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CiieA PAIKO Inpexparasate Ha AeveniMeTo Morar sa ce HaGmOABAT CHMITTOMM Ha OTHEMAHE. AKO Bee He © neoBxoaHMO NpowexaaHe Ha Tepanns ¢ OXCHKONOH Ce NPenopEYBa NOCTENeHHO NOMFOKABAHE Ha sMesHava 2008, 38 1a ce waGerHe Nossa Ha a€cTHHeHTeH cHHApoM. CHMITTOMMTe Ha OTHEMAHE MoraT sia BKVOURAT NposseaHe, MHIPHATa, TaKPHNALIKR, PHHOPEs, TPeMop, XHnepxHaposa, GestoKoHicTBO, |EKUTAMMS, KOHBYNCHH H GEICBHHE. ‘Muro patko, ocoBeH0 Np BHCOKH 203K, MOKE a HACTBNM XHNepANresHA, KOATO He PearHpa Ha NO- HATATBUIHOTO YBemMMeHHE Ha LOSMpoBKaTA Ha OKCHKOAOK. Moke Aa ce Hao‘ NOHMDKABAHE Ha OvaTa Ha OKCHKOJOH WIM NIPEMMHABaHe Ha pyr aTTepHATHBCH ONHOKA. ier, 10-ce Ha. oH (snovi # ‘Monte a ce paspiiat ToneparTiiocT M GbyaHYeCKA H/T TICHXHYHa 3ABHCHMOCT pH MHOTOKPaTHO pHoxeHHe Ha ONHOHIH, KATO OKCHKOZOH. ‘Muoroxpatvara ynorpe6a Ha OxcHkon0H AkTaBHC MOxe a nOBesle 20 pascrpolicrso, AuDxALNO ce a ynorpe6ara 1a onHonan (Opioid Use Disorder, OUD). 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HeBponerTHU, aHTHXHCTaMHINH, AHTHEMCTHUM, AHTHMaPKHHCOHOBHL JeKapeTBeHM MPONYKTH) MOTaT 1a SACHAAT ANTHXONMHEPrMNHHTE HEKCNAHH PeAKLUH Ha OKCHKOAOH (karo KONCTHNALUAS, cyXoTa B YCTATA HIM MHKUIOHHM HapyLNeHHs). ‘Oxcion0n ce meTaGonnsupa ocHosHo ot CYP3A4 ¢ nomouira na CYP2D6. AkrupHoctute Ha Tes ba MeTaGOnHTHH MeTHWWA Morar 2a GeaaT MEXHOHpAHM HAH MHLAYUNpAHH OT past eaHOBpeMentio MpHnaraii# NeKapcTBa NAH XpanH. VirxnGirropure 1a CYP3A4 xato MakponHann aHTHGHoTHuM (Hanp. KTapHTpOMHUH, epHTPOMHUMH }cTenHTpOMMUKTH), aS00BH AHTHMHKOTHLM (HAN. KeTOKOHASOM, BOPHKOHASON, HTpakOHAsaN H nosakoHas0n), npoTeasHH MEXHGHTOpH (Hanp. GOUeNPEBMP, PHTOHABHP, HRAHHABH, HeNbHHABHD H CaxsHasHp), UAMETILIAH H COK OT rpelinbpyT, MOraT 2a NOBCAAT 10 HAMARCH KIKPBHC Ha OKCHKORON, KOETO MOKE 1a NPHYMHH NOBHUIABAHE HA MIASMEHHTE KOHLICHTPALMH Ha OKCHKOAOH. To -Ta3M MPHYHHa Mowe 2a Ce HATOAKH ChOTBETHA KOPEKUMA Ha 203ATA Ha OKCHKOOH. Tlo-nony ca name HaKOH KONKpeTHH NpHMEpH: © Hrpaxonaaon, mouten uixH6uTop Ha CYP3A4, npunarax no 200 mg nepopasHo 8 Npomboxenwe Ha ner aNH, nosmuasa AUC Ha nepopaniins oKcHKonON. CpenHo, crojiKocrra wa AUC € np6ansienno 2.4 mstu no-sicoxa (aManason 1,5 -3.4). © Bopakonason, winxn6irrop na CYP3A4, npxnarai no 200 mg asa msTH AHeBHO B npomWDKEHME a 4eTape ain (400 mg kato mopeHTe aBe no3H), noBisuaBa AUC Ha nepopasina OKCHKOZON. Cpenno, crofnocrra na AUC e npu6nisntento 3.6 meth no-BHcoxa (ananasoH 2,7 -6,6), © Teavrrpomaun, nixH6HTop Ha CYP3A4, npunaran no 800 mg nepopanio B npomBaKEHHE Ha eTHpH ani, nosiitiasa AUC Ha nepopania oxcuxonoH, Cpeato, cro#Hoctra Ha AUC € npuGaus#renso 1,8 mvH no-excoxa (aHanasoH 1,3 -2,3). © Cok or rpeiindpyr, snmxnGirrop na CYP3A4, npazarans no 200 ml tp msTH aneBHo NpomBIMkeHHe Ha eT AHH, NoBMUIaBA cTofHocTTa Ha AUC Ha nepopaatina OKCHKOTOH, Cpeano, ctoiinocrra aa AUC ¢ npuGawstrento 1,7 meta no-BHcoKa (ananasoH 1,1 -2,1)- iiayxropate na CYP3A4 Karo Hanpumep pucbanrmun, KapGamasemit, eHHTOHE HBT KatsTapnon MoraT na HEUIyLMpaT MeTaGOTHSMa Ha OKCHKOZON 4 a 1OBeqaT 10 NOBHitIaBaHe KAMPBHHCA Ha OKCHKOIOH, KOETO MOE 2a NPHMMITH HaMaAnABAHE MasMeHHTE KONLEHTPAWHH Ha OKCHKOION. Mone aa ce Hato>Kn osara Ha OKCHKOOH Aa ce KOpHTMpa cRoTRETHO. Tlo-nony ca aanenn HakoH KoHKpeTHH npHMEpH: © 2Kxorrusr xasrrapnon, muzyxtop na CYP3A4, npHnaran 8 21038 oT 300 mg TpH MBTH ZHeBHO B NpomurxeHne Ha neTHaneceT AHH, NoHWOKaBA cTofiNocTTa Ha AUC Ha nepopaniis OKCHKORON. Cpeano, ctoiinoctra na AUC e npbansirrento ¢ 50% no-nlicka (o6xBat 37 -57%). © Paibannaun, witayxrop Ha CYP3A4, npxtaran 032 oT 600 mg BemHBH AHEBHO B TpomuMKeHHe Ha CeneM sUMH, TOHIEKaBA CTOHHOCTTa Ha Nepopaniina oKCHKOAON. CpeaHo, cTofinocrra wa AUC € ¢ 86% no-HeKa. Jlexapersa, KoHTO MHXHGHpaT akTHBHocTTa Ha CYP2D6, KaTo napoKceTHH H XHHNIUH, Morar 2a AoBenAT 10 HaMaTABAHE KANPiHea Ha OKCHKOZOH, KOeTO Moke fa NPeAWSBNKA NOBHUIABAHE Ha mia3MeHHTe KOHUeHTPAUHH Ha OKeHKOAON. He ¢ wapecren ecpexta Ha apyritte Ha0eHSHMMH HAXHOMTOpH BEPXY MeTaGamHSMa Ha OKcHKORO} Heo6xonHMo e sa ce B2eMaT Nox BUKMauMe BLaMOKHIHTe BaaMMozelicTans. [loTeHIUMaAi OKCHKOROH BEPKY tUHTOXpOM PASO extsHMH He € NpOYHBAH in vitro HAH in vivo. SSE/H/1226/001-0031A028Tipn camospemenHo npivloxkeHHe Ha KYNapHHOBM AHTHKOaryZaNTH C OKCHKODOH xHAPOXTOpHA kancy.1M ca HaGaNO]AKAHM KIKHHYNO HASHMI MPOMEHH B MEXKTyHApORHOTO HOPMATHSHpAHO otnoienne (INR) # 8 aiseTe nocoKH. 46 Depruauter, Cpemennoct w Kupmene Ynorpe6ara Ha TosH neKapcTecH npoaykT TpAOBa No BRIMOAHOCT na ce HAGATBA MPH NAUMENTKH, KouTO ca GpeMennit HAM KEPMAT. Bpementocr Taunrrre 32 ynorpeGara wa oKcHKo0H Mp 6pemeHHH wKeHH ca orpaHieHH. JeuaTa, poneHH oF Maliki, KOHTO ca NpHEMAIH ONHOMAK Nes NocneaHHTe 3 no 4 cenNMUK MpenH paxiaHeTo, TpA6BA na waar naGmozasani 2a nossa Ha pecnpatopHa nenpecus. BesMoxHo ¢ fa ce Ha6monaBaT ‘CHMITTOMH Ha OTHEMaHH PH HOBOpOREHH OT MaliKH, KONTO NPOBEAAT NeHeHHE C OKCHKONON. ‘OkcHkoa0H npemiiiasa npes nauesrara. FIpH mpoy'paHiTa ¢ OKCHKONON BEPXY 2KHBOTHH He CE {YeTaHOBAEAT TepaToreHHH HK EMGPHOTOKCHYHH e*peKTH. OKCHKOOH TpAGBA ia Ce HSNO.TSBA MO BpeMe Ha 6peMeHHOCT caMo ako NloNATa HANBHUIABA BLIMOXHITE PHCKOBE 30 NHNOsI HAM HoBoponeHoTo. Kepmene ‘OkcHkon0H npemHHaBa B KBPMaTa H MOXE a NPHAMHM pecrHpaTopHa AENpecHA NpH HoBOpOTEHOTO. Tlo TasH mpH4nHa OKcHKOIOH He TpABBa 2a ce HanOTIBA OT KEPMELIH MaiiKH. 4.7 Edexra supxy cnocoSnocrra 3a mogupane n paGora ¢ maura Oxcnkonon Mome 1a Hapywin cnocoBrocrTa 3a wodupante # paGora c aunt (sx. TOHKa 4.8). Tipa yreppacta cra6wina Tepanna He ce Hariara o6uia sa6pava 3a ynpasncsme Ha npeso3Ho cpencrao, Jlexysauust nexap TpaGsa aa NpeueHH MHAMBHAYAAHO BCRKA KONKPeTHa CHTYaLU. 48 Hexeaann sexapersenm peaxuun Penoe na npodana sa Gesonachoct OxcHxon0H Moxke 2a npeaHsBHKa pecrparopHa aenpecus, MHosa, GpoHXHaNHH cnasMH H cnasMM Ha rnakara MycKysaTypa H Mowe a NOTHCHE KAULINMHHE pedreKc. Cone Mtn Bs Tocouentre kaTeropii 3a ¥ecToTa wanonspaT cneaHaTa KOHBeHUHA: MHOrO HecTH (21/10), HeCTH 21/100 20 <1/10); wesecrH (1/1 000 20 <1/100); peak (21/10 000 0 K06a, 2. Ornenere esa GnncTepxa KaeTka no nepdopypaniTe AHHH 3. BHHMaTenHo oTAeneTe NOATOKKaTa, 3a a OTBOPHTE A>KOba, 7. TIPHTEXKATE.1 HA PA3PEUIEHHETO 3A YIIOTPEBA Teva BV. Swensweg 5 2031 GA Haarlem Huaepnannna 8, HOMEPHA PA3PEINIEHHETO 3A YNOTPEBA Oxcukoaon Axrasnc 10 mg raspam xancyau - per. No 20130045 Oxcnkozon Axrapnc 20 mg Taepan xancynn - per. Ne 20130046 9. ATA HA ITBPBO PA3PELIABAHE/HOJHOBABAHE HA PA3PELIEHHETO 3A, YMOTPEBA Alara va mpso paspeurasane: 17.01.2013 r. ‘Dara wa nocneano noaHosssave: 19.09.2018 r. 10, ATA HA AKTYASM3HPAHE HA TEKCTA 24.01.2024 ‘SEMH/1226/001-003/A/028 2