EK, 47-0 ma rapounen wBE: KPATKA XAPAKTEPHCTHKA HA IPONYKTA 1. WME HA JIEKAPCTBEHHA TIPOAYKT Hsoxer cnpeit 1,25 mg/nosa cnpell sa yorua anrasnna Isoket spray 1,25 mg/dose oromucosal spray 2. KAMECTBEH Hf KOJIMYECTBEH ChCTAB 12,7 g pastaop (= 15 ml) camppxa: 375 mg usocop6uzamumtpar (isosorbide dinitrate). 1 npscxaane (= 0,05 ml) chaspxa: 1,25 mg wsocopOnaaunutpat (isosorbide dinitrate). 3a IIHHA CIHCHK Ha NOMOUUNTe BeecTBA BHACTe TONKA 6.1. 3. JIEKAPCTBEHA ®OPMA Crpet sa yerna anrapuna- Pastbopsr e Guetpa x npospawiia TesHocT ¢ MupHc, monoGeH wa eraHion, 4. KIMHWYHH JAHBH 4.1 Tepanesrawam noxasauns soxer enpett 1,25 mp/aosa enpeil sa yeria surapuuta € noKasaHt 32: © Tipoopanaxraxa 1 nesenie Ha axrvsia nextopic © Ocrsp mutbaper na mHoxapaa © Ocrpa nesoxamepua nenocrarsanocr 42 Jomponxa u nau ua npnacaenne Hosnposka Tlosposxara ce onpenens Taxa, ve na cvorvereTsa Ha nyskaurTe Ha MatenTa. 1-3 anpscksanus 8 yorara ua muTepaarh or OKoI0 30 ceKyH/IM NO BpeMe Ha UpHCTEM AIH HemiocpencrBeHo mpesm dcuIiecKo W/MIH YMCTBEHO HaTOBApRANC, KOTO MOKE Na MpeAHSBMKA npwersn, EjWHHWHaTa no%a OF 3 RNPECKRAHUS pH NENeHHE Ha OCTEP NPHCTHM Ha AHTHHA NeKTOPHE MOxE ‘a Gane HaNBMUeNA camo NO HapHIHO eKapcKO Ykasane. Tipu ocrsp uudapkr'a MHoKapaa WAH OcTpa cEpueuiia Hedocrarb4HocT, HatianHara 09a ¢ 1-3 supocksaina. B cayvait Ha manca Ha pesysrar 10 5 MHHYTH, Moxe fla ce HanpaBH ole e7HO AOMAHHTEAHO BMpECKBARE. B cayaali we HAMA OKOGpenMe pes cremeammTe 10 MHKYTH, Trapuenmu e cmapyecka evspacmHawa nannn, se © neoSxomHMo ananTupante Wa NosaTa mpH nallMeHTH B crapyecka BE3pacT. Treduampusna nonynayua Besonackocrra # expukacrwoctra Ha wsocopOW\HAHTpar MpH slewa Bee OlNe He € ycTAHOREHa. 4.3 Mpormponoxasanna © CopuxuysersutteaiocT KbM akTHBHOTO BelLiecTBO, KbM APYTH HITPOCBEANHeHHA WiTH KEM Hakoe oT noMoumTe BenjecTBA © Octpa uupxymaropia HegocrarssHocT (aioK, Kona) Kapamorenten wok (OczeH aKo He Ce TONARPKa saowOMMTEsHO Kpalitio AHaCTOAKO HAArAHe ¢ TloMoUITa Ha NOAXORAULK cpencTsa) Xnneprpodusna oSctpykTHBia KapanomnonarHa Kouerpuxtupen nepexapaat (Copxeana Tamnonana ‘Teacka xanloToHs (ciicTomMo KPbBHO HaxAraHe NO-AHCKO oT 90 mm H) ‘Tema xinososemna Tlo epeme Ha nevenve ¢ HuTpATH He TpaGBA aA ce wsnoMeaT dochoanecrepain MaxHOHTOpH (Han. cHaReHapHs, BapmeHadn H Tamaradrta, Bue TOUKH 4.4 u 4.5) © Tlo wpeme Ha nesenwe c MMTpaTH He TpaGBA aa ce WaNlONaBA PHOUHTyaT, KOTO © ‘cTHMy TaTOp Ha pasTeopHMara ryaHunaT-unKsiasa (siDwTe TONKA 4.5) © Octpa anemus 44. Cnenuaam npexynpensiesus m npennasin MepkH npx ynorpeGa Hsoxer cnpeti 1,25 mg/aosa cnpeil 3a ycrHa avrasHua Tpx6Ba xa ce wanon3Ba MHOrO HMATENHO H MOM exapCKH KONTO pst © Hacxo mwactosHo Hansrane (Ha mbIHeHe), HaNpHMEp IPH OCTHP MEapKT Ha MHOKApAA, MOHIKeHA AesoKaMepHa GYHKIWA (nesoKaNepHa HejocTaTEAHOCT). Ja ce HaGArBA ‘oHWKeHHe Ha CHCTOMHOTO KPEAKO Hangrane ox 90 min Hg. © Creviosa na aopria wun metrpastia krana © BaGonsnanus, compsaH ¢ rloBiuteHo BBTpeNepenHO Hansraue (20 MomeHTa NlocneABAlO NOBHUIaBAHe Ha BBTpeNepENHOTO Manarane © wAGMONABAHO eNWHCTEEHO MPH iv. pRAOACHUE Ha BHCOKH ROSH TAMWEpHAOB TpHHTPAT). Oprocrarauna auccynxuna Ha UMpKYneTopHaTa perynauNA ‘Teacxo HepHOApOSHO saGonaBAHe HaGmonasann ca passirTie Ha Tosepanc (HaManeHa edhnKacHocT) M KpEctocaH TONepaAHe KOM pyr BHTOBE JexapCTHa, ChABpRalliM HHTpATH (HaManeHO JelicTEHE B cAYYal Ha MpenMUHO aevenne © uTpaTH), 3a Ja ce HIGerHe HaManaBaHe Hil sary6a Ha ReficTeMeTO, TpAOBA AA ce naGRrBa ynorpeGaTa Wa BHCOKH 203i Tlament# 1a noxurepxaino newenne ¢ Hocop6wuMHHTTpaT TpxGsa 2a GonaT npemyMpeneHH a He npKemar npoayKTH, cbmepanun ochonuectepasii: HXNGHTOPH (HAN. cHACHADAN, ‘Tananadua 4 Bapzenapi.a). JlevenHeTo ¢ H30copOHUMAMTpAT He TpAGEA fa ce MpeKECBA, 3a 28 ce mpnemar ocbonuectepaati HNXHGHTopH (Hamp. cuageHadua, Bapaenadyr H TazanadHn), Topas mawoxKHo ysemesHe Ha pHCKa OT TOsRA Ha NPHCTSM Ha aHrHHa NeKTOpHC (BJ rouKn 4.3 4 4.5).He rpa6sa xa ce wsnonsna HsocopOnIMHHTpaT (cnpeH sa YorHa AMraBHUA) MpH cneuHO aevenHe Ha MaUMeHT, KONTO ca MpHeAM ocHomMecTepasHH HHXHOUTODH (tlaMp. cHaReHARH, Bapaenadier Tazanacwa) B pankitTe Ha 24 aca (48 waca 3a TananadAn). Tlaunenra, KowTo wanonsear H30copOMAIHHKTpAT pH cneUHO nevenMe, TpAGBA 2a Gouat peaynpesteHn Aa He npHeMaT NPOAYKTH, Chatsprauiw GocoaHEcTepaani HUXKOHTOPH (HAN. cHaaenadun, papaenadun w-rananadun) (BeckTe TONKH 4.3 1 4.5). Xwnoxcemus. ‘Tapa 1a ce BHUMABa IH NALKEHTH C XHTIOKCEMHA H BEHTHsIaMHOKeH / nepdbysHOHeH auicBanaite peneacTaie na GenonpoGwo sabonaBaHte Hal HcXeMia CopaeHHa HeAOCTATD'HOCT. Karo moutes sasonmaararop, Haoxer cmpeit 1,25 mg/nosa cnpell 3a yorwa surasiua Moxe Ja owexle AO NlopmuuteHa epysus Ha XXTOBEHTHANDaNM YSACTBUM, BHOWABAHE Ha BeHTHTAMMOHKHS / nepdpysMOHHHR ANCGasaHe H NO-HaTATBIIHO HAMAABAHE Ha fapuMaMHOTO aptepuamno wanarante Ha KHcnopona, Tlo speme na nevennero ¢ Maoxer enpelt 1,25 mg/nosa cnpelt sa yerwa anrasuua TpaGwa sa ce usGarsa ynorpeOara Ha ankoxoa, Thi KATO MOXE Ja YoHAM XHNOTEHSHBHNS M BaZORMTATH PAIL My eden (sincre To¥KA 4,5). Woxer enpeii 1,25 mg/qosa enpeli sa ycTHa aurasuya chmepxa MANIK KONANeCTBA eTAOT (aKoxon), no-Manko or 100 mg 8 eqHa 03a. B caysaii Ha mimanenter, o6wHpeH KOHTAKT ¢ KOKATA CBC ChabpxanHeTO Ha HaoKer cnpeli 1,25 me/sooa cnpeit sa ycria zmrasia, sacerHarara KOxa TpAGua wenHara 2a ONE NOWNCTeHA. B nporusen cay'ati pasteopet Moke Aa Obie a6cop6upay OF KOKaTa H TOBA Aa AOBENE LO Cepuosii HexenaHH JeKapcTBeHH PeaKUM (BK. ToUKa 4.8 HexkenaHH slekapcTseHH peakUM). 4.5 Boaumonelicrane ¢ apyrd xexapersens mpoaykr a apyra op! 1a BaaMMonelicreHe EmnoupemenHoTo npvemane Wa JeKapeTBeHH MPOAYKTH, NOHICKABAIIIH KPHBHOTO HaAATaHe, KATO Gera-Gnoxepu, KaNuWeaH AHTArOHHCTH, BasomuaTaTopH, ACE-uHxn6etTopH, MAO-HHXNOHTOH H Ap. Waa xXoNGdHaNNATA C AIKOXON, MOxe 2a 3ACHAM XHMOTEHSHBHOTO peHCTBHE Ha Hsocop6uanannrpar. Tosa Moxe aa ce HaGmoqasa W Mp HesponenTayK H TPAUHKAMYH axrugenpecanti. Comprereaumat npnew wa Hs0Ket cnpeit 1,25 mg/zosa enpeli sa yora aurapnua ¢ ACE- HHXHOHTOPH HAH aprepHAUIHH BASONHAATATOPH Mowe Za GoAe KeTAHO BIaHMONeliCTSHE (BHATE TouKa 4.1), OcweH AKO aNTHxHTepTeHsHBRHTE exbeKTH ca MpEKOMEPHH, KATO B TOI cayualt ‘TpaGBa fa ce MOMHCAM 3a HaMANABANe Wa sOSaTa Ha CAMAHA HM H Ha Bata AeKApCTBEHTE npoay«ra. XunorensasHiaT ebexr a us0copGHAAMAMTpAT Moe fa Obre NOTENLKPAH, ako ce MSNON3BA entospemento c pochonwecrepasHn HAXHOMTOpH (Han. cHneHadan, Tanaradaa Bapnenadin), (sioxre To¥KH 4.3 # 4.4). Tosa € sBsMOXHO 1a OBE AO KHBOTOSACTPAWABAIL cupaeo-cpnooH yoroxnenus, Tlauvrenta xa Texenwe ¢ HB0copOMAANNNTpAT He TpAGBA 2a prewar ocosuecrepatar aii Gurope (Harp. canaenaiua, Tana H sapaesad Tlaywenri, npuemauun dpocoawectepasii KHXHGHTOpH (Hamp. cHIeHAMILA, Ta sapaesacpua) He TpaGsa aa Gwaar sekyRann mo eneuinoct ¢ HaoKer cnpel 1,25 mf qa 3a YorHa aMTaBHua B PaMKHTe Ha cHemBauuITe 24 vaca creA NpHeM Ha cHnneHagMAH, Bapaentagina nau pamaure ta cneaBauTe 48 4aca Ha Taxaaagpi,Ynorpebara Ha wsocopOnAmHNTpAT ¢ pHOUMTYAT, KOTO € CTHMYnaTOp Ha pasTBOPHMATa ryanwnar-nkiasa, € mpoTHBonoKasaia (BiOKTe To¥Ka 4.3), Teil KATO eHOBpeMeHHOTO pHAOKEHHE MOXE 2a NOBENE AO XHNOTOHNR. Tlannure npennozarar, we xoraro wsocop6iumaNnurpar ce npHema enwospeMeHHo “uxHApoeproraMm, TOBA Moxe 1a TOBHIUH KPHBKITE HiBa Ka AHXAAPOEPrOTAMHE H HeTOBHA cedex. Canponrepns (retpaxnnponontepne, BH4) € xopaxtop Ha as0T-oKcHa cuHTeTasaTa, Tipenopitea ce nosnineno BiniMaline npH eNHOBpeMeHHa ynoTpeGa Ha NeKAPCTBO, KOETO ‘coppska canponTepHH ¢ BCNKAKBH BeULCCTBA, KOHTO MpeaMSBHKBAT BASOAMNETALINA pes BoguelicTane BUPXY MeTaGon3Ma HAH AelicTENeTO Ha asoTex Oxcita (NO), BKMONNHTE:THO xnacl¥eckure NO zoHOpH (Hanp. ranitepH0s tpatezpat (GTN), wsocopGuaauumrpar (ISDN), Waocop6MAMOHONHTpaT H Apyr¥).. 46. Deprunurer, 6pemennocr m Kupmene Peprysurer Hama namin zaMeu sa sesnelicrsHeTo Ha Hs0CoPOHAAMKUTpAT BEPXY epTUslATeTa NPM Xopa. Bpemenoct Tipoyubailiata BLPXy BLAMPOHSBOACTBOTO, MPOBEHEHH NPH TMbxOBE H Sali He AOKABBaT yapexaauo jleHetee BEpKy saponmuta, ABMmKAIO ce Ha usocopOuAIMMUTpaT. He ca MpoBerknan ocTaTbHHO x AOOpe KONTPOAMpAHH TIpoy¥RARHs NIpH GpeneHHi eH. TH KaTo MpoyssaHHATa MpH WEOTHH He BHHArH MOTaT a NpeCKAKAT OTTOBOpA MpH Xopa, wsocop6uAIuANTpaT He TpxGBa a ce mpinara Ha GpeMeHHM ‘KEIM, OCBEH B cayHAHTC Ha aGcomoTHa HeOBXORUMOCT, EMMHCTHENO OT eKap H MPH HOCTORHEH KOHTPOA. Kepuee Hama oxonsaTeamn Hu ROCTaTESHO AAHIIK 3a OTPeHEAAHE Ha pHICKa TIpH HOBOpOeHH NO BPEME xa xepMetie, Ha naHHy, ve HHTpaTiHTe ce OTAERAT C MAlINNHOTO MRAKO M MOraT a NMpeNWIBHKAT MerxeMOroGHHeMia Mp HOBOpogeHu. CrenewTa Ha ekeKpeTHpaHe Ha KNTPOFAMUEpHH B aliHnHOTo MaaKO Ke € OnpexeneHa. HeoBxonHMo € wa ce HarTONIBA C AKUMAHKe MPH KpMEMUA eHH. 4.7 Eger sepry enocoSuocrra 3a wiopupane H paGora ¢ MaIMHiH Wsoxer cnpeit 1,25 mg/nosa cnpell sa yorna mrannua MOxe 1A NlonmHse peaKMMHTE Ha aywentTa 20 creneHt, 1a napyire cnocoSHocrra 3a wodupane unk paGora ¢ MauuMn, Tos etext ce sacuimpa 8 KOMGHHaLKa ¢ anKOXom. 4.8 Hexeaauu aexapersenn peaxuan Yectorara Ha Hexxenanuire sekapcTBeNn peaKuM € OnpeNeseHa, KAKTO calemIBa: MHHOTO 4ECTH (21/10), weeru (21/100 xo <1/10), neyecry (21/1 000 10 <1/100), peaxn (21/10 000 10 MDKM Ma ceneKTUBHATA ANsaTaus Ha ToneMn KopOHapHH CBOE. [IpeAHSBHKAHATA OT MHTpATH HAATALUAR Ha KonaTepaniute apTepil Moxe Aa nonoGpi nepdysiara ta nocTCTeHOTHUHUs MHOKapAL Huvpatirre pasuinpaar cburo H exclleHTpHuHiTe creHO3M, Toil KATO Te MOFAT 1A porwsozelicTaar Ha feaMOXKHH KONCTPHKTHAHK dbakTopH, AeHCTBALMM BOPXY Takara Myckynarypa wa wacToTo Ha xopouapHoTo crecueHHe. Hleulo noBeve, KopOHApHHsT criasyM Moxe 4a ce Hamann ¢ noMoutra Ha wiTpaTH. Hurrparire nonoSpasar xemonmHavmkara np noKol m paGora mpi nanieHTH, CTpAaULH OT sacroiina cepslewa nenocrarb4ocr. Tos Ozaronpaaten edbext OGxpaula HAKONKO MCXAHHIMA, BToRa NHCTO NoAoGpsBAKe Ha KualaTa peryprHTaluiA (ABIMKaMLA Ce Ha HaMaNeHA KaMepHa uaTaitia) M NOHWKABAHETO Ha MHOKEPAHATA KHCAIOPOAHA HYMN. (C Hamanananero wa xHCnOpOaHTe HY ARAM H YBeNHYeHOTO CHABAABAHLE C KHCTOPOA ce HAMATABA oGnactra na itokapawo yapencnave. Cnenosarenio, OCopGHALAMHITpAT Moe na € noNe3eH TMpH onpeaeneHH MauveNTH € MpeKapan HH apxT Ha MIOKAPzA, Edpexrite sspxy apyrn CHCTEMH H oprann skstio¥Ba OpoHxomNAaTanR, PenaKcaMa Ha MyonyamTe Ha CTOMALHO-SPEBHHA TPAKT, ATEMHNTE W NHKONHH Katam, Ma aM 34 omnyckave Ha raakara mycKynarypa Ha MaTKaTa. Mexanusem Ha aeiicTBHe: Tlogo6wo na nowiky oprannunH HurTparH, HsocopSuaRHtuTpar AelicTBA KATO ACKOP wa azoTeH ‘oxcna (NO). As0THUAT oKcHA npeRH3BHKBa OTMYCKAHE Ha raankeTa MYCKYnaTypa Ha CbAOBETE ‘pes CTAMy.raMMsTa Ha rYAHWAIHN WNKaSA H MOCTENBALLOTO NOBMLABAKE Ha BETPEKETRHHATA KonWeMTpaLna Ha UMKTHSEHS ryaHOsKH MoHOdociat (CGMP). Tosa ctamyampa CGMP- a Jlexara Bepura Ha MHOSHHa M NOHWKaBaHe Ha KOMTPAKTWINTETA.5.2 @apmaxoxnneruan cooiiersa Cae snpecKsane B yorHara KyxHHa, axTHBHOTO BeutecT#O wsocopGwanHHATpaT ce aBcopEupA Svpso or amrannua. PapwaxororuanuTe e*pexTa ce Mabmonapar 1-3 wunyTH onea nputarane Ha Vsoxer enpeit 1,25 mg/nosa cnpeli sa yerua mrasia, a MaKcHMaaHo JonYcTHMTE TgaNeHtH ua B pankuTe Ha 3-6 MHNYTH. Eanwamanpaneto ce HOBSpulBa c nepHOn Ha nOTy:KHBOT 30-60 atiyta, B pamkure wa 90-120 minayra naasMenara KonesTpaugrs cna OTHoBO 0 HavaNHTe ‘crofivocru. HsocopGHiansitTparer ce mera6onstsnpa 20 KsOCOpOWA-2-MOHOHITpAT H aocopOnz-5-NoNOHUTpAT KATO NepHoga na NOAYRHBOT c CoOTBETHO 1,5 10 2 u 4 x0 6 aca. H para MetaGomuTa ca dapMakoNOrHsHO akTHBHH. [Buowanwunocr: Cnen nepopanko npaioxeHie Hs0copOHZUHHITpaT HMA SsHasHM expe Ha ppsoTo npemmnasatte, BomeM 10 GxoHasmMuHocT OT OKaAO 15-30%. Hsoxer enpelt 1,25 mg/aosa cnpeli sa yerHa anrasnua e HskmONNTeAHO MpeAHasHaveH 3a pwioxenie B ycTHaTa KyxHHa. 3a0SuKansiikH CTOMAILIKO-pesHKA TPaKT, jleKapCTBEHOTO BeMLECTBO AOCTHITA AMPEKTHO 10 CHCTEMHOTO KPBROOOPHIEHHE, KATO COTBCTHO Ce HIGATBA Gepsna vepHopoGeH NeTaGomsoM. Io To3H HasHH Ce OCHTYpABA SHAYHNO BIICOKA Guouannanocr or 60-10%. 53 Tipeaxamanann anne 3a Gesonacuoct Ocrpa ToKcwunoer: Vsesesnanwata 3a octpa ToKeIAHOeT He NloKaIBaT HAKAKBH OCOGeHH pHIcKOBE. Xpouwsna TOKCHYHOCT: Hocrespaiuara 3a xpolMMia ToKcHaHOCT, mponeneHH TPH nTBXOBe HM xy'CTA NOxKaseaT TOKCHSHH edexTH KATO LIHC cinerroMn # YBeMHYaDAHe Ha MacaTa Ha 4epHHE Ap06, KoraTO Wa0copGHAURMEITTpAT Ce TIPHEMa B 03H TIO-BHICOKH cLaTBeTHO OT 480 H 90 mg/kg TenecHe Tero 3a eH. Penponyicruit #cnempanHs: Hawa jamam OT MonMTRANMSTA —MpH -xHBOTHM, MpeaOneraM TeparoreHieH eeKT Ha MocopGasuansirpat. Myrarentiocr: Hoasa aanHu 3a MyTareHHocT OT HscvTesBaHa, IpoBeXeHH, KaKTO in vitro, TaKa H in vivo. Kanueporennoct: TIposeaewute npoxbackuTeaHH RoMHTBAHHA MPH NarbXOBE He AavAT HOKASATECTBO 3a xanweporetocr. 6 @APMAIEBTHUBH JAHHH 6.1 Comeok na nomountuTe BemecTBa Erawon, maxporon 400 62 HecwsmecrumocrnHama nponsena necbemectHMocT 40 MoMeHTa, 63 Cpok ua roanocr S roan 64 Cnenuaan yenosus wa cexpanenne ‘Tosu aeKapcrseH mpoaYKT He HSHCKRa CreMNANHH YonOBHA Ha CBXPAHEHHE. 65 Janumsa onaKosxaTa Tisponysara ontexoska e 20 ml enpeli nowra, Hanpanena or Kadpabo crakio H 634, Aos¥paua nowna, awn aaxou exarepxca we rlo-wanko oF 300 oan (BmpecKEAHiNs) no 1,25 mg weocopSwmunTpar. Onaxoskn, compan 1 crpeli. 66 Cnenuaauy npeanasin mepkn mpx mxeLpasue H paora Bunwanne! Pastsoper © 3a anppcksaue 8 yerara, Jla ne ce aaHutea! TIpeau repaonatannara ynorpeba Ha chpea, scsaropst tpa6sa a ce HaTHCHe HAKONKO myTH (apes steko nowmaite) 70 Towa Ha pasHomepHo nyaaepHsnpane, Beve cnpest € rovos 34 yniorpe6a. ‘Ako chipeat He © No.38aH NOBeNe OT E/MH EH, ITePBOTO BIPLEKBANE TPAGBA 1a € BUE BRSYXA, 3a .aa ce rapantupa moma nocnensalta 038. To Bpeme na ynorpe6a ¢ HeoGxomuMo quaKOHLT Ha Ce ABPALH BEB BepTuKasHO NOAOKEHHE C Aosavopa varope. PasTROpBT ce BMpBcKBA B YCTATA 0 CeAHNS HAMHH: = Tloema ce asi60Ko sox. + Sanwpara ce amxer + Catnexane a xosmpamara nowna jexapcrporo ce BnpEckBa p ycrara (ToBa MOme Aa npeauasika Yoeitiane 3a Nexo napewe Ha esHKa) ~ Sarpaps ce yorara n ce npomeskasa fla Ce AMMA caMO TIpes HOCA B NPOMbIDKEHHE Ha OKONO 30 cexynan. 3aGenerxxa: Erukerbr wa dyaxowa Ha crpes maa siak ,peuika” 8 omHOTO noxe, Korato HHBOTO Ha ‘TeMHOCTTa BBB dTaKoHa LOCTHTHE TASH TOUKA, KATO MADKA 34 GesOTIacHOCT Tps6BA a Ce cha6quiTe ¢ oa onaxosxa Hsoxer cnpeli 1,25 mg/osa cnpell 3a yerna Hrapnua. Bus Boek cayuali, orkopenust cnpell Moxe Za ce HsnON3Ba, JOKATO MPH HeKO HaBexkAaHe Ha GuiakOH, xkpast Ha TpEGuuKaTa Wa noMmaTa € BCe ole MOTONeH B TeMHOCTTA. 7. TIPHTEXKATEJI HA PA3PEUIEHMETO 3A YOTPEBA Merus Labs Luxco I 8.2.208, Val des Bons Malades L-2121 Luxembourg Jhoxcen6ypr 8 HOMEP(A) HA PA3PEINEHHETO 3A YIOTPEBA 20000341 9. JATA HA ITBPBO PA3PEIIABAHE/IOJHOBABAHE HA PASPEIEHHETO 3A. YIOTPEBA Zara wa mspso paspeuasane: 08 tox 2000 r. Tava wa nocneano noawossBane: 27 wali 201 r. 10. JATA HA AKTYAJIM3MPAHE HA TEKCTA Tlekemspi, 2022 r.