lixhomekeke kwindlela oyilandela ngayo imikhombandlela yokuthatha iipilisi zokulawula ukuzalwa. Okungcono ukulandela umkhombandlela, amathuba okuba ukhulelwe.

Ngokusekwe kwiziphumo zophando lweklinikhi, malunga ne-3 kwabali-100 yabasetyhini banokukhulelwa kunyaka wokuqala basebenzisa iTri-Lo-EstaryllaTM.

Le tshathi ilandelayo ibonisa ithuba lokukhulelwa kwabasetyhini abasebenzisa iindlela ezahlukeneyo zolawulo lokuzalwa. Ibhokisi nganye kwitshathi inoluhlu lweendlela zokulawula ukuzalwa ezifanayo nokusebenza. Ezona ndlela zisebenzayo ziphezulu kwetshathi. Ibhokisi esezantsi kwetshathi ibonisa ithuba lokukhulelwa kwabasetyhini abangasebenzisi zolawulo kwaye bazama ukukhulelwa.

Ngubani ongafanele athathe i-Tri-Lo-EstaryllaTM?

Sukuthatha iTri-Lo-EstaryllaTMukuba u:

umsi kwaye ungaphezulu kweminyaka engama-35 ubudala
ndinegazi egumbini, iingalo, imiphunga okanye amehlo
ubenengxaki ngegazi lakho elenza ligaxeke ngaphezu kwesiqhelo
ube neengxaki ezithile zevalvevu zentliziyo okanye ukubetha kwentliziyo okungavunyelwanga okwandisa umngcipheko wokuba namahlwili egazi
wahlaselwa sistroke
wahlaselwa yintliziyo
Uxinzelelo lwegazi olungenakulawulwa ngamayeza
unesifo seswekile ngentso, iliso, imithambo-luvo, okanye ukonakala kwemithambo yegazi
uneentlobo ezithile zentloko ye-migraine ebuhlungu ene-aura, ukuba ndindisholo, ubuthathaka okanye utshintsho kumbono, okanye nayiphi na intloko ebuhlungu ukuba ungaphezulu kweminyaka engama-35 ubudala
unengxaki yesibindi, kubandakanya amathumba wesibindi
Thatha nayiphi na indibaniselwano yeziyobisi ye-Hepatitis C equlathe i-ombitasvir / paritaprevir / ritonavir, kunye okanye ngaphandle kwe-dasabuvir. Oku kunokunyusa amanqanaba e-enzyme yesibindi i-alanine aminotransferase (ALT) egazini.
unayo nayiphi na into engachazwanga eyophayo kwilungu lobufazi
ukhulelwe
wayenomhlaza wamabele okanye nawuphina umhlaza onovakalelo kwiihomoni zabasetyhini

Ukuba nayiphi na kwezi meko yenzeka ngelixa uthatha iTri-Lo-EstaryllaTM, yeka ukuthatha i-Tri-Lo-EstaryllaTMngoko nangoko kwaye uthethe nomboneleli wakho wezempilo. Sebenzisa izinto zokuthintela ukukhulelwa ezingezizo ezomzimba xa uyeka ukuthatha iTri-Lo-EstaryllaTM.

Kufuneka ndixelele ntoni umboneleli wam wezempilo ngaphambi kokuba ndithathe iTri-Lo-EstaryllaTM?

Xelela umboneleli wakho wezempilo ukuba:

ukhulelwe okanye ucinga ukuba ukhulelwe
badandathekile ngoku okanye bebekhe badandatheka ngaphambili
ubutyheli besikhumba sakho okanye amehlo (i-jaundice) ebangelwa kukukhulelwa (cholestasis yokukhulelwa)
ukuncelisa okanye ukucwangcisa ukuncancisa. UTri-Lo-EstaryllaTMunokunciphisa inani lobisi lwebele olwenzileyo. Inani elincinci lamahomoni kwiTri-Lo-EstaryllaTMunokudlula kubisi lwakho lwebele. Thetha nomboneleli wakho wezempilo malunga nendlela efanelekileyo yokulawula ukuzalwa kwakho xa uncelisa.

Xelela umboneleli wakho wezempilo malunga nawo onke amayeza owathathayo,kubandakanya amayeza amayeza kunye nalawo e-counter, iivithamini kunye nezongezelelo zemifuno.

UTri-Lo-EstaryllaTMinokuchaphazela indlela amanye amayeza asebenza ngayo, kunye namanye amayeza anokuchaphazela indlela eyi-Tri-Lo-EstaryllaTMiyasebenza.

Wazi amayeza owasebenzisayo. Gcina uluhlu lwazo ukubonisa umboneleli wakho wezempilo kunye nosokhemesti xa ufumana iyeza elitsha.

Ndingayithatha njani iTri-Lo-EstaryllaTM?

Funda iMiyalelo yokuSebenzisa ekupheleni kolu lwazi lweMonde.

Zeziphi iziphumo ebezingalindelekanga ezinokubakho zeTri-Lo-EstaryllaTM?

Njengokukhulelwa, iTri-Lo-EstaryllaTMkunokubangela iziphumo ebezingalindelekanga ezimandundu, kubandakanya amahlwili egazi kwimiphunga yakho, isifo sentliziyo, okanye icala elinokubangela ukufa. Eminye imizekelo yamagazi amanzithinzithi abandakanya amahlwili egazi emilenzeni okanye emehlweni.

Ukugqabhuka kwegazi okunokwenzeka kunokwenzeka ngakumbi ukuba uyatshaya, utyebe kakhulu, okanye ungaphezulu kweminyaka engama-35 ubudala. Amagqabantshintshi egazi anokwenzeka ukuba kunokwenzeka xa:

qala ngokuthatha iipilisi zokulawula ukuzalwa
qala kwakhona iipilisi zokulawula ukuzalwa ezifanayo okanye ezahlukeneyo emva kokungazisebenzisi inyanga okanye nangaphezulu

Fowunela umboneleli wakho wezempilo okanye uye kwigumbi likaxakeka esibhedlele kwangoko ukuba unayo:

intlungu yomlenze engayi kuhamba
ukuphefumla ngokukhawuleza okukhulu
utshintsho olukhawulezileyo kumbono okanye ubumfama
iintlungu zesifuba
ngesiquphe, intloko ebuhlungu ngokungafaniyo neentloko zakho eziqhelekileyo
ubuthathaka okanye ubundindisholo engalweni okanye emlenzeni
kunzima ukuthetha

Ezinye iziphumo ebezingalindelekanga ezimbi zibandakanya:

iingxaki zesibindi, kubandakanya:
okanye
amathumba enqabileyo esibindi
okanye
i-jaundice (cholestasis), ngakumbi ukuba ngaphambili ubunayo ikholestasis yokukhulelwa. Fowunela umboneleli wakho wezempilo ukuba ulubhelu kolusu lwakho okanye amehlo.
igazi elonyukayo.Kuya kufuneka ubone umboneleli wakho wezempilo ukuze ujonge uxinzelelo lwegazi lonyaka.
iingxaki ze-gallbladder
utshintsho kwiswekile kunye namafutha (cholesterol kunye ne-triglycerides) amanqanaba egazini lakho
Intloko entsha okanye ebandayo kubandakanya iintloko zentloko
ukopha ngokungaqhelekanga okanye ngokungaqhelekanga kwilungu lobufazi kunye nokubona phakathi kwexesha lokuya exesheni, ngakumbi kwiinyanga ezintathu zokuqala uthathe iTri-Lo-EstaryllaTM.
ukudakumba
umhlaza onokwenzeka ebeleni lakho kunye nomlomo wesibeleko
ukudumba kolusu lwakho ingakumbi emlonyeni wakho, amehlo, nasemqaleni wakho (angioedema).Tsalela umnikezeli wakho wezempilo ukuba unobuso obudumbileyo, imilebe, ulwimi lomlomo okanye umqala, ezinokukhokelela ekubeni kubenzima ukugwinya okanye ukuphefumla. Ithuba lakho lokuba ne-angioedema ukuba uphakamileyo unembali ye-angioedema.
amabala amnyama esikhumba ajikeleze ibunzi lakho, impumlo, izidlele kunye nomlomo wakho, ngakumbi ngexesha lokukhulelwa (chloasma).Abasetyhini abaqhele ukufumana i-chloasma kufuneka bakuphephe ukuchitha ixesha elide elangeni, kwiindawo zokulungisa i-tanning, nangaphantsi kwezibane zelanga ngelixa bethatha iTri-Lo-EstaryllaTM. Sebenzisa i-sunscreen ukuba kufuneka ubekwe elangeni.

Zeziphi iziphumo ebezingalindelekanga eziqhelekileyo kwiTri-Lo-EstaryllaTM?

intloko ebuhlungu (kubandakanya migraine
isicaphucaphu nokugabha
iingxaki zamabele
okanye
ukuthamba, iintlungu kunye nokungonwabi
okanye
ukwanda kunye nokudumba
okanye
ukukhupha
okanye
Ingono yengono
isisu esibuhlungu
intlungu kunye nexesha lakho (umjikelezo wokuya esikhathini)
Utshintsho lwemo, kubandakanya ukudakumba
induna
usulelo lobufazi
ukudumba
ukutyeba kwakho
ukudinwa

Ayizizo zonke iziphumo ebezingalindelekanga ezinokubakho kwi-Tri-Lo-EstaryllaTM. Ngolwazi oluthe kratya, cela umboneleli wakho wezempilo okanye usokhemesti.

Unokuxela iziphumo ebezingalindelekanga kwi-FDA ngo-1-800-FDA-1088.

Yintoni enye endifanele ukuyazi ngokuthatha iTri-Lo-EstaryllaTM?

Ukuba ucwangciselwe naluphi na uvavanyo lweelebhu, xelela umboneleli wakho wezempilo ukuba uthatha iTri-Lo-EstaryllaTM. Uvavanyo oluthile lwegazi lunokuchaphazeleka yi-Tri-Lo-EstaryllaTM.
UTri-Lo-EstaryllaTMayikhuseli kusulelo lwe-HIV (i-AIDS) kunye nezinye izifo ezosulela ngokwabelana ngesondo.

Ndingayigcina njani iTri-Lo-EstaryllaTM?

Ivenkile yeTri-Lo-EstaryllaTMkubushushu begumbi phakathi kwama-68 ° F ukuya kuma-77 ° F (20 ° C ukuya kuma-25 ° C).
Gcina iTri-Lo-EstaryllaTMnawo onke amayeza apho abantwana bangenakufikelela khona.
Gcina kude nokukhanya.

Ulwazi ngokubanzi malunga nokusetyenziswa okukhuselekileyo nokusebenzayo kweTri-Lo-EstaryllaTM.

Amayeza ngamanye amaxesha amiselwe ezinye iinjongo ngaphandle kwezo zidweliswe kwiphepha elineenkcukacha ngezigulana. Sukusebenzisa iTri-Lo-EstaryllaTMngemeko ebengayichazanga. Musa ukunika iTri-Lo-EstaryllaTMkwabanye abantu, nokuba baneempawu ezifanayo nezo unazo.

Olu lwazi loMonde lushwankathela olona lwazi lubalulekileyo malunga neTri-Lo-EstaryllaTM. Ungabuza ikhemesti yakho okanye umboneleli ngenkathalo yezempilo malunga neTri-Lo-EstaryllaTMoko kubhalelwe iingcali zempilo.

ipilisi ye-m2a4 57344 i-oxycodone

Ngolwazi oluthe kratya, tsalela umnxeba iXiromed, LLC. ngo-1-844-XIROMED (844-947-6633).

Ngaba iipilisi zokulawula ukuzalwa zibangela umhlaza?

Iipilisi zolawulo lokuzalwa azibonakali ngathi zibanga umhlaza webele. Nangona kunjalo, ukuba unomhlaza webele ngoku, okanye ubukhe wanayo ngaphambili, sukusebenzisa iipilisi zokuthintela inzala kuba ezinye iintsholongwane zomhlaza webele ziwathambile amahomoni.

Abasetyhini abasebenzisa iipilisi zolawulo lokuzalwa banokuba namathuba aphezulu okufumana umhlaza womlomo wesibeleko. Nangona kunjalo, oku kunokuba ngenxa yezinye izizathu ezinjengokuba namaqabane esini ngakumbi.

Kuthekani ukuba ndifuna ukukhulelwa?

Unokuyeka ukuthatha ipilisi nanini na unqwenela. Cinga ukutyelela umboneleli wakho wezempilo ngaphambi kokukhulelwa ngaphambi kokuba uyeke ukuthatha ipilisi.

Yintoni ekufuneka ndiyazi malunga nexesha lam xa ndithatha iTri-Lo-EstaryllaTM?

Ixesha lakho linokuba lula kwaye lifutshane kunesiqhelo. Abanye abantu basetyhini banokuphoswa lixesha. Ukopha ngokungaqhelekanga kwilungu lobufazi okanye ukubonwa kungenzeka xa uthatha iTri-Lo-EstaryllaTM, ngakumbi kwiinyanga zokuqala zokusetyenziswa. Oku kuhlala kungengxaki enkulu. Kubalulekile ukuqhubeka nokuthatha iipilisi zakho kwishedyuli yesiqhelo ukunqanda ukukhulelwa.

Zithini izithako eTri-Lo-EstaryllaTM?

Izinto ezisebenzayo:Ipilisi nganye emhlophe, eluhlaza okwesibhakabhaka, kunye neblue iqulethe i-norgestimate kunye ne-ethinyl estradiol.

Izinto ezingasebenziyo:

Ithebhulethi emhlophe:i-crospovidone, i-lactose anhydrous, i-magnesium stearate, i-polyethylene glycol, i-polyvinyl yotywala, isitashi esenziwe kwangaphambili, i-talc kunye ne-titanium dioxide.

Ithebhulethi eluhlaza ekhanyayo:I-crospovidone, i-FD & C Blue No. 2 indigo carmine aluminium echibini, i-FD & C Blue No.1 ichibi elihlaza okwesibhakabhaka, i-FD & C ye-5 ye-tartrazine aluminium echibini, i-lactose anhydrous, i-magnesium stearate, i-polyethylene glycol, i-polyvinyl yotywala, isitashi esenziwe kwangaphambili, i-talc kunye ne-titanium dioxide.

Ithebhulethi eblue:crospovidone, FD & C Blue No.2 indigo carmine aluminium echibini, FD & C Blue No.1 eliqaqambileyo blue aluminiyam echibini, FD & C Yellow No. 6 kwelanga yellow fcf aluminium chibi, lactose anhydrous, wemagniziyam stearate, polyethylene glycol, polyvinyl utywala, pregelatinised starch, talc, kunye ne-titanium dioxide.

Ithebhulethi eluhlaza:crospovidone, FD & C Blue No.2 indigo carmine aluminium echibini, FD & C Yellow No.5 tartrazine aluminium echibini, lactose anhydrous, lecithin (soya), wemagniziyam stearate, polyethylene glycol, polyvinyl utywala, pregelatinised isitatshi, talc, kunye titanium dioxide.

Imiyalelo yokusetyenziswa

UTri-Lo-EstaryllaTM
(iipilisi ze-norgestimate kunye ne-ethinyl estradiol, i-USP)

(okanye u-YES-ti-mate, i-ETH-i-nil es-tra-DYE-ol)

Ulwazi olubalulekileyo malunga nokuthatha iTri-Lo-EstaryllaTM

Thatha1ipilisi yonke imihla ngaxeshanye. Thatha iipilisi ngolandelelwano olujolise kwisixhobo sakho sepilisi.
Musa ukutsiba iipilisi, nokuba awusabelani ngesondo rhoqo. Ukuba uyaphoswa ziipilisi (kubandakanya ukuqala kwepakethi kade)unokukhulelwa.Iipilisi ezininzi ozikhumbulayo, kokukhona kunokwenzeka ukuba ukhulelwe.
Ukuba unengxaki yokukhumbula ukuthatha i-Tri-Lo-EstaryllaTM, Thetha nomboneleli wakho wezempilo. Xa uqala ukuthatha iTri-Lo-EstaryllaTM, ukubonwa okanye ukuphuma kwegazi phakathi kwamaxesha akho kunokwenzeka. Nxibelelana nomboneleli wakho wezempilo ukuba oku akuyi kuhamba emva kweenyanga ezimbalwa.
Ungaziva ugula esiswini (isicaphucaphu), ngakumbi kwiinyanga zokuqala zokuthatha iTri-Lo-EstaryllaTM. Ukuba uziva ugula esiswini, sukuyeka ukuthatha ipilisi. Ingxaki ihlala ihamba. Ukuba isicaphucaphu sakho asimki, tsalela umnikezeli wakho wezempilo.
Iipilisi ezingekhoyo zisenokubangela ukubonwa okanye ukuphuma gazi, nokuba uthatha iipilisi eziphosiweyo kamva. Ngeentsuku osela kuzo iipilisi ezimbini (2) Kufuneka ndenze ntoni xa ndiphoswa naziphi na iipilisi zeTri-Lo-Estarylla TM? Apha ngezantsi), unokuziva ugula kancinci esiswini sakho.
Akuqhelekanga ukuphosa ixesha. Nangona kunjalo, ukuba uphoswa lixesha kwaye awuyithathi iTri-Lo-EstaryllaTMngokwemikhombandlela, okanye uphoswe ngamaxesha ama-2 ngokulandelelana, okanye uziva ngathi ukhulelwe, tsalela umnikezeli wakho wezempilo. Ukuba kuvavanyo oluqinisekileyo lokukhulelwa, kuya kufuneka uyeke ukuthatha iTri-Lo-EstaryllaTM.
Ukuba uyagabha okanye urhudo ngaphakathi3 ukuya ku-4iiyure zokuthatha ipilisi yakho, thatha enye ipilisi yombala ofanayo kwisixhobo sakho sepilisi esongezelelweyo. Ukuba awunaso isixhobo sepilisi esongezelelweyo, thatha ipilisi elandelayo kwisixhobo sakho sokuhambisa iipilisi. Qhubeka uthatha zonke iipilisi ezisele ngokulandelelana. Qalisa ipilisi yokuqala yesixhobo sakho sepilisi elandelayo ngosuku emva kokugqiba isixhobo sakho sepilisi yangoku. Oku kuyakuba lusuku olu-1 ngaphambi kokucwangciswa kwasekuqaleni. Qhubeka neshedyuli yakho entsha.
Ukuba ukugabha okanye urhudo ngaphezulu kosuku olu-1, iipilisi zakho zolawulo lokuzalwa azinakusebenza kakuhle. Sebenzisa indlela eyongezelelweyo yolawulo lokuzalwa, njengeikhondom kunye nokubulala isidoda, de ube ujonge umboneleli wakho wezempilo.
Yeka ukuthatha iTri-Lo-EstaryllaTMubuncinci iiveki ezi-4 ngaphambi kokuba wenze utyando olukhulu kwaye ungaqali emva kotyando ngaphandle kokucela umboneleli wakho wezempilo. Qiniseka ukuba usebenzisa ezinye iindlela zokuthintela ukukhulelwa (njengeikhondom kunye nokubulala amadlozi) ngeli xesha.

Ngaphambi kokuba uqale ukuthatha iTri-Lo-EstaryllaTM:

Thatha isigqibo sokuba leliphi ixesha losuku ofuna ukuthatha ngalo ipilisi. Kubalulekile ukuyithatha ngexesha elifanayo yonke imihla kwaye ngokulandelelana njengoko kuyalelwe kwisixhobo sakho sepilisi.
Unazo izinto zokuthintela ukukhulelwa (ikhondomu kunye nokubulala amadlozi) ezikhoyo kwaye ukuba kunokwenzeka, ipakethe epheleleyo yeepilisi xa kufuneka njalo.

Ndiqale nini ukuthatha iTri-Lo-EstaryllaTM?

Ukuba uqala ukuthatha iTri-Lo-EstaryllaTMkwaye awuzange usebenzise indlela yolawulo lokuzalwa kwehomoni ngaphambili:

Kukho iindlela ezi-2 zokuqala ukuthatha iipilisi zokulawula ukuzalwa. Ungaqala ngeCawa (ngeCawa yokuQala) okanye ngosuku lokuqala (uSuku 1) lwexesha lakho lokuya esikhathini (Usuku lokuQala lokuQala). Umboneleli wakho wezempilo kufuneka akuxelele ukuba uqale nini ukuthatha ipilisi yakho yolawulo lokuzalwa.
Ukuba usebenzisa iSunday Start, sebenzisa izinto zokuthintela ukukhulelwa ezingezizo iihomoni ezinjengeekhondom kunye nokubulala amadlozi okokuqala7iintsuku ozithathayo iTri-Lo-EstaryllaTM. Awudingi ukukhusela inzalo ukuba usebenzisa usuku lokuqala.

Ukuba uqala ukuthatha iTri-Lo-EstaryllaTMkwaye utshintsha enye ipilisi yolawulo lokuzalwa:

Qala iTri-Lo-Estarylla yakho entshaTMpack ngemini enye oza kuqala ngayo ipakethi elandelayo yendlela yakho yolawulo lokuzalwa yangaphambili.
Musa ukuqhubeka uthatha iipilisi kwipakethi yakho yolawulo lokuzalwa lwangaphambili.

Ukuba uqala ukuthatha iTri-Lo-EstaryllaTMkwaye ngaphambili ndisebenzisa iringi yelungu lobufazi okanye ipransdermal patch:

Qalisa ukusebenzisa iTri-Lo-EstaryllaTMNgosuku ubuya kuphinda usebenzise iringi okanye ipatch elandelayo.

Ukuba uqala ukuthatha iTri-Lo-EstaryllaTMkwaye utshintsha indlela yeprogesin kuphela njengokufaka okanye inaliti:

Qalisa ukuthatha iTri-Lo-EstaryllaTMNgomhla wokususwa kokumiliselwa kwakho okanye ngomhla owawuza kuba nawo ngenaliti yakho elandelayo.

Ukuba uqala ukuthatha iTri-Lo-EstaryllaTMkwaye utshintsha isixhobo se-intrauterine okanye inkqubo (IUD okanye i-IUS):

Qalisa ukuthatha iTri-Lo-EstaryllaTMNgomhla wokususwa kwe-IUD yakho okanye i-IUS.
Awudingi ukukhusela inzalo ukuba i-IUD yakho okanye i-IUS isuswe ngosuku lokuqala (Usuku 1) lwexesha lakho. Ukuba i-IUD yakho okanye i-IUS isuswe nangoluphi na olunye usuku, sebenzisa into engeyiyo eye-hormonal back-up contraception enjengeekhondom kunye nokubulala amadlozi kwiintsuku ezisi-7 zokuqala ozithathileyo iTri-Lo-EstaryllaTM.

Gcina ikhalenda yokulandelela ixesha lakho:

Ukuba eli lixesha lokuqalauthatha iipilisi zokulawula inzala, funda,'Ndiqale nini ukuthatha iTri-Lo-EstaryllaTM? 'ngentla. Landela le miyalelo nokuba yeyiphiUkuqala kweCawaokanyeUmhla woku-1 wokuqala.

Ukuqala kweCawa:

Uya kusebenzisaUkuqala kweCawaukuba umboneleli wakho wezempilo ukuxelele ukuba uthathe ipilisi yakho yokuqala ngeCawa.

Thatha ipilisi1ngeCawaemva kokuba ixesha lakho liqale.
Ukuba ixesha lakho liqala ngeCawa, thatha ipilisi '1' ngaloo mini kwaye ubhekisele kuSuku 1 Imiyalelo yokuqalisa engezantsi.
Thatha1ipilisi yonke imihla ngolandelelwano lwepilisi ngexesha elinye ngosuku ngalunye28iintsuku.
Emva kokuthatha ipilisi yokugqibelaUmhla wama-28ukusuka kwisixhobo sepilisi, qala ukuthatha ipilisi yokuqala kwipakethi entsha, kwangolo suku lweveki njengepakethi yokuqala (ngeCawa). Thatha ipilisi yokuqala kwipakethi entsha nokuba unayo okanye awunayo ixesha lakho.
Sebenzisa izinto zokuthintela ukukhulelwa ezingezizo iihomoni ezinjengeekhondom kunye nokubulala amadlozi okokuqala7iintsuku zomjikelo wokuqala owuthathayo iTri-Lo-EstaryllaTM.

Umhla woku-1 wokuqala:

Uya kusebenzisaUmhla woku-1 wokuqalaukuba ugqirha ukuxelele ukuba uthathe ipilisi yakho yokuqala (Usuku 1) kwiusuku lokuqala lwexesha lakho.

Thatha1ipilisi yonke imihla ngolandelelwano lweblister pack, ngaxeshanye ngosuku ngalunye, ukwenzela28iintsuku.
Emva kokuthatha ipilisi yokugqibelaUmhla wama-28ukusuka kwipakethe yeblister black, qala ukuthatha ipilisi yokuqala kwipakethi entsha, kwangolo suku lweveki njengepakethi yokuqala. Thatha ipilisi yokuqala kwipakethi entsha nokuba unayo okanye awunayo ixesha lakho.

UTri-Lo-EstaryllaTMIza ngepakethe yeblister. Funda le miyalelo ingezantsi xa usebenzisa iblister pack yakho.

Ipakethe nganye entsha ine blister ineepilisi ezingama-28

Iipilisi ezi-7 ezimhlophe ezinehomoni, kubaIintsuku 1 ukuya ku-7
Iipilisi ezi-7 eziluhlaza eziluhlaza kunye nehomoni, kubaIintsuku ze-8 ukuya kwe-14
Iipilisi ezi-7 eziluhlaza kunye neehomoni, zeIintsuku ezili-15 ukuya kuma-21
Iipilisi ezi-7 eziluhlaza (ngaphandle kwamahomoni), zeIintsuku ezingama-22 ukuya kuma-28.

NGAPHAMBI kokuba uqale ukuthatha iipilisi zakho

1.
GQIBA NGELIPHI IXESHA LOMNTU OFUNA UKUTHATHA IPHilisi YAKHO.
Kubalulekile ukuyithatha malunga nexesha elifanayo yonke imihla.
2.
Ipakethe yeepilisi ezingama-28 ineepilisi ezingama-21 ezimhlophe, eziluhlaza okwesibhakabhaka, kunye neblue 'esebenzayo' (ezinamahomoni) onokuzithatha iiveki ezintathu. Oku kulandelwa yiveki e-1 yeepilisi 'zokukhumbuza' eziluhlaza (ngaphandle kwamahomoni).
3. KANYE FUNDA:
1) apho kwipakethi ukuqala ukuthatha iipilisi,
2) ngoluphi uhlobo lokuthatha iipilisi (landela iintolo),
3) Amanani eveki njengoko kubonisiwe kumzobo ongezantsi.

4) QINISEKA UKUBA ULUNGILE NGAMAXESHA ONKE:
OLUNYE UHLOBO LOLAWULO LOKUZALWA (njengeikhondom okanye ukubulala amadlozi) ukuze ulusebenzise xa usiya kuphoswa ziipilisi.
UKONGEZA, IPEKILEYO EPHELELEYO.

Kufuneka ndenze ntoni xa ndiphosa nayiphi na iTri-Lo-EstaryllaTMiipilisi?

Ukuba uphoswa ipilisi enye kwiiveki 1, 2, okanye 3, landela la manyathelo:

Thatha ngokukhawuleza ukuba ukhumbule. Thatha ipilisi elandelayo ngexesha lakho eliqhelekileyo. Oku kuthetha ukuba ungathatha2iipilisi ngaphakathi1usuku.
Emva koko qhubeka usela ipilisi enye yonke imihla de ugqibe ipakethi.
Awudingi ukusebenzisa indlela yolawulo lokuzalwa xa ulala ngesondo.

Ukuba uphosa iipilisi ezimbini kwiveki yoku-1 okanye kwiveki yesi-2 yepakethi yakho, landela la manyathelo:

Thatha iipilisi ezi-2 ezilahlekileyo ngokukhawuleza kunye neepilisi ezimbini ngosuku olulandelayo.
Qhubeka nokuthatha1iipilisi yonke imihla de ugqibe ipakethe.
Sebenzisa indlela engeyiyo yehomoni yolawulo lokuzalwa (njengekhondom kunye nokubulala amadlozi) njengokubuyisela emva xa usabelana ngesondo kwiintsuku ezisi-7 zokuqala emva kokulahleka kweepilisi.

Ukuba uphosa iipilisi ezimbini ngokulandelelana kwiVeki yesi-3, okanye uphulukane neepilisi ezi-3 nangaphezulu ngokulandelelana ngeVeki yoku-1, yesi-2, okanye yesi-3 yepakethi, landela la manyathelo:

Ukuba uyi-Starter Starter yoSuku:
Yilahle yonke ipakethi yepilisi kwaye uqalise ipakethe entsha kwangolo suku.
Awunakho ukuya exesheni kule nyanga kodwa kulindeleke oku. Nangona kunjalo, ukuba uyaliphosa ixesha lakho iinyanga ezi-2 zilandelelana, tsalela umnikezeli wakho wezempilo kuba unokukhulelwa.
Unokukhulelwa xa usabelana ngesondo ngexesha lokuqala7kwiintsuku emva kokuba uqalile iipilisi zakho. KUFUNEKA usebenzise indlela engeyiyo yehomoni yolawulo lokuzalwa (njengekhondomu kunye nokubulala amadlozi) njengokubuyisela emva xa usabelana ngesondo kwiintsuku ezisi-7 zokuqala emva kokuba uqalise iipilisi zakho kwakhona.
Ukuba uyi-Starter Starter:
Qhubeka uthatha ipilisi enye yonke imihla kude kube ngeCawa. NgeCawa, lahla yonke ipakethi kwaye uqalise ipakethe entsha yeepilisi kwangolo suku.
Sebenzisa indlela engeyiyo yehomoni yolawulo lokuzalwa (njengekhondom kunye ne-spermicide) njengokubuyisela emva xa ulala ngesondo ngexesha lokuqala7kwiintsuku emva kokuba uqalile iipilisi zakho.

Ukuba unayo nayiphi na imibuzo okanye awuqinisekanga malunga nolwazi olukule ncwadana, tsalela umnikezeli wakho wezempilo.

Olu lwazi lweMonde kunye neMiyalelo yokuSebenzisa ivunyiwe yiU.S.Ukutya kunye noLawulo lweziyobisi.

Iimpawu ezidwelisiweyo luphawu lwentengiso olubhalisiweyo lwabanini bazo kwaye azizizo iimpawu zorhwebo zeXiromed, LLC.

Yenziwe yiLabatorios Leon Farma S.A., Spain

yeXiromed, LLC. IFlorham Park, NJ 07932

Imveliso yaseSpain

ISityhi sikaJanuwari 2018

PI-120-00

INqununu yePhaneli yokuBonisa

I-NDC 70700-120-85

UTri-Lo-EstaryllaTM
(Amacwecwe eNorgestimate kunye ne-Ethinyl Estradiol, USP)
0.18 mg / 0.025 mg, 0.215 mg / 0.025 mg, kunye no-0.25 mg / 0.025 mg

Iiyunithi ezi-3 (i-3x 28 ikhadi leblister)

Rx kuphela

I-TRI-LO- ESTARYLLA
Ikhithi ye-norgestimate kunye ne-ethinyl estradiol
Ulwazi lweMveliso
Uhlobo lweMveliso INKCAZELO YABANTU ILELAYIBHILE YEZIYOBISI Ikhowudi yento (Umthombo) I-NDC: 70700-120
Ukupakisha
# Ikhowudi yento Inkcazo yephakheji
1 I-NDC: 70700-120-85 IKHATHONI ezi-3 kwibhokisi enye
1 I-NDC: 70700-120-84 Ipakethe ye-1 BLISTER kwi-1 KARTON
1 1 KIT kwi-1 BLISTER PACK
Ubungakanani besahlulo
Icandelo # Ubungakanani bephakheji Ubungakanani beMveliso iyonke
Icandelo 1 7
Icandelo 2 7
Icandelo 3 7
Icandelo 4 7
Icandelo 1 le-4
I-TRI-LO- ESTARYLLA
I-tablet ye-norgestimate kunye ne-ethinyl estradiol, egutyungelweyo
Ulwazi lweMveliso
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
EZIQHELEKILEYO (EQHELEKILEYO) EZIQHELEKILEYO 0.18 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.025 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
ICROSPOVIDONE (I-15 MPA.S KWI-5%)
I-LACTOSE YONKE
IMAGNESIUM STEARATE
IPOLYETHYLENE GLYCOL, ENGAQHELEKANGA
IPOLYVINYL UTYWALA
YOKUQALA, IKONA
TALC
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala MHLOPHE Inqaku akukho manqaku
Imilo ROUND Ubungakanani 5mm
Incasa Ikhowudi yoShicilelo SZ, T5
Iqulathe
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina KUNYE091232 01/01/2018
Icandelo 2 le-4
I-TRI-LO- ESTARYLLA
I-tablet ye-norgestimate kunye ne-ethinyl estradiol, egutyungelweyo
Ulwazi lweMveliso
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
EZIQHELEKILEYO (EQHELEKILEYO) EZIQHELEKILEYO 0.215 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.025 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
ICROSPOVIDONE (I-15 MPA.S KWI-5%)
I-FD & C IBHULE NO. 2
I-FD & C IBHULE NO. 1
I-FD & C YELLOW NGOKOMTHETHO. 5
I-LACTOSE YONKE
IMAGNESIUM STEARATE
IPOLYETHYLENE GLYCOL, ENGAQHELEKANGA
IPOLYVINYL UTYWALA
YOKUQALA, IKONA
TALC
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala LUHLAZA (luhlaza okwesibhakabhaka) Inqaku akukho manqaku
Imilo ROUND Ubungakanani 5mm
Incasa Ikhowudi yoShicilelo SZ; T6
Iqulathe
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina KUNYE091232 01/01/2018
Icandelo 3 le-4
I-TRI-LO- ESTARYLLA
I-tablet ye-norgestimate kunye ne-ethinyl estradiol, egutyungelweyo
Ulwazi lweMveliso
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
EZIQHELEKILEYO (EQHELEKILEYO) EZIQHELEKILEYO 0.25 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.025 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
ICROSPOVIDONE (I-15 MPA.S KWI-5%)
I-FD & C IBHULE NO. 1
I-FD & C IBHULE NO. 2
I-FD & C YELLOW NGOKOMTHETHO. 6
I-LACTOSE YONKE
IMAGNESIUM STEARATE
IPOLYETHYLENE GLYCOL, ENGAQHELEKANGA
IPOLYVINYL UTYWALA
YOKUQALA, IKONA
TALC
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala LUHLAZA Inqaku akukho manqaku
Imilo ROUND Ubungakanani 5mm
Incasa Ikhowudi yoShicilelo SZ; T7
Iqulathe
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina KUNYE091232 01/01/2018
Icandelo 4 le-4
I-TRI-LO- ESTARYLLA
I-tablet ye-norgestimate kunye ne-ethinyl estradiol, egutyungelweyo
Ulwazi lweMveliso
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Izithako ezingasebenziyo
Igama lezithako Amandla
ICROSPOVIDONE (I-15 MPA.S KWI-5%)
I-FD & C IBHULE NO. 2
I-FD & C YELLOW NGOKOMTHETHO. 5
I-LACTOSE YONKE
LECITHIN, ISOYBEAN
IMAGNESIUM STEARATE
IPOLYETHYLENE GLYCOL, ENGAQHELEKANGA
IPOLYVINYL UTYWALA
YOKUQALA, IKONA
TALC
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala LUHLAZA Inqaku akukho manqaku
Imilo ROUND Ubungakanani 5mm
Incasa Ikhowudi yoShicilelo SZ; J1
Iqulathe
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina KUNYE091232 01/01/2018
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina KUNYE091232 01/01/2018
Umlebheli -Xiromed, LLC. (080228637)
Umbhalisi -IPHARMA EXIROMED ESPANA, SL (468835741)
Xiromed, LLC.

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