SefuTvis danarTi furceli: informacia pacientisaTvis femostoni konti ...

gaqvT an odesme gqondaT Rrma venebis Trombozi (sisxlis koltebi Rrma venebSi, rac iwvevsSeSupebas, romelsac Tan axlavs tkivili da temperaturis momateba), an filtvis embolia (sisxliskoltebis migracia venebidan filtvebSi; gaqvT an bolo dros gqondaT simptomebi, gamowveuli sisxlis koltebis arteriebSi migraciiT, mag.tkivili gul-mkerdis areSi (stenokardia, an miokardiumis infarqti), insulti; gaqvT, an gqondaT darRvevebi RviZlis mxriv, romelsac Tan axlda RviZlis funqciuri testebismaRali maCveneblebi; gaqvT porfiria (metaboluri darRveva).SewyviteT femostoni kontis miReba da dauyovnebliv mimarTeT eqims Semdegi simptomebis anmdgomareobis gamovlinebisas:- SeamCnieT, rom Tqveni kani, an membrana gayviTlda; es ukeT Cans Tvalis TeTr nawilze (siyviTle)- sisxlis wnevis mniSvnelovnad gazrda- Tavis Zalian Zlieri tkivili (Sakiki);mniSvnelovani informacia femostoni kontis zogierT komponentzefemostoni konti Seicavs laqtozas. Tu eqimma giTxraT, rom gaqvT zogierTi Saqris autanloba,preparatis miRebamde rCevisaTvis mimarTeT eqims.gamoiCineT gansakuTrebuli yuradReba femostoni kontis gamoyenebisashormonCanacvlebiTi Terapiis dawyebamde, an mis ganaxlebamde eqimi dagisvamT SekiTxvebs im daavadebebisSesaxeb, romlebic gaqvT an gqondaT warsulSi, an naTesavebis daavadebebis Sesaxeb. aseve eqimiCagitarebT fizikur gasinjvas, rac moicavs mkerdis gasinjvas da ginekologiur gasinjvas. femostonikontiT mkurnalobis periodSi eqimma regularulad unda gagsinjoT da CagitaroT mamografia. Tqvenieqimi getyviT ramdenad xSirad gesaWiroebaT gasinjva.mkurnalobis pirveli Tvis ganmavlobaSi SeiZleba gamovlindes wyvetili sisxldena, an sisxlis laqebi.acnobeT Tqvens eqims, Tu amgvari sisxldena gamovlinda mkurnalobis bolo periodSi, an gagrZeldamkurnalobis dasrulebis Semdeg. eqimi mizezis dasadgenad CagitarebT damatebiT gamokvlevebsendometriumis biofsiis CaTvliT, raTa gamoiricxos endometriumis kibo.Tu estrogenebiT mkurnaloba gitardebaT ramdenime wlis ganmavlobaSi maRalia mkerdis kibosganviTarebis albaToba. es riski damokidebulia mkurnalobisxangrZlivobaze da ubrundeba mkurnalobis dawyebamde arsebul maCvenebels mkurnalobis Sewyvetidanmaqsimum 5 wlis Semdeg. amitom regularulad unda gaisinjoT mkerdi (TviTgasinjva; eqimi getyviT Tura niSnebi miuTiTebs mkerdis kibos arsebobaze).sisxlis analizis, an mamografiis Catarebisas (mkerdis radiografia) uTxariT eqims, rom iRebTfemostoni kontis, radgan hormonCanacvlebiTi Terapia gavlenas axdens analizis maCveneblebze.aseve gTxovT acnoboT eqims Tu gaqvT an gqondaT Semdegi daavadebebi, an simptomebi. Tqveni eqimigadawyvets SeiZleba Tu ara TqvenTvis femostoni kontis miReba.femostoni kontiT mkurnalobis periodSi aucilebelia samedicino Semowmeba ufro xSirad Tu gaqvT, angqondaT Semdegi darRvevebi, an Semdegi CamonaTvalidan gaqvT romelime situacia: leiomioma (saSvilosnis fobroma) an endometriozi (darRveva, romlis drosac saSvilosnos qsoviliaris sxeulis sxva nawilebSic, Cveulebriv saSvilosnosTan axlos myof organoebSi); Tromboemboliis anamnezi, an am darRvevis ganmapirobebeli faqtorebi (ix. qvemoT); avTvisebiani simsivnis ganviTarebis risk-faqtorebis arseboba (mag. mkerdis I xarisxis kibo); sisxlis maRali wneva; darRvevebi RviZlis mxriv (mag. RviZlis adenoma); Saqriani diabeti venebis mxriv garTulebiT, an mis gareSe naRvelkenWovani daavadeba (qoleliTiazi) Sakiki an Tavis Zlieri tkivili; sistemuri wiTeli mglura (autoimunuri darRveva) endometroumis gazrda; epilefsia; bronquli asTma; otosklerozi (darRveva, romelic gavlenas axdens smenaze yurSi mimdinare cvlilebebidangamomdinare); hormonCanacvlebiTi Terapiis pirveli ramdenime Tvis ganamvlobaSi SeiZleba adgili qondes mciresisxldenas (sisxlis laqebi), magram Tu es grZeldeba ufro met xans, an mkurnalobis dasrulebisSemdegac, gTxovT mimarToT Tqvens eqims; gulis daavadebebi; Tirkmlis ukmarisoba;

saxis da kisris SeSupeba, rac iwvevs sunTqvis gaZnelebas; miokardiumis infarqti; insulti; sisxlis koltebi, ZiriTadad qveda kidurebis venebSi, rac iwvevs tkivils da SeSupebas; mkerdis kibo; endometriumis hiperplazia (endometriumis zomaze metad gazrda), an endometriumis kibo; Zlieri, araregularuli, an mtkivneuli genitaluri sisxldena.am reaqciebis aRmocenebisas dauyovnebliv unda SewyvitoT preparatis miReba da mimarToT eqims.klinikuri kvlevebisas da postmerketingul periodSi iyo cnobebi Semdegi gverdiTi movlenebis SesaxebxSiri gverdiTi movlenebi (vlindeba 10 pacientidan 1-ze nakleb pacientSi): Tavis tkivili, Sakiki; gulisreva, muclis tkivili, gazebis gamoyofa; qveda kidurebis kunTebis spazmi tkivili gul-mkerdis areSi tkivili menjis areSi; wyvetili sisxldena, an sisxlis laqebi; daRlilobis SegrZneba (asTenia); wonis momateba/daklebaaraxSiri gverdiTi movlenebi (vlindeba 100 pacientidan 1-ze nakleb pacientSi): kanis alergiuli reaqciebi, kanze gardamavali gamonayari, qavili (pruritusi); depresia, libidos Secvla, SfoTva; vaginaluri kandidozi (TeTri xaWosebri gamonadeni, gamowveuli Candida albicans-iT); sisxlis maRali wneva; koWis, fexebis, an TiTebis SeSupeba (periferiuli SeSupeba); darRvevebi sisxlZarRvebis mxriv (periferiuli vaskularuli daavadeba, varikozi, venebisTromboembolia); naRvlis buStTan dakavSirebuli darRvevebi, saWmlis monelebis darRveva; zurgis tkivili Tavbrusxveva; gaxangrZlivebuli sisxldena, mtkivneuli sisxldena; saSvilosnos fibromis gazrda; saSvilosnos yelis sekretis raodenobrivi da vizualuri cvlileba;iSviaTi gverdiTi movlenebi (vlindeba 10000 pacientidan 1-ze met pacientSi): RviZlis funqciis cvlileba, zogjer Tan axlavs siyviTle, asTenia, muclis tkivili da zogadidiskomforti; cvlilebebi Tvalis mxriv (rqovanas mrudis gazrda); kontaqturi linzebis autanloba; premenstrualuri sindromis msgavsi simptomebi; mkerdis gazrda.Zalian iSviaaTi gverdiTi movlenebi (vlindeba 10000 pacientidan 1-ze nakleb pacientSi) da ucnobisixSiris gverdiTi movlenebi (romelTa Sefasebac ver xerxdeba arsebuli monacemebis safuZvelze): sisxlis wiTeli ujredebis raodenobis Semcireba (hemolizuri anemia); qorea (kunTebis araregularuli, uneblie SekumSva); miokardiumis infarqti; insulti; Rebineba; kanis feris Secvla; yavisferi laqebi kanze (qloazma, melazma), rac SeiZleba darCes mkurnalobis Sewyvetis Semdeg,polimorfuli eriTema, kvanZovani eriTema, vaskularuli purpura, angioedema; porpuriis gamwvaveba.

65 wels gadacilebul qalebSi xangrZlivi hormonCanacvlebiTi Terapiis dros maRalia demenciisganviTarebis riski.mimarTeT Tqvens eqims, Tu hormonCanacvlebiTi saSualebebis gamoyenebis Semdeg gamovlinda uecarisisxldena. hormonCanacvlebiTi Terapiis Sewyvetis Semdeg sisxldenis gagrZelebis SemTxvevaSiaucilebelia damatebiTi gamokvlevebis Catareba, raTa gamoiricxos darRvevebi endometriumis mxriv.SesaZloa Seicvalos sisxlSi konkretuli proteinebis da hormonebis koncentracia. ar xdeba gavlenaorganizmis hormonebis moqmedebaze. sisxlis analizis Catarebisas acnobeT eqims, rom iRebThormonCanacvlebiT saSualebebs.mimarTeT Tqvens eqims, an farmacevts Tu romelime gverdiTi movlena xdeba mwvave, an SeniSneT iseTimovlenebi, romlebic ar aris CamoTvlili am danarT furcelSi.5. femostoni kontis Senaxvis wesiSeinaxeT bavSvebisaTvis SeumCnevel da miuwvdomel adgilas.SeinaxeT original SefuTvaSi 30 0 C dabal temperaturaze.ar gamoiyenoT femostoni konte SefuTvaze miTiTebuli vargisianobis vadis gasvlis Semdeg (EXPSemdeg). vargisianobis vada exeba Tvis bolo dRes.preparatebi ar gadaagdoT sakanalizacio wylebSi, an sayofacxovrebo narCenebTan erTad. kiTxeT rCevafarmacevts preparatis ganadgurebasTan dakavSirebiT. es zomebi daicavs garemos dabinZurebisagan.6. damatebiTi informacia6.1 ras Seicavs femostoni konti- aqtiuri nivTierebebia: 1mg estradioli 1.03mg estradiolis hemihidratis saxiT da 5mg didrogesteroni.sxva komponentebia: birTvi - laqtozas monohidrati, hipromeloza, simindis saxamebeli, kremniumisdioqsidi koloiduri, uwylo; magniumis stearati;garsi: opadrai OY-8734, romelic Seicavs titanis dioqsids (E171), yviTeli rkinis oqsidi (E172), wiTelirkinis oqsidi (E172), hipromeloza, makrogoli 400.femostoni kontis aRwera da SefuTvis SigTavsifemostoni konti warmodgenilia Semogarsuli, mrgvali, 7mm diametris, ormxrivamozneqili, mowiTaloforToxlisferitabletebis saxiT, erT mxares gravirebiT ”379” da meore mxares – “S”.kolofSi moTavsebulia 1 an 3 kalendaris tipis al/pvq blisteri 28 Semogarsuli tabletiT.savaWro uflebis mflobeli da mwarmoebelisavaWro uflebis mflobelisolvei farmasiuTiqals/ Solvay Pharmaceuticals B.V.C.J. van Houtenlaan 36,NL-1381, CP Weesp,holandiamwarmoebelisolvei biolojiqals/ Solvay Biologicals B.V.Veerweg 12NL-8121, AA Olst,holandia