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    2020-12-23-121392

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    © All Rights Reserved
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    4 views20 pages

    2020 12 23 121392

    Uploaded by

    malassezia

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
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    KPATKA XAPAKTEPHCTHKA HA IIPOAYKTA, 1. BME BA JEKAPCTBEHWA DPOAYKT ‘AGwsox 10 mg TaGnerKx Abizol 10 mg tablets 2. KAMECTBEH H KOJIMMECTBEB CbCTAB Beaxa TaGnerka ceaspaca 10 mg apmnmpason (aripiprazole). Tlowommr pemectna ¢ uspecruo nelicran: Boaxa rabnerxa o 10 mg chmepxa 73,95 mg MAKITOM KATO MOMOMIO BetECTBO M YepBEH AENECH OKC (E172) xaro ouneruren, 3a mmm crmcLx Ha NOMOMHHTe BeteCTRA BIOKTE TOuKA 6.1. 3, JIEKAPCTBEHA ®OPMA Te6nerxa ‘TaGneriare ca npanour ain, po2osH, c penedito oGosnasenne 10“ or enuata crpasia Ha TaGneTKara. 4. KIHBWOHH AHH 4.1 Tepanesraams noxasanns ‘AGwson € noxasant 38 neenne Ha ModpeHux Np BESPACTHH H IOHOMIM Ha Bugpact Hag 15 roAME. AGro0N © nokasaH 3a sCweHHe Ha yMepeHH Ao TeMKH WANKING emmomH mpH GunonspHo abeKTHBHO ‘PascTpolicrso M sa npegoTepaTanane Ha HOBH MaHHMINH EMO TPH NAlWeNTH, KONTO CTPAET MpeAHMHO OT MAHHIMH eMH2ONH, H MHHTO MAHHIINH enHZOnH Ce NOBMHABAT OT NedeHMe ¢ APHTIATIpAsoN (Bx. TOHKA 5.1). AGws0a € noxasaH 3a nevenne 20 12 ceqMMUM Ha yMepeHH NO TexKN Manin enM30nH TIpa GuNosApHO aupextusno pascrpolicrno Tan I pH rowoune tia # Ha 13 roma (ax. ToaKa 5.1). 4.2 osuponxa m nasma ua upunomenne Aoauponxa Bespacmnu: Mheoppenua: Tipenopepanara navamsa aHemna yosa AGwoon e 10mg wim 15mg, ¢ nonmupxauia meena A038 15 mg, TMpHeAAHA BENE AHEBHO, HeSABUCHMO OT XPAHeHETO. AGuson © eexruen px oan or 10 mg 20 30 mg anceno. He ¢ waSmonasana opumena edjexTaBHOCT MpH ‘Os O-BHCOKH OT MpenopsyBaviaTa AHeBHA nosa oT 15 mg, BEMPeK, Me MPH OTAEIHH TAUEHTH O-BHCOKIE ROSH Mone aa Guner OT noma, MaxcuManuaTa aesHia 00a He Tpa6Ba na Mansuanana 30 mg. Manuioru emusodu npu 6unorapno asbexmueno pascmpoticmeo mun I: Tipenopswnanara Havana nosa AGiox ¢ 15 mg, mpunoxena Bemmx AHeBHO, NesABHCHMO OT XPALeHETO karo MoWoTepar HK KoMGnEEMpana Topammis (WK. TOWKA 5.1). [pH HAKOM MAINICHTH 1o-BHCOKH HO3H ia Gwar or nonsa. MaxcrMantiara questa nose 1e TpaGpa 2a nagmmmana 30 mg. Tpedomepamasane na peypdueu na nawuicru emesodu npu Gunoxspuo axpexmusno pa ‘3a MpemorspaTasae Ha HORM MAHMMHH erumOAM MPH NALIHEHTH, KOHTO ca Ip! MonoTepamia wn KoMGHMMpaHa Tepars, HeNCHHETO MPOABIDKABA B CBULATA AOSMPORKA, BKMOYHTENHO HAMATABAHE Ha Josara, TpaGEa Wa Ce OOMHCART B SABHCHMOCT OT KIHHHYHOTO cecToame, Treduampuna nonyxayp: (Hhaxordpent rp ono nw) 15 cob nspacm: Tipenopeanatiara nose AGmon ¢ 10mg AHEDHO, MpHTOKEHA BEMEK IHCBHO, HeSABHCHMO OT XparicHCTo. JTlesermeto TpaGea a Guue sanownaro ¢ jose of 2 mg (c apyunpeson nepopanen pasTEop) B MpOnEDKERHE 1a jsa MM, THETpHpaRA AO 5 mg 2a Ole MBA MIM AO AOCTHTaHe Ha NperlopbuNTenHATa AHeRHA Nose oT 10mg. Tipu HeoSxommwoct, nocaemamno nopuINenane Ha AosuTe TpaGea 2a ce HANpABH Che CTomKK OT 5 mg, 6e3 1A Ce HANBHUNABA MAKCHMANHaTA ZHeBHA 2038 oT 30 mg (sxK. TOHKa 5.1), AGis0n © efbixaceH mpx nosh ot 10 no 30mg anesHo. Tip room He ¢ HaGmozasana nosmUeHa ehuxactoct MpH aKeskM Nom no-sHcoKH oT 10 mg, BEMPeXH He HAKOM NAENTH MORE Ha Ce NOBMHART Gnaronpuxrio ot no-aicoxiTe Noss. AGws0n He ce Mpenopeysa sa naLMeHTH ¢ uMEOdpenHa Ha BEspact nox 15 roRMHH, NOpanH OTCLCTEHE HA ‘asm 38 GesonacHocr m edpsneacnocr (mx. To=KH 4.8 H 5.1). ‘Manuinu enusodu npu 6unoaspno axpermusno pascmpoiicmso mun I npu ronoutu wa u nad 13 codunu! Tipentopssnrreniara nosa AGwson ¢ 10 mg mpHeTa BeAWEX AHeBHO, HeSABHCHMO OT xpatteHeTo. JieveHHeTO ‘7pa6ea aa canone c 2 mg (epanunpaaon nepopanen parreop) sa 2 14H, THTpHpA ce nO 5 mg 3a ome 2 AHN, 38 ‘AA ce AOCTHTHe MpenopeunTemHaTa AHeBHA A038 oT 10 mg. Tipomwocremocrra sa nevesHero TpaGea a © MHHHMaTHaTa HEOGXOI¥MA 38 KOHTPON Ha cHMITTOMMTE 6¢3 a nampemasa 12 cemmmnun. He ¢ naGxtonapano nosuuasanie Ha eiukacHOCTTa pH 03H Mo-BHCOKH Ot 10 mg ‘AuesHO, a mHeBHa foca or 30 mg Ce CHEPaBA Che CLINeCTReHO MO-BHCOKA WecTOTS HA HexenaHHTe TlexapCTBeHH peaKUHH, BIGUOMMTeTHO eKCTpAIIMpAMIWIHM CEOHTHX, COMHONCHTHOCT, OTHANHBIOCT -yeenitenne Ha TernoTo (ax, TowKa 4.8). Tlo TasH MpHAMBa, NO3H nO-BuCOKH oT 10 mg aNeBHO TpaGRa sa ce panera 8 MSKMOTIETENHM CAH H IPH CTPMKTHO KHTREHHHO HaGmoneHne (Bx, TONKH 4.4, 4.8, 1 5.1). Crmeorsysa TORMINEH PHCK OT HEACNAEH JeKAPCTBCHH PeGKLUH CBBPSANH ¢ BPHTUMPaION 3a NO-MnARETE naupeuTa, To Tasn npernmia AGO He TpaGea a ce UsnONsBa npu NAUEHTH NON 13 rORMHM (EK. TORK 4.8 45.1). yerawonena. Hanwimrre 0 MOMeHTa aH ca ONMCaHM B TOHKA 5.1, HO He Moxe Ra Gune HaNpaBeHa Tpenoptka no oTHoMeHHe Ha NOsuPoBKaTa. Taxpwenmu ¢ nepnodpo6no yepexcoane: He ce manara xopexipis Ha 2o38Ta MIpH nalIMeHTH ¢ neKo 0 yMepeHO TeaxKo YepHompo6Ho Hapyinenne, Hama ROCTATLAHO AAMIEH, 2a 1a GbsAT HANPABCHM NPENOPLAH OTHOCHO PEKENA Ha AOSHPANE TPH NALBEHTH C TEKKO Yepeaane Ha yepuxia p06. Tip Teo nalmetra © HeoOXONHMO BHAMATEAHO ONpeAeMAHe HA nOsATa. Bampexa Tosa, npa naiierrire © TexKO NepHONpoOHO YapeRMANe, MaXCHMaNHaTA jIMesHa nO3a oT 30 mg ‘7paGea ja ce mpwara.c nosMIeHO sHMMaHKe (Ix. TORK 5.2). Tlanuenmu c GoGpewo yepeacdane: He ce nanara xopexinas na nosera npH natthertH c 6yOpemo yepexnane. Tayuenmu ¢ cmapvecka esapacm: He e yerawonena e*)exrvBHOCTTa Ha apurumpason 3a sieveHHe Ha uHSopetmHA HM GNOREpHO adexTABHO PascrpolicTko MpM nalweNTH Ha BEspact HA _M HAR 65 romMuHa BEspacT. B pesymrat HA no-ronaMa MYBCTBHTeNHOCT Ha TAM NONYAMMK, SANONBARETO HA NECHHE ¢ NO-HHICKH HO3H TPAOBA 2a ‘cay'nitte, Korato Tosa e KTHIHIHO OMpanaaHo (Bx. TONKA 4.4), Hox: He ce nanara xopexiis Ha NO38Ta pH NaUNeHTH OT CHCKH NON B CpABHeHMe ¢ TeOH OT MISKKH Nom (Bx. rouka 5,2). Tiywene: Hinadien npensix mevaGomrraix mr Ha apHminpason, He ce HaNara KopeKLMS Ha OSETa UPH Ayia (=X. rowxa 4.5). Adanmupane na osama, nopadu ssawnodelicmena: B caywaii wa ensospeewia ynorpe6a Ha apHManpason ¢ Mom HixHOWTOpH Ha CYP3A4 ux CYP2D6, nosaTa Ha apHMHnpason Tpa6sa ga ce peayumpa. Tipu crupane wa neveHmeTo c HAXNOHTOpH Ha CYP3A4 Win CYP2D6 (usBaxqaneTo HM oT KOMGHHHpAHOTO NeYeHMe), JOsATA HA ApHNUANpAI0T TpaGEA Na Ce NORMINH (Kx, ‘rouxa 4.5). Tip eamoppenennioro npiomcHe Ha apxmunpason ¢ MOUTH HaNyKTOpH Ha CYP3A4, nosaTa wa ‘apHnumpason rpabsa na ce nosuun. Fp crmpane Ha TeyeHHeTo ¢ HHAyKTOpH Ha CYPIA4 (HspaxqanteTo HM OF KOMBMUNpestoTO NeveHHe), AosaTa Ha ApHIHMpa2on TpAGRA AA ce NOWDKN o OOWIalinATa NpenopEABaHa nosa (sx. Touxa 4,5). ‘asm wa mpynoxenne 3a nepopasmio mpunomeHHe. 43° Ulpormponoxssanna CopexyyBcraHTenHocT KEM AXTHRHOTO BeIeCTBO WIN KEM HaKOe OT MOMOUITE RetocTEA, MEpoCtH B Touxa 6.1. 44 Cnenganun apeaynpexqenas © upennaan mepin mpm ynorpeba Tlo pene na axmmemoritimoro evente, nonOSpaBaHeTO HA KIMEHNHOTO CECTONHHE HA NANBEHT MOE 7 OTHeMe OF HAKOIKO THM NO HAKOMTKO Cem. Tipes TOSM MepHom nanvewTuTe TpxGBA Za GLIAT NOX nocromsmo naGmoneHHe. BrsunxsaneTo Ha cyRUWAHO moBeReNHe € MpHCEINO 28 ricimuMecKHTe saGoneRANM H acpexrapuuTe porcrpolicraa H m HAKOH Cny¥aM 2a Hero ce CROGUIABA CKOPO CEA saNONBAHE WIM CHE” CMAN 8 TEpamTETA C AETHTICHKOTHUN, MOOHTENHO Hc apHTMNpanod (lok. TosKA 4.8). Tepammxtra ¢ aHTHNICHACTHU TpxGBa na ce cbITToTBa ¢ HAOMONCHHE Ha BACOKOPHCKOBHTE MaleHTH, Pesys1TaTH OT eMHREMHONOTHIHO MPoyyBaHe Cpe nauetrTH uneoppora Hm GHNOApHO aibexrHDHO pascrpolictso NpemOnarar, we TAMA NOBEILIEH PACK OT cxnonnocr KEM caMoySuiicrso mp ynoTpea Ha ApHIVENpasoT B cpaBHeHHe C ApYTH AHTHNCHXOTHLM. Wndopmanusra py negmarpuunera Monynaiia We © OCTaTEYHA, 3a AA Ce ONEHM PHCKA MPH no-MIaZH TauveHTH (Tog 18 TONMIIHA BESpACT), HO CBINECTBYBAT NOKASATENCTBA, HE CYMLMAMHST PUCK OCTARA H CHIE ITepaHrre 4 CeMHUH Ha sleeHHe C STHIIMYHH aHTMMICHXOTHIM, BKUOTHTENHO ApHTIHNpasoN. Cepnesno-cenony BapyieHna: APHITHMpason TpaGea AA ce MpHCIAra MpeyMTESTHEO MPH NALIMeHTH ¢ AOKAIAHO CEPACIHO-CHnOBO sA6ORNBAHE (apexapan mucbapwr Ha MHOKapria WIM HcxeMMHHa GonecT Ha CEPUIETO, CbpseMHa HenOCTATHMMOCT WIM HapyuieHux Ha NpOBOAMMOCTTa), MOSENHO-cBuOBO sAGOUMBaHe, YoHOBHA, KOHTO G6NKA ZOBEMH 0 Mpenpasnonoxchie KEM XHMOTOHHE (OGesS0NHEBAHe, XHNOBOTEMMA H JeYCHHe C aTHXHNeprerrainet TeKapeTBena NpOZYXTH) WIM KM XHNEpTOHMS, B TOBA YHCTO YoKOpeHA WIM MIOKANECTREHA, CroSwen ca caysan Ha BevoveHt TpoNGemGomesM (BTE) npu naueHTH, mpweMamy ayrruncHxoTHHHA cpenersa, Ti karo mpH Tem nalydeHTA seco ce HaGmonaxeT MpanOGHTH puckosn axTopH 3a BTE, scuKt [BsOMONGH PHCKOBH GaKTOpH cHeNBA ya GKnAT HACHTHKLUAPARK TpCAM H No BpeMe Ha Tepamwsra c AGus0n W 1a Osuar npesMpHETH MpeRAHTHBHH MepKA Tipu xmas mpoysnasis c apamtanpason uectorara Ha Yawoxanane na QT-wrrepsana © Guna cpashmna © ‘asi mpa nnaue6o. Kaxro m npy apyrure axTHIICHXOTSNs, APHIIEMIpASON TPAGEA MA Ce WANOIIBA MPEATALTHBO "pH nanuesrms © damauma uoropws 38 yirsiokasane Ha QT-MTTepBana. ‘Tepousia JHcKHBesHA: Tipa examen mpoyseanns 2 MpomoKeHHe Ha e7IHA FORMS WIM MO-MANKO, CAy‘asTe Ha HEOGXONEMOCT OT JCXCHHE Ha MOMBAAMTE Ce WCKHHESHM TIO BPEME HA TeNeHAeTO ¢ apHTULTpascul He ca yecTH. TIpH HoaBara Ha [MpaSHAILH ¥ CHCTTOMH Ha TAPANBNA RHCKHCGHX MPH NaLWeHTH Ha AesewAe c AGuSON, Tpx68a a ce OGMHCT WLMOAHOCTTA 38 HAMATABAKE Ha 2OSKTA WIM MPeKPATABANE Ha NeseHMeTO. TesK CHMITOMH MOE BPEMCHHO 7a Ce BIOWIAT HATH 1A C€ NOMBRT, OPH CNEN TPEKDATABAHE Fa sIOYEHNSCTO. Apyrn excrpanupamwayn CHMITTOMH: B iommwam npoysmaix na epHninpaon npn eua ca HAGMONARAHH aKeTHE H napwanicomesM. Tpa ‘Homsara Ha MpHSHOU H cHMmTrOMH Ha ApyrH EPS pa nalMeHT MpHemaliiy apsTUAMpascn, TpsOBA sa ce ‘OBMMICIN BESMOAROCTTA 9a HAMAIIABAHE Ha NO34Ta H SHMMATETHO KTMHHYHO HAGMOTCHHC. ‘Hesponenmmen manarien cunpom (NMS): NMS e norenpianHo ¢baTaeH KOMILICKC OT CHMITTOMR, KOHTO © CBLPSAH C AHTHNCHXOTHSENTE NeKapCTBEHH Mponyxta. B knaMiHH Mpoy¥BaHHs cA AOKnaTBAHM penKU cmytan Ha NMS 110 BpeMe Ha JeHeHHE C apanumpason. Kansoraiire mpoxsi sa NMS ca xanepnupexcus, MYCKy/ua PMTMAHOCT, HapyIeN MeHTAIEH ‘rary H 2aNinH 38 apToHONNa HecTaBiWIiOcT (IPOMeHH B TIynca H KPEBHO HAAATANE, TAXHKAPAAA, MHadopesa 1M cepresia apanuus). Jlommunrrenio MOKe a ca HaNMue HK MOBMINeHH cToMHOCTH Ha KpearHit ocdorunasara, muornoGuuypus (pa5noMuamma) H Ocrpa GLOpewna HenocTarbaHOcT. CroSinasa ce CEO ‘Taxa, oGave, W 38 NOBSHINEHH CTORHOCTH Ha KpeaTHH dochoxuasa M paGnoMHoma, He HeNpeMeHHO SEB wpsaxa c NMS. Axo nauwerite passusT nprstalin WM cMrTrOMM, xapaxreprH 3a NMS, 11H maar Heo6ACHHMO BHICOKA TeMnepatypa Ges HOTBRUTETEM KTH npesanm Ha NMS, npwema Ha BCH ANTHTCHXOTIFTHH neKaporBeHH MPOTyKTH, BKnO‘HTETHO AGx30n, Tpa6Da fA Ce NpeyCTaHOBH. Tepuope: 1B iimswara npoyssaiun ca 2OKTasIBAHH HEYECTH CTY'aH Ha rEpHoge Mo BpeMe Ha NeHeHNe ¢ apHMMUTpAGON. Ero samo, apununpason TpaGsa 7a ce MpHnara C MOBHIEHO BHUMAHHE MDH MAUHEHTH MPeKAPAJH B MHHAIOTO CMIESOM HA FEPHONE WITH CBCTORKIE, CEDPSAHH C rBPHOBC. B 1px maneGo-xormponmparm npoyseaxus ¢ apununpason pn Buapacrum nausenTn (n=938, cpesia maspact 82,4 r., or 56 10 99 r.) © ncMxosa, cmepaatia ¢ GoxlectTa Ha AnuxafiMep, MAupIeHTHTe Ha seNeHHe © APHMUNPASON ca GIN HBROKEHH HA MO-TOIIM PACK OT CMBPTHOCT B CpABHCHHE © TpyMTA Ha NEYEHAC C maaue60o. Cusprioctta mpi mauler mie 1a neveHue c apamunpason ¢ Guna 3,5% » cpannerue ¢ 1,7% mpi Tpynara na aesenme c naneGo. Maxap ue mpHaMuHre sa cMEprTa ca GHA paxnasEH, nopeveTo ca GHIH CBLPSAHH CBC CEPREYHO-CENOBM WHLDUeHTH (HATIP. CEPResHa HEAOCTATEUHOCT, BHEIANHA CAPT) HIH adexun (Harp. miesors). Hepe6po-eacrysapwu neocesanu pearyaau: B cemprre npoysparns ce cso6utasa on nepeGpo-RackyapH Newcenaim peaxipi (nan. wiCyr, MpexomHa nexemmana gvaxa), ® TOBA Yoo H GaTATEN MUIMAeHTM (cpemHa BEspact 84 r., ot 78 Ao 88 r.). O6mo MPH 1,3% or nanwesyre Ha nevenue ¢ apHnvmpason ce CKOSuIARA Sa HepeGPO-BACKYNIApHH HEXEN PEAKLIAH B epannenne ¢ 0,6% or nauvennre wa sevenme ¢ niane6o. Pawakara He © craTucraNeckH setaumua. B enHo XGIHHHAHO MpoysBavle ¢ dmccHpatia Nova Gave ce CLOOMABS 3a SHATHIMA RPEKA MORUTY NOSATA H OTTOBOPA H uuepe6po-BackynapHire peaKIAH MpH nAlnekTH a NeeHe c apHTNpAsoN. ‘Apinmpaso7 He e NOKASaH 54 leveHMe fia cHKOSA B CrenCTRHE HE NeMeHITAs. Aunepramcemns H saxapex aua6er: Ha csoGmesua 8 romeponeaun, 8 wxKOH cy npexoNMepuR u caBpoana © ‘wMepocMonapHa KOMA HIM CMbPT, MPH MAUPIEHTH Ha JeICHHe C ATATMMHM aHTH f AGuson, PuckosHTe ¢axTopH, KoHTO Moke a NOBERET MAMReHTHTe AO TEXKE ‘SETTLCTABAHE H IpeMXoAHH sabonsBAHHA OT AuaGeT B ceMelicTBOTO. B KIMHHYHH Mpo He ca HaGmonaRAHH SHED PEIN NO CTHOMEMME MECTOTATA HA HEMENAKHTE eax, CBBPSARH C xanepramkemna (BknOHTeNHO nuaGer) HI HO OTHOMeKHe Ha aBHOpMHA MaGOpaTOpHH cTOHHOCTH ta FRHKEMHA B CpasHeHHe ¢ Miaye6o, Hana TOTHH PHCKOBH AHHH 3a CBLPSAHH C XHMCPTIHKEMAA HEKENAHH PeAKIBIH MPH TANHeHTH NEKYBAHH c APHMHMpANON HC APYTH GTHIEMEM GHTHNCHAOTHL, 34 A Moe 2a ce ‘Hampana cpanneune, [laumernrre, AekybaHM ¢ IKAKBH RTHICHXOTHLINH, BRMOHTETHO H AGHDON, TpxGBA a Guar HaGmonasaet 28 MpHBHAIM Hi CHDATTOMH HA XHTeprAMKeMHA (HaMp, NOAAIANICHS, NONKYpHS, nonmparaa M cxaG0ct), KATO ChCTOAHMETO HA TIRIVREHTH Coe SaKapeH mHAGET WIN C PHCKOBH AKTOPH 38 ‘SaxapeH HAGeT TpaBbA Na Ce KONTPONHpa, HOpaN ONACHOCT OT RAOMIABAHE HA FMOKOSHHK KOFTPOM. Copsxsyectparennocr: Kaxro npH apyri xieKapcreenH npogyKTH, TAKA M pH APHTMpAIOA Menke NA BLOUMKGIAT PeaKIVN HA ‘CBPBXYYBCTBMTENHOCT, XapaxrepHsHpAlIn CE C AIEPTHUHH CHMTTTOMH (BX. TOHKA 4.8). Yecmrapane Ha rernoro: ‘YeemmapatieTo Ha TernoTo ce wa6monasa YecTo MpH GonHH oT mmodpeHHs H GHNOAEpHA MAKE nOpaTH CUMbTETBAI SAGORKBAITER, HSTONSBAE HA AHTHTICHXOTHIM, 32 KOHTO Ce SHAE, YE BOAT 0 YREIMUABAHE HA ‘TeT0, HESNPABOCHOBCH HAYRH HA KHBCT, KATO MOXE fla Ce CTUFHE 10 TKKH YoNORHEHMR, 3a yaeTHYaRAHe HA TernoTo Ce ChOGIIABA B OCTMEPKETHHTOBHS NEPHOA MpH NALINEHTH CHC SHBUTERHH PHCKOBH (aKTOPH, MaNpHMep MpenMMHO saGoIeBANe OT NMAGET, HAPYIICHAX HA TIMTOBMINATA KIC WAH ANeHOM Ha ramogesara, B KIHHNNHA MpOyUBAHHA HAMA AAHHH, Me APHTMMMIpASON UPETSBHKEA KIHAWIHO 3Ha%HMO ‘YeecuMaBAHe Ha TErNOTO pH BESpACTHM (Bx. TONKA 5.1). B KAHNE NpoysBaRAK MpH loHoMM ¢ GumonspHa ‘MAHA, apmampazosi ce cuEpaBa ¢ yBemmaBaHe Ha TeT7IO cHen 4-ceaMHTHO aeyeHe. IORoUM ¢ GHNOREpHE Manus TpxOba 18 ce Mpocneyasar 3a yBemasaHte HA TerAOTO. AKO ce HaGMOIABA KIHHHYHO SHAIHMO yeennvenwe na TernoTo, TpaGpa fa ce OOMHCT HaManaBaHe Ha oseTa (Bx. TONKA 4.8), Tncbarus: Esopareania HenomsHavoct H ACKMpaNNIA co CBLPSBAT © HeYOHHETO C AHTHMCHXOTHUK, BKMONHTEIHO apamimpason. ApHIMMpsson H UPYTH AHTHICHXOTHYEH BXTHBHM Bewlecrsa TpaGsa fla ce HsnonsBar ‘MpeqasB0 Mp MANAEHTH ¢ pHCK OT MHEENOHE. ‘Tistonormno pnevenne xem xazapra: Tloknanpann ca cyan na naTonorHHo RACYCHHe KOM xasapTa No BPeMe Ha OCTMAPKETHHITORHA NepHON MPH NAWUEHTH NPHEMALIM APHNAMPYION, HEGABNCHMO OT TOBA ‘an ca MMariH Taxaba attamnesa, TTatweHTH ¢ allaMHesa Sa NATONOTHTIHO BeeHHE KLM XaapTa Morar ga GsnaT HeNOKEKH Ha M1O-TOREM PHCK H TPROBA Ha Ce MpOCHeAKBAT BHMMATEATHO (BOK. ‘roaxa 4.8). comsrerpam ADH ruBHC man ‘Bumpexs we Gunonspxoro apextmssio pascrpolicrao Tam | w ADHD wecto ca comeTeTmain ‘CUCTORHI Ca HANNAH Orpannet AHH 34 eNHOBPEMeHHOTO MPATOMCHHE Ha APHIMAMPAsON ‘crunrynaertn. Tlopaat TasH Mpwsna TesH nexapcTaa TpaGxa ja Ce MpwIArAY € OcoGeHO BEHMAHHE, KoraTO ca B KOMOMHALH, 45 Bhanmonelicraue ¢ npyra xexapernens mpoxyXH m apyra @opME na BsaumoneiierBme Tlopamut cpos a:-agpenepriven\ peuetrropeHt aiTaroHmbM, apHIIMNpason MOK Jia YCHIK etbeKTa HA HAKOM ANTHXETEpTeHUBHH CpencTsa. Tlopeau ochostma esexr Ha apununpasoa sepxy LHC, ¢ neoSxonHMo noBHIueHO BHHNAHHe tipH YnoTpeGaTa Ha apHmmpesou B KOMOuHANA ¢ aNKOXON HIM ApyTH neKapcTBa, ZeHicTBaMH BLpxy LHC, ¢ noreHTMamHa BESMOAGIOCT 3a TlORBA Ha HEXENAHH HeXapCTBeHlH PeaKLMH, KATO CeAMpAHe (BA. TOKE 4.8). ‘TpsGna 2a ce BHOARA MOTO, AKO ApMIMNPAION ce NpwAnara eAHOBPEMEHHO C /IEKAPCTRERH NO a VxnGvropwre ma cromamnara xucenmanoct, H2-anraroumcra daMOTHMHR, HAM@INBAT CKOpOCTTa Ha a6cop6uHa Ha apHTTHMpAsoN, Ho TOSH ecbeKT HAMA KIHHHGHA SHAYHMOCT. Apmmmpazos ce Mera6omEmpa pes MHOKeCTRO METAOONNTHH TETHIMA, BICMOUBAILDK EITSHMAITE CHCTEMH (CYP2D6 u CYP3A4, no He w CYPIA. Ero 3aino, npu myutaux He ce Hanara KopeKIMAA Ha 103873, B wmumneaio mpoy'manie cc apap nobponomn, MourmsT mnaGHTop wa CYP2D6 (xan!) mom AO nosimmasanie na AUC Ha apunsmpenon coc 107%, noKavo croiiHocrTa Ha Cox ocTasa Hemposentena, AUC # Cras Ha NexRApO-epHTHMpavoN, KoHlTo € AKTHREH MeTOOONMT Ha APHNMpAGON, HaMasaBaT CLOTBETHO ¢ 32% 47%. Tipu exuonpemensioro nparoxenne ua AGwon c xHKNUIH, nOsaTa ua AGHI0N TpxGea na Cuae aManesia NOXTH HanotosHiia cipaMo OOwsaitHo npesmmcnanaTa nosa. TlonoGHm exper MOE Jia Ce ONAKBaT WnpH apyrH oui wnxu6rropH a CYP2D6, karo dryoKceTHH H NapOKCETHH, MOpaM KOCTO © HeoBXOTHMO ceMoTo peyLIMpaHe Ha Osea. B xaminraHo mpoysmaHe pH SpaBH OSpOBOAUR, MoxuEHET HEXHOHTOp CYP3A4 (KeroKoHAs0n) noBuuiAnA AUC H Coax Ha apkIMpason choTBeTHO ¢ 63% 137%. AUC 4 Coe Hl eXHAPO-apHMANpAsO Ce MORHINABRT cworsero cée 77% w 43%. Tipu CYP2D6 Gasun Gast meraGannsaTopm eAHOBpeMeHHOTO MpMNOXCHNE Ha Moupa wxuGwrops Ha CYP3A4 Moxe sla ROBCAE 110 TO-BCOKM TLIASMeN KOHICHTPALMM Ha APAMHTIpEION, 3B cpanuerme c tesH np CYP2D6 Gxpau meraGommatopu. [pm ¢HOBpeMeHHO MpHTOKCHHE Ha KETOKORASO WIK Apyra Moun mxuEuTopA Ha CYP3A4 u AGwos, tpsGsa Aa One Hampavena OUeHKA Ha csorHomenueTo nonsa/pack sa nauwenra. Tip enwospemera ynorpeba Ha KeToKosIazon 1 AGH0N, ZosaTa ia AGw20m1 TpaGza Ja ce HaMamit HANONoBHA, cTpaMO OGwaaHi¥o npHnaranara jio3a. TloaoGie epexTH MOXKe a ce OMAKBET H MPH APYTH MOU MEXHGHTOpH Ha CYP3A4, xaTo wrpaxousson uw HIV-nporeasin wiocuGwTOpH, NOpaTH KOETO € HeOSKONKMO CBINOTO pemYUMpAHe HA O9aTa. Tipu npeycranosspane npuewa ha CYP2D6 wn 3A4 mexaburop, AosaTa a Aion TpaGBa 1a Ce NOBHIIH 10 ‘Tash Mpwraralia mpeaH SanoyBane Ha KOMOMHHPAHOTO TeweHHe. Koraro cna6u minxn6utopa wa CYP3A4 (Ramp. uurTaseM wm ecuprraompan) wim CYP2D6 ce wstioxssat entionpemetno ¢ AGmon, Moxxe a ce OuaKRa Cra60 NOBMIABANE Ha KONTEHTPANKATE HA APHTTHNpASON. Crea exHospemerio npunoxenve wa xapGaMasenma, owen wuzyrop Ha CYP3A4, uameperrre ‘TeoMerpHaHMH cpeniIH Ha Cass H AUC Ha apHmTampason ca GHIA TO-HCKH CEC ChOTRETHO 68% H 73% cmpAMO ‘TeaH pH CaMocTosTeNHO Mpioxkernie ua apHrCAMpenon (30 mg). {ToAoSHo Ha TOBE, TeOMETPHNEHTE CPeMHH xa Cum « AUC na nexnpo-apunumpason, chet ¢AHOBpeMeHHO NPHIOKEHHC © KapGaMaseriHn ca OHLAM TIO- HHCKH CKOTBETHO C 65% 171%, cipsMo Te3H IPH CAMOCTORTENHO NPANOKEHHE HA apHTATTPESO., ipa emiospeenna ynorpe6a a AGimom 4 xapGamasemmm, n0saTa va A6wsoa Tps6sa 2a Gene yqpoens. TlogoGin ehexr Mowe JA ce ONAKBET H NH APYTH MOMIEH uAAyKTOp Ha CYP3A4 (Karo pudbaMmATTAH, PagaGyrnn, demrroun, denoSapGnran, npHMHHOH, edasupent, NeBMpamMm H ACKIT KasTapHoH), KoeTO anara nioxo6Ho niosMmasane Ha nosara. [Ip npeycrasiosasaHe Ha mpuema na Noume CYP3A4 HRAYKTOPH, nOBaTA Ha apHTTAMIpsson TpAGoa 7A Gene HaMAKena 70 o6WuasIO NPHIATAHETA 1038. Tipu eaospemenniara ynorpeGa Ha RammpoaT HK muna ¢ apHMAnpason, He © HAGmMORABAHA KoMEHHO ‘HHA MPOMAHA B KOHILCHTAUUMHTe Ha apHMATIPAsOM. Ceporonusios cHHapom: cKoCMABAHH ca cay'IAH 1a CEpOTOHHHOB CMHUIPOM MPH MALHCHTA MpHEMALIH ‘SpHMENP@DON, KATO € MESMOREHA NOXBA HA NPHCSHALI H CHMITTOMH CBEPSANA C TOBA CECTOMIe, ‘oco6eHo MpH eNHOBPEMeHHO MPHENaNE Ha CepOTOHHHEprHMAH NeKAPCTBEHM NPORYKTH, KATO nanpumep SSRUSNRI wis Taxina, 38 KOHTO € HIBeCTHO, Ye NOBMINABET KOMCHTpALWETA Ha B cenmareus npoyspamiz acca or 10-30 mg apunmpason aIaro He ca noxioaTi meraGommma ua cyGcrparite Ha CYP2D6 (choTHomennero aexcrpomeropdan/3. (capbapua), 2C19 (owenpason) w 3A4 (aexcrpoweroppas), Ocven Tons, Ero samo, He ce ONAKBA APHMHNPESOM fla ROPENE NO KIMINFHO SHATHME NeKAPCTBCHH ESAHMORCHICTERA C eKapeTBeHH MpORYKTH, METUMpALH OT TeAH etRINKHH cHETENH. Ips eaHospenesmoro mpaioxeune Ha apvNHnpAson ¢ BaANMpoaT, HTH HH TAMOTPUTIN He ca HaGMORABALM |CWEDTINO SHAWN TPOMEHH B KONUEHTPOUMOITE HA RANNOT, NTH WAM AMOTPATRE. 46 — Seprammrer, 6pemennocr m xxpuene Bpemennioct He ca nponeauann cLoTeeTHH KoITpONMpaHl Mpoy'¥eaHUs ¢ apuMnpason TH Opemerun xerH. JlOKIAREAKN ca KORTEHHTASINN aHOMATIHN, OOaNe, He MOK fA Ce YCTAHORH IPKUMNIO-CICACTECHA BPEIKS C Tipoysaiaorra npit 2xmaoTio He eTOWAT BKEMORHOCTTA 38 HOARE Ha ToKCHHOCT (wx.TONA 53). ‘Taumenrire tpsGna na Gout copeTBaHH 1a OCBCROMAT JeKYBALIMA NeKap B cayaal Ha TloxBa Ha 6peMenHOCT WOM, @KO MAAHMpeT TAKABA TO BPeMe HA NeseHHeTO ¢ apHTuMpason. MlopanM HEROCTATEYRHTE ARHHH 38 GesonacHocT MPH XOpA H PesyATATHTE NONYYEHH OT PeMPOYKTHBHNTE NpoyYBaHHA MPH XHEOTHH, TOK ReKapcTBeH NpoRyKT He TpxGea a ce Mpwara no BpeMe Ha OpeMeHNHOCT, OCReH ® CHYYAMTE, KOrATO ‘Ouaxearara nos ACHO ONPARAEBA NOTEHUWATHHK PACK 38 THIONA. Tips Hopoponenn, WanOXEHH Ha AHTHNCRXOTHUM (BKITOSITE:IHO apHTENpAson) pes TPETHK TPMMCCTEp Ha GpemesHocTra Waa PHCK OT HECIAHH NEKAPCTBCHH PeaKUMMH, BKIUONBAMIM CXCTPANMPAMHNHM CHMITTOMH ‘WHIM CHMMTOMH Ha OTHEMaHe CEM PAKNAKETO, KOHTO MOXKe MA BAPRPAT No TexeCT H NPORWOKHTENHOCT. Towsanpaum ca cxytan ua PLoO yaa, XUNepTOHHS, XHNOTOKHS, TPeMOP, COMHONeHTHOCT, pecrMpaTopeH TwcTepe IK XpaHHTeTH peocrpolicrsa. 3aTosa, HosoporeumTe TpsGsa Jia OwIAT RHVMATEAHO MousrTopapaH. Kepmene Apurumpason ce otnens 8 kypara. Maimetrkire TpaGsa na haat CBBETBAHH 2a He KBPMET TIO BpeMe Ha eYeHHETO c apHMATpAso.. 4.7 Eépexrn spxy cnocoSnocrra sa wodspane m paGora c maura Kaxro np apyrare artrincuxoram, namenTire TpaGna na Goat ¢ MOBUIEHO BHUMAKHe NpH paboTa ¢ NOTCHIMATHO OMACHH MAINHHH, BKIOHTENHO MpeBOGHH CPeACTBA, AOKATO He Ca HAITKIHO CUTYPHH, 4e ‘eveHNeTO ¢ APHTIMpAON HAMA OTPHUATETEN eeKT EEPAY IIMIEHNETO Ha TesH NetoCTH. IPH HAKOH TeMMaTpHAHH TaIHEHTH ¢ GuTlOAspHO adexTHBHO paxcTpolicTao THN I ce HaGMOAABA NOBMUIeHA YECTOTA Ha ComnonenTHOCT u oTmamHanocT (Box. TO™Ka 4.8). 48 Hexeasna aexapereens peaxnun Pesiome ua mpoduna Ha Seomacuoct Hai-ecto noKnamnantire HEKCTANM seKApCTRCHM eAKIKM » Naue60 KONTpoMpAHH MpoysBanma ca BKATISHA H Tage, MOABABANIH ce pH HA” 3% OT NalHeHTHTE, JeKyBAHH ¢ Nepopasien apHTHNpasan. Bewska Hewenaun neKapeTseHH peaxupM ca WSGpoeHH no CHCTeMO-OpraHeA Kiac M HecTOTa: MHOTO NecTH = 1/10), weet & 1/100 a0 < 1/10), Hevecru (= 1/1600 a0 < 1/100), penx @ 1/1000 no < 1/1000), moro eaxa (< 1/10 000) 4 ¢ newssecrHa HecTora (OT HaMMUHHTe HAHHA He Moxe na Ore nampancna ouctra). [IpH BCAKO TPYNMpaHe NO YeCTOTA, HEKGIAHHTE PeaAKUMH CX NPCICTARCHH B MGXOAAM pel NO oTHOMeHHE Ha ‘raxnara cepHosHocr. Yeerm Heveera C wemspecrua uecrora (or nanwsamre fasua we Mowe na Gene Bampapeua onenxa) Hapymenna ua xpuara Ki mammguara cncrema Hapyoremma a MMYRMATA cHCTeMa ‘IpypHTyc wn ). ‘Hapymenns ua Kmepnporaxtamemns | JlmaGerta ‘euAoKpammara cucrema xuinepocomapia koMa TwaGerua xeToauyn03a Xunepramxemns ‘Hapymenna naa | Saxapen ssaGer “uneprancenn ‘XwnowarpHeMHs mera6oan3Ma " Anopexcna xpanemero Hamanapane wa TermoTo ‘Yeeswriasave Ha TerA0TO. Temxwima napymenaa | Bescsmue ‘Tenpecna Cymmeaest om, ‘Tpepoxnocr Xumepeexcyamsocr cyMIEMa HIeaNHR Beanoxolicrao vowspuiexo camoySulicrmo (Bm. ‘rouxa 4.4) Tleronoriso mnesenne xew xasapT Arpecus Bra6yna Hepstiocr Hapymennx wa | Axara Tapausta aackunesax | Hesponemmwsen mepomara cncrena Exctpammpasaui actors Mamarien —_cHHlapoM ‘apymenan (NMS) ‘Tpemop Tenepamsupanst TrapoSomme TOHWYHO-KIOHHH Cena npunaren Tan “grand Comuoneruocr mal’ ‘Samasnoct Ceporormios cHapOM Hapymene na rosopa | Hapymeuns na owmre | 3awernero spenne ‘Cspaewmn uapymrenms: “Taxaexapaar Buesana aeoGacnnma euspr Torsades de pointes Yawwwasane ona QT ‘Cinonu mapymenua ‘Oprocrarmana >xaMMoToHAR ‘PecumpaTopas, [PAA Kemnae MeqmaCTRBAIOR mapymenus ‘Cromamno-apesun | Koncrunaums ‘wapymenna Tvcnencix mapymenaa, Onucanne na ye6parm HexenaHn peaKunn Excrpanupamaaan cammronn (EPS): Mbusoppenus B mpomsmacrreso, 52-cemmwao KONTpOTMpAKO MpOY"BAHE, NPM MALKEHTHTE Ha NeYEHHE ¢ apAMMAMpAsON Karo usx0 ¢ ua6moganana no-nHeKa wocToTa (25,8%) na EPS, BKMORTEAHO NAPKHHOOKETLM, AKATIOUA 1 AMCKHHESHA, B CPABHEHHe ¢ NALIMCHTHTe nekysaHA ¢ xanonepanon (57,3%). Epa mpomumarenno, 26- ‘ceasarano, ‘nnaneGo-KoNTpOEpaHO mpoysane, vecToTeTa Ha EPS upH MMMHeRTATe Ha MeeHHe ¢ apuminpeson © Guia 19% csorserno 13,1% npa namewrite ot rpynata Ha naaneGo. B npyro 26- ‘ceaNarno KOHTpOTHpaHO Mpoyssase, ecrorara xa EPS NpH NalmMeHTHTe HA HeMesMe C apSITAMAsON € Guna 14,8% m ceorsemuo 15,1% npa nauvenTire Ha neseHMe ¢ OnaH3AITHH, Manuiinu enusodu na Gunonapno amexmueno pascmpoiicmeo — B 12-cemmutH0 KoHTpOMHpaHO MpoyyBate ‘ecroTaa Ha EPS ¢ Guna 23,5% mpi naumedrite Ha neveHme ¢ apanunpason x 53,3% npH nauneNTHTe Ha srevenne ¢ xanonepazon. B 7pyro 12-cemaraso npoyusane wectoraTa na EPS ¢ Guna 26,6% npu nauewrete a nevexne c apumunpason 4 17,6% np nauweHTHTe Ha TeNeHHe c mul. Lip mnrocpousaTa 26- ceNMMHHA nommpaaina basa Ha niaiteSo KoMTponMpao NpoysBaHe, vecTorara wa EPS MpH nauvetrrare Ha NeweHe apunumpason e Guna 18,2% w 15,7% npa nanwewrate oT rpynara wa nnatre6o. Akamesun B mnayeGo xostpormpasn npoysmaxns, YecToTara Ha axaTHSHA pH nanweHTM ¢ GunonEpHO paocrpolicrBo € Gana 12,1% npa sexysasrre ¢ apmmumnpeaon u 3,2% np rpynara wa nnaneGo. Tipx nawsesere c immodpenns NecToraTa Ha aKeTituan © Gua 6,2% npn nexynanieTe c apumunpenoa H 3,0% npn rpynara Ha mane6o. Aucmonur-pearaus, ceypocania c nexapcmeenua Knac: ‘CuyartoMate Ha ZHCTOUHS, YASIOKeHH AGHOPMEM KOHTPAKUM HA MYCKYHM FPyMA, MORE AA Ce NOREAT MPH MYBCTONTENHM MMAMBHIH 110 BPEME HA MTKPBYTE HEKONKO AHH Ha neNeHMe. CHMITTOMATe Ha AACTOHHS BKMOTSAT CIESEM HA BPSTHHTE MYCKYNM, OHSKOTA TIpOrPeCHpaI| NO CrATAHE B FpIOTO, SaTpymHEHO DermEMIAHe, seTpyaHeHO amuraNe WHT MpOTpysHA Ha csmKa. BonpeKH Ye TesH CHMITTOMM MOKE sta co THORBET H TIPH HHCKH ACH, Te Ce NOSBABAT HO-ECTO H CA NO-TERKA NPH NO-MOMINETE H pH MPHAraHHTE B T1O-BHCOKH 03H AHTHNCHXOTHUH OT MmpRO MoKomeHHe. TlopHmeH PHCK OT OCTpA AHCTOHHA ce HAGMONaBa MpH .MIKETe M MIPH NO-MaBAYETe BESpACTOBH TpytIH. Hpoxaxmun BB rommmrann npoysnania 24 on06perntre NOKAsaHHS H B NOCTMAPKETHHTOBAK TepHOn, MpH HSNONSBAE Ha APANAApAZON ce HAGMONARA KANTO YBeMUMEHHe, TAKA H HAMAERME HA CePYMHMA MPONAKTHH, B CpaBHenHe ¢ HEXONHOTO HHBO (TOuKa 5.1). Alabopamopnu napamempu Tipx cpasermtero na apumunpason a nzane6o, no oTmomenne wa Gpox naumestra Mpi KoHTO ca HaGmonaBald ‘XIMEWYHO SHAYHMH MIPOMCHH B PYTHHEMTe NaSopatopHH H AHITHIHHTe MapaMeTpH (Bx. TouKA 5.1), He ca MAGMOTABAHH OTHHHGHO SHAM pesmi. Tonmiuasane wa CPK (kpearunun docipoxumasara), ‘oG6MKHOBEHO MPEXOTHO H ACHMITTOMHO € HAGMOTABAHO MpH 3,5% OT TANHEHTHTe HA sIeveHHe ¢ APAUMpAsON, 's cpapnetne 2,0% or maumesire Ha ruiaue6o. ‘eamarperma nonyasns: hwsoxppenus npu ronoutu nau nad 15 200. B kparxocposo KIMHMUKO nualle60-KoHTpomHpano mpoyuBade Hs 302 OHOUIM (Ha BE9pact 13-17 ross) © mESospesnts, SeCTOTETA H BHAR AA HEKRAHMTE peaKuNM ca NOROGHM Ha HAGMORABAEMTE NpM BESpACTHO TAIBICHMH, © HBKTOYEHNE HA CIEHHTE HEACHAHM CBOKTHS, KONTO CA HAGIONABSHA TO-MECTO TIPH TOHOMI, "MpweMAMI NepopaMHO apxTuNpaso (M4 NO-YecTo B cpasHieHe ¢ mnaMe6o): COMHOREHTHOCTICEMALIH H ‘eXCTPANMpAMHAHH HApyMeHHA ca NoKnaNBaHA MHOTO YecTO (= 1/10), Kcepocromus (cyxora B ycTara), TOBHMIEH aTleTHT H OpTOCTaTHsHA XHTOTOHA ca ROKNAIBANE HeCTO > 1/100, <1/10). TIpodwmer na Gesonactiocr n 26-cenmeHo, oTBOpeHO pasmpeHo HsTETTBALe © NonOGeH Ha Mpodana Ha Gevonactioer wa KpeTKocposHo, nualle60-KoHTpaTHpaHO mpoywsane. TpopumT wa Gesonacuoct Ha mearocpowo, mpoiino-camnc, mnauieGo KomTponMpaiio mpoyapatie © CbiNO CxONeH, C WAKTONEHNE Ha cneqHHTe peaKIHH, KOHTO Ce CLOSUNABAT MO-YECTO, OTKONKOTO MPH NeAHETPHUHK NAUMEHTH, TIpHEMALLM muraueGo: secTo ce choGmIasa 22 HAMANABAHE Ha Ter30TO, NORMIABAKE Ha MHCYAMHA 8 XPEBTA, apuTMHX 1 nesxonenns (21/100, < 1/10). B m6pauta ronouecka rionynaupix ¢ uunodperns (13-17 rommen) © excnosmums 20 2 ronun, cayaalire Ha HVCKH cepyMin HuBa Ha NPONaKTHH MpH THOM OT KeHCKH NOR (<3 ng/ml) w oT AeswKH Mon (<2 ng/ml) ca Gum cuoTeetuo 29,5% 0 48,396. B nunanexkara (13-17 roaHHA) nomynalis ¢ mnOdperHE, c exCTOSHI Ha apurumpason ot $70 30 mg ® npoawoKene Ha ao 72 Meceta, CHyMaMTe Ha HHCKM CepyMHM MMB ma ponakrini pa xewre (<3 ng/ml) u anxcere (<2 ng/ml) Gxxa croraeTHo 25,6% u 45,0%. B ame menrocpowmm npoysbansia pit 1oHouIH (13-17 rommy) ¢ mmodpeux m naunerrH c GunosspHo pa2crpolicrno, neKyBaH c ApMTIMNpasON, HeCTOTETA HA HHCKM CePYMHH HHBA HA MponaXTHH TPH eH (<3 ng/ml) m wre (< 2 ng/ml) © evorsemHo 37,0% u 59.4%. Manion emusodu npu 6unoxapno aipexmusno pascmpoiicmso mun I npu ronouas Ha u wad 13 20dunu Uectorara u Tuna wa HeaenaalTre nekapcTaeHM peaxiIMH pH 10MOMIH ¢ GiMNOREpHO agveKTHBHO paxcTpolicrso TH I ca NONOGHH Ha TesH IPH BESPACTHH, C HSKMONCHHE Ha CiI¢MMHTE: MHOTO YeCTH € 1/10) consionexrrocr (23,0%), excrpanipamnasio napymenne (18,4%), axarucus (16,0%) u ormagnanocr (11,8%); wecra (> 1/100, < 1/10) Gonka » ropuara a6uommuamna oGnacr, ysenuyenne "Ha cEpNesuaTa NecTOTA, yBemMABAHE HA TErOTO, MOBMIIEH ATteTH, MYCKY:1HO NOTPEIBAHe AMeKMHESHS. (Cremunre HeaxeaHH siexapcTReHH PeakUHH ca MILI BePORTEH NO303ABHCHM XBPAKTep: excrparmpanuavio napymesme (esc centara uecrora 10 mg, 9,1%, 30 mg, 28,8%, nnaue6o, 1,7%); ‘H axaTwsHa (cic cneduata yecTora 10 mg, [2,1%, 30 mg, 20,3%, mnatye6o, 1,7%). Cpemmure npomen » TexecHoro Terno npu roxourn ¢ GunonspHo aexrasHo pascrpolicrso tam I na 12-ra w 30-ra cemmnnua 28 apunnpason ca 2,4 kg # 5,8 kg m rp nmnane6o cuoreeruo 0,2 ke # 2,3 ke. Tipw nexmarpuiara Nonynaupn, COMHOTEHTHOCT HM OTHAMHAIOCT ca HAGMORARAHH M0-YeCTO NH rmuguesTa c Gymonspio pascrpolicrno CTKONKOTO MH TaLbieTH € WInO‘peHTs. Tips neanarpwensara Gunonspaa nonynatms (10-17 rome) pa excriosmap 20 30 cemamat, SecTOTATA Ha HHCKH Ita Ra MpOAKTHH B Cepysa pH smAMBHLIH OT weHIeKH Hon (<3 ng/ml) W ‘MEAMBHIH OT wbiKH TON (<2 ng/ml) ¢ Gana cLoTBETHO 28,0% H 53,3%. CyoSuapaye na nonosHpsHM HewenaHl peaxuyH CyoSmuananeTo na nonosmparnt HexxeAaHH peaKUKH cHem paspemasane 3a ynoTpeGa Ha WeKapeTBeniiR TMpORVKT ¢ Bexcio, Topa TosRonaea a NOMA HaHMONeHHETO Ha CLOTHOMEHAETO NORA/PHCK 38 JlekapcTBeHita npoayET. HexcenaHre peaxuaH Moe ja Goaar cboGmeHH AHpeXTHO pes: Vosrreamerreawa arenas no xexapersara (HAJI): ya. Tiana Fpyes Ne 8 Tp. Coda 1303, ‘Ten. +359 2 8903417 ‘ex. noma: bda@bda bs, yeGcaitr: www.bda.bg 49 Tipexosupane TipusHaun H cummrromy B KcIHHWAHH MpOy'BAHHA H OT TOCTMAPKETHHTOB OMHT © YCTAHOREHO, e cHTy"AltHOTO Mpenosmpane cao ¢ ApHTHNpason Np BASpACTHH NalWeHTA, 3A KOKTO © C56 mpeGresremso qo3a 20 1260 mg, He e AOBen0 no Garam nocnenuun. Ha6m0! MpHSHAUM H CHMMTOMM OT MCTHIOHCKA rena TONKA, BKMOUBaT GescBHHe, npexomna sary6a Ha cusHaHwe 1 ‘eKCTPANMpaMEAHH CHMITTOMH, Teverme nps upexospaste Jlevermero mipa npenosupare, Tpa6sa a BKNOWBA NO;UIpAALO ACHEHME, OCHTYpaBAHe HA NPOXOXHMH TWXATOMOL ITSTHINA, OKCHTERALVA M BCHTWTALUAG, KAKTO H RESHAMABAHCTO HA CHMITOMATHYHO neveHHe. ‘TpsGsa fa ce mua mpemsut nepoRTHOCTTA OT ynoTpeGaTa HA HAKONXO AeKapeTaeHH upoxyKTa. Ero saiKo © eoGXomMM HeseOaReH KONTO Ha CBPNCYHO-CBNOBATA CHCTeMA H BKMOUBEHETO HA HeNpeKLCHATO eneKTPOKApAHOrpadcKo MpocmezmBAHe 3a yAABANETO Ha BbIMO-KHA apyTMus. TipH BCSKO NOTBEPLEHO WK TOROSHpaHO npenOsMpaHe c ApHMEMpason € HeOGXOTHMO NOCTORHHO MpOcHeAABAHE HA NALMeHTA 30 HerOBOTO ITIHO BESCTAHOBABRHE. 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B 26-cennBTYHO, NBOMHO-CIANO, MY:TTH-HALIMONANHO, CpaARHMTENHO MpOYHBAHE c OnaNSaMTAR THpE 314 BRSPACTHH NANMCHTA C MIMODPEHHA, B KOETO YBENHYeHHETO HA TernoTO € MEPRMHWHAa xpaitHa TOuKa, SHAYHTETHO NO-MaNIKO NAUMEHTH cA HMA Hali-Mamko 7% YBOMMYCHHE HA TEFNOTO, CHPAMO WXONHHTE cTolivocTa (Hanpimtep YeemricuHe ua TeroTo ¢ nal-Manko 5.6 kg MPH cpeaHO weKoNHO Term ~80,5 kg) npH rpynata na apuranpason (N= 18, un 13% or oueneHtre naynenT#), » epasseune c onarsanma (N= 45, wie 33% oT ouenentrre naupenT#), Thunwdnu napeorempu: Tipt oGo6men aan a numumure napaeTpx oT nnaue6o KOMTPONpAHK KAMHMSHM MpOy'SAKIEA pH SESPACTHM, HAMA JAH, He apHMNpes0n MPHIMAABA KIMHUYHO SHANMMM MpOMeHH B HMBATa Ba OGUIAS xouiecTepar, tpursmepazvrre, HDL # LDL. -O6ut xonecrepon: NecToraTa Ha npoMeHHTe B HHBaTa OT HopManHu (<5,18 mmol/l) xem BucoKH (26,22 mmol/l) ¢ 6wna 2,5% mpx apamampason v 2,8% mpx nutauleGo, a cpemHaTa NpoMEHA OT SXORNO MURO € Gua - 0,15 mmol (95% CI: -0,182, -0,115) mp apummpason m -0,11 mmol (95% CI: -0,148, -0,066) npx ninaue6o. ~Tparaunepis wa raanHo: Necrorara Ha MpoMeHHTe B HisaTa OT HopMaH (<1,69 mmoV/) KuM BHCOKH (= 2,26 mmoV/) e Guna 7,4% npH apunempason u 7,0% npa nnaue6o, a cpemsiata MPOMaHA OT HIXORHO HHBO € Gnna -0,11 mmol (95% CI: -0,182, -0,046) npu apummpasox x -0,07 mmoV/ (95% CI: -0,148, 0,007) np nase6o. -HDL: sectorara wa nponemme a unzata or Hopman (2 1,04 mmol/l) xox nMcxH (

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