Tipen yorpe6a wa never sunmarenno npowajre ro yravereor6, Ganelén compa fan wnebopnaunie 2a 8x. - Yyeaime 20 ynamemeorra. Mawes Ke mpeba da 20 npowumame noernopH. ‘Axo uname Cononeumena rpawerea, obpameme ce xa] Bauuon doxmep, ‘apuayaam unu woduuuvoea coompa 20) nak Bu enponuuan Baw nuH0 u He mpe6a Os uns 20 daeame Ho Opyeu mute, [Gudojiu woxe da uur Haumemu, Oypu u aro HueHume sHauu Ha 2aGonyearee CO UEmU a Baume. - Koumakmupajme 20 Bewuom dormop, chapsoyea uy Meguyuncks coempa doxonky [Bu ce nojasam Hexou necaKaHu deloma, exalt u Hecaxart Geimea ROU He CO 1aBooevu 80 oeaa yrarmneo. Budeme 20 denim 4 YMATCTBO 3A NAUMEHTOT Avodart / AsonapT 0,8mg mex xancyna Dutasteride Vie w anjpeca na nocuTanot Ha onoGpeHve 3a crasaibe 50 npomeT TravcoCwirrknaju Excnopr Suuunren Mongon, enka Bpiranvia Tperctasrnuts0 Cxonje Yn, Autos Tonos 6p. 1/4.wesauw, 1000 Cxonje, P. Maxenouyja, ten 02 3298 766, Npowasonuren GlaxoSmithKline Pharmaceuticals $.A, Nlosvaw, Noncra tro compas ova ynarerao: Ulme npememaeyea Avodart u 3a wmo co ynompeBysa imo mopa da snaeme, nped da ynompebume Avodart; Kaxo da 20 ynompebyaame Avodart Moxa necaxanu dejemea (seanquu) ‘Uyeaibe u pox wa ynompeba; Codpua na naxysamemo w ocmanemu uncbopMayLL. 4. ro npercrasyea Avodart w 3a urro ce ynorpe6ysa ‘Avodart ce ynorpe6yaa 2a rperwan ita maxi co aronenenia npocrara (GennrHa xunepnnasyja va npoctara) - wexahuapaseH pact Ha npocranwiara xneana, Npenwaeuwan on npewyMepHa—npoyKuwja Ha OpMOHOT.-—wapeven -ynanporecrocrepon apesenin mixnutoph we 5-andba peayaraca, Sfonewenvor pact Ha nfocTarara Mame ma AoBeAe fo ypaKe luo ce noTeuoTHK co npoTOKOT Ha ypuNaTa W noweCTa nr Toaner. Victo Taka Moxe a npenmseHKa wnasoT Ha ypriara ja Oi ‘nocna®. Ako He ce Tpervpa, nocToM puauK KounneTHO Ala ce Gnowpa NpoTOXOT Ha ypnia (ayia ypunapsa peTeHuWja), Toraw © HeOmoneH wTeH meaUMICI ott‘TpeTuaH, Bo Hexon enysan HeonxoReH © xMpypUbKA Sacbar, 3a fa Ce oTCTPAKH Hn Hamann ronemmwara va npoctarara, Avodart ja awanyeanponynuvjata Ha sunporectocTepor, uo NoMara pa ce Hawanh npocrarara w fa ce oneciat ‘utanronTe, Ha To] Hav ce nauanlyea pHaMKOT On akyTHa ypuiapHa even H NotpeSara of xapypune aarpar Avodart woxe, voto rake, a oe ynopebyea co apyr nex, Hapeven tamsulosin (uro Ce Kopwcri sa nawanyeaie Ha cinunToMuTe oA stoneMena npoctera). 2, ITO TPEBA JIA 3HAETE NPE 1A FO YNOTPEBMTE AVODART Hemojre ma ro ynorpe6yaaro AVODART: Hloxonyy cre aneprwvin wa dutasteride, pyr S-ana peayerasa WKMOWTOPH, coja, KaPHKN ui Ha HeKOja APyTA CocrOjKA Ha OBO) Nek (ra0poenn 80 gen ~imnare cepnosito saGonynamse Ha ypHKoT Apo. % Axo emerare jexs neutto on npeTxoRV0 HaBpoeHoTo ce onHecysa Ha Ba, Ho aemajre ro 080, nex Ges npeTxogHa KONCYNTaUNa CO BauIMOT fOXTOP. O80] nex 0 nawener ncxtysneo 3a many, He cuce na ro ynorpeGysaaT Ket, Aeua wanonecuerrn Mpeaynpenyaarea # mepkst a npernasnmeocr Pasronapajre co Baumor Aoxrop npea fa sanosneTe na fo ynorpeGysare Asonapr. ~ apectere ro Baunor oxrop 2a npoGnemute KOM ri MMaTe CO UpHMOT [ApO®. Aro cre nan Hexoe sa6oryeaive Ha UpHior ApO5, MOKED Ke Tpeba 2a wanpasuTe nonamrenit avaran, noneka ro senate Avodart. ~ Kenn, neua w agonecuerra He cuear na pojaar 80 forwp co ourerenn xanoynw og Avodat, Gajejiv akrushara cyncranuvja Mox® a oa ancopOnpa ipery roxara, Bo cny¥aj va nonip co ourtereki xancynn, sonara Ha oWrakToT Mopa BonMaUl Aa ce HaMMe co Bona M canyt ~ Kopnotere xongou 3a speme Ha cexcyannn onnocu. Dutasteride & "Rpwcyre# Bo cnepnara Ks wanarte KON 3eMaat Avodart, AKo napTHepxara © ann woxe fa Guige Bpemiowsa, raa wopa ga vaSernyea onvp co Baulera ‘cnepita, Guaeiia dutasteride moxe sa smvjae aps Hoplanior Pasko) Wa uaunoTo Sobe, Dulasteride ro Kamanysa Opojor ha cnepwarosonniTe, ‘onyheHor Ha cnersara W nojeuenocra Wa cnepwarosountiTe. O8a MOxe 1a ja Hamar Bawssra nnoaoc, Avodart snujae apa vecror 3a FICA (npoctara-cnewwxpmen aliTured), Uo Hevoraw ce kopicTH sa onepuaive na Kapigom Ha Npocrarara, Bauer ‘ROKTOp Tpe6a Aa akae sa oB0j etbext co Uen 2a npaaunio Tontyeaive Ha Deayntaruro of Tecror aa oTspiBaise na pax Ha npacrarara, Ako npaeiye Tect 28 NCA, raxewe my Ha Bauwor foKrop eka aewtare Avodart. Max KOH seniaar Avodart tpeGa ponobno a npasar IICA recroen, Bo krumano vonuryBaive Ha manor co sroneMeH pHHK Of NojaBa Ha pax Ha npocTara, MaxuTe YOM seMane Avodart Hitane cepMozoH OGnink Ha pak Va pocrata novecrooTKonry Mant Kou He aeMane Avodart. Ecpector Ha‘Avodart ape nojasera Ha obo) ceprosen oGrik Ha pak Ma npocrara ce yurre ne e jacer = Avodart moxe a nponwannia aronemyearwe Ha rpanue (nojKsTe) w nupia wyactaxTenHocT. floconsy osaa npoMeNa cTaNe BoshewwpyBasKa van ower 2aBancxure rpyrn MAM McueAOK on SpanaBMuTe, kontoynnuparre Aorrop 22rca iuTO aBie NOMENA MOXEOM C2 aHaUN Ha cepnoaa cocroj6a, Kako UrTO © pax Ha ADjxa (rpaa). > Koncynrupajre ro Baumor goxrop nu cbapuauenr axo mate Gino KaKon pawarba 80 epcxa co Avodart Aipyru nexosn w Azonapt Yopecrete ro Balitot AOKTop axo 2eMaTe, NeomaMiNa cre seMane unH HoxeGH fo aomare Hox} npyr nek. Hexow neko mane fa pearypaat co Avodart n nome Aa ce nojasar HecaKaHit zejeres, Bo Twe nexooa cnafaar: ~Sepantunn (vorparl) wn Garonsew) ‘npaTacon): = Pwronannp (ritonavir) wiv wiqunaup (indinavir) (2a XB), = Wirpaxonaaon (itrakonazole) unn keroKowason (ketokonazole) (sa raGnsia vncberaia) + Hecbasonon (nefezodone) (atrinenpecte) © amcha Gnoxaropi (ea sronewena npocrata Mu sxcoK ypBeN HIpHTACOR). jazem (28 aNCOK pBCH > —Mavecrere ro Baumot aoxrop ako seMaTe Hex) Of OBwe NexoBM. Moxe6n fee pea fa ce wavanu aoaara wa Avodart ulto ja semare. Avodart co xpana wt nijanouw ‘Avodart Moxe fa ce aewa co un Ges xpana Bpemenocr, noowe x ctepranirer | KenurTe KOM ce Gpenona (Wik KOK Moxe fa 2a6peMoNaT) He cMeaT Ha AOjAaT BO ‘monup co owrreren ancynn. Dutasteride ce ancopSvpa npery roxara w moxe na Bnujae eps HopMANKNCT paano] Ka MAKOTO GeBe. PuaMKOT e OCOeHO BHCOK BO nppirre 18 wegen on| GpeeHocra, Koperete KoNAoM 28 epee Ha coxcyannu onnocn. Dutasteride @ npicyreN 20 Ccnepmara xa) Maporre Kei sowaat Avodart, Ako napTMepxara e wn woxe fla GME Spemeva, Yaa Mopa fa veberHyea onp co Bauara cnepua, > — Kowraxrupajre ro Bauor joxrop 3a cover axo ovat co dutasteride Boseise m ynpasyaaree wa MaulnnW Manny © sepojar#o nexa Avodart woe na enujae wa Bausara cnoco6Hocr 3a soseise vu ynpanyeaise co aun‘Anonapr compu newarHn om coja x0} nex coApxa newiraH Of Coja, Koj WOKE Ala conpy coja Macno. floKanKy cre |neprUin Ha Kalaipnen ani Ha Coja, HENOjTe fa ro ROpuCTHTe OB) nek, 3. KaKo na ro ynorpo6yaare Anonapr Coxoraw semajre ro Avodart ovaKa Kako wo Bu kaxan BawMor goxrop Wnw Sapwauesr. HepenoanoTo sewaise Ha neKoT, wowe a anvjae Ha chenerevo Ha TICA speanocrare. Konoymupajte ce co Baulor foctop whi chapkayesT RoKenky he cre curypi. Konkaa noza e noxpesiia ~ Mpenopasiana ora © onta xancyna (0.5mg), eaMaw Ha jen, TontueTe ja sranoynara wena, o> sona. He ja yBarajre una kpWeTe vancynara. KowraltoT o conprornara He Kancynata MOX® Jia npenWaaAka Gonka 60 ycraTa Hn ‘pnoro. ~ Tepanuara co Atodart © ponrotpajia. Hexow wave sa6enexysaer pano onoSpyzaise Ha wehurre citanrom. Mefyroa, apyra maxi wome6u Ke peda a senaar Avodait 6 meceun una noseke, npeA Aa NowyecTaysaar emer Mpononmere aa seware Avodart oxonky onro Komy wo Bi npenopasan Baumor noxrop. ‘Ano cro aewane noronewa aoza on Avodart orkonny usro rpe6a Kowrakmmpajre fo Baumor noxTop wi capmauear 2a cose. povonky cre sexane oronewa fosa on Avodat xancynire, ‘Ano ete saGopasune na oMere Avodart He ynotpebyeaire soja nosa sa qa ja Hagomecrure saGopasenara fosa. Cao sewere ja Bawiara chente gosa ko sooGmiaeHioro epee. He npectanysajre ja semare Avodart 6ea coner He npecranypaire ja sexzre Avodart Gea npeTxoRio ace KoHcyntupare co Bawnor AoxTop. Moxetu ke Swjar norpeOHn Ao 6 weceut Hn noseke NEA na TO aaGenenarre edpekror. > Axo uware Apyru npawawsa 2a ynorpe6ara Ha-oBo} nex, npauuajre ro Baumor joxrop an dbapmauier. 4. MOKHM HECAKAHM NEJCTBA Kaxo w cwre nexoBn, oBo| nex momo fa npenwanuka HecaKann psjcraa, MaKo He raj cwre naunenrn. Anoprnenn pean ‘haus wa aneprucen peaiawn mone na Guar: = cin Ha KoxaTa (iro MoKe fa Youle); + yprukapuja ( — Kowraxrupajre ro Bauer AOKTOP BeAKaN ako uNaTe HeKO} ON BNE ‘ommront u npecranere sia 20mave Avodart Mocta Hecaxann aojerea (Qeue wacaxavu dojemea moxe da ce jaeam xaj 1 Ha 10 waxy, Kou sextaam Avodatt = Hewoxnocr fa ce necTurHe # ORG eperunjaTa (ulmomenyuja), o8a WOKE ‘Ra nponomar W no npecTaHok Ha seMaivero Ha Avodart = Hamanyeaise Ha oxkcyanara wen6a (niGago), o8a ome fa NpopOTIN H nO npectanox na sewarsero Ha Avodart; noTeuKovant co darynauyja, xaKO WTO © HaManyeaiee Ha BonyMeNor Ka ‘canteia reswocr d2noGone 3a BpeMe Ha coxcyaNHNOT ONHOC, OFA MONE a Inponornar W RO ApecrAHOK Ha sewaysero Ha Avodart, = sfonenyaame Ha noire (fpanute) wn Conta wyscreurenvocr (aerouacraie); ~Bpromnannua, xOre ce seMa co tamsulosin. Mlomanny secrt wocanann acjersa Osuie necaxant dejomeasrone da co jazam 0 1 Ha 100 Max, Kou seuaam Avodart: ~ vapawjanio sarajyeaise (cpyero crakysa niowanny edukacho 80 enyunyesive Ha KpsTa Hus TenoTo. Moxe ja ce nojasar cnTomn xaKo Hegoctarox Ha BoaAyx, exCTPEMeH JaMOp M OTEKYEaKLE Ha sTHOGOBUTE o2ere), = FyBeive ha KocaTalanaiiara (aooSutiaeko oA Tenoro) MMM pact Ha woca Henoatarn Hockann ochoxrn ‘Operaerujara ve Hoxe a 6iyge npouewea o9 pacnonoxrasie nogarouN: enpeciia; Banka n oroK Ha Tecrucao, Fipujanynamwe wa Hocaranu pejeraa Kourakrupajre ro Baumer foxrop win ¢bapwiayesr poronry Bu ce nojasar HeKoH Hecarani nelerea, pinyayaaior W HecaKAKI AejcTBA KON He ce HaOpoeHn Bo oBaa ‘ynaTerao, Cekoe HecaKavo fejcTB0 MOMETe, NETO Taxa, AMPEKTHO la r0 npriawTe M Tpeky Hewwronaniiior enctem 2a npvjasyearbe, Co coxoe npujaayeaiwe va wecaKanin zelerea, Bie nowarare fa ce Ao6yjar noseke wicbopkeauin oxony BesbenKocra Ha 080) nex 6. Kako aa ce 4yva Avodart Slexor sypaire ro Ha wecra nejoctannn sa neua. He ro syeaire Avodart wa tennepatypa wa 30°C. He ro ynorpe6yrajre one) nek no AaTyMor Ka wcTexOT Ha pok ure aenen va KapTOHCNOTO naKyBaibe uM Ha Gnuctep naxy juor Ha lcTeKOT Ha poxOT Ha yrorpeBa ce onHecyea Ha nocneAAMCT mn He m cbpnaite stexosnre npery otnagin Boge ann 80 jowawen oman. Konoymrupajre ce co Bauivor cbepmauesr Kako w Kane Aa rH WoIppniTe neKoBHTeluo noseke He 1H ynorpebysare. Cave wepia iia npernasnisocr npuaoNecyaaar sa ‘saumrrra Ha yunoTvata oxonMia 6. Conpxana wa naryaarwero # ocranan micpopMayn UWiro compan Avodart ‘AnruaHara cyncranua © dutasteride. Cexoja meka kancyna compra 0.8 mg dutasterde Apyrure nomownn cocrojan ce Bo kancynara: ovo W AMEMMYSpHAH Ha KanpuTHHalKanpHHA FeCerna Gyrunarex xunporcironyen (E921). + OGanekara Ha Kaneynara: wenaTi, cmiuepon, aTaKHya avoKonR (E171), 2xOnT Meneses oko (E172), TpHrMLepHa (openeH navoU), NeUATHK (Moe 2a con coja waco) Karo warnoga Avodart wcompxuna wa naxyeaiseTo ‘Avodart mene xancynv c2 sisjonmet, HenpOsipM, KONTH KancymA Of Mek 2xenaTan co oshaka GXCE2. Tue ce nocranii ao naxyoaive of 10, 30, 50, 60 90 ‘wert xancynit. Cure naryaiba nome fa He ce facranii a nasapor (wapeeTupan) Hawne wa sonanaise Jlokor ce wagaza 80 anera cao spa ocioea Ha neKapexr peyent. po) u aaryit ua OgoGpenne 2a crazaibe Ha nexor 80 npomer 19-2118 09 08/07/2018 Aarys Ha nocnenwa peorsuja Ha sitarpewnoro ynarerso clanyaput 2078