Tri-Estarylla

Lub npe dav: norgestimate thiab ethinyl estradiol
Dosage form: ntsiav tshuaj
Chav kawm tshuaj: Cov tshuaj tiv thaiv kab mob

Ntawm nplooj ntawv no

• Boxed Warning
• Indications thiab siv
• Dosage thiab Administration
• Daim ntawv siv tshuaj thiab muaj zog
• Contraindications
• Ceeb toom thiab ceev faj
• Cov Kev Phem Tsis Zoo/Sib Phem
• Kev Sib Tham Tshuaj
• Siv nyob rau hauv cov neeg tshwj xeeb
• Kev noj ntau dhau
• Kev piav qhia
• Clinical Pharmacology
• Nonclinical Toxicology
• Kev tshawb fawb soj ntsuam
• Yuav Ua Li Cas Muab / Cia thiab tuav
• Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Cov lus qhia thiab kev siv rau Tri-Estarylla

Cov tshuaj tiv thaiv qhov ncauj

Tri-Estarylla ™ (norgestimate thiab ethinyl estradiol ntsiav tshuaj) yog qhia rau kev siv los ntawm cov poj niam uas muaj peev xwm xeeb tub los tiv thaiv cev xeeb tub [saib KEV KHO MOB (14) ].

Pob txuv

Tri-Estarylla ™ yog qhia rau kev kho mob ntawm pob txuv vulgaris nyob rau hauv cov poj niam tsawg kawg yog 15 xyoo, uas tsis paub contraindications rau qhov ncauj contraceptive kho mob thiab tau ua tiav menarche. Tri-Estarylla ™ yuav tsum tau siv rau kev kho pob txuv nkaus xwb yog tias tus neeg mob xav tau cov tshuaj tiv thaiv qhov ncauj rau kev yug menyuam [saibClinical STUDIES ( 14 )].

Tri-Estarylla Dosage thiab Administration

Yuav Ua Li Cas Pib Tri-Estarylla ™

Tri-Estarylla ™ (norgestimate thiab ethinyl estradiol ntsiav tshuaj), yog dispensed nyob rau hauv ib lub pob hlwv [saibYUAV UA LI CAS YUAV TSUM PAUB / NTAUB NTAWV THIAB HLOOV ( 16 )].Tri-Estarylla ™ tej zaum yuav pib siv hnub 1 pib lossis hnub Sunday pib (saibTable 1).Rau thawj lub voj voog ntawm Hnub Caiv Pib Hnub Caiv, yuav tsum siv txoj kev tiv thaiv ntxiv kom txog thaum thawj 7 hnub sib law liag ntawm kev tswj hwm.

Yuav Siv Li Cas Tri-Estarylla ™

Table 1: Cov Lus Qhia rau Kev Tswj Xyuas Tri-Estarylla™

Pib Tri-Estarylla™tom qab Abortion los yog Miscarriage

Thawj peb lub hlis twg

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Tom qab kev rho menyuam thawj peb lub hlis twg lossis nchuav menyuam, Tri-Estarylla ™ tuaj yeem pib tam sim ntawd. Tsis xav tau ib txoj kev tiv thaiv ntxiv yog tias Tri-Estarylla ™ pib tam sim ntawd.

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Yog tias Tri-Estarylla ™ tsis tau pib hauv 5 hnub tom qab txiav tawm ntawm cev xeeb tub, tus neeg mob yuav tsum siv cov tshuaj tiv thaiv kab mob uas tsis yog tshuaj hormones ntxiv (xws li cov hnab looj tes thiab tshuaj tua kab mob) rau thawj xya hnub ntawm nws thawj lub voj voog ntawm Tri-Estarylla ™.

Peb lub hlis thib ob

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Tsis txhob pib mus txog 4 lub lis piam tom qab rho menyuam thib peb lub hlis twg los yog nchuav menyuam, vim muaj kev pheej hmoo ntawm cov kab mob thromboembolic. Pib Tri-Estarylla ™, ua raws li cov lus qhia hauv Table 1 rau Hnub 1 lossis hnub Sunday pib, raws li xav tau. Yog tias siv hnub Sunday pib, siv cov tshuaj tiv thaiv kab mob uas tsis yog tshuaj hormonal ntxiv (xws li cov hnab looj tes thiab tshuaj tua kab mob) rau thawj xya hnub ntawm tus neeg mob thawj lub voj voog ntawm Tri-Estarylla™. [Saib KEV PAB CUAM (4) , CEEB TOOM THIAB KEV TIV THAIV (5.1) , thiab FDA-pom zoo tus neeg mob Labeling .]

Pib Tri-Estarylla™ tom qab yug me nyuam

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Tsis txhob pib mus txog 4 lub lis piam tom qab yug me nyuam, vim muaj kev pheej hmoo ntawm cov kab mob thromboembolic. Pib siv tshuaj tiv thaiv kab mob nrog Tri-Estarylla ™ ua raws li cov lus qhia hauv Table 1 (saum toj no) rau cov poj niam uas tsis siv tshuaj tiv thaiv hormonal tam sim no.

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Tri-Estarylla ™ tsis pom zoo siv rau cov poj niam lactating [saib Siv rau hauv cov neeg tshwj xeeb (8.3) ].

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Yog tias tus poj niam tseem tsis tau muaj lub sijhawm tom qab yug menyuam, xav txog qhov muaj peev xwm ntawm ovulation thiab conception tshwm sim ua ntej siv Tri-Estarylla ™. [Saib KEV PAB CUAM (4) , CEEB TOOM THIAB KEV TIV THAIV (5.1) , Siv rau hauv cov neeg tshwj xeeb (8.1 thiab 8.3) , thiab FDA-pom zoo tus neeg mob Labeling ].

Ua ntej Koj pib noj koj cov tshuaj

ib.

Txiav txim siab ntev npaum li cas hnub koj xav noj koj cov tshuaj.
Nws yog ib qho tseem ceeb uas yuav tsum tau coj nws ntawm tib lub sijhawm txhua hnub.

ob.

Saib ntawm koj cov tshuaj BLISTER PACK

Cov ntsiav tshuaj muaj 21 cov tshuaj nquag (nrog cov tshuaj hormones) noj rau 3 lub lis piam. Qhov no yog ua raws li 1 lub lis piam nco ntsoov cov tshuaj ntsuab (tsis muaj tshuaj hormones).

3. TSIS MUAJ:

ib)

qhov twg ntawm pob pib noj tshuaj,

ob)

nyob rau hauv dab tsi thiaj li yuav noj cov tshuaj (ua raws li cov xub)

3)

Lub lim tiam tus lej raws li qhia hauv daim duab hauv qab no

4. YUAV TSUM TAU TXAIS NYIAJ NYIAJ TAG NRHO:

Lwm hom kev tiv thaiv kev yug menyuam (xws li hnab looj tes lossis tshuaj tua kab mob) siv los ua ib txoj hauv kev rov qab yog tias koj tsis tshuaj.

Ib qho ntxiv, tag nrho cov tshuaj hlwv pob.

Tsis nco qab ntsiav tshuaj

Cov lus qhia nyob rau hauv rooj plaub ntawm Gastrointestinal Disturbance

Yog hais tias ntuav hnyav los yog raws plab, kev nqus yuav tsis ua tiav thiab yuav tsum tau siv tshuaj tiv thaiv ntxiv. Yog ntuav lossis zawv plab tshwm sim li ntawm 3 mus rau 4 teev tom qab noj cov ntsiav tshuaj ua haujlwm, tuav qhov no raws li cov ntsiav tshuaj tsis tau [saib FDA-pom zoo tus neeg mob Labeling ].

Tri-Estarylla ™ Siv rau pob txuv

Lub sijhawm pib ntawm kev txhaj tshuaj nrog Tri-Estarylla ™ rau pob txuv yuav tsum ua raws li cov lus qhia rau kev siv Tri-Estarylla ™ ua tshuaj tiv thaiv qhov ncauj. Nrog rauQHOV CHAW UA HAUJ LWM THIAB KEV KAWM NTAWV (2.1)rau cov lus qhia

Daim ntawv siv tshuaj thiab muaj zog

Tri-Estarylla ™ ntsiav tshuaj muaj nyob rau hauv blister cards. Txhua pob hlwv muaj

28 ntsiav tshuaj hauv qab no:

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7 ntsiav tshuaj dawb (active) yog puag ncig, debossed nrog SZ ntawm ib sab thiab T2 ntawm sab nraud thiab muaj 0.18 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

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7 lub teeb xiav (active) ntsiav tshuaj yog puag ncig, debossed nrog SZ ntawm ib sab thiab T3 ntawm sab nraud thiab muaj 0.215 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

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7 ntsiav tshuaj xiav (active) yog puag ncig, debossed nrog SZ ntawm ib sab thiab T4 nyob rau sab nraud thiab muaj 0.25 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

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7 ntsiav tshuaj ntsuab (inert) yog puag ncig, debossed nrog SZ ntawm ib sab thiab J1 ntawm lwm sab.

Contraindications

Tsis txhob sau cov tshuaj norgestimate thiab ethinyl estradiol rau cov poj niam uas paub tias muaj cov xwm txheej hauv qab no:

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Muaj kev pheej hmoo siab ntawm cov kab mob venous lossis venous thrombotic. Piv txwv li cov poj niam uas paub txog:

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Haus luam yeeb, yog tias muaj hnub nyoog tshaj 35 xyoos [saib BOXED WARNING thiab CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Muaj cov hlab ntsha sib sib zog nqus los yog pulmonary embolism, tam sim no lossis yav dhau los [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Tau txais los yog tau txais hypercoagulopathies [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Muaj kab mob cerebrovascular [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Muaj kab mob coronary artery [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Muaj thrombogenic valvular lossis thrombogenic atherosclerosis ntawm lub plawv (piv txwv li, subacute bacterial endocarditis nrog kab mob valvular, lossis atrial fibrillation) [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Muaj kev tswj tsis tau ntshav siab [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.4 )]

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Muaj ntshav qab zib mellitus nrog cov kab mob vascular [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.6 )]

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Muaj mob taub hau nrog cov tsos mob ntawm lub paj hlwb los yog mob taub hau migraine nrog aura [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.7 )]

ib.

Cov poj niam muaj hnub nyoog tshaj 35 xyoos uas muaj mob taub hau migraine [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.7 )]

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Cov qog nqaij hlav hauv siab, benign lossis malignant, lossis kab mob siab [saib CEEB TOOM THIAB KEV TIV THAIV (5.2) ]

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Undiagnosed abnormal uterine los ntshav [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.8 )]

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Kev xeeb tub, vim tias tsis muaj laj thawj siv COCs thaum cev xeeb tub [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.9 ) thiab siv rau hauv cov neeg tshwj xeeb ( 8.1 )]

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Mob qog noj ntshav mis lossis lwm yam tshuaj estrogen- lossis progestin-sensitive cancer, tam sim no lossis yav dhau los [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.11 )]

• Kev siv tshuaj sib xyaw ua rau kab mob siab C uas muaj ombitasvir/paritaprevir/ritonavir, nrog lossis tsis muaj dasabuvir, vim muaj peev xwm rau ALT nce [saibCEEB TOOM THIAB KEV TIV THAIV ( 5.3 )]

Ceeb toom thiab ceev faj

Thromboembolic Disorders thiab lwm yam teeb meem vascular

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Tso tseg norgestimate thiab ethinyl estradiol yog tias muaj qhov tshwm sim ntawm arterial thrombotic lossis venous thromboembolic (VTE) tshwm sim.

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Tsis txhob noj cov tshuaj norgestimate thiab ethinyl estradiol yog tias muaj qhov tsis pom kev tsis pom kev, proptosis, diplopia, papilledema, lossis cov kab mob hauv lub qhov muag. Ntsuam xyuas rau retinal vein thrombosis tam sim ntawd [saib TXOJ CAI TSHIAB (6.2) ].

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Yog tias ua tau, nres norgestimate thiab ethinyl estradiol tsawg kawg 4 lub lis piam ua ntej thiab mus txog 2 lub lis piam tom qab kev phais loj lossis lwm yam kev phais uas paub tias muaj kev pheej hmoo siab ntawm VTE nrog rau thaum lub sij hawm thiab tom qab lub sij hawm ntev immobilization.

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Pib norgestimate thiab ethinyl estradiol tsis pub dhau 4 lub lis piam tom qab yug me nyuam, hauv cov poj niam uas tsis pub niam mis. Qhov kev pheej hmoo ntawm postpartum VTE txo qis tom qab lub lim tiam thib peb tom qab yug me nyuam, qhov kev pheej hmoo ntawm ovulation nce tom qab lub lim tiam thib peb tom qab yug me nyuam.

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Kev siv COCs ua rau muaj kev pheej hmoo ntawm VTE. Txawm li cas los xij, kev xeeb tub ua rau muaj kev pheej hmoo ntawm VTE ntau lossis ntau dua li kev siv COCs. Qhov kev pheej hmoo ntawm VTE hauv cov poj niam uas siv COCs yog 3 txog 9 tus neeg rau 10,000 tus poj niam-xyoo. Qhov kev pheej hmoo ntawm VTE yog qhov siab tshaj plaws thaum thawj xyoo ntawm kev siv COCs thiab thaum rov pib tshuaj tiv thaiv kab mob hormonal tom qab so ntawm 4 lub lis piam lossis ntev dua. Qhov kev pheej hmoo ntawm tus kab mob thromboembolic vim COCs maj mam ploj tom qab siv tsis tas.

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Kev siv COCs kuj ua rau muaj kev pheej hmoo ntawm cov hlab ntsha thromboses xws li mob stroke thiab myocardial infarctions, tshwj xeeb tshaj yog cov poj niam uas muaj lwm yam kev pheej hmoo rau cov xwm txheej no. COCs tau pom tias yuav ua rau muaj kev pheej hmoo ntawm cov kab mob cerebrovascular (thrombotic thiab hemorrhagic strokes). Qhov kev pheej hmoo no nce ntxiv thaum muaj hnub nyoog, tshwj xeeb tshaj yog cov poj niam hnub nyoog tshaj 35 xyoos uas haus luam yeeb.

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Siv COCs nrog ceev faj rau cov poj niam uas muaj kab mob plawv.

Kab mob siab

Lub siab ua haujlwm tsis zoo

Tsis txhob siv cov norgestimate thiab ethinyl estradiol rau cov poj niam uas muaj kab mob siab, xws li kab mob siab viral kab mob siab lossis mob hnyav (decompensated) cirrhosis ntawm daim siab [saib KEV PAB CUAM (4) ].Kev mob hnyav lossis mob ntev ntawm daim siab ua haujlwm yuav xav tau kev txiav tawm ntawm COC siv kom txog thaum cov cim ntawm daim siab ua haujlwm rov qab mus rau qhov qub thiab COC ua rau raug tshem tawm. Txiav tawm cov tshuaj norgestimate thiab ethinyl estradiol yog tias daj ntseg tshwm sim.

Kab mob siab

Norgestimate thiab ethinyl estradiol yog contraindicated nyob rau hauv cov poj niam uas muaj benign thiab malignant daim siab mob [saib KEV PAB CUAM (4) ]. Hepatic adenomas yog txuam nrog kev siv COC. Kev kwv yees ntawm qhov muaj feem cuam tshuam yog 3.3 tus neeg mob / 100,000 tus neeg siv COC. Kev tawg ntawm hepatic adenomas tuaj yeem ua rau tuag los ntawm kev mob plab hauv plab.

Cov kev tshawb fawb tau pom tias muaj kev pheej hmoo ntau ntxiv ntawm kev tsim cov kab mob hepatocellular carcinoma nyob rau lub sijhawm ntev (> 8 xyoo) cov neeg siv COC. Txawm li cas los xij, kev pheej hmoo ntawm mob qog noj ntshav hauv COC cov neeg siv tsawg dua ib kis ntawm ib lab tus neeg siv.

5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

Thaum lub sij hawm soj ntsuam nrog cov kab mob siab C ua ke cov tshuaj noj uas muaj ombitasvir / paritaprevir / ritonavir, nrog lossis tsis muaj dasabuvir, ALT nce siab dua 5 npaug ntawm qhov txwv siab tshaj ntawm ib txwm (ULN), suav nrog qee kis ntau dua 20 npaug ntawm ULN, tau nce ntau. Ntau zaus hauv cov poj niam siv cov tshuaj ethinyl estradiol, xws li COCs. Txiav tawm norgestimate thiab ethinyl estradiol ua ntej pib kho nrog kev siv tshuaj sib xyaw ua ke ombitasvir / paritaprevir / ritonavir, nrog lossis tsis muaj dasabuvir [saibKEV PAB CUAM (4)]. Norgestimate thiab ethinyl estradiol tuaj yeem rov pib dua li ntawm 2 lub lis piam tom qab ua tiav kev kho mob nrog kab mob siab C ua ke nrog tshuaj noj.

Ntshav siab

Norgestimate thiab ethinyl estradiol yog contraindicated nyob rau hauv cov poj niam uas tsis tswj ntshav siab los yog kub siab nrog vascular kab mob [saib KEV PAB CUAM (4) ].Rau cov poj niam uas tswj tau zoo ntshav siab, saib xyuas ntshav siab thiab nres Norgestimate thiab ethinyl estradiol yog tias ntshav siab nce siab.

Kev nce ntshav siab tau raug tshaj tawm hauv cov poj niam noj COCs, thiab qhov kev nce ntxiv no feem ntau tshwm sim hauv cov poj niam laus uas siv sijhawm ntev dua. Qhov tshwm sim ntawm kev kub siab nce nrog kev nce qib ntawm progestin.

Kab mob gallbladder

Cov kev tshawb fawb qhia tias muaj kev pheej hmoo me me ntawm kev tsim kab mob gallbladder ntawm cov neeg siv COC. Kev siv COCs tuaj yeem ua rau cov kab mob gallbladder uas twb muaj lawm. Cov keeb kwm yav dhau los ntawm COC ntsig txog cholestasis kwv yees muaj kev pheej hmoo ntxiv nrog kev siv COC tom ntej. Cov poj niam uas muaj keeb kwm ntawm cev xeeb tub-txog cholestasis tej zaum yuav muaj kev pheej hmoo ntxiv rau COC ntsig txog cholestasis.

Carbohydrate thiab Lipid Metabolic cuam tshuam

Ua tib zoo saib xyuas cov poj niam prediabetic thiab ntshav qab zib uas noj cov tshuaj norgestimate thiab ethinyl estradiol. COCs tuaj yeem txo qis kev ua rau cov piam thaj.

Xav txog lwm txoj kev tiv thaiv kab mob rau cov poj niam uas tsis tswj tau dyslipidemia. Ib feem me me ntawm cov poj niam yuav muaj qhov tsis zoo lipid hloov pauv thaum nyob ntawm COCs.

Cov poj niam uas muaj hypertriglyceridemia, los yog tsev neeg keeb kwm ntawm no, tej zaum yuav muaj kev pheej hmoo ntawm tus mob pancreatitis thaum siv COCs.

Mob taub hau

Yog hais tias ib tug poj niam noj norgestimate thiab ethinyl estradiol tsim mob taub hau tshiab uas rov tshwm sim, tsis tu ncua, los yog hnyav, ntsuas qhov ua rau thiab txiav tsis siv cov norgestimate thiab ethinyl estradiol yog qhia.

Xav txog kev txiav tawm ntawm norgestimate thiab ethinyl estradiol nyob rau hauv cov ntaub ntawv ntawm ntau zaus los yog mob migraine thaum lub sij hawm siv COC (uas tej zaum yuav prodromal ntawm ib tug cerebrovascular tshwm sim).

Los ntshav tsis xwm yeem thiab Amenorrhea

Unscheduled Bleeding thiab Spotting

Unscheduled (tawg los yog intracyclic) los ntshav thiab pom qee zaum tshwm sim hauv cov neeg mob ntawm COCs, tshwj xeeb tshaj yog nyob rau thawj peb lub hlis ntawm kev siv. Yog hais tias los ntshav tsis tu ncua los yog tshwm sim tom qab lub voj voog dhau los, xyuas seb qhov ua rau muaj mob xws li cev xeeb tub lossis mob qog noj ntshav. Yog tias tsis suav nrog pathology thiab cev xeeb tub, cov ntshav tsis xwm yeem tuaj yeem daws tau dhau sijhawm lossis nrog kev hloov pauv mus rau lwm yam tshuaj tiv thaiv kab mob.

Hauv kev sim tshuaj ntsuam xyuas ntawm norgestimate thiab ethinyl estradiol, qhov zaus thiab lub sijhawm ntawm kev tawg los ntshav thiab / lossis pom tau raug soj ntsuam hauv 1,647 tus neeg mob (21,275 lub voj voog ntsuas) thiab 4,826 tus neeg mob (35,546 lub voj voog ntsuas), feem. Tag nrho ntawm 231 (4.8%) cov poj niam txiav tsis siv tshuaj norgestimate thiab ethinyl estradiol tsawg kawg yog ib feem, vim los ntshav los yog pom. Raws li cov ntaub ntawv los ntawm kev sim tshuaj, 13 mus rau 38% ntawm cov poj niam uas siv norgestimate thiab ethinyl estradiol tau ntsib los ntshav tsis tau teem caij rau ib lub voj voog hauv thawj xyoo. Cov feem pua ​​​​ntawm cov poj niam uas tau dhau los / tsis tau teem sijhawm los ntshav yuav txo qis thaum lub sijhawm.

Amenorrhea thiab Oligomenorrhea

Cov poj niam uas siv norgestimate thiab ethinyl estradiol tej zaum yuav muaj amenorrhea. Qee tus poj niam yuav muaj amenorrhea lossis oligomenorrhea tom qab txiav tawm ntawm COCs, tshwj xeeb tshaj yog thaum muaj tus mob no ua ntej.

koj puas tuaj yeem siv tylenol nrog amoxicillin

Yog tias tsis tau teem sijhawm (hla) los ntshav tsis tshwm sim, xav txog qhov muaj feem yuav xeeb tub. Yog hais tias tus neeg mob tsis tau ua raws li lub sij hawm noj tshuaj (tso ib los yog ntau lub active ntsiav tshuaj los yog pib noj lawv nyob rau ib hnub tom qab nws yuav tsum muaj), xav txog qhov muaj peev xwm ntawm cev xeeb tub thaum lub sij hawm ntawm thawj lub sij hawm tsis nco qab thiab coj cov kev ntsuam xyuas tsim nyog. . Yog tias tus neeg mob tau ua raws li cov cai tswj hwm thiab tsis ua ob lub sijhawm sib law liag, txiav txim siab cev xeeb tub.

COC Siv ua ntej lossis thaum ntxov cev xeeb tub

Kev tshawb fawb txog kab mob kis thoob qhov txhia chaw tau qhia tias tsis muaj kev pheej hmoo ntawm kev yug me nyuam hauv cov poj niam uas tau siv cov tshuaj tiv thaiv qhov ncauj ua ntej cev xeeb tub. Cov kev tshawb fawb tseem tsis tau qhia txog cov txiaj ntsig teratogenic, tshwj xeeb tshaj yog nyob rau hauv kom deb li deb ntawm kev mob plawv thiab kev txo qis ntawm lub cev muaj kev txhawj xeeb, thaum cov tshuaj tiv thaiv qhov ncauj raug coj los ua tsis tau thaum cev xeeb tub. Tsis siv cov norgestimate thiab ethinyl estradiol yog tias cev xeeb tub.

Kev tswj hwm ntawm COCs txhawm rau txhawm rau tshem tawm los ntshav yuav tsum tsis txhob siv los ua kev kuaj cev xeeb tub [saib Siv rau hauv cov neeg tshwj xeeb (8.1) ].

Kev nyuaj siab

Ua tib zoo saib xyuas cov poj niam uas muaj keeb kwm ntawm kev nyuaj siab thiab txiav tawm norgestimate thiab ethinyl estradiol yog tias kev nyuaj siab rov tshwm sim rau qhov hnyav.

Carcinoma ntawm lub mis thiab Cervix

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norgestimate thiab ethinyl estradiol yog contraindicated nyob rau hauv cov poj niam uas tam sim no muaj los yog muaj mob cancer mis vim hais tias mob cancer ntawm lub mis tej zaum yuav hormonally rhiab heev [saib KEV PAB CUAM (4) ].

Muaj cov pov thawj tseem ceeb uas COCs tsis ua rau muaj mob qog noj ntshav ntawm lub mis. Txawm hais tias qee qhov kev tshawb fawb yav dhau los tau qhia tias COCs tuaj yeem ua rau muaj mob qog noj ntshav ntawm lub mis, kev tshawb fawb tsis ntev los no tsis tau lees paub qhov kev tshawb pom no.

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Qee cov kev tshawb fawb qhia tias kev siv COC tau cuam tshuam nrog kev pheej hmoo ntawm kev mob qog noj ntshav hauv tsev menyuam lossis intraepithelial neoplasia. Txawm li cas los xij, tseem muaj kev tsis sib haum xeeb txog qhov uas qhov kev tshawb pom no yuav yog vim qhov sib txawv ntawm tus cwj pwm kev sib deev thiab lwm yam.

Qhov cuam tshuam rau Kev khi Globulins

Cov tshuaj estrogen ntawm COCs tuaj yeem nce cov ntshav cov ntshav ntawm thyroxine-binding globulin, kev sib deev hormone-binding globulin, thiab cortisol-binding globulin. Kev hloov pauv cov thyroid hormone lossis cortisol kho yuav tsum tau nce ntxiv.

Saib xyuas

Tus poj niam uas noj COCs yuav tsum tau mus ntsib nws txhua xyoo nrog nws tus kws kho mob kom kuaj ntshav siab thiab rau lwm yam kev kho mob uas qhia.

Kab mob Angioedema

Hauv cov poj niam uas muaj keeb kwm ntawm angioedema, exogenous estrogens tuaj yeem ua rau lossis ua rau cov tsos mob ntawm angioedema.

Chloasma

Chloasma tej zaum yuav tshwm sim, tshwj xeeb tshaj yog nyob rau hauv cov poj niam uas muaj keeb kwm ntawm chloasma gravidarum. Cov poj niam uas nyiam chloasma yuav tsum tsis txhob raug tshav ntuj lossis hluav taws xob ultraviolet thaum noj cov tshuaj norgestimate thiab ethinyl estradiol.

Kev Phem Tsis Zoo

Cov kev cuam tshuam loj hauv qab no nrog kev siv COCs tau tham txog lwm qhov hauv kev sau npe:

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Mob plawv mob plawv thiab mob stroke [saib BOXED WARNING thiab CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Vascular xwm txheej [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ]

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Kab mob siab [saib CEEB TOOM THIAB KEV TIV THAIV (5.2) ]

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Cov tshuaj tiv thaiv tsis zoo uas tau tshaj tawm los ntawm cov neeg siv COC yog:

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uterine los ntshav

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Ntshai

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Lub mis mos

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Mob taub hau

Kev sim tshuaj ntsuam xyuas

Vim tias qhov kev sim tshuaj ntsuam xyuas tau ua nyob rau hauv cov xwm txheej sib txawv, cov txiaj ntsig tsis zoo tshwm sim hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem ncaj qha piv rau cov nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab tej zaum yuav tsis cuam tshuam txog cov nqi hauv kev kho mob.

Kev nyab xeeb ntawm norgestimate thiab ethinyl estradiol tau soj ntsuam hauv 4,826 tus poj niam noj qab haus huv ntawm cov menyuam muaj peev xwm muaj peev xwm koom nrog 6 qhov kev sim tshuaj thiab tau txais tsawg kawg 1 koob tshuaj norgestimate thiab ethinyl estradiol rau kev tiv thaiv. Ob qhov kev sim no tau randomized active-tswj sim thiab 4 yog uncontrolled qhib-label sim. Hauv 3 qhov kev sim, cov ntsiab lus tau ua raws li 24 lub voj voog; hauv 2 qhov kev sim, cov ntsiab lus tau ua raws li 12 lub voj voog; thiab hauv 1 kev sim, cov ntsiab lus tau ua raws li 6 lub voj voog.

Kev Ua Phem Tsis Txaus Siab (≧ 2% ntawm cov ntsiab lus):Qhov tshwm sim tsis zoo tshaj plaws tau tshaj tawm los ntawm tsawg kawg 2% ntawm 4,826 tus poj niam yog cov hauv qab no kom txo qis qhov tshwm sim: mob taub hau / migraine (33.6%), teeb meem ntawm lub mis (xws li mob lub mis, loj, thiab tawm) (8%), qhov chaw mos. kab mob (7.1%), mob plab / plab hnyuv (5.6%), kev puas siab puas ntsws (xws li kev hloov pauv ntawm lub siab thiab kev nyuaj siab) (3.8%), qhov chaw mos tawm (3.2%), thiab kev hloov pauv hauv qhov hnyav (xws li qhov hnyav nce, nce lossis txo) ( 2.5%).

Cov Kev Phem Tsis Zoo Ua Rau Kev Kawm Tsis Muaj Kev Kawm:Tshaj li qhov kev sim siab, nruab nrab ntawm 9 txog 27% ntawm cov neeg kawm tau txiav tawm qhov kev sim vim muaj kev cuam tshuam tsis zoo. Feem ntau cov kev phiv tshwm sim (≧1%) ua rau tsis ua haujlwm yog: metrorrhagia (4.3%), xeev siab / ntuav (2.8%), mob taub hau / migraine (2.4%), lub siab tsis zoo (xws li kev nyuaj siab thiab lub siab hloov pauv) (1.1%) , thiab hnyav nce (1.1%).

Qhov Teeb Meem Tsis Txaus Siab:mob cancer ntawm lub mis (1 yam), carcinoma ntawm lub ncauj tsev menyuam nyob rau hauv situ (1 yam), kub siab (1 yam), thiab migraine (2 yam).

Postmarketing Experience

Cov kev phiv tshuaj ntxiv hauv qab no tau tshaj tawm los ntawm thoob ntiaj teb kev tshaj tawm kev lag luam nrog norgestimate / ethinyl estradiol. Vim tias cov tshuaj tiv thaiv no tau lees paub los ntawm cov pej xeem tsis paub meej qhov loj, nws tsis yog ib txwm ua tau kom ntseeg tau tias lawv cov zaus los yog tsim kom muaj kev sib raug zoo rau kev siv tshuaj.

Kab mob thiab kab mob:Cov kab mob urinary;

Neoplasms Benign, Malignant thiab Unspecified (Incl. Cysts thiab Polyps):mob cancer mis, benign mis neoplasm, hepatic adenoma, focal nodular hyperplasia, lub mis cyst;

Immune System Disorders:Hypersensitivity;

Metabolism thiab noj zaub mov tsis zoo:Dyslipidemia;

Psychiatric Disorders:Kev ntxhov siab, insomnia;

Nruas System Disorders:Syncope, convulsion, paresthesia, kiv taub hau;

Qhov muag tsis pom kev:Qhov muag tsis pom kev, qhov muag qhuav, tiv thaiv lub lens intolerance;

Pob ntseg thiab Labyrinth Disorders:Vertigo;

Mob plawv:tachycardia, palpitations;

Cov xwm txheej vascular:Cov hlab ntsha sib sib zog nqus thrombosis, pulmonary embolism, retinal vascular thrombosis, kub ntws;

Cov xwm txheej Arterial:arterial thromboembolism, myocardial infarction, kev huam yuaj cerebrovascular;

Ua pa, Thoracic thiab Mediastinal Disorders:Ua tsis taus pa;

Mob plab hnyuv:Pancreatitis, mob plab, raws plab, cem quav;

Hepatobiliary Kev puas tsuaj:Kab mob siab;

Cov tawv nqaij thiab cov ntaub so ntswg subcutaneous:Angioedema, erythema nodosum, hirsutism, hmo ntuj tawm hws, hyperhidrosis, photosensitivity cov tshuaj tiv thaiv, urticaria, pruritus, pob txuv;

Musculoskeletal, Connective Tissue, thiab Pob Txha:Cov leeg nqaij spasms, mob hauv qhov kawg, myalgia, mob nraub qaum;

Reproductive System thiab mis tsis zoo:Ovarian cyst, suppressed lactation, vulvovaginal dryness;

General Disorders thiab Administration Site Conditions:Mob hauv siab, mob asthenic.

Kev Sib Tham Tshuaj

Nrog rau daim ntawv lo ntawm cov tshuaj siv ib txhij kom tau txais cov ntaub ntawv ntxiv txog kev sib cuam tshuam nrog cov tshuaj tiv thaiv hormonal lossis lub peev xwm rau kev hloov pauv enzyme.

Tsis muaj kev tshawb fawb txog tshuaj-tshuaj yeeb tshuaj tau ua nrog norgestimate thiab ethinyl estradiol.

Cov txiaj ntsig ntawm Lwm Cov Tshuaj ntawm Cov Tshuaj Tiv Thaiv Kab Mob Ua Ke

Cov tshuaj txo cov ntshav plasma concentration ntawm COCs

Cov tshuaj los yog tshuaj ntsuab tshuaj uas ua rau muaj qee yam enzymes, suav nrog cytochrome P450 3A4 (CYP3A4), tuaj yeem txo cov ntshav plasma concentrations ntawm COCs thiab ua rau txo qis cov txiaj ntsig ntawm COCs lossis ua kom cov ntshav tawm. Qee cov tshuaj lossis tshuaj ntsuab uas tuaj yeem txo cov txiaj ntsig ntawm cov tshuaj tiv thaiv hormonal muaj xws li phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, John thiab cov khoom uas muaj St. Kev sib cuam tshuam ntawm cov tshuaj hormonal contraceptives thiab lwm yam tshuaj yuav ua rau kom ntshav los ntshav thiab / lossis kev tiv thaiv tsis ua haujlwm. Qhia cov poj niam kom siv lwm txoj kev tiv thaiv kab mob los yog txoj hauv kev rov qab thaum siv cov enzyme inducers nrog COCs, thiab txuas ntxiv kev tiv thaiv rov qab rau 28 hnub tom qab txiav tawm cov enzyme inducer kom ntseeg tau tias kev tiv thaiv kab mob.

Colesevelam:Colesevelam, cov kua tsib kua qaub sequestrant, muab ua ke nrog COC, tau pom tias txo qis AUC ntawm EE. Cov tshuaj sib cuam tshuam ntawm cov tshuaj tiv thaiv kab mob thiab cov tshuaj colesevelam tau txo qis thaum ob cov khoom siv tshuaj tau muab 4 teev sib nrug.

Cov tshuaj ua kom cov plasma concentrations ntawm COCs

Kev tswj hwm ntawm atorvastatin lossis rosuvastatin thiab qee cov COCs uas muaj ethinyl estradiol (EE) nce AUC qhov tseem ceeb rau EE los ntawm kwv yees li 20 txog 25%. Ascorbic acid thiab acetaminophen tuaj yeem ua rau kom cov ntshav EE ntau ntxiv, tejzaum nws yog inhibition ntawm conjugation. CYP3A4 inhibitors xws li itraconazole, voriconazole, fluconazole, kua txiv hmab txiv ntoo, los yog ketoconazole tuaj yeem ua rau cov ntshav plasma ntau ntxiv.

Human immunodeficiency virus (HIV) / Kab mob siab C (HCV) protease inhibitors thiab non-nucleoside thim rov qab transcriptase inhibitors

Cov kev hloov pauv tseem ceeb (nce lossis txo) hauv cov ntshav plasma ntau ntawm cov tshuaj estrogen thiab / lossis progestin tau raug sau tseg hauv qee kis ntawm kev tswj hwm nrog HIV protease inhibitors (piv txwv li, nelfinavir, ritonavir, darunavir / ritonavir, (fos) amprenavir / ritonavir. , lopinavir / ritonavir, thiab tipranavir / ritonavir] lossis nce [piv txwv li, indinavir thiab atazanavir/ritonavir]) / HCV protease inhibitors (qis [piv txwv li, boceprevir thiab telaprevir]) lossis nrog cov uas tsis yog-nucleoside thim rov qab transcriptase inhibitors (qis dua, los yog nce [piv txwv li, etravirine]).

Cov txiaj ntsig ntawm Kev Tiv Thaiv Kev Tiv Thaiv Qhov Ncauj Rau Lwm Cov Tshuaj

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COCs uas muaj EE tuaj yeem cuam tshuam cov metabolism ntawm lwm cov tebchaw (xws li cyclosporine, prednisolone, theophylline, tizanidine, thiab voriconazole) thiab ua kom lawv cov ntshav ntau ntxiv.

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COCs tau pom tias txo cov ntshav plasma concentration ntawm acetaminophen, clofibric acid, morphine, salicylic acid, temazepam thiab lamotrigine. Qhov tseem ceeb txo qis hauv cov ntshav plasma concentration ntawm lamotrigine tau pom, yuav yog vim qhov induction ntawm lamotrigine glucuronidation. Qhov no yuav txo tau qaug dab peg; Yog li ntawd, kev hloov kho ntau npaum ntawm lamotrigine tej zaum yuav tsim nyog.

Cov poj niam ntawm cov thyroid hormone hloov kho yuav xav tau koob tshuaj ntau ntxiv ntawm cov thyroid hormone vim tias cov ntshav siab ntawm cov thyroid-binding globulin nce nrog kev siv COCs.

Kev cuam tshuam nrog kev sim kuaj

Kev siv cov tshuaj tiv thaiv kab mob steroids tuaj yeem cuam tshuam cov txiaj ntsig ntawm qee qhov kev sim kuaj, xws li coagulation yam, lipids, qabzib kam rau ua, thiab khi cov proteins.

Concomitant Siv nrog HCV Combination Therapy - Lub siab Enzyme nce

Tsis txhob muab cov tshuaj norgestimate thiab ethinyl estradiol nrog HCV cov tshuaj sib xyaw ua ke uas muaj ombitasvir/paritaprevir/ritonavir, nrog lossis tsis muaj dasabuvir, vim muaj peev xwm rau ALT nce [saibCEEB TOOM THIAB TSEEM CEEB (5.3)].

Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Muaj tsawg lossis tsis muaj kev pheej hmoo ntawm kev yug me nyuam hauv cov poj niam uas tsis siv COCs thaum cev xeeb tub. Kev tshawb fawb epidemiologic thiab meta-analyses tsis pom muaj kev pheej hmoo siab ntawm qhov chaw mos lossis qhov chaw mos yug me nyuam (xws li kev mob plawv thiab kev txo qis qis) tom qab raug rau cov tshuaj COCs tsawg ua ntej xeeb los yog thaum ntxov cev xeeb tub.

Tsis txhob muab COCs los ua kom tshem tawm los ntshav raws li kev kuaj cev xeeb tub. Tsis txhob siv COCs thaum cev xeeb tub los kho kev hem lossis rho menyuam tawm.

Niam laus

Qhia tus niam laus kom siv lwm hom kev tiv thaiv kab mob, thaum ua tau, txog thaum nws tau txiav nws tus menyuam. COCs tuaj yeem txo cov kua mis hauv cov niam mis. Qhov no tsis tshua muaj tshwm sim thaum pub niam mis zoo; Txawm li cas los xij, nws tuaj yeem tshwm sim txhua lub sijhawm hauv qee tus poj niam. Cov tshuaj tiv thaiv qhov ncauj me me thiab / lossis cov metabolites muaj nyob hauv cov kua mis.

Kev siv menyuam yaus

Kev nyab xeeb thiab kev ua tau zoo ntawm norgestimate thiab ethinyl estradiol tau tsim nyob rau hauv cov poj niam uas muaj hnub nyoog yug me nyuam. Kev ua tau zoo yuav tsum zoo ib yam rau cov tub ntxhais hluas hnub nyoog qis dua 18 xyoo thiab rau cov neeg siv 18 xyoo thiab laus dua. Kev siv cov khoom no ua ntej menarche tsis qhia.

Tsis muaj qhov sib txawv tseem ceeb ntawm Tri-Estarylla ™ ntsiav tshuaj thiab cov placebo hauv qhov kev hloov pauv hauv tag nrho lub lumbar qaum (L1-L4) thiab tag nrho cov pob txha pob txha pob txha ntom ntom ntawm lub hauv paus thiab Cycle 13 hauv 123 tus tub hluas ntxhais hluas nrog anorexia nervosa hauv ob-dig muag, placebo. -controlled, multicenter, ib-xyoo kev kho mob ncua sij hawm soj ntsuam rau lub hom phiaj los kho (ITT) cov pej xeem.

Kev siv Geriatric

Norgestimate thiab ethinyl estradiol tsis tau kawm nyob rau hauv cov poj niam postmenopausal thiab tsis qhia nyob rau hauv cov pejxeem.

Hepatic Impairment

Lub pharmacokinetics ntawm norgestimate thiab ethinyl estradiol tsis tau kawm nyob rau hauv cov kev kawm uas muaj hepatic impairment. Txawm li cas los xij, cov tshuaj hormones steroid tuaj yeem ua tsis zoo rau cov neeg mob uas muaj lub siab tsis zoo. Kev mob hnyav lossis mob ntev ntawm daim siab ua haujlwm yuav xav tau kev txiav tawm ntawm COC siv kom txog thaum cov cim ntawm daim siab ua haujlwm rov qab mus rau qhov qub thiab COC ua rau raug tshem tawm. [Saib KEV PAB CUAM (4) thiab CEEB TOOM THIAB KEV TIV THAIV (5.2) .]

Lub raum tsis zoo

Cov tshuaj pharmacokinetics ntawm norgestimate thiab ethinyl estradiol tsis tau kawm hauv cov poj niam uas muaj lub raum tsis zoo.

Kev noj ntau dhau

Tsis muaj ntawv ceeb toom txog qhov mob hnyav los ntawm kev noj tshuaj ntau dhau ntawm cov tshuaj tiv thaiv qhov ncauj, suav nrog kev noj los ntawm cov menyuam yaus. Kev noj ntau dhau tuaj yeem ua rau cov ntshav tawm hauv cov poj niam thiab xeev siab.

Tri-Estarylla piav qhia

Txhua yam ntawm cov khoom hauv qab no yog kev sib xyaw ua ke ntawm qhov ncauj uas muaj cov tshuaj progestational norgestimate thiab cov tshuaj estrogenic compound ethinyl estradiol. Norgestimate raug xaiv raws li (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) thiab ethinyl estradiol yog tsim los ua (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3,17-diol).

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Txhua ntsiav tshuaj dawb muaj 0.18 mg norgestimate thiab 0.035 mg ntawm ethinyl estradiol. Cov khoom xyaw uas tsis muaj zog muaj xws li crospovidone, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

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Txhua ntsiav tshuaj lub teeb xiav muaj 0.215 mg norgestimate thiab 0.035 mg ntawm ethinyl estradiol. Cov khoom xyaw uas tsis muaj zog muaj xws li crospovidone, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

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Txhua ntsiav tshuaj xiav muaj 0.25 mg norgestimate thiab 0.035 mg ntawm ethinyl estradiol. Cov khoom xyaw uas tsis muaj zog muaj xws li crospovidone, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

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Txhua ntsiav tshuaj ntsuab tsuas muaj cov khoom xyaw inert, raws li hauv qab no: crospovidone, D & C Yellow No.10 aluminium Lake, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

Tri-Estarylla - Clinical Pharmacology

Mechanism ntawm Action

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Cov tshuaj tiv thaiv qhov ncauj

COCs txo qhov kev pheej hmoo ntawm cev xeeb tub feem ntau los ntawm kev txo qis ovulation. Lwm cov txheej txheem ua tau tuaj yeem suav nrog kev hloov pauv ntawm ncauj tsev menyuam uas cuam tshuam cov phev nkag mus thiab kev hloov pauv endometrial uas txo qhov kev pheej hmoo ntawm implantation.

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Pob txuv

Pob txuv yog ib qho mob ntawm daim tawv nqaij nrog ib tug multifactorial etiology, nrog rau androgen stimulation ntawm sebum ntau lawm. Thaum kev sib xyaw ua ke ntawm ethinyl estradiol thiab norgestimate nce kev sib deev hormone-binding globulin (SHBG) thiab txo qis testosterone dawb, kev sib raug zoo ntawm cov kev hloov pauv no thiab txo qis ntawm qhov mob ntawm lub ntsej muag pob txuv hauv lwm tus poj niam noj qab haus huv nrog cov tawv nqaij mob no tsis tau tsim.

Pharmacodynamics

Tsis muaj kev tshawb fawb pharmacodynamic tshwj xeeb tau ua nrog norgestimate thiab ethinyl estradiol.

Pharmacokinetics

Kev nqus

Norgestimate (NGM) thiab EE tau nqus sai sai tom qab kev tswj hwm qhov ncauj. NGM yog metabolized sai thiab ua tiav los ntawm thawj qhov dhau los (nrog plab hnyuv thiab / lossis hepatic) cov txheej txheem rau norelgestromin (NGMN) thiab norgestrel (NG), uas yog cov metabolites tseem ceeb ntawm norgestimate.

Peak serum concentrations ntawm NGMN thiab EE feem ntau mus txog 2 teev tom qab kev tswj hwm ntawm norgestimate / ethinyl estradiol. Kev sib xyaw ua ke tom qab ntau qhov koob tshuaj ntawm 250 mcg NGM / 35 mcg EE koob tshuaj yog kwv yees li 2-fold rau NGMN thiab EE piv nrog kev tswj hwm ib koob. Cov tshuaj pharmacokinetics ntawm NGMN yog koob tshuaj raws li NGM koob tshuaj ntawm 180 mcg rau 250 mcg. Lub xeev ruaj khov ntawm EE yog ua tiav los ntawm Hnub 7 ntawm txhua qhov kev siv tshuaj. Lub xeev ruaj khov ntawm NGMN thiab NG tau ua tiav los ntawm Hnub 21. Cov khoom tsis-linear tsub zuj zuj (kwv yees li 8 npaug) ntawm NG raug pom los ntawm kev sib raug zoo siab rau SHBG, uas txwv tsis pub nws cov kev ua haujlwm lom neeg.(Table 3).

Zaub mov nyhuv

Cov nyhuv ntawm cov khoom noj ntawm cov tshuaj pharmacokinetics ntawm norgestimate thiab ethinyl estradiol tsis tau kawm.

Kev faib tawm

NGMN thiab NG muaj kev sib khi heev (> 97%) rau cov kua roj ntsha. NGMN raug khi rau albumin thiab tsis yog rau SHBG, thaum NG raug khi feem ntau rau SHBG. EE feem ntau khi (> 97%) rau cov ntshav albumin thiab ua rau muaj kev nce hauv cov ntshav ntshav ntau ntawm SHBG.

Metabolism

NGM yog feem ntau metabolized los ntawm thawj-pass mechanisms hauv plab hnyuv thiab / lossis daim siab. NGM tus thawj active metabolite yog NGMN. Cov kab mob siab tom qab ntawm NGMN tshwm sim thiab cov metabolites suav nrog NG, uas tseem ua haujlwm, thiab ntau yam hydroxylated thiab conjugated metabolites. Txawm hais tias NGMN thiab nws cov metabolites inhibit ntau yam P450 enzymes hauv tib neeg lub siab microsomes, raws li kev pom zoo noj tshuaj,nyobCov concentrations ntawm NGMN thiab nws cov metabolites, txawm tias nyob rau hauv cov ntshav cov ntshav siab tshaj plaws, kuj qis dua piv rau qhov inhibitory tas li (Ki). EE kuj tseem metabolized rau ntau yam khoom siv hydroxylated thiab lawv cov glucuronide thiab sulfate conjugates.

Kev tso tawm

Cov metabolites ntawm NGMN thiab EE raug tshem tawm los ntawm lub raum thiab fecal txoj hauv kev. Tom qab kev tswj hwm ntawm14C-norgestimate, 47% (45 mus rau 49%) thiab 37% (16 mus rau 49%) ntawm cov tshuaj radioactivity raug tshem tawm hauv cov zis thiab quav, raws li. Tsis hloov NGM tsis tau kuaj pom hauv cov zis. Ntxiv rau 17-deacetyl norgestimate, ntau cov metabolites ntawm NGM tau raug txheeb xyuas hauv tib neeg cov zis tom qab kev tswj hwm ntawm radiolabeled NGM. Cov no suav nrog 18, 19-Dinor-17-pregn-4-en-20-yn-3-one, 17-hydroxy-13-ethyl, (17α)-(-); 18,19-Dinor-5β-17- pregnan-20-yn, 3α, 17β-dihydroxy-13-ethyl, (17α), ntau yam hydroxylated metabolites thiab conjugates ntawm cov metabolites.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

[Saib CEEB TOOM THIAB KEV TIV THAIV (5.2 , 5.10) thiab Siv rau hauv cov neeg tshwj xeeb (8.1) .]

Kev tshawb fawb soj ntsuam

Kev tiv thaiv kab mob

Hauv peb qhov kev sim tshuaj hauv Teb Chaws Asmeskas nrog norgestimate thiab ethinyl estradiol, 1,651 cov poj niam hnub nyoog 18 txog 38 xyoo tau kawm txog 24 lub voj voog, ua pov thawj tag nrho ntawm 24,272 lub voj voog ntawm kev raug. Cov pej xeem ntawm haiv neeg yog li ntawm 73 mus rau 86% Caucasian, 8 mus rau 13% African-Asmeskas, 6 mus rau 14% Hispanic nrog rau cov neeg Esxias lossis lwm yam (≦1%). Tsis muaj kev cais tawm ntawm qhov hnyav; Qhov hnyav ntawm cov poj niam raug kho yog 82 mus rau 303 lbs, nrog rau qhov hnyav ntawm kwv yees li 135 lbs. Qhov kev xeeb tub yog kwv yees li 1 cev xeeb tub rau 100 tus poj niam-xyoo.

Hauv plaub qhov kev sim tshuaj nrog norgestimate thiab ethinyl estradiol, 4,756 tus poj niam hnub nyoog 15 txog 41 xyoo tau kawm rau 24 lub voj voog, muab tag nrho ntawm 45,244 lub voj voog ntawm kev raug. Cov pej xeem ntawm haiv neeg yog li ntawm 87 mus rau 90% Caucasian, 6 mus rau 10% African-Asmeskas, nrog rau cov neeg Esxias (≦1%) lossis Lwm yam (2 txog 5%). Tsis muaj kev cais tawm ntawm qhov hnyav; Qhov hnyav ntawm cov poj niam raug kho yog 80-310 lbs, nrog rau qhov hnyav ntawm kwv yees li 132 lbs. Qhov kev xeeb tub yog kwv yees li 1 cev xeeb tub rau 100 tus poj niam-xyoo.

14. 2 Pob txuv

Norgestimate thiab ethinyl estradiol tau raug soj ntsuam rau kev kho mob pob txuv vulgaris hauv ob qho tib si randomized, ob qhov muag tsis pom kev, placebo-tswj, multicenter, rau- (28 hnub) kev tshawb fawb voj voog. Ob puas nees nkaum-ib tus neeg mob tau txais Tri-norgestimate thiab ethinyl estradiol thiab 234 tus neeg mob tau txais cov placebo. Lub hnub nyoog nruab nrab ntawm kev tso npe rau ob pawg yog 28 xyoo. Thaum kawg ntawm 6 lub hlis, qhov nruab nrab tag nrho cov kab mob suav tau hloov pauv ntawm 55 mus rau 31 (42% txo) hauv cov neeg mob kho nrog norgestimate thiab ethinyl estradiol thiab los ntawm 54 mus rau 38 (txo 27%) hauv cov neeg mob zoo sib xws nrog cov placebo.Rooj 4summarizes cov kev hloov nyob rau hauv lesion suav rau txhua hom lesion. Raws li tus neeg tshawb xyuas qhov kev ntsuam xyuas thoob ntiaj teb tau ua nyob rau qhov kawg mus ntsib, cov neeg mob kho nrog norgestimate thiab ethinyl estradiol tau pom qhov kev txhim kho tseem ceeb hauv cov kab mob tag nrho piv rau cov neeg kho nrog cov placebo.

* LOCF: Kev soj ntsuam zaum kawg tau nqa mus tom ntej

Yuav Ua Li Cas Muab / Cia thiab tuav

Yuav Ua Li Cas

Peb-EstaryllaTM(norgestimate thiab ethinyl estradiol ntsiav tshuaj, USP) muaj nyob rau hauv cov hlwv uas muaj 28 ntsiav tshuaj raws li hauv qab no:

Txhua daim npav blister muaj 21 ntsiav tshuaj nquag thiab 7 ntsiav tshuaj tsis ua haujlwm.

7 ntsiav tshuaj dawb (active) yog puag ncig, debossed nrog SZ ntawm ib sab thiab T2 ntawm sab nraud thiab muaj 0.18 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

7 lub teeb xiav (active) ntsiav tshuaj yog puag ncig, debossed nrog SZ ntawm ib sab thiab T3 ntawm sab nraud thiab muaj 0.215 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

7 ntsiav tshuaj xiav (active) yog puag ncig, debossed nrog SZ ntawm ib sab thiab T4 nyob rau sab nraud thiab muaj 0.25 mg ntawm norgestimate thiab 0.035 mg ntawm ethinyl estradiol.

7 ntsiav tshuaj ntsuab (inert) yog puag ncig, debossed nrog SZ ntawm ib sab thiab J1 ntawm lwm sab.

NDC 70700-121-84, ib lub thawv uas muaj 1 tus neeg lub thawv

NDC 70700-121-85, ib lub thawv muaj 3 tus neeg lub thawv

Kev cia khoom

•

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F) [saib USP Controlled Room Temperature].

•

Tiv thaiv los ntawm lub teeb.

Khaws kom deb ntawm cov menyuam yaus

Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Saib FDA-pom zoo tus neeg mob daim ntawv lo ( Cov Ntaub Ntawv Tus Neeg Mob thiab Cov lus qhia rau kev siv ).

Qhia cov neeg mob txog cov ntaub ntawv hauv qab no:

•

Kev haus luam yeeb ua rau muaj kev pheej hmoo loj ntawm cov hlab plawv los ntawm kev siv COC, thiab cov poj niam uas muaj hnub nyoog tshaj 35 xyoos thiab haus luam yeeb yuav tsum tsis txhob siv COCs [saib Boxed Warning ].

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Muaj kev pheej hmoo ntawm VTE piv rau cov tsis siv cov COCs yog qhov loj tshaj tom qab pib lub COC lossis rov pib dua (ua raws li 4 lub lis piam lossis ntau dua lub sijhawm tsis pub tshuaj) tib yam lossis COC sib txawv [saib CEEB TOOM THIAB KEV TIV THAIV (5.1) ].

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Tri-Estarylla™ tsis tiv thaiv kab mob HIV (AIDS) thiab lwm yam kab mob sib kis.

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Tri-Estarylla ™ yuav tsum tsis txhob siv thaum cev xeeb tub; yog tias cev xeeb tub tshwm sim thaum siv Tri-Estarylla ™ qhia tus neeg mob kom tsis txhob siv ntxiv [saibCEEB TOOM THIAB KEV KOOM HAUM ( 5.9 )].

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Noj ib ntsiav tshuaj txhua hnub los ntawm qhov ncauj ntawm tib lub sijhawm txhua hnub. Qhia cov neeg mob yuav ua li cas thaum cov ntsiav tshuaj tsis tuaj [saib KEV PAB CUAM THIAB KEV PAB CUAM (2.2) ].

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Siv cov txheej txheem rov qab los yog lwm txoj kev tiv thaiv kab mob thaum siv cov enzyme inducers nrog Tri-Estarylla ™ [saib DAIM NTAWV CEEB TOOM (7.1) ].

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COCs tuaj yeem txo cov kua mis; qhov no yuav tshwm sim tsawg dua yog tias kev pub niam mis zoo tsim nyog [saib Siv rau hauv cov neeg tshwj xeeb (8.3) ].

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Cov poj niam uas pib COCs tom qab yug me nyuam, thiab cov uas tseem tsis tau muaj lub caij nyoog, yuav tsum siv lwm txoj kev tiv thaiv kab mob kom txog thaum lawv tau noj ib ntsiav tshuaj rau 7 hnub sib law liag [saib KEV PAB CUAM THIAB KEV PAB CUAM (2.2) ].

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Amenorrhea tuaj yeem tshwm sim. Xav txog kev xeeb tub thaum muaj amenorrhea thaum lub sij hawm thawj lub sij hawm tsis tuaj. Txiav tawm cev xeeb tub thaum muaj amenorrhea nyob rau hauv ob los yog ntau tshaj sib law liag [saibCEEB TOOM THIAB KEV KOOM HAUM ( 5.8 )].

Tsim los ntawm Laboratorios Leon Farma S.A., Spain rau

Xiromed, LLC. Florham Park, NJ 07932

Lub Ib Hlis 2018

Tus neeg mob pob Insert

Peb-Estarylla™ (tsis pom zoo thiab ethinyl estradiol ntsiav tshuaj, USP)

(no-JES-ntawm- phooj ywg, ETH-i-nil nws yog-nruab nrab-DYE-ol)

Dab tsi yog cov ntaub ntawv tseem ceeb tshaj plaws uas kuv yuav tsum paub txog Tri-Estarylla™?

Tsis siv neeg Tri-Estarylla™ yog tias koj haus luam yeeb thiab muaj hnub nyoog tshaj 35 xyoo.Kev haus luam yeeb ua rau koj muaj kev pheej hmoo mob plawv mob hnyav los ntawm cov tshuaj tiv thaiv kev yug menyuam, suav nrog kev tuag ntawm lub plawv nres, ntshav txhaws lossis mob stroke. Qhov kev pheej hmoo no nce nrog hnub nyoog thiab cov luam yeeb uas koj haus luam yeeb.

Dab tsi yog Tri-Estarylla™?

Peb-Estarylla™yog ib hom tshuaj tiv thaiv kev yug menyuam (qhov ncauj contraceptive) siv los ntawm cov poj niam los tiv thaiv cev xeeb tub.

Tri-Estarylla ™ kuj tseem siv los kho mob pob txuv vulgaris hauv cov poj niam hnub nyoog 15 xyoos thiab laus dua, uas tsis paub keeb kwm ntawm kev ua xua lossis teeb meem noj tshuaj tiv thaiv kab mob, thiab tau pib lawv lub cev xeeb tub (lub sijhawm). Tri-Estarylla ™ yuav tsum tsuas yog siv los kho pob txuv ntawm cov poj niam uas xav noj tshuaj tiv thaiv kev xeeb tub los tiv thaiv kev xeeb tub.

Yuav ua li cas Tri-Estarylla™ ua haujlwm rau kev tiv thaiv kab mob?

Koj txoj kev xeeb tub yog nyob ntawm seb koj ua raws li cov lus qhia rau kev noj koj cov tshuaj tiv thaiv kab mob. Qhov zoo dua koj ua raws li cov lus qhia, qhov tsawg dua koj yuav xeeb tub.

Raws li cov txiaj ntsig ntawm kev tshawb fawb soj ntsuam, kwv yees li 1 ntawm 100 tus poj niam yuav xeeb tub thaum thawj xyoo lawv siv Tri-Estarylla ™.

Cov kab ntawv hauv qab no qhia tau hais tias muaj feem yuav xeeb tub rau cov poj niam uas siv ntau txoj kev tswj kev yug menyuam. Txhua lub npov ntawm daim ntawv muaj cov npe ntawm txoj kev tiv thaiv kev yug menyuam uas zoo sib xws hauv kev ua tau zoo. Cov kev siv tau zoo tshaj plaws yog nyob rau saum daim ntawv. Lub thawv nyob rau hauv qab ntawm daim ntawv qhia txog kev xeeb tub rau cov poj niam uas tsis siv kev tiv thaiv kev xeeb tub thiab sim xeeb tub.

Leej twg yuav tsum tsis txhob noj Tri-Estarylla™?

Tsis txhob noj Tri-Estarylla™ yog tias koj:

• haus luam yeeb thiab muaj hnub nyoog tshaj 35 xyoos
• muaj ntshav txhaws hauv koj txhais tes, ob txhais ceg, ntsws, lossis qhov muag
• muaj teeb meem nrog koj cov ntshav uas ua rau nws txhaws ntau dua li qub
• muaj qee yam teeb meem ntawm lub plawv lossis lub plawv dhia tsis zoo uas ua rau koj muaj kev pheej hmoo ntawm cov ntshav txhaws
• tau mob stroke
• tau mob plawv
• muaj ntshav siab uas tswj tsis tau los ntawm cov tshuaj
• muaj ntshav qab zib nrog raum, qhov muag, paj hlwb, lossis cov hlab ntsha puas tsuaj
• muaj qee yam mob taub hau migraine hnyav nrog aura, loog loog, tsis muaj zog lossis hloov tsis pom kev, lossis mob taub hau migraine yog tias koj muaj hnub nyoog tshaj 35 xyoo.
• muaj teeb meem rau daim siab, nrog rau cov kab mob siab
• noj cov tshuaj Hepatitis C ua ke uas muaj ombitasvir/paritaprevir/ritonavir, nrog lossis tsis muaj dasabuvir. Qhov no tuaj yeem nce qib ntawm daim siab enzyme alanine aminotransferase (ALT) hauv cov ntshav.
• muaj tej yam tsis tau piav qhia qhov chaw mos los ntshav
• cev xeeb tub
• muaj mob qog noj ntshav mis lossis mob qog noj ntshav uas nkag siab rau poj niam cov tshuaj hormones

Yog tias ib qho ntawm cov xwm txheej no tshwm sim thaum koj noj Tri-Estarylla™, nres noj Tri-Estarylla™ tam sim ntawd thiab tham nrog koj tus kws kho mob. Siv cov tshuaj tiv thaiv tsis yog tshuaj hormones thaum koj tsis noj Tri-Estarylla™.

Kuv yuav tsum qhia dab tsi rau kuv tus kws kho mob ua ntej noj Tri-Estarylla™?

Qhia rau koj tus kws kho mob yog tias koj:

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cev xeeb tub los yog xav tias koj yuav xeeb tub

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muaj kev nyuaj siab tam sim no los yog muaj kev nyuaj siab yav dhau los

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muaj yellowing ntawm koj cov tawv nqaij los yog ob lub qhov muag (jaundice) tshwm sim los ntawm cev xeeb tub (Cholestasis ntawm cev xeeb tub)

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pub niam mis los yog npaj pub niam mis. Tri-Estarylla ™ tuaj yeem txo cov kua mis uas koj ua. Ib qho me me ntawm cov tshuaj hormones hauv Tri-Estarylla ™ tuaj yeem nkag mus rau hauv koj lub mis. Tham nrog koj tus kws kho mob txog txoj kev tswj kev yug menyuam zoo tshaj plaws rau koj thaum pub niam mis.

Qhia rau koj tus kws kho mob txog txhua yam tshuaj uas koj noj,suav nrog cov ntawv sau tshuaj thiab cov tshuaj hauv khw muag khoom, cov vitamins thiab tshuaj ntsuab tshuaj ntsuab.

Tri-Estarylla ™ tuaj yeem cuam tshuam txoj kev ua haujlwm ntawm lwm cov tshuaj, thiab lwm yam tshuaj yuav cuam tshuam rau Tri-Estarylla ™ ua haujlwm zoo npaum li cas.

Paub cov tshuaj koj noj. Khaws ib daim ntawv teev npe los qhia koj tus kws kho mob thiab tus kws muag tshuaj thaum koj tau txais cov tshuaj tshiab.

Kuv yuav tsum noj Tri-Estarylla™?

Nyeem cov lus qhia rau kev sivThaum kawg ntawm Cov Ntaub Ntawv Tus Neeg Mob no.

Dab tsi yog qhov tshwm sim loj heev ntawm Tri-Estarylla™?

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Zoo li kev xeeb tub, Tri-Estarylla ™ tuaj yeem ua rau muaj kev phiv loj, suav nrog cov ntshav txhaws hauv koj lub ntsws, plawv nres, lossis mob stroke uas yuav ua rau tuag taus. Qee qhov piv txwv ntawm cov ntshav txhaws hnyav muaj xws li cov ntshav txhaws hauv ob txhais ceg lossis qhov muag.

Cov ntshav txhaws hnyav tuaj yeem tshwm sim tshwj xeeb yog tias koj haus luam yeeb, rog rog, lossis laus dua 35 xyoo. Cov ntshav txhaws hnyav yuav tshwm sim ntau dua thaum koj:

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thawj zaug pib noj tshuaj tiv thaiv kab mob

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rov pib cov tshuaj tiv thaiv kev yug menyuam zoo ib yam lossis sib txawv tom qab tsis siv lawv li ib hlis lossis ntau dua

Hu rau koj tus kws kho mob lossis mus rau chav kho mob xwm txheej ceev tam sim yog tias koj muaj:

Lwm cov kev mob tshwm sim loj muaj xws li:

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cov teeb meem hauv siab, suav nrog:

ib.

tsawg daim siab mob

ob.

jaundice (cholestasis), tshwj xeeb tshaj yog tias koj yav tas los muaj cholestasis ntawm cev xeeb tub. Hu rau koj tus kws kho mob yog tias koj muaj daj ntawm koj cov tawv nqaij lossis qhov muag.

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siab ntshav siab.Koj yuav tsum mus ntsib koj tus kws kho mob kom kuaj xyuas koj cov ntshav siab txhua xyoo.

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teeb meem gallbladder

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Kev hloov pauv hauv qab zib thiab rog (cholesterol thiab triglycerides) qib hauv koj cov ntshav

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mob taub hau tshiab lossis mob hnyav ntxiv nrog rau mob taub hau migraine

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tsis xwm yeem los yog qhov txawv txav ntawm qhov chaw mos los ntshav thiab pom ntawm koj lub cev xeeb tub, tshwj xeeb tshaj yog nyob rau thawj 3 lub hlis ntawm kev noj Tri-Estarylla™.

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kev nyuaj siab

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tuaj yeem mob qog noj ntshav hauv koj lub mis thiab lub ncauj tsev menyuam

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o ntawm koj cov tawv nqaij tshwj xeeb tshaj yog nyob ib ncig ntawm koj lub qhov ncauj, qhov muag, thiab hauv koj caj pas (angioedema).Hu rau koj tus kws kho mob yog tias koj muaj lub ntsej muag o, daim di ncauj, qhov ncauj tus nplaig lossis caj pas, uas yuav ua rau nqos tau nyuaj lossis ua pa nyuaj. Koj lub sijhawm muaj angioedema ntau dua yog tias koj muaj keeb kwm ntawm angioedema.

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tsaus ntuj thaj tsam ntawm daim tawv nqaij nyob ib ncig ntawm koj lub hauv pliaj, qhov ntswg, lub puab tsaig thiab ib ncig ntawm koj lub qhov ncauj, tshwj xeeb tshaj yog thaum cev xeeb tub (chloasma).Cov poj niam uas nyiam chloasma yuav tsum tsis txhob siv sij hawm ntev nyob rau hauv tshav ntuj, tanning booths, thiab nyob rau hauv lub hnub teeb thaum noj Tri-Estarylla ™. Siv tshuaj pleev thaiv hnub yog tias koj yuav tsum nyob hauv tshav ntuj.

Dab tsi yog qhov tshwm sim feem ntau ntawm Tri-Estarylla™?

•

mob taub hau (migraine)

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mob lub mis los yog rhiab, loj los yog tawm

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mob plab, tsis xis nyob, thiab roj

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kab mob ntawm qhov chaw mos thiab tawm

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kev xav hloov, nrog rau kev nyuaj siab

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ntxhov siab

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hloov qhov hnyav

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daim tawv nqaij ua pob

Cov no tsis yog tag nrho cov kev mob tshwm sim ntawm Tri-Estarylla ™. Yog xav paub ntxiv, nug koj tus kws kho mob lossis tus kws muag tshuaj.

Koj tuaj yeem tshaj tawm cov kev mob tshwm sim rau Xiromed, LLC. ntawm 1-844-XIROMED (844-947-6633) lossis FDA ntawm 1-800-FDA-1088 lossis www.FDA.GOV/Medwatch.

Dab tsi ntxiv kuv yuav tsum paub txog kev noj Tri-Estarylla™?

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Yog tias koj tau teem sijhawm rau kev kuaj sim, qhia rau koj tus kws kho mob koj tau noj Tri-Estarylla ™. Qee qhov kev kuaj ntshav yuav cuam tshuam los ntawm Tri-Estarylla ™.

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Tri-Estarylla™ tsis tiv thaiv kab mob HIV (AIDS) thiab lwm yam kab mob sib kis.

Kuv yuav khaws Tri-Estarylla™?

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Khaws Tri-Estarylla ™ ntawm chav tsev kub ntawm 68 ° F txog 77 ° F (20 ° C txog 25 ° C).

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Khaws Tri-Estarylla ™ thiab txhua yam tshuaj tawm ntawm cov menyuam yaus.

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Khaws deb ntawm qhov kaj.

Cov ntaub ntawv dav dav txog kev nyab xeeb thiab siv tau zoo ntawm Tri-Estarylla™.

Cov tshuaj qee zaum raug muab rau cov hom phiaj uas tsis yog cov teev nyob rau hauv Daim Ntawv Qhia Txog Tus Neeg Mob. Tsis txhob siv Tri-Estarylla ™ rau ib qho mob uas nws tsis tau sau tseg. Tsis txhob muab Tri-Estarylla ™ rau lwm tus, txawm tias lawv muaj cov tsos mob zoo ib yam uas koj muaj.

Cov Ntaub Ntawv Tus Neeg Mob no sau cov ntaub ntawv tseem ceeb tshaj plaws txog Tri-Estarylla ™. Koj tuaj yeem nug koj tus kws muag tshuaj lossis tus kws kho mob rau cov ntaub ntawv hais txog Tri-Estarylla™ uas tau sau rau cov kws kho mob.

Yog xav paub ntxiv, hu rau Xiromed, LLC. ntawm 1-844-XIROMED (844-947-6633).

Cov tshuaj tiv thaiv yug menyuam puas ua rau mob qog noj ntshav?

Cov tshuaj tiv thaiv kev yug menyuam tsis zoo li ua rau mob qog noj ntshav. Txawm li cas los xij, yog tias koj muaj mob khees xaws mis tam sim no, lossis tau muaj yav dhau los, tsis txhob siv cov tshuaj tiv thaiv kev yug menyuam vim tias qee cov qog nqaij hlav mis yog qhov nkag siab rau cov tshuaj hormones.

Cov poj niam uas siv cov tshuaj tiv thaiv kev yug me nyuam yuav muaj feem ntau dua me ntsis ntawm kev mob qog noj ntshav. Txawm li cas los xij, qhov no yuav yog vim muaj lwm yam xws li kev sib deev ntau dua.

Yuav ua li cas yog kuv xav xeeb tub?

Tej zaum koj yuav tsum tsis txhob noj tshuaj thaum twg koj xav tau. Xav txog kev mus ntsib koj tus kws kho mob kom kuaj xyuas ua ntej cev xeeb tub ua ntej koj tsis noj tshuaj.

Kuv yuav tsum paub dab tsi txog kuv lub sijhawm thaum noj Tri-Estarylla™?

Koj lub sijhawm yuav sib dua thiab luv dua li niaj zaus. Qee tus poj niam yuav tsis nco lub sijhawm. Qhov chaw mos los ntshav los yog pom tshwm sim thaum koj noj Tri-Estarylla ™, tshwj xeeb tshaj yog thaum thawj ob peb lub hlis ntawm kev siv. Qhov no feem ntau tsis yog teeb meem loj. Nws yog ib qho tseem ceeb uas yuav tau noj koj cov tshuaj ntxiv raws sij hawm kom tsis txhob muaj menyuam.

Dab tsi yog cov khoom xyaw hauv Tri-Estarylla™?

Cov khoom xyaw nquag:Txhua ntsiav tshuaj dawb, lub teeb-xiav, thiab xiav muaj cov norgestimate thiab ethinyl estradiol.

Cov khoom xyaw uas tsis muaj zog:

ua tshuaj tua kab mob ua rau koj quav cawv

Cov tshuaj dawb:crospovidone, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

Lub teeb-xiav tshuaj:crospovidone, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

Blue tshuaj:crospovidone, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch.

Cov tshuaj ntsuab:crospovidone, D & C Yellow No.10 aluminium Lake, FD & C Blue No.2 pas dej, lactose anhydrous, magnesium stearate, thiab pregelatinized starch

Cov lus qhia rau kev siv

Peb-Estarylla™ (tsis pom zoo thiab ethinyl estradiol ntsiav tshuaj, USP)

Cov ntaub ntawv tseem ceeb txog kev noj Tri-Estarylla™

•

Noj 1 ntsiav tshuaj txhua hnub tib lub sijhawm. Noj cov tshuaj nyob rau hauv qhov kev txiav txim qhia ntawm koj lub hlwv pob.

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Tsis txhob hla koj cov tshuaj, txawm tias koj tsis sib deev ntau zaus. Yog tias koj tsis nco cov tshuaj (xws li pib lub pob blister lig)koj tuaj yeem xeeb tub.Cov tshuaj ntau dua koj nco, qhov ntau dua koj yuav xeeb tub.

•

Yog tias koj muaj teeb meem nco ntsoov noj Tri-Estarylla ™, tham nrog koj tus kws kho mob. Thaum koj thawj zaug pib noj Tri-Estarylla ™, pom los yog lub teeb los ntshav nyob nruab nrab ntawm koj lub sijhawm yuav tshwm sim. Hu rau koj tus kws kho mob yog tias qhov no tsis ploj mus tom qab ob peb lub hlis.

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Tej zaum koj yuav hnov ​​​​mob rau koj lub plab (zaub mov), tshwj xeeb tshaj yog thaum thawj ob peb lub hlis ntawm kev noj Tri-Estarylla ™. Yog tias koj mob plab, tsis txhob noj tshuaj. Qhov teeb meem feem ntau yuav ploj mus. Yog tias koj xeev siab tsis ploj mus, hu rau koj tus kws kho mob.

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Cov tshuaj uas ploj lawm tuaj yeem ua rau pom los yog los ntshav, txawm tias koj noj cov tshuaj tsis tuaj tom qab. Nyob rau hnub koj noj 2 ntsiav tshuaj los ua rau cov tshuaj tsis tau (saib Kuv yuav ua li cas yog tias kuv tsis nco cov tshuaj Tri-EstaryllaTM? hauv qab no), koj tuaj yeem hnov ​​​​mob me ntsis rau koj lub plab.

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Nws tsis yog qhov tsis yooj yim kom nco ib lub sijhawm. Txawm li cas los xij, yog tias koj tsis nco lub sijhawm thiab tsis tau noj Tri-Estarylla ™ raws li cov lus qhia, lossis nco 2 lub sijhawm ua ke, lossis xav tias koj yuav xeeb tub, hu rau koj tus kws kho mob. Yog tias koj tau kuaj cev xeeb tub zoo, koj yuav tsum tsis txhob noj Tri-Estarylla ™.

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Yog tias koj ntuav lossis raws plab tsis pub dhau 3 mus rau 4 teev tom qab noj koj cov tshuaj, noj lwm cov tshuaj uas muaj xim tib yam los ntawm koj lub pob hlwv ntxiv. Yog tias koj tsis muaj cov tshuaj blister ntxiv, muab cov tshuaj ntxiv rau hauv koj lub pob blister. Txuas ntxiv noj tag nrho koj cov tshuaj uas tseem tshuav nyob rau hauv kev txiav txim. Pib thawj ntsiav tshuaj ntawm koj lub hlwv ntim tshuaj tom ntej hnub tom qab ua tiav koj cov tshuaj blister tam sim no. Qhov no yuav yog 1 hnub ua ntej tshaj li qhov tau teem tseg. Txuas ntxiv rau koj lub sijhawm tshiab.

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Yog tias koj ntuav lossis raws plab ntev dua 1 hnub, koj cov tshuaj tiv thaiv kev yug menyuam kuj yuav tsis ua haujlwm zoo. Siv txoj kev tswj kev yug me nyuam ntxiv, xws li hnab looj tes thiab tshuaj tua kab mob, kom txog thaum koj mus ntsib koj tus kws kho mob.

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Tsis txhob noj Tri-Estarylla ™ tsawg kawg 4 lub lis piam ua ntej koj tau phais loj thiab tsis txhob rov pib dua tom qab kev phais yam tsis tau nug koj tus kws kho mob. Nco ntsoov siv lwm hom kev tiv thaiv kab mob (xws li hnab looj tes thiab tshuaj tua kab mob) thaum lub sijhawm no.

Ua ntej koj pib noj Tri-Estarylla™:

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Txiav txim siab hnub twg koj xav noj koj cov tshuaj. Nws yog ib qho tseem ceeb uas yuav tsum tau coj nws tib lub sijhawm txhua hnub thiab nyob rau hauv qhov kev txiav txim raws li qhia ntawm koj lub pob hlwv.

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Muaj cov tshuaj tiv thaiv tiv thaiv kab mob (condoms thiab spermicide) muaj thiab yog tias ua tau, ntxiv cov hlwv ntim tshuaj ntxiv raws li xav tau.

Thaum twg kuv yuav tsum pib noj Tri-Estarylla™?

Yog tias koj pib noj Tri-Estarylla™ thiab koj tsis tau siv txoj kev tiv thaiv kev yug menyuam ua ntej:

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Muaj 2 txoj hauv kev los pib noj koj cov tshuaj tiv thaiv kev yug menyuam. Koj tuaj yeem pib hnub Sunday (Sunday Start) lossis thawj hnub (Hnub 1) ntawm koj lub sijhawm cev xeeb tub (Hnub 1 Pib). Koj tus kws kho mob yuav tsum qhia koj thaum twg yuav pib noj koj cov tshuaj tiv thaiv kab mob.

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Yog tias koj siv Hnub Caiv Pib, siv cov tshuaj tiv thaiv tsis yog tshuaj hormones xws li hnab looj tes thiab tshuaj tua kab mob rau thawj 7 hnub uas koj noj Tri-Estarylla ™. Koj tsis tas yuav tshuaj tiv thaiv rov qab yog tias koj siv Hnub 1 Pib.

Yog tias koj pib noj Tri-Estarylla™ thiab koj tab tom hloov los ntawm lwm yam tshuaj tiv thaiv kev yug menyuam:

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Pib koj lub pob tshiab Tri-Estarylla ™ nyob rau tib hnub uas koj yuav pib pob tom ntej ntawm koj txoj kev tswj kev yug me nyuam yav dhau los.

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Tsis txhob noj cov tshuaj ntxiv los ntawm koj lub pob tshuaj tiv thaiv kev yug menyuam yav dhau los.

Yog tias koj pib noj Tri-Estarylla™ thiab yav tas los siv lub nplhaib ntawm qhov chaw mos los yog qhov chaw hloov pauv:

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Pib siv Tri-Estarylla ™ nyob rau hnub koj yuav tau rov thov lub nplhaib tom ntej los yog thaj.

Yog tias koj pib noj Tri-Estarylla™ thiab koj tab tom hloov los ntawm txoj kev progestin nkaus xwb xws li kev cog qoob loo lossis kev txhaj tshuaj:

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Pib noj Tri-Estarylla ™ nyob rau hnub ntawm kev tshem tawm koj cov implants los yog hnub uas koj yuav tau txhaj tshuaj tom ntej.

Yog tias koj pib noj Tri-Estarylla™ thiab koj tab tom hloov los ntawm cov cuab yeej hauv plab lossis lub cev (IUD lossis IUS):

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Pib noj Tri-Estarylla ™ hnub ntawm kev tshem koj cov IUD lossis IUS.

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Koj tsis tas yuav siv tshuaj tiv thaiv rov qab yog tias koj qhov IUD lossis IUS raug tshem tawm thawj hnub (Hnub 1) ntawm koj lub sijhawm. Yog tias koj cov IUD lossis IUS raug tshem tawm rau lwm hnub, siv cov tshuaj tiv thaiv tsis yog tshuaj hormones xws li hnab looj tes thiab tshuaj tua kab mob rau thawj 7 hnub uas koj noj Tri-Estarylla™.

Khaws ib daim ntawv qhia hnub kom taug qab koj lub sijhawm:
Yog qhov no yog thawj zaugkoj noj tshuaj tiv thaiv menyuam, nyeem, 'Thaum twg kuv yuav tsum pib noj Tri-Estarylla™?'saum toj no. Ua raws li cov lus qhia no rau hnub SundayPib los yog Hnub 1 Pib.

Hnub Sunday pib:
Koj yuav siv Hnub Sunday Pib yog tias koj tus kws kho mob hais kom koj noj koj thawj ntsiav tshuaj rau hnub Sunday.

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Noj tshuajibhnub Sundaytom qab koj lub sijhawm pib.

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Yog tias koj lub sijhawm pib hnub Sunday, noj tshuaj '1' hnub ntawd thiab xa mus rau HnubibPib cov lus qhia hauv qab no.

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Nojibntsiav tshuaj txhua hnub nyob rau hauv qhov kev txiav txim ntawm lub hlwv pob nyob rau tib lub sij hawm txhua hnub rau28hnub.

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Tom qab noj cov tshuaj kawg rauHnub 28los ntawm lub pob hlwv, pib noj thawj ntsiav tshuaj los ntawm lub pob hlwv tshiab, nyob rau tib hnub ntawm lub lim tiam raws li thawj lub pob hlwv (Sunday). Noj thawj ntsiav tshuaj hauv pob tshiab seb koj puas muaj koj lub sijhawm.

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Siv cov tshuaj tiv thaiv tsis yog tshuaj hormones xws li hnab looj tes thiab tshuaj tua kab mob rau thawj 7 hnub ntawm thawj lub voj voog uas koj noj Tri-Estarylla ™.

Hnub 1 Pib:
Koj yuav siv aHnub 1Pib yog koj tus kws kho mob hais kom koj noj koj cov tshuaj thawj zaug (Hnub 1) ntawm lubthawj hnub ntawm koj lub sijhawm.

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Nojibntsiav tshuaj txhua hnub nyob rau hauv qhov kev txiav txim ntawm lub hlwv pob, tib lub sij hawm txhua hnub, rau28hnub.

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Tom qab noj cov tshuaj kawg rauHnub 28los ntawm pob hlwv, pib noj thawj ntsiav tshuaj los ntawm ib lub pob tshiab, nyob rau tib hnub ntawm lub lim tiam raws li thawj pob. Noj thawj ntsiav tshuaj hauv pob tshiab seb koj puas muaj koj lub sijhawm.

Peb-Estarylla™ los hauv pob hlwv. Nyeem cov lus qhia hauv qab no rau kev siv koj pob blister.

Ua ntej koj pib noj koj cov tshuaj:

ib.

YUAV TSUM NYEEM NTAWV NO:

Ua ntej koj pib noj koj cov tshuaj.

Txhua lub sij hawm koj tsis paub yuav ua li cas.

2.YUAV TSEEM CEEB TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG TIAG LI OS.
Yog tias koj tsis noj tshuaj koj yuav xeeb tub. Qhov no suav nrog pib lub pob lig.

Cov tshuaj ntau dua koj nco, qhov ntau dua koj yuav xeeb tub.

3.Ntau tus poj niam tau pom los yog lub teeb los ntshav, los yog tej zaum yuav mob rau lawv plab thaum lub sij hawm thawj 1 mus rau 3 ntsiav tshuaj. Yog tias koj hnov ​​​​mob hauv koj lub plab los yog pom los yog los ntshav, tsis txhob noj tshuaj. Qhov teeb meem feem ntau yuav ploj mus. Yog tias nws tsis ploj mus, nrog koj tus kws kho mob tham.

4.MIM TSEEM CEEB TAM SIM NO tuaj yeem ua rau pom los yog lub teeb los ntshav, txawm tias thaum koj tsim cov tshuaj uas tsis tuaj.

Nyob rau hnub koj noj 2 ntsiav tshuaj los ua rau cov tshuaj uas ploj lawm, koj tuaj yeem hnov ​​​​mob me ntsis rau koj lub plab.

5.Yog tias koj muaj ntuav lossis zawv plab, lossis yog tias koj noj qee yam tshuaj, suav nrog qee cov tshuaj tua kab mob, koj cov tshuaj yuav tsis ua haujlwm zoo.

Siv cov txheej txheem rov qab (xws li hnab looj tes lossis tshuaj tua kab mob) kom txog thaum koj kuaj nrog koj tus kws kho mob.

6.Yog koj muaj teeb meem nco ntsoov noj cov tshuaj, nrog koj tus kws kho mob tham txog yuav ua li cas kom noj tshuaj kom yooj yim dua lossis siv lwm txoj kev tswj kev yug menyuam.

7.Yog koj muaj lus nug lossis tsis paub meej txog cov ntaub ntawv hauv daim ntawv no, hu rau koj tus kws kho mob.

Ua ntej koj pib noj koj cov tshuaj

1.Xav tias lub sij hawm twg ntawm hnub koj xav noj koj cov tshuaj.
Nws yog ib qho tseem ceeb uas yuav tsum tau coj nws ntawm tib lub sijhawm txhua hnub.

2. Saib ntawm koj lub hnab ntim tshuaj

Cov ntsiav tshuaj muaj 21 cov tshuaj nquag (nrog cov tshuaj hormones) noj rau 3 lub lis piam. Qhov no yog ua raws li 1 lub lis piam nco ntsoov cov tshuaj ntsuab (tsis muaj tshuaj hormones).

3. TSIS MUAJ:

1. qhov twg ntawm pob pib noj tshuaj,

2.Yuav ua li cas thiaj noj cov tshuaj (ua raws li cov xub)

3. lub lis piam tus lej raws li qhia hauv daim duab hauv qab no.

4. YUAV TSUM TAU TXAIS NYIAJ NYIAJ TAG NRHO:

LWM YAM TSEEM CEEB (xws li hnab looj tes lossis tshuaj tua kab mob) siv los ua tus txheej txheem rov qab yog tias koj tsis tshuaj.

TXOJ CAI TSHIAB, PAUB PILL PACK.

Kuv yuav ua li cas yog tias kuv nco Tri-Estarylla™ tshuaj?

Yog tias koj tsis nco 1 ntsiav tshuaj hauv Lub Limtiam 1, 2, lossis 3, ua raws li cov kauj ruam no:

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Nqa nws sai li sai tau thaum koj nco qab. Noj cov tshuaj tom ntej ntawm koj lub sijhawm. Qhov no txhais tau tias koj tuaj yeem noj 2 ntsiav tshuaj hauv 1 hnub.

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Tom qab ntawd txuas ntxiv noj 1 ntsiav tshuaj txhua hnub kom txog thaum koj ua tiav pob.

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Koj tsis tas yuav siv txoj kev tswj kev yug menyuam rov qab yog tias koj muaj kev sib deev.

Yog tias koj tsis nco 2 ntsiav tshuaj hauv Lub Limtiam 1 lossis Lub Limtiam 2 ntawm koj pob, ua raws li cov kauj ruam no:

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Noj 2 ntsiav tshuaj sai li sai tau thiab noj 2 ntsiav tshuaj rau hnub tom qab.

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Tom qab ntawd txuas ntxiv noj 1 ntsiav tshuaj txhua hnub kom txog thaum koj ua tiav pob.

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Siv txoj kev tiv thaiv kev yug menyuam uas tsis yog tshuaj hormonal (xws li hnab looj tes thiab tshuaj tua kab mob) ua rau rov qab yog tias koj tau pw hauv thawj 7 hnub tom qab koj cov tshuaj uas ploj lawm.

Yog tias koj tsis nco 2 ntsiav tshuaj ua ke hauv Lub Limtiam 3, lossis koj tsis nco 3 lossis ntau cov tshuaj ua ke hauv lub lis piam 1, 2, lossis 3 ntawm pob, ua raws li cov kauj ruam no:

Yog tias koj yog Hnub 1 Pib:

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Muab pov tseg tas ntawm cov ntsiav tshuaj thiab pib ib pob tshiab rau tib hnub ntawd.

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Tej zaum koj yuav tsis muaj koj lub sijhawm rau lub hlis no tab sis qhov no xav tau. Txawm li cas los xij, yog tias koj tsis nco koj lub sijhawm 2 lub hlis sib law liag, hu rau koj tus kws kho mob vim tias koj yuav xeeb tub.

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Koj tuaj yeem xeeb tub yog tias koj tau pw hauv thawj 7 hnub tom qab koj rov pib koj cov tshuaj. Koj YUAV TSUM siv txoj kev tiv thaiv kev yug menyuam uas tsis yog tshuaj hormonal (xws li hnab looj tes thiab tshuaj tua kab mob) ua rov qab yog tias koj tau pw hauv thawj 7 hnub tom qab koj rov pib koj cov tshuaj.

Yog tias koj yog Hnub Sunday Pib:

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Noj 1 ntsiav tshuaj txhua hnub kom txog rau thaum hnub Sunday. Hnub Sunday, muab pov tseg tag nrho thiab pib ib pob tshiab ntawm cov tshuaj nyob rau tib hnub.

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Siv txoj kev tiv thaiv kev yug menyuam uas tsis yog tshuaj hormonal (xws li hnab looj tes thiab tshuaj tua kab mob) ua rov qab yog tias koj tau pw hauv thawj 7 hnub tom qab koj rov pib koj cov tshuaj.

Yog tias koj muaj lus nug lossis tsis paub meej txog cov ntaub ntawv hauv daim ntawv no, hu rau koj tus kws kho mob.

Cov Ntaub Ntawv Tus Neeg Mob thiab Cov Lus Qhia rau Kev Siv no tau pom zoo los ntawm US Food and Drug Administration.

Peb-EstaryllaTMyog ib lub cim lag luam ntawm Xiromed, LLC.

Cov npe teev npe yog cov npe lag luam ntawm lawv cov tswv thiab tsis yog cov cim lag luam ntawm Xiromed, LLC.

Tsim los ntawm Laboratorios Leon Farma S.A., Spain rau

Xiromed, LLC. Florham Park, NJ 07932

Rev. Lub ib hlis ntuj 2018

PIB 121-00

PRINCIPAL DISPLAY PANEL

NDC70700-121-85 Ib

3 units(3x 28 tab blister card)

Peb-EstaryllaTM
(Norgestimate thiab Ethinyl Estradiol ntsiav tshuaj, USP)

0.18 mg / 0.35 mg, 0.0215 mg / 0.35 mg, 0.25 mg / 0.35 mg

Rx xwb