KPATKA XAPAKTEPHCTHKA HA IIPOAYKTA 1. WMEHA JEKAPCTBEBHS DPOJYKT acai anaaBarne Tenoreies severe te. LOPE OL SE Konaxston MM 10 mg/ml moxexutnonen pastbop Konakion MM 10 mg/ml solution for injection 2. KAYECTBEH H KOAMYECTBEH CLCTAB Beaxa anya Konakion MM cemepxca 10 mg sirramnn K, duromenanion (phytomenadione), Ph. Eur. 51 ml. ‘Averys MM 10 mg/ml » emeces mauenex pastsop (MM) xa acreuna kucemmea/reumrras. Ena AMMyma OT TBMHO CTBKO ChmBpxa 1 ml OT GucTpHA eMeceH wuUETeHt pasTBOp ¢ 10mg BHTANHE Ky (eGem Ha narsaeane 1,15 ml) sa nepopamto Han napeHTepannio npwuioxKenHe, Tlomommo semectso c wapectHo JelicTaue Tosa nexapersex mposyxt comepaa HATpHiH, 1o-MasiKo OF | mmol (2,64 mg #a 1 ml), re. mpaxuveck He Cbstbp>ka HaTpHi. 3a manus chcex na lomoMpTe ReUecTBA BUDE TOUKA 6.1 3. IEKAPCTBEHA ©OPMA Hisoxexunovien pasrsop Hiroxexumontuure pasrnop e Gucrep so cnaGo onanecuesrest 4. KAMAE JAHRE 41 Tepanesraan noxasagus Konakion MM ¢ noxasan karo altTHJoT Ha aHTTHKOarymaHTTH OT KYMapHHOB THIT 3a eseHHe HA KPBBOHSAHB WIE PHCK OT KPBBOHSIMB B pesyATaT Ha Texkka ,ARTOMPOTPOMGHHEMHA” (7.€. HeNOCTHT 1a xpesoczcupsammn dascropu II, VII, IX X) ¢ pasnuuna eTHOROTHA, BKTIONHTEIO NpeLOSHPAHE HA AITHKOAryAaHTH OT KYMAPHEOB THN, TEXHOTO KOMGHHHpaHE c GbeHHLAGyTasOH H ApyTH opm Ha xammosirramastoza K (Wamp. npl OGerpYKTHBHA ACb:ITEKHUA, KATO M NPH YepHOAPOGHH H HpeBIEA HapymeHna cnen MpORBTAGTENHO AeYeHHe ¢ ANTUOHOTHIM, cynhonaMeAAH HTK cammnnANATH). 3a npodunacruxa m nevenwe Ha xemoparisina Gonecr mpH HonoponeHH TpAGss 2a ce HanOMIe neqwatpasmaus Konakion MM aurtyi (2 mg/0,2 ml). 42 Hoauponka u Crauaapms josyposKa Tipu meaicxu uru oicusomosacmpawiascuyu xpeeousmusy, Hanpumep no speme na anmunoazynaimne ssevenue: JlewenveTo © KYMapHHOBHA aHTTHKOSry.aaHTr TpaGBa fa Ce mpeycTauosH H Konakion MM sa ce oxexcrupa Casto unTpapeHosHo (6 MpOmBDKEHHE Ha TloHe 30 CeKYEH) B 038 OT es iV Ba npaoKenue ‘ipscio sampasena rviaaxa (FFP) Wik mipoTpoMOntioe KoMILIeKceH KOHMeHTpar Heo6xogMMoct jlosaTa Ha BMTaMHH K, Moxke Ja ce oeTOpH. batTipenoporu 3a dosupane na sumamun K; npu nanuenmu c 6eacunnmonno eucoxo MexcdynapooHo opmanerapano coomuowenue (INR) coc un 6e3 nex xpreousnus: Aurmxoarynaat | INR Tepopasen paramme Ky Marpasenosen suraman Ky ‘Bapdapun 5-9 | 1,002.5 mg 3a nayanna 0,5 go 1,0 mg. ‘mpomana 2,0 0 5,0 mg 3a Gspaa npousua | 0,5 0 1,0 mg (Gomarensio 1,0 20 2,0 mg, ako INR octane Bucoxo cen 24 4.) >9 [2.5.20 5.0 mg (0 10.0 mg) 10mg. Aucwoxywapon | 5-8 | 1,020 2,0 mg 10,10 2,0 mg >8 | 3.0205,0 mg 1,0 20 2,0 mg Deunporymon | 5-9 | 2.02050 mg 2.0.n0 5,0 mg >9 {2.0 n0 5.0 mg 2,0.10 5,0 mg 210 | He ce npenopssa ‘Hiwuesnayannio ananrmmpaaa 03 Tipenopexu sa doxupane ua sumanun K, npu nayuenmu coc cuno unu acusomosacmpauasaiyo kepsene: Anrukoaryaant feet Enuonpemenno acvenne Bappapur | Canwo xupsene 50 x0 10,0 mg FP wan POO ‘Kuporosacrpamanamo | 10,0 mg FFP, POC nm pexomOunanren xeppene gaxtop Vila Tusnorywapon | Cuno wxpaene 50mg FFP, PCC wx nporpontnnosn scomueerparn u daxrop VIL Dennporjan | Canwo eepeenee | 50mg POC INR <50 Canao xepeesee | 10,0 mg POC INR >5,0 *EEP — npacuo sanpazena niasma "PCC — npomponGunos Komnnexcen konuenmpam TpsGna na ce orGenexu, ne Hali-paniuxr empexr or serenMeTo ¢ aitramnn Ky ce HaGmionasa cre 4 6 aca H nopank ToBa NpH NaUHeHTHTe ¢ TEXEK KPBBOHEATN Moke fia € NOKasaHa saMecrirTesTHa ‘Tepammas c Koaryaaumonn GaKTopu (na ce O6cbAM c xeMaTonor). (Coeunamay nonytaums Tayuenmu 6 cmapyecra exspacm Tipu naunesrrure » craptecka Bespact ce nAGmMORABA TeHLICHLNIA KEM f1O-TOMAMA YYBCTBMTEMHOCT NO ornomenne Ha o6psulaHeTo Ha anrTHKoarysiaitTHoTo steficrsHe ¢ Konakion MM. Tlopame rosa AOsHpoBKaTa NPH NAUMeHTHTe OT Ta3H rpyna Tpx6Ba na OyAc Ha AONHATa NpenopEdHTenHa TPAHHUA. Foxasano e, 4e macs nos or 0,5 20 1,0 mg i.v. nH mepopanen Birra K, ecbexrHpio HaMAnEBAT INR 30 < 5,0 pannsrre wa 24 aca, Flewa ua evspacm om I do 18 20dunu Jlexysaniust sxeKap We OnpereTH OMTUMaNHaTa Jo3a COPE NOKssAHHATA H TETNOTO Ha TANMEHTA, Cyo6masa ce, ¥e emnoKparna osa o7 enHa geceTa oT MusiNaTa i.v. Osa Ha Berra Ky ‘esbexcrupia 2a oSpbitanteTo ta GescuMtrroMnio BricoKo (> 8) INR mpH neta 8 HO6PO Ka cxctosune, [penopessa ce KoHeyMTaMH ¢ XeMaTONOT OTHOCHO NOAXOAALNITE C4} Wa BeAKO sete, pH KoeTO ce OGMHCAA NpHROKeHe Ha Konakion MM. iv leaf Bepostinire noxasatitis a mpHioxeHne Ha BHTaMHH K, mpH jetta ca OrpaHiueHH H\MOKE Aa BxmONBaT: a1. Tleuac wapyuenus, koro sxanpensrcrsar a6cop6unsra Ha nurancn K (xpormraria Mapa, KucTHYHA bOPO3a, ATPESH Ha AUTBUHHTE MBTHULA, XEMATHT, UBONHAKHA). 2. Jlewa c nenoxpasmane, KowTo ony'asar UMMpOKOCTTeKTEpHM abrrASHOTHI. 3. HepwoapoGtn sa6onaanna. 4. Tlaunesrra, nonywapauin axTKoarysianTHo nesenne c Bapbapnn, np KowTo INR € yBeMHIeHo sBbH TepanesTHMttTe MpaHIMLMK H TOpANH TOBA Te Ca HBTOKEHH Ha PHCK OT KBPBCHE HLA KEPBAT, xaxro 4 Conan c INR p TepanestHsitH rpariMun c KEpBeHe. Tipu Tepanestusmara wirTepseHuns pH MalIMeHTH, HexyBaHM c BaphbapHl, TpAGBa Na ce BIEMAT TMpenei1 ipwsatrre, nopamH KONTO eTCTO ce seKyBa c BapcbapeeH, KaKTO H AANH arTHKOaryASHTHATA ‘Tepanus TpxGsa 1a NpomTDKM WM He (HAN. NpH AeTe © MeXaHMHA Kana Ha CEPUCTO WTA MatoroKpaTimt TPoMGoeMGomHHH YCHOKHEHHA), Toil KATO HMA BepOXTHOCT MPHIOREHHETO Ha BHTAMHH K, aa nosmse arrruxoaryaaxrrxoro nelicreHe Ha Bapiapuat 8 npomemxceiHe ta 2-3 cement. Alosupoexa ua cumamun Ky ‘Via manxo 2aHHH orHocio ynorpeGata na Konakion MM mpx aeua wan 1 rowna. He ca wseEpumeart Npoyspann 3a onpenenaue Ha AosaTa npH Aeua c KpEBOHINMB. IpenopsBAT Ce cneAHHATe OSHPOBKH BBS OCHOBa HA KAHHMMHHS OTT: Kpreowsnue npu deya: 2-Smgiv. Bescunmmonnu deya c puck om xepeene: 1 -Smgi.v. TiporpomGnnosure ipa TpxGa 7a ce HaMepaT 2 70 6 HAca NO-KECHO H, AKO OTTOBOPET HE € RoctaTbuet, 1o3aTa Moe 7A ce MlOBTOpH. YecToTO MoHHTOpHpatte Ha xpEBOCLEUpBaLNHTe aKTOpH, ‘SaBHCeMIK OT BHrTaMHH Ky, € AuEHTeHORAAHO MPH TeSK MaLHeHTH Topnute npenopekn 38 NosHpane Ne BKMOTEAT Aelia, NeKYBAHH ¢ BapdapHH, KOHTO TpsGBa 1a MpomBKaT TepaMarra c aNTHKOAryAaHTH, Hosopodenu u xepaavema na eespacm nod I 200una Tipu resn nauenra tpaGea na ce Hanonsea neavatpuusiis Konakion MM anys (2 mg/0,2 mal). ‘Hace ua npwroxenne Konakion MM anys e npegwasiayent 2a uitpapenioswo IH mepopasino MpAnoxeuHe. PasTBOPBT B aMmyaata He TpaOBa fla Ce CMECBA C [PYM JeKAPCTRA 28 NapeHTepATHO MPHLOKEHHE, HO MOIKE Ila Ce MeoKexcTupa, KoraTO © NONXONAULO, & ONHATA HaCT Ha HiXpySHOMHaTA cHeTEMA. Tlepopaxno npusoawenue Konakion MM pastaop moxke sla ce mpianara nepopaitio cic CnpHUOBKA NO CHEAKMS Has: HeoGXOAHMOTO KONMMECTBO Ce HSTETTA OT AMMTYNIaTA C OMOLLITA Ha CIIPHHHOBKa ¢ NpHKpeneHa Mra. ‘Orcrpansiea ce armara or cnpHHoakara u CbmSpxAHHeTO Ha CIPHHUOBKATA Ce TIPHAra AHPEKTHO B yerara na nauwettra. [pommpa ce ¢ Tesmoct. 43° Tiporsnonoxmanus + CepexsyscrarTenHocr KBM HTOMEHAIHOH WIM KEM HAKOE OT NOMOUUNHTE a6 pocHH B TouKa 6.1. y VS, - Hirrpaqyexyatio mpitoxkerme nopasm prick or eno edeexr ¢ mponsiraarrest 9 na pirrasont K,, KoeTO MO%ke a ROBE NO TPYAHOCTH MPH NOAHOBABAH Hd “Teparma; KAKTO M pick OT Opagybane Ha xeMATOM TPH NAMCHTH, es BHTHKOArYNAHTHO HeMeHHe. Senet 3 SEtien pe44 Coenen Peaynpeaienua w mperinasaK mepka mp ynorpesa Koraro ce sexynar naunesTH ¢ Texkxo yapeetia YepogpoOHa dysxuns, Tpa6pa 1a ce HMA MpenBHA, ‘se emma anmryna Konakion MM 10 me/iml comopoca 54,6 mg rnkoxonmesa Kncemuna TOBA MoH 1a opene Jo wsmecrBane Ha 6mypyGnra. HeoGxomHMo ¢ aaMNaTenHO MpocnenmBase Ha INR cre, mpxaarave 4a Konakion MM mpi naupiesra ¢ Teakko yapesteta sepHonpo6Ha yunanta. Tipu ynorpesa coaspxcannero ta anmynara TpaGea na ¢ 6xicTpo. Benescreve Ha HempaBisito CExpaHeHKe, CBMBpKAHCTO MOKE fa Cras METHO WH 1a Ce pasMeNM wa cHoese. B TaKbs cmyaalh aumynara We papa na ce ynotpetaea. Tipu notemmanio stevanim WK Texkka KPSBONSTHBH, T/DKAIIM Ce Ha NpeAOsHpAHe HA KYMAPHHOBH antuxoarynaxt#, Konakion MM tps6na za ce npuara GasHo HipaneHOsHo, KaTo 3a 24 waca He ‘rpaGna aa ce nptinarar mioseve or 40 mg. Teparturra c Konakion MM TpaGea na ce npanpyakasa oF AOMBAHHTeNHO Te4eKHe ¢ nO-OBps OEKT, KATO KPBBONPETMBAHE Ha LWIA KPBB HAH KPLEOCECHPBALIA ‘axtopx. Korato ce npasit xpbEoMpenHBaHle Ip NALweNTH C HSKYCTBEHA KNaNa Ha CEPHETO 38 AeveHHe Ha TEKH WH NOTEHUNATHO jeTaAHH KPLEOHSTIBH, TpAGBA a ce HNOTBA MPACHO sampaseta naasMa, ‘Bucorst zosm Konakion MM (venaqsemasatt 40 mg aHestio) Tpa6sa na ce ws6arBat, aKO ce peABYOK.A TONCHHCTO ¢ ANTAKOATY.NAHTE 1A NPOWOKM, THE KATO HAMA OMHT ¢ HOH HAs MAKCHAATHO 40 mg anesto H nlo-aucoKiTe 03H MOKO J1a NPCAUSBHKAT HeowaKsaHH Heenan Loma. Knnsavaurre > EsTMTBAIUHA ca NlOKAsATH NOCTATEAHO HaMAsIeHKe Ha NPOTPOMOHHOBOTO BpeMe ¢ NpenlopbweTestaTA ‘ROsHpOBKA. [IPR TALK KPLEOHSING MOKE 1A Ce HAAOKH MPEAMBAHE Ha NPACHA KPLB, HOKATO ce "AKA AA ce nporp ediexTbr na perrannHit K;. errant Ky we e axmigor wa Xenapma. ‘Tost nexapersex nponyer cbaepaca HaTpHil, no-ManKo oF 1 mmol (2,64 mg wa 1 ml), 7.6, TMpaxruseckn He ChAUpaKa HaTpHlt. 45 Bsaumoseticraue ¢ apyra Jekaperseum npoaykTH # Apyr Gopou wa nsamMogeticrame He ca vasecTan sHasnnn mamwonelicTai OCbeH AHTAroHMSMpane Ha e*peKTa Ha KYMApHHOBHTE aurruxoarynantH, EquospeMenioTo MpHnOKeHHe Ha AHTHKONBY.ICAHTH Moke a Hapyiin AeHCTBHETO a parastny Ki. 46 @epruanrer, Gpemesmocr u kBpmene He ca npopexaann xorrpanupann mpoysatis c Konakion np OpemeHii xen, KaKTO H Tipit aemnoran, Bsa OcHoBa fa MHOrOrOsMIHHH KAMHHYEH onirT OBaNe BeaonAcHo € sa Ce JOMYCHE, He HATO BiTamun Ky, HATO NOMOMINHTe BeMeCTBA, ChirepalH ce B ekapcreesara dopma Ha Konakion, umat ‘WaKAKBH PenpOZYKTHBHK TOKCHKOWIOTHEHH e*EXTH, KOTaTO JleKapcTBOTO ce NpMNAra B penopaamrenuara sosa. Karo mpi ncwseH aekapctaa o6aue, Konakion tpaGsa 2a ce mpwnara mx Gpemetntn xxextH camo ako niox3aTa 3a MaliKaTa HaIKXEBpAA PHCKA 3a TUTORA. Toff karo suraae K; He npemaHasa necko mauesTapHara Gapnepa, He ce npenopoysa Konakion a ce mpuaara np Gpemen KaTo npopwaakrnxa Ha XeMoparvstia Gonect MPH KOBOPOREHOTO. Camo maka 4act oF npanoxestia yan K; npeMtiaea B xepwata. TIpanoxeuneTo Ha Konakion » Tepanesreennt ose CooTBeTHO pH KOpMaSIH He MPeXCTaBIABS PACK a KEPMAETATE. “etn 7p Konakion o6a%e He ce nperloposa npr KepMasiKH 94 MpodHNaXTHKa Ha XeMoparHk =~ osoponenoro. »4.7 Edjexra sspry cnocoSuocrra 3a mopupane m paGora c Mamunm Henpanoxwno 48 Hexesauu nexapernenn peax: ‘Hexcesanirre nekapcTBerl peaKUMH ca npecTaBeHM NO-OMY Ho CHCTeMO-OPraHHM K1lAcOBe H YecTOTA. Yecrorara ce onpesens karo: sor ecru 1/10), seers @ 1/100, < 1/10), nesecra © 1/1 000, < 1/100), pearst @ 1/10 000, < 1/1 000) 1 sshoro penx (< 1/10 000), axstowrrenko oraemHH ‘cpoOmenna. Hapywenus na wnynnama cucmena ‘Maro pemsas: anadiuraxrirani peaxunn cnem Herrpasenosto mprtomenne Ha Konakion MM. O6uu napywenur u edexmu na sicmomo Ha npuroocenue ‘Muoro peaki: BexosHo apastene wan d1c6HT BEB BpEsKa C KETpaneHOSHO MpHtoxeHHe Ha Konakion MM. ‘CroSulapane wa nonosHpann HeakenaHh peaKUAH CroSumasanero Ha nonosHpann rexenark PeaKUME c7ten paspemanane sa ynorpeGa Ha neKapeTBetA Mpoayi ¢ paakno. Toa nosRonaBa sla NpOATBIMAH HAOMORCHHETO Ha ChOTHOUICHHCTO NON3A/PHCK 38 exapeTacHna nponyr. OT MeqHUMECKHTe CeMHATHCTH Ce WSHCKBA Na cEoSulaBaT ResKa onosHpaNa. Hexeaata peaxiuex 4pes: ‘Vorrsmrreana arena no exapereara Ya. odlanaan Cpyen"” Ne 8 1303 Cogs ‘Tea.: +35 928903417 yeGcattr: www.bda bg 49° Tipexosmpane He ca wsnecTH KoHHOHMHM CHMMITOMH, KOHTO Ma Ce OTHABAT Ha XHNepAHTaMIMHOGa Ka BirTasGN Ky. Tlomnosasaieto na aHfTHKoarynanTHara Teparinx MOME sta Ce TORTIE, 5, @APMAKOJIOPH4HH CBOMCTBA 5.1 @apmaxormmamnanu ceotersa apwaxorepanestunia rpyna: Brramun K # apyra xemocramaus, ATC xoa: BO2BAO! Buramini K, (puromenagnon), axtupnara ckctanka na Konakion, e mpoxoaryaatren dpaxtop...Karo KoMmionenr 4a YepHompoOwara KapGoxciuasia cucteMa sifrannn Ky y¥acraa B (OCTTpaHcaatIMOKHOTO xapGoxcuanpasie Ha Kpbsocecaprautn ¢paxropH II (aporpomGux), VIL, IX w X, M KpBBOCKCHpBARKECTE ‘auzxnGirTopx nporeas C x npoten S. Kysapmonrre vexx6xpar penyxuexra a pian K; (cAHoHORA ‘bopma) 20 sirrannn K; xaapoxHHO, xaTo MpexOtEpaTanaT CbillO PestyUKpAHETO ;10 xMHOHOSA (popMa Ha arannm K, entoxcan, koltro ce oGpasyaa cen KapGokciumpaneTo. Birrasmnt K; ¢ anraroHdct Ha alTTHKOArynalrTHTe OT KYMapuHOB THN, Hanp. dbexmpoKyMon. Tol oGa¥e Me HeyTpasHsHpa axTHBHOCTTa Ha XemlapHH; NPOTAMHE € akTaronNcTsT Ha Xenapa. Koravo € MeOGXONHM aIETHZOT Ha aHTHKOAryAAHT, BAOKHO € Ja Ce MBNIONSBA CAMHAT BHTAMMH Ky, TBH KATO ananoahTe na miranini K, ca SHaNHTeno TO-ManKO e*herTHBEH, = Burramun Ky ne © ecpextusen npx HacnencTRena XHMONpOTPOMGMHEMHA Wa, MHAyWApaHa OF Teakka YepHonpoGHa HEOCTATBAHOCT. fo B omecenua konouzex pastsop Ha Konakion MM, sutamuu K; € pasteopett ¢ noM¢ Fa ‘dromonornsnia KoTOMANA CHCTEMA, KORTO EBINO Ce HANMpA B OPrAHIAINA H Ce CHCTOH OT GUTH 5_worouna kycennia, Tlopany oTeécTEMeTO Ha OpraHN4HiH pasTBOPHTENH, CMECCHHAT KONIOMAEH PaASTBOP na Konakion MM ce ntowaca 06pe mpi WHTpaBeHOsHo TIpTOKeNHe. Heduampusna nonynauun ‘Ego mpocntekomno panomiranpano KofTponmpano npoyBaHe BKMOKBA 44 KEpMayeTa (Ha BESPACT 1-26 cemmmam) ¢ xomorupana xunepSunupybunemus (HaHOnaTHTNeH HeoHaTancH xenatur - 17 TanweHT#, Gtuapna aTpesux - 13, xonecTasa npa ToTamo NapeHTepamyo xparieHe ~ 3, CHHAPOM Ha Alagille -2, nenocrar ha antha 1 axrretpencnnt - 2, cmApoM Ha crscTena axsrbuKa - 2.4 5 apyre alarHO3H (pykToseMts, raaKroxeMMs, XOMeOXOBA KHCTA, HEKPOTHOMDAlll €HTEPOKOTHT, urromeranosupyces xenarw). Cpaniiasaia ¢ bapmaKowamieTHkara H edpukactiocTTa mpi Mepopanka ‘cupaMo MitTpazeHostia npodwnakruka cbc cMeceH MHUenapeN BiTaMtE K mpi KepMasera c xonecTarH¥Ho YepHOApoHO saGanaBaHe, Ocuosnirte raaepsaita KpTepun ca GMM cepyMHHre KOHUENTpANIM Ha serramm K] et 1a NeqocTarb4no KapGoKcwtpan NpoTpoMGKH (PIVKA-D}) npeaH v.10 4 HH c7eH eaHoKpaTHa Osa OT 1 ‘mg merrpapeniosHo unit 2 mg epopanHo cMeceH MauenapeH K1. Cpasitermie ¢ 6110 rIpaserto Ht MEMAY bara Wa K1 24 aca cnex nepopanno npitioxenne Ha KI ¢ nneata npe 14 sqpasu Honopoment, 1a KoHTO e npwoxeHa cBMaTa 1038. Pesyzrrarv: mp npHemaneTo 18 kbpavera (41%) ca aman nosmurenn usa Ha cepyment PIVKA-I 4 ‘ocem (18%) ca marm MiickH KoRMeHTpauIH Ha K1, rloxassatudt cYOKAMEITIeH HeLOCTHT Ha BUTAMEI K. Menuanute cepyaen konuctpauii Ha K1 ca Gath nonOGHH B rpynara c nepopanHo Hc MTTpaBeHOsO MpaorkeHe Ha aXOMHO HBO (0,92 crpamo 1,15 ng/ml), KaTO Te ca ce NOBMUIANH 20 139 ng/ml mect aca cnea uxTpasexosto npuoKeH KI, Ho camo 20 1,4 ng/ml cen nepopanHo mpwiorkerme, B rroceatiata rpyna nmcKata meauantia crofixoct (0,95 ng/ml) WiMpoKHaT AWanasoH {<0,15-111 ng/ml) wa cepyment KI ce cpaBiiasar HeGnaronpkATHO ¢ MHOTO M10-BHCOKHTE HBA ‘Qnenmanin 77, ananason 11-263 ng/ml), HabmonananH MpH SApABK KEPMAYET, Ha KONTO € MpHAoxena cbujaTa Nepopamta 7osa, KOeTO MoxasBa HapylueHa H HerlocToRHHa 4pesta aBcop6upea MPH ‘xonectarismure Kepéavera. Texectra Ha ManaGcopOuHa e 6rina TaKana, 1 camo 4/24 (17%) ocTurat no nocteneHHo Hapacteaite wa cepyanus KI > 10 ng/ml. Tamme or eano perpocnexrusio mpoysave roxaaear, ve execenMirstiara nepopasitia powraxtuxa e Gwra epexrunna sa npeorapatasane Ha KSpeeHe NOpay HeNOCTUT Ha BHTAMECH K (VKDB). O6uyo 507 850 xsi GeGera ca Gham poneHH mpes MepHoa Ha MpoyuBatieTo — oT KoeMBpH 1992 r. 20 ton 2000 r. Or TesM kBpMavera choTBeTHO 78% u 22% sa nomysnaM Mepopanta 4 uiTrpanyexynva mpopwaaktixa, 7.2. oKoT0 396 000 HoBoposeHK ca nlonyxAaK nepopastia npopwutaxruka mpu paxsaHeTo. MIpenopevna ce execenMnuia epopasiia MpopiiiakrHika pH BCHHKH xepmavera, aKo Te ca xpanesiM raapHo No ecTecrseH Has. Mepopania mpodusakTuka c sirramwe K. ‘NpH paxaneTo ¢ 2 mg uToMeHaRKOH, NOcHe RAHA oT execemMHuNA NepopanHa Npo*puaKTHKa © sxramnn K; I mg e npwarax or poasremrre no 3-mMecessa ssspacr. He ca OTKpHTH ciTyHaH Ha VEDB, r.¢. ectorara e Suna 0-0,9:100 000 (95% CD. 52 @apmaxoxunerwanm cnoiictna AGcop6una Enno dapmaxoxmuerasmo npoyweane noxassa, ¥¢ MM pasteopsr na sirawun K;, mpatoxex TepopaTHo, ce aBcopSxpa Sups0 w exhexTHBHO. Tlepoparanre nose wa stcranan K, ce aGcopSupar npennwHo OT CpenHNHTE ACTH Ha TEHKOTO 4EPBO. ‘Cucremsata GHonammmunioct cre nepopano mprstomene ¢ OKoNO 50%, ¢ tmAPOKH TpaHHEH Ha smurrepittanenyamna bapHaGumnocT. Hasanoto wa nelicrawe ce waGmorana mpu6nusirreano 1-3 aca ‘omen aITpaseHoaHo MpHnoxcHHe K 4-6 sca Cale epopaMHo MpHIOxeHHE. Pasmpenenenne Ocuosnust kommaprien Ha pasnpemteseune cboreerersa Ha masmenis oem. B 90% or surammit K1 © cappsaiic annonpotenmute (VLDL dppaxuita). Hopmansre konueHTpania a pram K, papxpat oT 0,4 no 1,2 ng/ml. Crea itrpasetiosHo nipfiéioiKeHHe ‘or 10 mg surat K; (Konakion MM) nviasmetioro tno caea 1 ac € ooo 500 ‘50 ng/ml enen 12 4aca. Burawnn K; ne npewitiasa recto npes maatiettrara H ce corenen B xepMara. 6Buompauebopmauna Buranemt K; ce mpespsuta 6epso 8 no-nonapim meraSommTH, exmomTeNo BuTaMat K,-2,3-enoKcHA. Hsnocrtia wact or Tosn MetaGoanr ce npespbina O6pario ams nuranit Ky. Exumwmpare (Crea metaGomuto pasrpaxxaane, siramnt K, Ce ekexperHpa 8 xCTbUKaTa H YPHnATa KATO ‘TmOKypOHNAHI H cyzaTH KoMOraTH. TepMHHATHHAT NOTYAUBOT MpH BEspAcTHM ¢ 14 +64, cer iy. mpunoxenne x 1046 4. cnex mepopantio npHaowenne. Tlo-anko or 10% oT osara ce excKpeTHpa B HenpoMeHeH BH 8 ypHnaTa, Upepuara a6c0p6inun Ha Buramua K, ce yepexkda pH paxiH4HH CLCTORHEA, BKIIONHTETHO Mana6cop6uHoHHH cHRLRPOMH, CHILIPOM Ha KECOTO YepBO, GILTHApHA ATPESIA H MANKpeACHA nenoctaTssnoct. TTopanit Tona, 2o30Ta npH Tash rpynia NaLkHettTH TpaGa a Goze 8 JoAHaTa Tparva Ha TpenopeaHTemHHs HANAN (Bx. TOUKA 4.2). 5.3. [peqkaunwsnn nanuu sa Gesonacnocr Henputoxcano 6 @APMANEBTHUBH JAHHH 6.1 Cres na nomomuure pemecrea Tawxoxonmesa xucesaia Harpues xunpoxeua learn Xaoporonopomtia Kicenwiia Boga 3a woxexayen 62 — Hecsomecrumocra Henpusnoxiato 63 Cpox na rognocr 3 romans. 64 Cnenmanmm yesopnm na cexpanenne Aa ne ce cuxpanasa naa 25°C. ‘Axmyantre sa ce coxpaHstnar b kapronesara onakoBKka, 2a fa Ce NpesIMaaaT OT COeTAMRIa, Za He ce wanonssa, axo pasTeoper © MBTEH. Tlopaay nperti, ceppsani Coc CTASHINOCTTa, HOHSTIO:ISBAHOTO ChAEpPKAHHE Ha OTBOPEHHTE AMITYAM He Mome a ce Homrompa M TPAGBA a ce HSKBRDAM. 65 Bua m comepmanne na onaxonxara Konakion MM ce npompexkna 8 aNnymit Of TEMHO CTEIKIO, CBI PACAIEH Lome becom Beaxa omakoana eosypoxa 5 anya, Y66 Cuenuaaun upeanasie mepxn npy waxeupanne m paGora Hama creupannn roneKnasnin, Hewsnonseanusr nekaperseHt npoaykr Win OTnamBsunTe MaTepHANH OT HeTO TpAGBa 7a ce HOXBEpANT 2B cooTBeTeTBHE c MecTHITe HUCKRAHIA. 7, MIPMTEXKATEJ HA PA3PEMIEHHETO 3A YOOTPEBA. Pow Buarapua EOL, ya. ,Baxo none” Ne 16, Copits 1618, Batrapns 8 HOMEP(A) HA PA3PEUIEHHETO 3A YIIOTPEBA Honep ua paspeusenero 3a ynorpeGa: 113312 Pernerpannorer No 20060152 9. {ATA HA ITSPBO PA3PEDIABAHE/TIOJHOBABAHE HA PA3PEWIEHHETO 3A YOTPEBA Zara wa mepso paspeuiapanc: 04.04.2006 r. Hara wa nocneauo noqHosasane: 17.05.2011 r. 10. [ATA HA AKTYAJIM3MPAHE HA TEKCTA Hoexempy 2017 r. Konakion e pericrpypana Tsproncxa mapa.