KPATKA XAPAKTEPHCTHKA HA MPOAYKTA £9 // 2709 BL/ PAS HP 26 6Y 18-07 D9 1. WME HA JIEKAPCTBEHHA IIPOLYKT AJIOPMA 5 mg dutnanpas TaGnerin ADORMA 5 mg film-coated tablets 2. KAMECTBEH H KOMYECTBEH CBCTAB Boaxa taGnerka cumppya: 5 mg sonnuiemos raprapar (zolpidem tartrate), exeueanenten wa 4.019 mg, soamanen (zofpidem) Tlomouitio() pemecTbo(a) c specTHo nelicTBne: Beaka TadneTka comppwa 47,55 mg naxTosa ‘MoHOXHApaT. 3a MBAMNA CruicHx Ha noMOUDUTTE wemLecTsa siDKCTE TOUKA 6.1 3. AEKAPCTBEHA ®OPMA ‘unupana TaGrerKa Yepseno-pos0sn, KpSraM, ABOHHO-mamoRHa dumsmpann TaGucras Ges enHTeM MepTa. 4. KAHHWYHH JAHRE 41 Tepanentasuu noxasanns Amopaa e mpesHasHavien 3a KpaTKoTpalluo NeueHMe Ha HHCONMIG MPM BLSpACTHM, B CECTOREHA TNH KOHTo GescsHNeTO HOM JO MHBANHAWSHPaHe WIHT NPHYHHABA Tex CrpeC 3a NAUMeHTa. 42 JJoamponxa w nama Ha npuzomenne Tosuposxa Tipomsmmmirresiocrra Ha rexerneTo Tpx6sa 23 Gaze pEawoxwO Hall-xparxa. [lo NPHEUWN Tx TpxOBA AR Gwne OT HAKOTKO AHH 0 HE CERMUILM C MAXCAMYM, BKIOSHTERHO MIpolleCa Wa NlOcTeNeHHO HAMANABAHE Ha nosara, 20 ¥eTHpH CEAMHI Tipouecer na noctenentio naxanzeaxe 4a nosara TpaGea 2a Sire cLoGpaneHi © MANHEHTA. B tiaxom cnywan Mowe na Gwe HeOGXOAHMO YaTKTKARANE CHea MaKCHMATHHA Nepuog Ha nevenme, Tosa He TpaGea 1a crasa Ges nowropiia CUCHKA Ha CECTORNHETO ta NANTEHTe. Brspacruu: ‘leienuero TpxGea aa ce npaaara kaTo enHoKpaTen NHEM M He TpAGEA Ma ce MpHara noBTopHO Mpes ‘emintara om Tpenopeunrreanara nena stove 3a seapactan © 10 mg w TpAGea na ce npHeMa HenocpenctaeKo npeaM cuit. TpaG0a a ce HaNION3Ba Hali-mncKara edekTHBHA 1HeBHa 1038 SOnMHUIEM, KORTO He TPAGEA nA wagrevmiapa 10 mg, ‘Taumeuru s crapyecka peapact: Tipw nanwerra p crapvecka Bxapacr MIM NH HSTOULEHM NauNeHTH, KONTO MoraT na Gear OcoGEHO yecraurrenni kbM esheRTHTe Ha 2onMLXeNos Taprapar, ce npenopbusa nove or § mg. Taaw 03a He ‘TpaOsa 2a ce npesnuasa. Hepuoapo6uo yay3a naumetTH NepHompobto yapexkaane, KONTO He OTARHAT slekapcraeHits NpOaYKT TonKORA 64p30, Koakoro Hopmautrre HKaIMBANH, ce npenopsyna soz or 5 mg. TaaM 1038 TpsGea xa Bure yBesaieta 0 10 mg, camo Korero KAMHSHHIAT OTrOBOp & HeaHleKBaTeH U eKapcTeCHILET NPOAYET ce Nloiiaea 06pe. Sonnnites we TpaGwa 2a ce nrioBa npH naneHTH C TERKO “lepHoApOGHO YEpeRxNAH, Tull KATO MOE 22a aonpuiece 3a emnedasonarua (Bx. TowKa 4.3).OGuuara 1038 sosmiuneMos Taprapar He TpAGBA 18 npesuuuana 10 mg mpH Benxi mauEHTH, Tenwerpwm Soanuen we ce npenopssa 3a yrlorpeda npx eta H ompacreaum nia BEapacr Ao 18 roAMH, Hopaiv anrica Ha AANA, KOMTO Da WonKpensT Heropara YlorpeGa a Taam FRIpaCTOBA rpyna. ‘Hanwsmire gokasareactsa OF m1aue60-KOHTTPONKpAHM KAHEHNTHH HSIIATBAMHA ca MpenCTaBeAH Towa 5.1 Hasw na npuaowenne 3a nepopaHo npnoxenne, Jlexapcrnetuar nponyxr TpaGea na ce npuema c TeYHOCT TO4HO lIpeAM sTAHE, 43° Mpormsonoxasanna Copexsysctenreniocr x6M akrHBHOTO BEUIECTBO HUME KKM HAKOE OF NOMOMLIKHNTE BeULeCTRA, mOpoett 8 ro1Ka 6.1 Moacrenus rpanic (Ocrpa wis rexcxa pecnpatopia nenpecna OGerpysrupna ceania amex Texxxa wepnonpobia Hesoctarssnoct Tipu annca na aan, soamuaeM He TpAGea a ce npesucea Ha jleua WAM naIWeHTH ¢ CUXOTH4HO saG0naBAHE. 44 Crenuaann npeaynpeaienus n npeqnasnu mepxm mpn ynorpeGa O6ina Honorees Tipwsumtara 2a Geaceuutero tpx63a sa Gute naeHTHepMuN/pana, Koraro ToBa ¢ BesMOMHO. OcHOBHIETE [Ip#4HHM TpsGsa za Geaat TeKyRAHH, MpeaM Aa ce NpenNAie XHTHOTHK. AKO cneN 7-14 AHeReH KypC Ha ‘even He Ce NOCTATHE NAMATABRITE Na GE3CEIMETO, TOBA MOXE 1a MOCOMBA HONHETO HA TEPBAHO rewxindecxo vni HaHMeCKO SABGORABAHE, KOETO TPAC a Gene OUHtEHO. (Obura mmgopmauia, oTHacaura ce 10 eihexti, HaGmomanann caes npHTArAKe Ha GeHIORHARerIMHH Hu Apyru xHTHOTHUHH BeUlecTBa, KONTO Tps6sa ja CART BGETH NPERBHI OT NpeAMCHAMINS AeKap, € ‘onucana no-nomy. Tewxomoropuo Hapyurenne npes cneasaums eH Kako ut apyra ceaarasnw/xwmoTiiiH TeKapcrea, 1 aonnAaeM npwrrexava L{}IC- neripecupaut ep. PHcKBT oF MCHXONOTOpHO HapymeHMe Npes ChemMBaNA Jen, BxAOHTeNHO HapyiteHa cnOCoOHOCT 3a wodupare, ce nosuuiasa aKo: ~ sOnnHNeM ce npHeMa 8 mitTepBan No-warDK OT 8 aca MpeaH sa GwTaT HSBEDUIBANH NeHHOCTH, KouTo Haucknat moputmteHo BuAManHe (Bx. TO4Ka 4.7); =e mpyera no-nicoxa or npenoppauTenHara 1038; = soammutem ce npmtara eanoepeMeHo c ApyrH stexapcrsa, noTackauta LIHC win ¢ mpyris sekaperea, KOuTO NOBHMABAT HHBATa Ha SOATINAEM B KPBBTA, HEIN C ATKOKON WH ynoTpeDA Ha apKorin. (mE. Tosa 4.5), Soanem 7pa60a a ce npHiena KaTO eIHFOKPATEH MPHeM HenocpeACTseKO MpeNH CBA H HE TpABEA na ce ‘pwnara nopropwo npes cpumiara HOU ‘ToneparruoerHsnectua sary6a Ha espukacnocr na xunOTHNHHTe eeKT# Ha KpaTKO nelicrsammt GewoanasenHnH H Gersoanasemmm-nonobnn cpeacTaa More fa ce paseue cite MHOrOKpaTHA yROTpEGA 3a HAKOAKO ceamnut. Sanzcumocr Ynorpebara na Seimoguasenmtn wan GersoqMasenue-nozoGNM cpencrsa Mome a AOBERE 0 PaSBUTHE Ha Gusuuecka w ricHXONOTUYECKa 3aB/CHMOCT OT Te3KMIpOAYKTH. PHCKKT OT 2aBHICHIMOCT Ce ypeTTTHaBa c osara u MpOIBMAHTEMHOCTTA Ha HeNENHETO, H € MO-TOEM MPH NAUKCHTH c AAMHEZA 3a NCHXHNHM aserpoticrpa w/iuns snoynorpeda ¢ ankoxoa HaH HapKoTHU. Taxusa nayuentH TpsGea na Gritar non AMMMATeNHO HAGmIONeHHe MpH ynorpebara Ha XHIHOTAUN, ‘Crea passusaue Ha dbusiecka 1aBHcMMOCT, PRIKOTO MPeKSCaHTE Ha JeseHHeTO Le Ce MPHApYKaBA oT ‘CHMITTOMH Ha oTHeMaHe. Te Morar fla BKIOYBAT raasOoTHe HAM MyCKysIHA Gonka, Kpaliia Tpeno;HOCT u tranpexenne, GesmoKolicTeo, oGepxsave u pasapasaurennocr. MIpy TERKH CAYYav MOrar sla Ce HOSBAT ‘cnequMTTe cHMIITOMI: nepeaTHsAMLAA, NeIepCOHANUsAULA, XHMepaKY3c, cKORAHIOCT HM HSTPBITAHE HA KPaliHMAUTe, CBPEXYYBCTINETENHOCT KEM CBETIMH, MYM H QHSHYECKH KONTAKT, XAsHOUMHAUHS HIM enMaerTuNHH MpHNAATAM. Pb sue Tipexozent cHapoM, npx Koftro cHMmroMuTe, AoBeNH Jo TeyeHHe c BeroAHAZeTANH HH Sewsonwanenaui-nor0OWn peulecrsa, Morar 1a Ce BIOWAT NH OTTErnAHE Ha XHIHOTHMOTO REIECTRO. oan cmuipom woke a ce pHApYRAka OT PYTH PeAKLNH, RRUORALLM TIPOMEH R HACTPOCHHETO, ‘Tpesomnocr m GesnOKOlicTBO. Bano € naumenrer aa Geae npeaynpeneH 3a ssaMonnocTra OT peGayHA heHoMeH, KETO NO TO3H Has ce NusHwiesnpa SeanoxoricraoTo oT 1acrenBaHe Ha NoROGHH CHNNTOMH MIpH Mpexparanane mpweMta Ha slekaperBoro, Hina zat, ne mpi Gersoamceniinn n Gemoanasenmn-nonoGwa epencraa ¢ Kparka NpomunscrremocT na nelicrane, (beHONeNST Ma oTHeMaHe MOMe Za ce NPORBH A peMKiITe Ha HETTepaana Ha NOIMpAHe, ‘9c0Gen9 Korato fosaTa e BuCOX ‘Toll Karo pHckST OT CHMITTOMH Ha OTHEMAHE/peGayHA dpeHOMEN € 10-BEpOsTHO a Ce PABBHE CTEM PAIKO TpexparaBade Ha eHeHHETO, NpenopBna Ce ILIABHO HaManABaHe Ha j03ara. Antena Bersoanasenmsurre tant Gexsomiasennl-noaoGnirre Bemiecrea MOTaT na MpenHBNKar aTepOrpaaa anvesia. CacTosieTo oGvikHoBeHo axaHHKHa HAKONKO Maca Ce NlormTuulaNe Ha nponykTa. C MeN sa ce aManit PHeKBT, PaUeHTHTe TpAGBA na TapaNTHPAT, He Lie HMET BLAMoAGIOCT 3a HENpeReHaT 8 NacoR cunt (a, Toma 4.8). 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Tlawnerrrt ¢ xponiusia auxaresiua Henocrarputioct ‘Tpa6sa xa ce Brumaba, KoraTo ce NpezTMcBa JoAMEEMOB Taprapar, Toil KaTO GesaoaMasenmmtre ca TOKaDATH, Ye YepexuaT AMUIAHeTO, Tpabea Chuo na Ce BIEMe NO BHAMAHMe, se GesmOKOHcTRO WK -me36yRa ca Guan onMcaNH Karo NpHaHaNM Ha ZeKOMMetCHpaNa AuXATeHiTa HeNOCTATEHOCT. Taunenru c rexxo vepHoapoSio vepexnaHe Bersomuasennnate 1 Gersomaserint-nonoGHirre BellecTBa He ca NOKaZaHH 9a NEYeHHE HA NaNWeHTH ¢ ‘TexKO vepHORPOBHO yapExAaNe, Twit KATO Morar 7a NpeAMSBHKAT eHuedanonaTHs (Bx. TOUKH 4.2, 4.3 4 48). ‘YnorpeSa npw naunesere 1 aaGonseanns: Bersoanasermmrre 1 GessommasenmisnogoSuure newecTea We Ce ripenlopbunat 3a IrepAHHO neueHHe. YnorpeSa npy nenpecua: Kaxro 4 apyrite cenaTheHi/xHnHOTH¥HH neKapersa, JoTmHeM Taprapat Tps6za Aa ce npHnara InpeqTiaauntBo pH MaNWeHTH, TOKAsBAIA CHMIITOMH Ha enpecHs, BuaMoHH ca CyMUaIN TPOBH. Tlopaa psswoxtoctra 3a yMMulieHO mpetosupane OT MaLWMeHTa, Ha Te3H NAllMeHTH TpA6sa fa ce AaBa ELIMOKHO Fail-MaIKOTO BISMOAHO KONHMECTBO AACKApCTBO. CBlllecTaYBA BEAMOKHOCT T.HAp. MackHMpAHa enpecia na crane marudecrua 10 BpeMe Ha ynoTpeGaTa Ha 3ommAeM. Tutt KATO GeacbuHeTO Moe 1a Gxne cuntrroM Ha enpecusTa, cBCTORAHETO Ha maLiMeHTa TpAGsa fa 6bie NpeOUeHIABAHO, aKO GescBHHeTO He ce ToRMERe. O6tua mit bopmanns oTHOcHO edpexTHTe, HaGmonaBAM pH NpWaraHero Ha XKTHOTHTINE cpeseTEA, KoaTo TpaGna ja Gte BIeTA OT NeKAPA ron BHUMAHHC ¢ OmTHcaHa ro-n0ny. Puck or. M01 Eqnospemernara ynorpe6a Ha SonniuleMos Taprapat 4 OMKOMTM Moxe a NOBeNIe HO CeNaAS, Pecnupatopna xenpecua, koma u cwrspr. [opaui Team pHCKOBe, CEIbTCTRALIOTO MIpesMICBAKe Ha CenaTHBHH neKapeTBa KATO GeHSOAMaeMMK HAH CpOIEIH NeKapCTBA KaTO SONTIAEM c ONORAH TpaGsa Za ce SAnasis 32 NAUMEHTH, 30 KONTO He € BKIMOMEH ATTepHATHRNH WBGOP Ha neHeHHe. Axo ce msema pelicHle sa npeqnMcBale Ha 3OsMeMOB Taprapar e”AHOBpeMeHHO © ONHORAL, BLOMODKHO Hail-kparko (Biticre ebuo - OSuxara nIpenopexa 3a Hoampane B To4Ka 4.2) Tlanviewrare tpaGna BHANaTeAHO fa Ce cxTeNAT 3a NPHAHAUM HM CHMTTOMH Ha DUIKERE ceaupane. B-Tasn epeaxa e cuHo npenopssirTenHo na HbopMupate nase cpesa, 4e ca 2amo3HATH C Te3H CHMMTOMH (BXK. TOUKA 4.5).‘YmorpeGa npy nausenTH c avamHesa 98 zoynoTpeOa ¢ 1 Hai ankoxos Bessonnasensanre # Gersonnaneni-noxoSaure seulecTsa TpaGaa sa ce WanoTaRAT C HAKMOSUTETHO siiwanie npx naxueHTH ¢ anaMitesa 32 stoynoTpeOa © ANKOXOA HAM AeKapcTba. TesM MaUMEHTH TpAGEA 42a Guaat nou BHAMaTeneH HAUDOP NpHt MOmyNasaHe Ha JOANHAEMOB Taprapar HIM APYF AHRHOTHK, ‘Toit KATO Ca WALOATEHH Ha PHICK OT MIPHBMKBAHE H NICHXONOTHYECKA ZaRHKCHMOCT. 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Tooa oxaxpa pmsiaHe BRPXY entocobHOeTTA 2a moduparte mH paGOTa © Hwaitime npedoud KoGunauis Hu Mone aa nacronnt saciinparie wa edbekra Ha NoTHckaHe Ha WeHtTpankaTe Hepsia cHicTeMa, cny'aH Ha eanlospemenio npiaoxenne ¢ axmuncuxoTun (HesponetrTuiy!), xHNHOTHUGK, aHKCHOMHTHUI/CemaTHBHIK cpeactaa, axTHAeMpecaHTEH CpenCTRA, NAPKOTHANN aNANTeTHUUH, AHTHEMMTeNTHYAH NexapcTRa, anecrerinun H airrerxncTaMmtn cue cenaTHEHO jelicraie [opaaH TOBA, eaoBpeNeHHOTO PpHAOKEHHE xa 3orITHmeM ¢ Te3Ht TeKaperaa More JA MOBI CBRANBOCTTA H MHXOMOTOPHOTO HapyUuleHHe Npes GreaBAMUA eH, BKMOSUETEAHO 2a HapyuM crlocoGHOCTTA 3a modupane (wx. ToHKA 44H TOHKA 4.7), CCeujo Taxa ca cpo6uasasi oem ciyyait Ha spHTerHH xaMONMMaLIMN Tpit TALENT, TPHEKATH sommes c aurunenpecaitH, sknowitrento GynPoTMoH, nesHnpastzn, QayOKCETH, CepTpAaMH pennapaxcnt. Enoppemenno npanoxente c dpnypoKeaMim MO%ke [1a NOBHLM HHBATa Ha OAMHLEM B KPBETA, esvionpescentia ynorpeGa we ce npenopema. B caysalt wa ynorpeGa na HapKOTHYHN aHAAIFETHIU, SACHLABAHETO Ha eypopHATA MO>KE Ma jOBENTE NO _YBeTMMaBaHE Ha NeMXOAOFMMECKATA SABHCHMOCT Onwowan: Tipu eanospeenna ynorpea Ha cexsriskn nekaperaa karo Gexom:azermn HIM epoaKM eKapeTRa avo Agopsa ¢ onmovit, Noniuasa ce picka oT cexauuia, airKaTeMHa Zenpeci, KoMa W eMEPT, NOpAH xymynaruauut UHC-jenpeeiuen edexr. Jlozara x mpogsinkrenuocra Ha eospeMernara ynorpe6a tpa6sa sa Gwar orpannen (wx. rosKa 4.4). “Y PASO HNXHGHTOpH H HNAYKTOpHE (Creaumennara, xouTo HExHGupar onpeexeHH YepHompOOHH eHSHMH (nlo-crreuHaTHO WATOXpoM PASO), Morat Ja NOBHIaT axrHBHOCTTA Ha GeHomMaseNKANTe M GersOnMasenHt-nonoGHHNTe areHTH. Ennospemensioro mpanoxerive ¢ uunpomproxcauii Moxa NORMUIM HABATA Ha ORIEN B KPBETE, ‘eaHospementia ynoTpeGa He ce npenopea. SonmisteMos Taprapat ce MeraGanHaipa OT HRKOM eN3MMH OT rpymata Ha lwroxpoM PASO, OckoBHAST ‘ensiim e CYP3AA ¢ yuactute a CYPIA2, Ceeamitenta, KoHTO HtixHOupat YepHoApOGHNTE CHAK, ‘ocoGeno CYP3A4 (Hamp. 2307080 AHTHNHKOTHIU, MAKPOMTN aHTHGHOTHA H COK OT MoraT 2a yBeaNYaT DraSNeHHTE KOHLIEHTpAUHK Ha ONOGPAT NeflCTRAETO Ha 30) ‘@apseaxozmasnius edexr Ha JoaniteMopHia Taprapar e Hasaen npr easioapenoiue CYPSA4 nunykTop Karo puhamnnui u acu Kasrapvion (St. John’s Wort), PudiMeraGoniMa a 3onmATeM, KOETO BOMH 0 MpHETIBHTENHO 60% HaNaNenMe Ha MaKCHMANHATA aasMeria KOMteHTpauns H BEPORTHO HaMtareka eXheKTHAHOCT. TlOTOGHH exbexTH MOE na Ce ONAKAT ‘coo Hc ApYrH MoM HHAyKTOpH He eHsHNE OT cvcTeMaTa Ha wrroxpoM PASQ- eHtHMH (HAN. apSamasen, 8 eHmTOMH). IKRITHR KaHTapHON € rlox=dan, we Ha apMAKOKUAETHTIHO soaunmonelicraite cbc sommnem. Cpeamnte crofisocrs a Cmax AUC ca nonWxeHM (H1O-HHCKH, cuorpeTHo € 33.7 m 30.0%) a Soames, NpHLTOXeH saeAHO C mB KaNTTApHON, 8 CpaABHEHHE CBC 30ATTEM MpHIOReH CEMOCTORTEsTHO. EAHOBPEMEMHOTO NPHAONEHNe ¢ HTAAT KAHTAPHION MORE [1d aman KupsHTe HitBa Ha JOATITEM, 1 3aTORA He Ce NpenopHsina. Bonpextt Tova, xoraro sommzemos Taprapar ce mpictare c rpaxoHason (sxnGxtTop Ha CYP3A4), apwaxoKunerwanure m GapaxonHHaMMuHNTe e*eKTH HE Ce HOMEHAT sHauMTeNHO, KuTHHHOTO SHaNenHe Ha TeSH pesyrTaTt € HeHsBeCTHO. Eavospeenioro npuaoxxenie na soaizeMoB Taprapar ¢ KeToKOHasOn (200 mg ja METH AHeBHO), outer inixnOuTop 1ta CYP3A4, YaRIOKABA CTHNMHALONHK NOTYAKHBOT Ha SONMILEMOB TapTapar, _yaenuvapa o6uuiim pasmep ta AUC Ht HaManasa BHAMHA TepopaTeH KINPBHE 8 cpaprieHe © 3oamazeos Taprapar nawoe nnaueGo. OGmaTa AUC 3a 30nMH{AeMOR Taprapat ce ysenuwana yMEpeHO ‘mpi exnonpemenma ynorpe6a.¢ KeToKoHasoa, yeeniiasa ce c KoCDHINeHT oF 1,83 8 cpaBtienHE CBC S0aMAReNOB Taprapar, NpHLAO-eH caMocTosTenHO. PyrHMHOTO KOPHTpaHe Ha 03eT@ Ha 3OAMHAEMOB ‘Taprapar He Ce CHHTa 34 HEOGXORHNO, HO NalweNTHTe TpAGHa na GunaT yReNONEHH, He HINOTSRAHETO Ha S0aMIZEMOR TapTapar ¢ KeTOKOHAIOA MOMe na 3ACHITH CenATHBHHTE efpeKTI. ‘Toit kato exsist CYP3A4 ua naxtia pons 9 GxoTpanebopMauuirra Ha 3ozMIeMOAKs TapTapAT, ‘TpAGBA Ra Ce HMAT B MPENBIA BESMOKTIN BIAHWOTEHICTBHA C JleKapeTBA, KOHTO ca cyOCTparH wt xaayseropn wa CYP3A4. Apyru nexapern: Koraro soanmien ce npwaara c saphapus, aMroKCHH, paHHTHAMH, We ca HAGMONABAKI 3AM apwaxoxnneruunn ss2nmoneficrsns. 46 @epruanrer, 6penennoer m kepmene Bpemesiocr Hana noctarsano aaHiut sa oueHKa Ha GesonacHocTra Ha sOnMHJeM TIO BpeMe Ha GpemexHocT. Bunpexn ve npoy'sainisra npit xim0THIE He ca NOKadanH TepaTOreHHt HAH eMEPHOTOKCHCYH expeKT, Geronacnocrra iio apeme 4a GpeMeNHOCT He e YcTaHOBeHE pM XOpA. Kaxro scwaxi apyrit zexapersa, 201miAeM Taprapar TpAGBa 2a ce vaGarBa Mo BpeMe Ha GpeMentiocr, ‘ocoSeHo pes MPBOTO TpHMeCeHHE. ‘Axo NPOAYKTDT ce Mpeanucea Ha 2keHa B AeTepONHA BBSpacT, TA TpAGEa Aa Gure mpeaympenena ne ce ‘CBEPKE CEC CBOR TeKAp c OFNeR CTINpAHE Ha MPONYKTA, aKO BEIHAMEPRA sa 3AOpeNeHee WAH MONOID, ¥e ¢ Gpementa. Ano To HaOXHTETHH MEIMURHCKH NPHNNAH, SO.INMEMOR Taprapar ce npwara no BpeMe wa kenara ‘ana wa Gpenentiocrra wis no Bpeme Ha paxxaaxeTo, nopaau apwaxoorMKoTo acifcrBNe Ha mpoayKTa Morar 2a Ge ovaKsar e:PeKTH BLPXY HOBOPOAeHOTO, KATO XHNOTEPAAKE, XHITOTONNS H YMepeno NOTHCKANe a minaneTo. Cay¥an Ha TExKO HeOHETANHO NOTUCKAME Ha ;DMMIAKETO B xpas Ha GpeMeHHOcTTa ca GH ‘RoxTagan rpm yrtorpeGara nn SomnmzeM c mpyrH NenpecaiTH Ha NeNTpaaTa HepsHAa CHCTENE. Hosoporents, sitTo MaRKH npomBIMAHTEsHO ca BREMaNIN GeHnonaxeNHHH WIA GeraomasenH-nonOGHH ‘opesicTaa npes nocreaMute craamn Ha GpCMCHHOCTTa, MOTAT 2a PASBHAT CHMITTOMH Ha OTHEMaHe B MOcTHATANHUa Kepuon & pesynTar Ka uaHYecKa saBNCHMOCT. ‘Kepmens:Sonmunemos Taprapar npeMHHasa B KbpMaTa B MHEMMAIHH KomM4ecTBa. CrenoRaTeNHo SonnMzeMon ‘Taprapar He TpaGea Aa ce HSTIONSBa flo Bpeme Ha KUpMeHEe, Tbii KATO edpeKTHTC BEPXY KEPMAYETO He Ca weoneaeanit. 4.7 Egexrm supxy cnocoSuocrra sa modupane m pabora c ManiHNR AgopMa nosiuasa 8 sHaunTenHa creneH chlocoSHocTTa 3a woduparte u paGora ¢ Maun, WospbopuTe Womleparopite Ha mannHn TpAGBA sa GuaaT npeAYMpENeHH, Ye KAKTO H NPH APYTH XHNHOTHML, € BLIMOAEH PHCK OT CBHLIHBOCT, YBC/IMHEHO BPEME 34 PEAKILAR, SaMANHOCT, CBHMBOCT, 7aMBrTeHO/IBOHNO BYpKqAHe H NOHIDKEHO BHHMALHE H Hapyutetia cHOcOGHOCT 32 WiodpHpanle Ha CyTpHHTa CneA JAeeHMETO (Gx. TowKa 4.8). C yen 2a ce HAMANH TOSH pHCK, Ce MperopE4Ba Mephos 38 NOYMDKA OT Nowe 8 Hace Mexay npHeMa Ha sonmiizeM u wopupane, paGora c MauIMHH HUI paGOTa tia BHICOKO. Hapyitiena cnoco6nocr 3a mopar H CECTORHHS KATO HaMpaNep ,,chH TIO RpeMe Ha wodpupane™ ca HacTeMBANH pH NpHEM Ha 3OAIMHLIEM CAMOCTORTEHO s TepaneETH¥HH 03H, Ocpen Tosa, exHoBpeMtennoTo MpHiomeHtHe Ha SOnMIAEM ¢ AUIKOXON H NpyTH s1eKapcTBa, NOTHCKALYE WHC, nosumasa pucka or noso6HH ceeTomHA (Bx. TOTKA 4.4 1 4,5), [laumeHTHTe Tpa6pa aa Onset penynpenenn Ja He ynorpeGasar aikoXON MAH NpyrH MCHXOAKTHBHM ReulecTRa, KOrATO MpHEMaAT soamiem. 48 Hexenann aexapernens peaxuust Creature nanny 3a Yectorara ca ocHonaTa 3a olteska Wa Heokes1aHHTe nexapcTReHN peaKUHH: Muro sectn (© 1/10) Yeorn (or > 1/100 0 <1/10) Heuectu (or> 1/1 000 0 < 1/100) Penk (or 2 1/10 000 no < 1/1 000) Munoro pestis (<1/10 000) (C noussectna sectoTa (oT HaNMYHHTE AHHH He Mo:Ke na Gaye HanpaBena oueHKa). isa Joxasarencrsa sa spuskata MekAy 10saTa M HEACIARHTE JekapcTACHH PeaKUMH, CBEPIAHH C -ynorpeGara Ha 3onmuzlem, ocoGeHo 2a HAKOH eBEpSaHK ¢ LIHC H CTOMAUIHO-NpeBHH CBOMTHA, “Tosm peaxunia wstnexkna ca caBpsAHH ¢ MIUINBAAYANHATA SYBCTRHTenHOCT Ce NOARABAT NO-HECTO 8 PAMKETe Ka enHH Hac CHIEN MIpHEMA Ha LekApCTacHH MPOAYKT, AKO HA\WMENTT He JTerwe WAM He SACL nemwara (2x. Towka 4,2). Couto Taka, Te Ce eay'BaT NO-eCTO pH NallMeNTH B CrapHecka BRIpACT. Hapyuenus na unynnama cucmena C wevapectia wectora: aurnoneaporisien oTOK Tewewinu napyusenua ‘Yectu: xaMouHHauan, 8536y2a, KOUIMApH, Tenpecus (Bx. TOUKA 4.4); Hewectu: cxctosime Ha OOspKAKOCT, pasnpasHHTeAHOcT, 6earOKOFiCTEO, arpects, COMIAMGYnIsDM (BK. touxa 4.4), eypopaano nactpoenne; Peaxu: Hapyuienna p aHOWTOTO; Muoro peaxn: sa6myavianavse, anneHMocr (cHEuIpoM Ha OTHeMarieTO, Win ,,febound exbeKTH MOxe 1a BLSHHKHAT cneA MpeKpaTabaHe Ha sIeHeHeTO); C Hew3sectHa YecTora: rise, NCHXO3H, HeoOm4aiiHo NoBeneRHe, Tosexevo or Teau newxnaxpisiin Hexesan ekapeTBeH peaKiNN ca CéDpsailt¢ mapanoK peaxnun Hapywenue na neponama cucmea ecru: eniwunocr, ranoGonue, siieHe Ha cBar, HSoeTpeHO GexeBiIe, KornirrHBHH avTeporpana aMHesna (ecpexTHTe Ha amHesHs MoraT Jla ObgaT cBLpaaHH c Heamel me Hesectu: napectesns, 1pemop, HapYUNeHHe Sep BHHMAHHeTO, HapyuleHMe Ha ro ea ee yePegku: nowuxeHo HUBO Ha cEaHAHHe Hapyuenns na ovame Hewecra: amnnionus, saunrsteuo penne; ‘Muoro penxi: Hapyuiexo spenne. Pecnupamopnu, 2pednu u meduacmoaru napyurenun Muoro peaxu: noTucKatie Ha AMuaHero (ix. TouKa 4.4). Cmonauno-peanu napywuenun Uectu: auapus, raene, nospbulane, KopemHa GomKa. Xenamo6uauapuu napyucenun Hewecta: Tosuiexo aio a wepnonpoOwnre eauMu; Peaku: xeniaroueny apo, xonecTaTHMNO HuIH CMeceHO tepHOApOGHO yEpexuane (BK. TOUKH 4.2, 4.3 44). Hapyuenns na wetaGonmswa M xpaxenero Hewecrm: napymienne Ha anerita, Hapywenua va xoocama u nodkooenama nroxan Penku: o6pws, expe, xunepxiaposa Pesei: yprakapy. Hapywenua na aycxymto-cxenemmama cucmena u cvedtarumenama nsx Yectu: Gonka B rep6a; Hesectu: muanru, myexynn coast, MyeKynia cnaGocr. Hagberagm w unpeemayes WecTu: Witbexuna Ha ropHH JMXATERHH METH, HHIpeKIO Ha NOAH MICXATENHH METHUA O6npu napywenua u edrexmu na nacmomo na npunoowenue ecru: ymopa; Peaxu: napywenme na noxomkara, naave (npenuMHO MpH MaumierTH B cTApHEcKa BEspACT H KOTATO SOnTMeM He € TIPHET ChoTBeTCTAHE C NpenopEKHTe) (=k. TOUKa 4.4); C Hemmnectma vecTora: nexapcrsetia TostepaitTHoct. c He Ha ONO conan CooSmananeTo Ha rlogosupann HexenaHH peakutHH Cnex pespeurapatie 9a ynorpeGa Ha neKapeTBeHHE Npoaykr e naxHO. ToRa NloaBosiaBa 2a NPOMDIDKA HaGMOAeHHETO Ha CKOTHOMIeNHeTO MOMSA/pHCK 3a nexaperaesita npotyxt, Or MeAHMAECKHTe crenwATHCTM Ce HOHCKBA Na ChOOulaBaT BeaKa NOROSMpaHA ‘Heesiana peakunr pe: Vormmrenna arenuna no nexapcreara yA. lamas Fpyen” No & 1303 Coopus Ten.: +359 2 8903417 yeGcaiir: www.bda.bg 4.9 Tpeaoampane Tipwsnaut emvaronsr B noxsamrre aa npenosypane camo ce s0nmUIeMoB TaprapaT aM APY NOTHEKAIH (bkcnormento ankoxoa), ce naGmonasa yapexaane Ha CbaHaHHETO, KOETO Baplpa OT OMA, KaxTo H N0-TeXpaTorpaNa, PaxMitHia OF TaaH MpH GewsoaMaxeMHHuTTe B npoyusanus, KovTo usmepar npouleHTa OT BpeMeTO, NpeKapaHo HED BCEKH eTaN Ha cost, O6O6UIENO ‘moxasbar, fe JONTMeM Taptapar sanazsa cos. [Ip mpenopounava Osa, 2onmMueM TaprapaT HAMA auHHe BUPXY NapaoKCamHaTa MpomwsDKHTesOCT Ha CBHI (REM). 3antaznavieTo Ha ZHHOOK ChiE (Craw TIT W TV ~ Gasex suanen coi) Moke 1a ce OGACHH c CeneKTHBHOTO cBBpaBaKe Ha OMera-1 peuertopirte csc SonnisleMon Taprapar. BowuKH YoTaHOBeHH expekTH Ha SONNMTeM Taprapat ce BugcTaHopasar of GelpoanasertiHonnA alrraronucr aymasenAt Panowuesuparrte uoniroatax noxaapar yGenyrestio ZoresaTencTH0 can 38 efpmkacwoersae LOmg soumieM.B parqoMasHpaxo Aeofiocaslo wanitTEaKe mpH 462 aupapH AOOPoBONLH B He-FAPHRE: bespact, npexomHo GescetiHe, sonnaem 10mg Hawanaa cpesHOTO RpeMe 3a =o i B cpantonme ¢ nate60, AoKaTo npw 5 mg sonnneM ce HaMaaasa C3 MuEYTH, —/ BB parqonessxpano npoitHo-casno womrsae mpi 114 nauveHTH 8 ue-crapyecka Gescanne, sosinuest 10mg HaMansina cpeslHoTO BpeMe 2a aacruspane ¢ 30 MHHYTH te aue6o, noxaTo npu 5 mg sonmigem ce naMariaRa © 15 METH.Tipn usKon nauvertu, no-ancka nosa o7 $ mg Moxke na Guse eeKTHBHa, Tleamarperania nonyaauis Tipu nauwewr wa sespact ron 18 roaHHH GesonacHocrTa W esuKachocrTa Ka 20nMHAeM He € _yerawoncna. [pn 8-cenwimsHo parutomHHpaHo, rviauleGo-KorrTponMpaKo Npoysnare pit 201 Zeua (Ha exspaer Mexay 6-17 roguHH) c HcomtR, acoUHpata ¢ AedMUUIT Ha BHUNAHNETO 1 xumepaxruatocr (ADHD), #e yens 1a ce aoKake edhxacnocrra wa toamanen 0.2Smg / kg / eH (€ maxonaria no08 oF 10mg / nev) B epassicrne c nuaneGo. owxWHHH H HeBpoorun paserpolicrea npencranasar nail-ectHre eReTAHt PeaKUIAH CBEPIAHH C eveHETO CHC soaieM cnpamo nijate6o Ht BKTOYRAT: saMaRHOCT (23,5 % cnpaMo 1,5%), rmaBoborme (12,5% cpawo 9,2%6) 1 xantounsraum (7.4% cnpanto 0%) (wx. ToaKE! 4.2, 4.3). 5.2 @apmaxoxaneritatn cnoierpa AGcop6yser SoanneM npirexasa eanospenento Gupsa aScopOiys M Haat Ha XHNHOTHYHOTO BEIMeficTaME. Buonatuiocrra e 70% exer nepopanno npistoxeHne, To# noxasea antteinia KHNETHTKA ‘TepanesTuuinte awanesoH Ha Zosupane, TepanesTHuHoro rurzaMeHO HHBO € Mexkay 80 1 200 ng/ml Maxchwasia nasmeva KORUCHTpAMlNK Ce ocTHra Mexy 0,5 H 3 "aca Ene MpHAOeHKETO. Paanpedenenue ‘OGennr Ha pasnpeaencrne npn sbspactun © 0,54 + 0,02 Vkg u ce nlonmkaRa 10 0,34 + 0,05 Vkg npa anweHTH B HanpesHana cTapHecka BEapacr. ‘Crenenra na cappspatte © nporenmn € 0 92.5 % + 0.1%. MeraSommasr npi peo mpemiwanane ‘epi APO BeamMa Ha oKO,TO 35%. JloKasatlo €, He MHOTOKPaTHIOTO MpHNoAeHTHe He NPONCH CorspanaveTo c MpOTEMMUTe, KOeTO NOKESRA JHINCA Ha KOHKYPeHLUA NEKAY 2ONTHLLEMOB TapTapaT M eropiste MeteSonmTH 2a Necrara 2a cBEpapart. Buompancepopuanpt Soamutes Taprapar ce MeraomlHpa "pes HAKO.TKO eHfs¥aN Ha 4epHOApOGHIIA LHFTOxpom PASO, Karo ‘ccuomsiat enum e CYP3A4 c mpnwoca wa CYPIA2. Tali xaro CYP3Ad urpae sexta pona B MeTaGomiGMa Ha SonmeneN TapTapaT, TpATBA 2a Ce HMAT B NPETRAN REAMOKHY BBAHNOACHCTBI C eKApeTBA, KOUTO ca cyGerpaTH Wim setayKTOpHC Ha CYP3AS. Bausunupane Enynniauvonunar nonyansor ¢ xparsx, epeauo 2,4 vaca (+ 0.2 vaca) m mpomrxutremocrra Ha aelierBue e 10 6 aca, Bewsxn meraGoma ca dbapmakoriorn4Ho HeakTHBHH Ht ce emuMmnmpar c ypunata (56%) ue uonpaxuennara (37%). Tipu npoyssama sonmuteos raprapar e noxasar, ve He ce o7aenx Hes muATINA, Cheyuasnu nonyrayuce TIpu naunentH c 6s6peuna nenocrarsuoct ce wa6mosiasa yMepeHO HaMaNABANE Wa KIPBHCA (aesasnicnmo or sxsMoxuia mama). JIpyrute hapwaxoxuHeTH¥HM napaMerpu OcTaBaT KewacerHarH. TInaaMenitre konlenrpaunn pH TauvtcHTH B cTapyecka BB3pacT H NH JIMUA ¢ HepHOmpoGHO yepeARAHE ‘ce nopuuapar. px mauutenra » craptecka meapacr ce naGmozasa HaMancH KaMpbHe. B rpyna OT MaLKeHTH Ha BEspACT 81-95 roamav, maxcuMammure rmiaaMenu KOHYeHTYpauni ca ce yRenMHTH c oKoN0 80% Oe3 aHaHTeTIa TpOMAHa 8 eAHMHHALNOHHUE NomyxWBOT. Tipu nauutewru ¢ sepHonpoSua unposa ce HaGaroaasa 5S-KparHo yResuvenie Ha AU YeINNCHHE Ha HonyAHBOTA, {33. Tipeaxanmuanu nannu 3a Gesonacnocr Hexuoueante qainn He noxassar ovoGeu puck 3a xopa na Gazeta Ha KonBeMAMLONAHTE Gapvaxorornn npoyssanus 3a Gesonacnocr, TOXCHMHOCT Mp MHOFOKDATHO IpHAAraHe, FeWoToKeHsHocT, KaNUeporeiteH NOTeHUMA, PeNPOAYKTHONA TOKCHNKOCT H TOKCHSHOCT 28 pasBiTHero. SaBanane na perannoTo paseuTHe H erorOKCHAHH ebexTH pu ruroxORe H salu ca KaBnoaaBAHH CANO pH jos waa MaxewasaTa woseuiKa 1090. Hana aoxasarescrpa 3a Teparoretics: NOTCHILAAA. @eprumer: Tipu npoysane ua eflexra sepxy pasMioxasaieTo 1a TIEXOBE, 2OsIMHIEM Hee HAA egleKT BEPKY eprunirera npn mexckn MAN KeHCK RUTEXOBE Cen AHEBAN MepopanKM nOGH OT 4 710 100 mg Sasake nn 5 20 130 rroTH mpenoppusaitara Zo3a mpH xopa B mg/m2, 6 OAPMAUEBTHYHH JAHHA 6.1 Crmcx na nomomunre semectea Jiaxro3a, monoxwapar Uenys0sa, wuxpoxprcrastia Harpyes uswecren tamkomar tam A Xunpomenora Marnesies creapar Cennemepe cyx 5212 poson, cbasprant: Xunpowenosa, Teny.1032, suxpoxpucrania ‘Trrranios auoxcnn E171 eprext xeresent oxen E 172 62 Hecwnmecramocra Henpnnoxawo 63 Cpox na ronnocr 5 (ner) roaunn. 64 — Cneumaanm yeonua wa eoxpaneune ‘Toau sexapernen nponykr He HaHieKBa cneWiaAtH YCHOBH 3a CHxPANENHE, CoxpaLBaltre B opurinanaara onaKonka, 38.18 mpeanasire OT cBeTTHHa. 65 Bunn chrepwanne wa onaxonKaTa ‘Durante raGnerKu ca onakoBaHA & Npospasen PVC / Al Gnvcrep. Onaxonka or 10 4 20 raGnersu. He sour s1toge onaKoeku Morat na Geaar nycHaTH 8 NpOIAKGA, 66 — Cneuuanni npeanasHM Mepxu npH wsxoxpasne u paGora ‘Hama cnenmasnu wsncKsanus.Honsmomasanasr aexapersets npoaykt Him OTHANbYNHTE MaTepHamH OT HeTO TAGE a Ce HSXBEPART B ‘choTBeTCTBHE ¢ MECTHIITe HSHICKBABNS. 7, TIPATEXKATEJI HA PA3PEIIEHMETO 3A YIIOTPEBA ALKALOID-INT do. Standrova ulica 4 1231 Ljubljana-Crnude Cropenns 8. HOMEP(A) HA PA3PELIEHHETO 3A YIIOTPEBA Agopma 5 mg duimupany taGnerKn — Per. Ne 20110709 9. ATA HA ITbPBO PA3PEIABAHE/IOJHOBABAHE HA PA3PEMIEHMETO 34 YIOTPEBA Tiara a mpao paspemapate: 06 Hexewspy 2011 Tlara Ha nocsemto nomuonasane: 14 Asryot 2018 10. ATA HA AKTYAJIM3HPAHE HA TEKCTA 0772019