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Topa nokaSBa, Ye ANETHIHCTERH ce OKHEHABA P30 0 UNCTHH MpEsH a NOCTArHE 10 OGMIOTO KPEAOOGpaulleHHe, KATO HUCKaTa HAAIHMHOCT He MOH fd CE ccanpsea ¢ HemisHa aGcopGUs, a 10-CKOpO c HHTEHSHBCH expexT HA MEPBO pemnnasane (first-pass MeraGonustm). Pasnpesencume Tlopaai wsaseuus e*pexr Ha Msps0 MpeMHtanane, GuoHMNOcTTA Ha Nepopanio NpwioweHHA auerimntcrent € camo oxano 10%, Tip Xopa MaKcMMANHH IInasMeHH KOHILeHTPAUM ca AOCTHTHNATA cea 1-3 aca, npa xoeTo mikoBaTa TiasMeHa KOHUCHTpAIua Ha aKTHBHUR MeTA6OAHT IUCTEHE € B mopanpxa Ha 2 pg/ml. HpaGmnsirrenso 50% or aueTHTUFCTeMH ce CBEpSBa ¢ muiasMeHHTe MpoTenti Pasnpenexenneto b Gextrre apoGone € MHHOTO BHCOKO (48%), B yal ‘Cuea nepopanuo npanoxcne, ekapcTsoTo npemunasa Npe3 3HAdHTeNeH MCTAGOIHSBM Ha ITbpBO MIpeMHHapane B CTeHaTa Ha Yepaara HB epHHa p06. AUeTHTIMCTEHH H HeroBHTe MeTAGONTH co pear B opranitawa B TpH paar OPM: HACTHHHO KaTO CBOGOARH cyGeTARUMM, LACTHYHO KATO (CBLP3aHH C MPOTeHHHTe MOcpexCTBOM Cu1a6H AMCYMPHAHM MOCTORE H YAaCTHYHO KATO UMCTEHH. ‘Yeranoneno e, we Cuoxpasietbopuauiutra Ce CLCTOM lIpeMMHO B AEALIETHAMPaHe, KOCTO ce CMATA 5a rraBnns axrop, onpenensuk HAcKaTa nepopania Gnonammanoct (aprBnKsuTenKo 10% or camoTo ‘RexapcTB0) Ha cnoGonen AlleTHLTLMCTEHH B ILIASMaTa M JIPYTH TENECHH TeUHOCTH KATO Gporxoansconaprms naBaxt. NoctHmanire p pesy.rTaT Ha TOBA NOBHIEHH UMPKY/IATOPHM Mia Ha [ayraTHoH Mpé Xopa ce eMsTar 3a MpoTekTHBeH eeKT M REPORTHO ca PesyMTET OT CTHMY:AHpAHHS edbayke of YepHus 2po6 H excTpaxenaTalen ryTaTHOH. Thhasmennst noxyoxnnor na anerisinctemt € oxoa0 | Hac H ce onpestens ry ‘uepHompobHa Gnorpanchopmansis. [opann Tosa, npM Hapynietia YepHOxpoot OAYPKHBOT ce ymmDKABA NO 8 vaca, Esunanupane Haz 1/3 or nepopamto npneris aneTwaunicremt (38%) ce exoxpeTHpa non (hopmara Ha HeaKTHBHM meraSonnTa (neopranmnn yaar, AMaueTHtunicTeM) npes OLbpeuHTe. ‘DapMakoKHHeTHYHH Mpoy"BAHHs MPH wimpagenosio IpHNOKeHHe Ha aleTHTMCTEHH NoKaspaT OGeM a pasnpezeene or 0,47 I’kg (o6ui0) 1 0,59 Ukg (peayumpan). Yeranonex e ruiasmen kampesic 0,11 Vh/kg (Guo) u_ pecnexrusno 0,84 Vhvkg (peayunpan), c TepMMHATeH ENMMAHANHOHEH NOsTy:KUBOT 1,95 4 (5,58 4 (pexyumpax)) Crea nepopamio npHioxenne peayimpannar N-anleTHsTuKcTeHH HMA TepPMHHATEH MOT KHBOT 6,25 aca. Auer mHcTeuH npesinana pes TVIALleHTara Ha IUTXOBE Me OTKPHT B AMHROTHYHATA TeHHOCT. nea 0,5, 1,2 #8 4aca or nepopano npanoxenne 1a 100 mg/kg TetecHO Tero aneTHADACTEHE, KOHLIeHTpaluisTa Ha MeTaGouMTa L-LMCTeHH B TIALeHTaTa H AMHHOTHYHATA TEYHOCT ¢ T10-BHCOKA, ‘OTKONKOTO B TLIasMaTa Ha Malikara, ‘He ca mpopexnas npoysnainix np Xopa 2a peMHHanane Ha aNeTHUDICTeUE B MaUeNTaTa, B alivMHOTO MOLIKO H 3a efpexTH EEPXY (beTyCa H KEpMAHETO. Hawa npoyusanns, cappsaun c npeMimananieTo ua aueriuupécrenH npes KpBENO-Mozs ‘Hara GapHiopa mpi xopa. 5.3 Dpeakamnuunn jannn 3 Gesonacuocr Qcrpa Toxewsnoct Tlpoyapanns 3a ocrpa ToxcaHocr Ha alleTHANMcTeHH He ca NoKasaTK CneungHaHa SyBCTBHTeNHOCT. (Comectaysar 2aHHit IpH Xopa, MOAy"HWIH HTPaBeHOSHO MAKCHMATHH AHeBHH 03H AO 30 g, AL|eTHILIACTEHH MpH HETFOKCHKalHA ¢ NapalleTaMosr. ‘Xponwuna roxcuunocr ‘ExcriepHMeHTain MpOy'saHHs OPH HAKOMKO KHBOTHHCKH BHLIA (MUTEX, Kye) ¢ NPOXBOKUTEAHOCT JO | rommtta ne ca noKasami naTonorHHinH NpoMeHH. ‘Tymoporetien u MyrareneH rovers Hee ce ouaxwar wyrarentn e”pexTa Ha atlerunuvcrewn, Pesyrarure or Tecr ¢ GaxrepuasmHit ‘opraiitsMi ca oTpaigaTe:t He e nscaeasaH TyMoporenHia NOTeHUHaN Ha aueTHAUHCTeHE, Penposyxrusna ToKcHsHOCT Tiposezens ca npoy¥sanna 3a TeparorenHoct mpl GpeMeHH salut M rurbxone, Hoy rlepopasiNit 03 alteTITIICTeMH No BpeMe Ha nepHona Ha opraHorenesara. JTeKapcrseHHTe HHBa ca oKoMI0 250- 500 4 750 me/kg pu satin # oxono 500-1000 1 2000 me/kg npx narsxose. [Ip nitro e2Ho or mpoyusamsra He ca naGmonanany eTycH c Aedopmannn. TIpoyusanua va epriuurreta, nepn- 1 nlocrHaTansioTo paseuTHe ca NposeneHH ¢ nepopaiHo IIpWlOxKeH ANETHIINCTEH MpH MuTBxOBe. Pesy.TATHTe OT TeIH NPOy4BANHs Ca NOKASAITH, HE AUCTHSIUNCTEHE Ne Hapyinapa ronaNATA DYHKUME, bepTAIMITETa, PORIAKETO, KEPMCHETO H HeoHaraHOTO pasBHtTHe, 6 ®APMAUEBTHYBH AHHH 6.1 Cuncsx ua nomommure semectsa Burranun C, Saxapus Harp, Baxaposa, ApomanissaropH (Men, mor). 62 Hecesmectumocra Bx, rouna 4.5. 63 Cpox aa roanoer 3 roaMHH. 7a we ce npanara cnen wsrasaHe Ha arava, OsHaveHa BPAY OMaKOBKaTa, 64° Cnemmasum yeaonms ua cexpanenne Ha ce coxpanssa npy Teuneparypa nos,25 °C. 7a ce nasw or cBetimHa. Zia ce coxpartasa Ha Maco, KeaocrsnHo 3a cua. 65 Jawan sa onaxosxara Opuruuanna onaxonka, canaprcaiia 6 u 10 camera, He nowskn sanose ontaxonkn Morar 1a Gena nycHaTH B nponaH6a. 66 Cnenuaaun npexnasnu mepkn pa wxBppasue Hama cneymannn vamcxsanns. 7. TIPHTEXATEJI HA PA3PEUIEHHETO 3A YIIOTPEBA Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Tepmarna 8. HOMEP HA PA3PEIIEHHETO 3A YNOTPEBA Per. No: 20030080 9. MATA HA ITBPBO PA3PEUIABAHE/IOHOBABAHE HA PA3PELIEHUETO 3A YIIOTPEBA Zara na mpeo paspeuranane 3a yrorpe6a 30.01.2003 ‘Tara na nonnosspane 07.04.2008 10, ATA HA AKTYAJIM3MPAHE HA TEKCTA 06/2021

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