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VSMbAHITENHA —_ no SEKAPCTBATA KPATKA XAPAKTEPHCTHKA i POH 7 7 9 Oe P south BUEN fab ease? ‘Pspeuerte we 1. HME HA JIEKAPCTBEHHS HPOAYKT “Ogosente Ne AKAPI] 75 mg crosamno-yeroliansn Ta6neTkH AKAPI] 150 mg cromammno-yero#unen TaGurerkis ACARD 75 mg gastro-resistant tablets ACARD 150 mg gastro-resistant tablets, 2. KAMECTBEH HM KOJIMMECTBEH CBCTAB Axapa 75 mg Besxa cromaumo-yeroiivusa TaGneTka chawpka 75 mg aueTHtcanHuuiosa xHcemana (acetylsalicylic acid). Axapa 150mg Beaka cromamiio-yeroliunea TaGneTka chmepxa 150 mg arteratcanMnona KHCEAHHA (acetylsalicylic acid). 3a meAMHA crncEK Ha NOMOMUTE BEUIecTBA BHDKTe TOUKA 6,1 3. JIEKAPCTBEHA ®OPMA Cromamo-yerofiaupa Ta6nerKa 75 mg: 6ana, ¢ opsa Ha cepue, apoiousEKHana dunwupana TaGAeTKA 150 mg: Gaza, xperaa, anofinonsiexnasta ganMHpana TaGzeTKa 4, KJIMBHUHH JABHR 4.1 Tepanestasnx moxasanna Hexemusia Gonect na epueTo H BCHUKH KIAHYEH cHTYaMUH, MpH KONTO © nperlopuuTreHO npenorepatanarsero Ha TpoMGouerua arperaus: - avlanesa 3a HecTaGunua creoKapaia, OcBeH Mo BpeMe ta ocTpara dasa; - Bropina npodiaaktexa Ha wHdbapKT Ha MHOKApAa; - _npexorsparanave Ha sanyuisakie Ha mpicamkara cxtem aopro-KoponapeHt Galinac (AKB); = kopowapia axrHonacraka, ocneH no apeme Ha ocrpara dasa; = BTopHana npodanaKruka Ha npexonnn HexemuttH araic (TIA) H HeXeMMUMH MosEAHO-chAOBH umuiactrta (CVA), cxea Kato ca HSKiIONCHA MHTpallepeSpanHit KPBBOHSTMEH. AKAPJ] we ce npenopssa np creunm cecromuns. Toi ¢ orpannen 20 propuutta npodumaKTHKA INpy xponwnio newenne. 42 Hoamponxa n Hosuposxa IH Ha MpHAOKENHe ‘TpaGea na Gene norspcen cueer oT neKap, npenH ranlowRatte tia AeweHHeTO 2a - -Avamnesa sa HectaGiwma creHokapaHs, ocaeH 110 BpeMe Ha ocrpara dpaza\ S a Ag, oot Cass Tipentopeuwreanara nasa e 75 mg 0 150 mg eax AHEBHO. = Bropwunta npoopanaxraxa wa wnbapet Ha mHoKapma: Tpenopsureanara z03a ¢ 75 mg no 150 mg BenHTxK AHeBHO. - _Tlpenoreparanane ua 2anyusane na npcaskara eneg aopro-Koponapen Gaiinac (AKB): Tipeniopssirrennara 20a e 75 mg no 150 mg sem sHeBHO. = Kopouapya aurmonsacraxa, ocnet no ppeme Ha ocrpara pasa: Tipenopsureauara osa e 75 mg n0 150 mg sear suentt0. ~ —_ Bropuama npodwnakraka Ha mpexomin Hexen araxn (TIA) H HexeMMun MosBsHO- chon numeHTH (CVA), cies Karo ca HaKOYEHM HHTpALepEOPAIIAH KPEBOHIMBH: Tipenopwurreanara no3a e 75 mg no 150 mg Beye nHeBIIO. Tlaypuenmu 6 cmaprecea sespacm Auerisicanmumnosara xacentia TpaGpa Jia Ce MpHnara ¢ NOBHICHO BHHMAHKE IpH NAMHeHTH B CTApyecKa BLOpAcT, KOHTO ca NO-TlOwaTAMBH Ha Hewerranm peaKionn, OOwsaiinara 203 3a BE3pAcTH ce penopbusa mpx smanca Ha GEGpeHHO WIM HepHONpoGHO yepexnaHe (Bx, ToUKH 4.3 H 4.4), JlewounETO ‘apsGea na ce npepasrnexna Ha peqoBiiH HirTepRamH, Treduampuwia nonyrayua AKAPI[ ¢ nporasonoxasan s neawarpHsiata onlynauuia ton, 16-romMuHa BEspacr (Box. TOK 4.3 4 44). Bodpewio u uepnodpobuo yepexcdane AKAPAI tpsGea 7a ce Hnow38a ¢ TloBMUIeHO BHMMaHMe TPH NaUKesTH ¢ Hapyilesa GxGpexma HK epHonpooua dbynKuus (1a ce HaGarea npn TexxH yapes). Mons, aioxTe ToHKH 4.3 4 4.4, Hawa Ha npwxoxerne Tlepopania ynorpesa. ‘TaGnevewre TpsGea Aa ce norsmuular Hen enen xpaneve ¢ ocrarEAHO TeHHOCTH (1/2 Yamla BOMA). ‘Cromaumo-ycrofiumeara TaG6neTKa HMA MOKDHTHE H He Ce paStlalla B CTOMaXa, KATO MO TOSH HASH NawastaBa UpasHeuva edpexr Ha aNETHAICATMILIORATA KNCEsIMHA BHPXY CTONAIIINATA NATASHA. 43 Tporanonoxarauns (Cipexuyscrantenvocr KbM aKTHBHOTO ReULeCTRO, /IPYH CANHIWAIATH HIM KKM HaKOe OT OMOUIETE BeulecTBa, H36poeHH B TOK 6.1. Xemoparwuna swaresa; KOarysIalOHHK HapyileHi: XeModiLIAs, TpOMGOUMTOMEHES. Axcrastia 1211 ¢ aviasuesa sa peLuunnsspauia nerrisita 36a WHI CTOMaMIeH/speneHt KPEBOKSTHB, HAH APYTH BHsIOBE KEPRetE KATO MOTKHO-CLAOBM KPLBOHSIABM. ‘Teaco 6u6peano yapexane. Texcxo 4eproapoSHo yapextane. ‘Texxka cepacia HenocrarpsHoct. Aniamniesa 3a acipHHos acTwatHuen MpHeTBM BCLEACTAKE CANMLUATATH WIM sleKAPCTBEHM TIPOAYKTH C mogO6HO Aelicrsue, ocoGeHo HecTepoHANH npoTHBoBEanamrTeaHA cpencTea (HCTIBC). Eqwospemennara ynorpeGa Wa MeTorpexcar B 103i oT 15 mg/ceaMHlta WK nO-TosIeMH ('3K. TONKA 4.5). B perma rpamecrep Ha Gpemetmiocrra. Zeua v onoum na sespact rion 16 roam, nopani puck or cnanpoM Ha Peli (ax. TouKa 4.4.) 4.4 Cnequannn npeaynpexaem mpeanasmH mepku ups ynorpeGa Akapa He € Nomxoaam 3a ynotpe6a Kato upoTHBOBEsnaauTeaHo cpeacTBo/ananreTuK/auTHnupeTHK AuerinicanmystosaTa kuicenuna TpxGsa Jia ce nossBa ¢ NOBHUICHO BHHMaNMe MIPH TiHeEHTH ¢ ACHHLUNT Ha TIIOKO30-6-pocdar DExHAPOreHasa, 3AILIOTO MOE JA BLIHHKHE XEMONHTHYHA AHEMHA, Aneruncauuiopara KHceNHHa MOE a Ce HBMOMIBA TIPH NALIHEHTH CBC COPEXHYBCTBHTENINOCT KEM Hocrepowavin npoTuBosEsrauirresiHH opesicTBa CAMO CIE BHAMaTe:THa OLIEHKa Ha Gazanca MEY pHcKoBe H non. AueTiuicanmuionara KHceTHHa Moxe 1a npenHasika OpOHXOCHAEM H ACTMATHMHH LIPMCTBMM HM APYTH peak Ha cBpLXuyBcTBHTeRHOCT. PHcKoBHTe *bakTOpH BKMONBAT: cEMIeCTBYBaMA acTMA, “xportrii pecnpatopH saGoaawanns, cena xpema c HOCHH nionKm4, CBILOTO Ce OTHACK H 38 AMHeHTH, KONTO okaseaT aneprittia peaKiAd M KEM JIpyrH BeUlecTBa (HANPHMED ¢ KOH peaKIAH, ‘copGeax 1H ypraKapen). Tipenopsyna ce nopHiieno BHHMAHHe MIpH NAUMeNTH, MpHEMALIH EAHOBPeMeHHO seKApCTBA, KOHTO Mora fla NOBHILAT PHCKA OT 438A HIIK KEPBEHe, KATO NepOpAlHH KOPTHKOCTepOMIM, aNTHKOary-TAHTH karo vapapms, cenexranai HiXHOMTOpH Ha OGpaTHoTo axBamtatie Ha cepoToumns (Bk. TONKA 4.5), KaKTO H MDH MaLINCHTA ¢ NoBMuMIeHa CKROHNOCT KEM KBpaeHe (1iaMp. c AespMUNT Ha BisTaMHH K). Auerwicanmuuionara Kucemia TpaGna sla ce npHiara ¢ HOBHUIeHO BHMMAHHe MpH nAUHeHTH ¢ apyuiena Ge6peuna Ka YepHOApOGHA bYHKUN, KATO € NPOTHBONOKASaKA MPH MALIHEHTH C TEKKO yopenena Gv6permia win Yepuoapobwa dbysxma (Bx. TONKA 4.3). Anerwicatmuiionara Kucestuia TpaGRa ja ce ripiirara ¢ HOBAIIEHO BHAMAHKe TIpH MAUMMeNTH Cc aviantHe3a 9a cTOMauNA HAM AYOREHATHA x32, SAMLOTO MOK a BESOGHOBH ssBeHATA CONECT HAA IMpesHsBHka KepBeHE OT CTOMAUIHO-HpeBHHA TpAKT. Tlaunesrrare c anamnesa 3a CToMaluINO-4pesHa TOKCH4HOCT, OcOGeHO TesH B HaNpenwata BESPACT, ‘TpaGra 7a choOulanat 2a ReMuKH HeO6HUAiHM KOPEMHN CHMATOMH (CrIeUATHO 3a CTOMAILHO-4peBHO Kbpsene), ocoGeHo B HavanHHTe crarm Ha neYeHMeETO. Koraro ce nomsar cToMauo-pestio xoppene iu1H 23Ba, nevenneTo TpsGna na Obie NpexpareHo. Tlopanu arurponGousrtuara ii axTHBMOCT, ALeTHLICAMMMNIORATA KHCENTHNA MOXe Na TOBERE AO {YithIDKEHO BPEME Ha KBPBEHE NO BPEMeE Ha HEIK CiTe” XHPYPTHMUHA METEPBEHUNR (BRINONHTEHO TPH MalTkH MpOUeAypH, KATO HaNpHMeD HsBaKNaHE Ha.366). AueTHACANHUMTOBATA KHCeAMHHA He TPAGEA a ce mpiaara 8 npomwixeune Ha 5 mH MpenK MulaHOBa ONepatix, OCOGEHO Ha OFM H Ha YUIM. AKAPI we ce npenoppusa no BpeMe Ha MeHOparua, Korato Moke 2a yReau4u MencTpyaaHo KBpBene. opr » Hncxn 203M, aueTRcaTHMVUIOBATa KHCENHHa HAMAAKBA OTIENIHETO HA MHKONHA KHCEMHHA, Tlopanu Tosu haxr, nauverra cuc CKAOHHOCT KM HaMaIeHa EXCKPENHR Ha MHKOMA KHCEMMHHA, MOraT a nonysiar nonarposex npHersn, Tlanuermire 8 crapsecka stapacr ca ocoGerio nonatsineH na neGnaronpusrinte e*pexri Ha HCTIBC, BRJNOYMTCAHO AeTH/ICAIMILWIOBA KHCEJIMHA, KATO OCOGCHO CTOMALIHO-YPEBHOTO KBPBCHE H neppopanusra Morar za Geaar haramn. Henpercocsiara npoxnDkITesma ynOTpeGA Ha 393 ‘TpaGpa na ce mGarna » cTapyecKa Bbapac, OPAIIA PHCK OT CTOMaNIHO-apeaHo KepagyZ Tipenm sanowsate Ha 2bsIrocpo4Ha TepaliMs C aCIIMpHH 3a JieYeHHe Ha CBpsle4HO 13 ]) Mosb"HO-ChNOBN 3aGoABAHUA, NALMeHTHMTe TAGBE MA Ce KONCYATHPAT Che CBOA I la rH NocbBeTEa 3a OTHOCHTEHHTE NpesMMCTRA B CPaBHEHHE C PHCKOBETE NPH BCOKH OT:IeNEH slauysetrr. HeoGxommo e nonimieto BHIIMAHNe npH nalHeHTH ¢ ananuieaa 2a xuMNepronN Wan copactHa NeAOCTaTSMHOCT, THH KATO ce CKOGUIARA 2a 2A/THPPKANE 118 TENHOCTH H OTOK BEB BPESKA C TENEHHETO C HCTIBC, CCepriosii KoxkiH peaxiinn, HAKOH OT KONTO aTamM, BKMTONHTEMHO eKcibosIHATHBeH AepMaTHT, ccunutpom 1a Stevens-Johnson TOKeH'Ha enmepMania HeKPONH, Ca JOKNABAKM MHOTO PAZKO BEB ‘ptaka ¢ ynorpebara na anleTHIcamHiHnopa xHcesHna (BK. TouKa 4.8). [pent Ha AKAPZ| Tpa6a 7a ce MpeycTAHOBH NIpH TepBA Tloska Ha KOEN OGPHE, HASH NESE HIM APYTH MpHSHAUH HA cBpextysorsiremoct. Teduampuina nonynayua B xovta Na HaKOM BHPYCHH zaGonsBaHis, ocoGeHO & cnyyattre Ha rpHn A, npn B wim Bapumeta- BHPYCHH HHcheKIIEA, NpeAHMHO MPH jetta 4 LOHOWH, CbilleCTBYBA PHCK OT CHHAPOM Ha Peli — PALIKO, vo sRaBOTOSACTpaMIaBaILO saGoABaHe. YiopHTO NOBpbULAHE B XOMA Ha MENpEKLULATA MOE Ja © MHAMKATOP 3a HosBaTa Ha cHRUMpOMa Ha Pell, Koltro MavicKBa HesaGaBHa MeZHUMHCKa MOMOUL Puoxbr of cunapoma Ha Peli & xowa 1a spycin MacbexuWiK Morke sia Ce YBeaIMHM MPH EAHOBPEMCHHO [MpHnOxeNve Ha ayeTHACATMUHLIOBA KHCeTHHa, BENPeKH Ye He € YeTaHOBeHA NpHUMHHO-ci1eNCTREHA sppsxa. Tlopanu nocosesire no-rope csoSpaxen4s, npoxykrH, cbADPIKAlIH aleTUNCAMHIBLTORA KHCENIHA, Me Tpa6pa 7a ce Hanomswar pH ella H tonOUNK os, 16-romMuHa BESpacT (Bx. ToKA 43). Tosa sexaperso cemepxca no-mastko or I mmol Rarpalt (23 mg) Ha ctomamHo-ycToiana TaGACrKA, Le, MOXE Ma Ce Kaxke, Ye TIPAKTHMECKH He ChALpIKA HATPHH. 45° Boanmopelieroue ¢ xpyra exapernenn npoaykru 4 apyrH PopMu wa esanMonelicrBme Tipormponoxasann xomGmaunn: ‘Memompercam, usnomean 6 do2u om 15 mg/cedsuya nu no-conen Auieriicanuuyanosara KHCesniTa NoRHUIaRA TOKCH'HOCTTA Ha MeTOTPEXCAT BYPXY KOCTHNA MOSBK ‘nopagia Hawanenta OxOpeveH KANPEHC Ha MeTOTpEKCAT OT MpOTHRORLANAAHTEAHH NekapCTBCHH ApoayKTH, BKTOMHTeNHO aleTHIcanHuMIOBA KNceMHHa. CanmiymnariTe WMECTBAT MeTOTpeKCaT OT HETOBHTe MCCTA 34 CBbP3BAHE ¢ ILIaSMeHHTe NPOTeHHH (BAC. TOAKa 4.3). KowGunawan, yavexsamut npeanasiit Mepki nM yiloTpeGa Haw KoHTO 1a Gear BSeTHLTIOR Memompexcam, smoxsaa 6 034 no-manu om 15 mg/eeduuya Aucrancammuyiosara Kiice7HMa NOBHILIABA TOKCHYHOCTTa Ha MCTOTPEKCAT BHPXY KOCTHHA MOSBK, opani WaMacienHix GROpevelt KIMPBHC Ha MeTOTPekKcaT OT NpoTHBORDATIATHTeNHK sTeKapCTBCHA MPOAYKTH, BRMOWHTETHO aueTHICATHUETOBA KHCeRHKa. CanHuMAnaTHTe HSMECTBAT MCTOTPEKCAT OT HeTOBHTe MecTa 3a CBEPSBAHe ¢ MUlasMeNTTe MPOTeMEH (RK. TOHKA 4.3). H6ynpowpen ExcrtepMenramin anit noxasBar, ¥e HOynpoden Mowe a HEXHOHpa eiheKTa Ha HHICKATA 203A aljeristeannuiwioga KycenHHa BEPXY TPONGOLMTHATA arperallHs, KOTaTO ce MSNONSBAT eawtospemchHo. Bunpexs Tosa, orpanieHiiaTa Ha TesH AHHH M HECHTYpHOCTTa GTHOCHO ekerpanoaaunsrra wa ex vivo AaMHUTe & KIHMHYHATA MpaKTHKA o3sHaNaBaT, He He MoraT Hanpasena KareropHtinn sakctio¥enHA 3a peosHara ynoTpeGa Ha HGynporbeH 1 He MO NPeABHA HAKAKE KAHHHUHO 3HANHM peposTeN exheKT NpH caysalinara ynorpeba Ha touka 5.1). Aumuxoazyaanmu, nanpunep Kymapunosu npouseodnu, xenapunt EaHOBpeMeHHOTO NPHIOKeHHE Ha ALCTHICAMHUMIOBA KMCCAMHA C AHTHKOAry2aHTH Karo BaphapHit Moxe a noBene 0 TloBHUTaRAHe Ha AKTHEHOCTTa Ha GHTHROSTYAAHTa: HOBHIULEK PHCK OT YIEIAABAEE Ha KopBCHeTO HC KPBEOICVINS, B PESYIATAT OT HBMECTBAHE Ha OpANHHTE ANTHKOATYTANTH OT MECTATA HM 3a CBBpaRaHe ¢ TaaaMeMHTe NPOTEHIH H AHTATPOMGoWTHATA AKTHBHOCT Ha aLleTHLTeATMNNTORATA xascemna (Bx. To¥Ka 4.4). Cenexmusnu uixubumopu na o6pamnomo saxsauyare na cepomonuna (SSRI) Tlosnmext puck or cToMalnHo-4peBHo KBpREHE TlopayH CHHEpruMHMs embeKT (1K. TOHKA 4.4). Apyeu HCTIBC, exwowumeano camausamu Eqwospemennara ynorpe6a na aueriicammunona xucenuna ¢ apyra HCTIBC nosauiasa pucka ot Yepena Ha AurapHitara Ha cromaxa W/W sBAHaeCeTONPECTHHKA M OT CTOMALIHO-YPCBHH kpbnowaiupn, Kaxro H or Gx6peuHa Yepenta & pesysTar na cHneprHssM exbexrH. JTexapemsenu npooyrmu, roumo nosiauaeam exekpeyusma na muxouna Kucesua 6 ypunama, xamo Gens6pomapon, npoBenewu) Tipu ynorpe6ara Ha ayerHsicanHuHnoba KHCeNHHa 2AeMIHO ¢ seKAPCTBEHH NPO/YKTH, KOHTO 3AcHNBar OTMenAHeTO Ha MKONNa KHCENHHA, Ce HaMANRa aKTHBHOCTTa Ha sIckapCTaaTa 3a NOAArpA (KouxypeHUMs no oTHOMEHNe eKCKpeUUsTa Ha MHKOMHA xxcenHHa OT GROpesMATe KaNANHeTa). Flueorcun Auenaicanmumionara kHcemHHa Hapynidoa GxGpesHaTa CKCKpeUM HA AMCOKCHH, KOETO BORK 10 OBMMaBanE Ha NHaSMeHHTe KOHLEHTpAU. AnmuduaGennu cpedcmsa, wanpunep wicymun u cyaponusypeiiun Tlopaai xuniorsuicemmuna akTuBHOCT H WaMecTBaHe 1a cysKDaHIUTypeHiHNTe NpONYKTH OT TeXEHTe ‘Mocta Ha CBDpspanie ¢ MasMeHHTe NPOTEHHH, AUCTILICAMMUUANONATA KHCETMNA NOKC Ja OBEN XWNOTTUKEMHUHHS edpexT Ha alTHaWAaGeTHITe cpencTea. TpomGomumuinu nexapemsenu npodyxnru wru Opyeu aumumpoudomuvnu taruGumopu (nan. murronuduns) EanospemenHoTo npiviowenne ¢ alleTHZICaMUMNOBa KHCeAHHA MOxKE 1a NOBMILIM PHCKA OT YiTuiKaBaHe Ha KEPBCHETO M KPEBOHANB. Fuypemurygu Hamanena amyperisma akrHsyoct pes sarppacave ta MarpHli gosta B OpranisMa, BCTEACTBHE Ha HaManeHaTa Momepynia paNTpaliny No MBTA Ha HAMaNIeH CHETes Ha peHANeH MpOCTAraAHAMH B Gxbpewrre. AueTancanmutsionata KHCCHHHa MOE Na NOBHIK OTOTOKCHSHOCTTA HA (pypoceMH. Cucmesoiu xopmuxocmepoud Exnonpemennoro npaioxenie c aleTHcaNMuHIORA KHCEAHIHA MORE 1a NORKIIM pHCKA OT CTOMANIHO-IpeBHH sGBH H KEPHENE, Na HAMA MuIgOMeHATA KOHLEHTPANU Ha CAMMIANATA TIO BpeNe a ne4eHMCTO C KOPTHKOCTEpOMIIM, KAKTO H a OBEN AO PHCK OT MpeAOSMPAHE Ha caAHUWLTATA CHE ‘crmpatiero Ha KopTaxocTeponaae (Bk. TONKA 4.4). Fonospenennomo npunoowcenue ¢ ACE-wixudumopu Hawazen arrruxuneprensupen eexr, sceacTsHe Ha rlonioxenara raomepysina dburrpauwa pes Nawasiawane Ha CurTesaTa Ha peHialeH NPOCTArIAHAMH, LeHiCTRALM e*eKTH Ha CRROPAUIMPABAHE. Bampoeea xucenuma AtjerisicanMutonara kucenniia YBes1H4apa TOKCHMHOCTTa Ha BA/MIpOeBATA KHCMHHA, KATO 3. HBMecTBa OT MecTaTa 3a CBBPSBaHe C ILIasMeHHMTE NpoTeMMH. Bannpoesara KACEIHKA 1 anTurpomOounriara alcrHBHOcT Ha alleTHAcaMMIwTOBaTa KHCesKHa NOpalK CHHeprHys Memasnuson Tipu eanonpeneven npvem Merawinon Moxke a Hanan esbexra Ha auleTHncaTHuWiopaTa KuCETHHA BEPXy TPoMGouMTHaTa arperauuea. CreAoBaTesHO, TasH KOMGHHAMUEA TPAGRA ja ce HBNOTBA C TOBMINeHO BHHMaHIHe NH NalWeHTH, NpHeMaul HHCKa 03a ACMHpHE 3a KaPAHONPOTEKUS. Aaxoxon Ennospeenoro mpveante ria ankoxom 4 alleTincaniuiiTona Kitceamna yseaHYaba PHCKA OT CcTowauliio-4peon HexenaRH peakita, HApHMep TACTPOHNTECTHRAMH a HAM actpowtrrecriniamio Kepacte. Hixu6umopu na rapSoanxudpasama Haanena excxpeuas na ayerasouaMHit; CAnMUIATaTHa HTOKCHKALS e HACTSMBATA MPH MaMVEHTH Ha ‘CXeMH € BHICOKH 105 caNHUATATH H HiNKHGHETOpH Ha KapSoaHxuApasaTa. KouKypenTHoto MpHTaraHe Ha WHXNGMTOpH Ha KapGoaHXHpasaTa, KaTO alleT@sOAMAN M cAMHUWIATH, MOXe 2a nOBENe NO TeKKA ‘auijo3a H MOBKILICHa TOKCHHHOCT Ha WeHTpasaTa HepBtia cHCTeNA, Anmuapudtu u adcopGenmu Exckpeuusta ia alieTHAICAMMUATOBATA KACENMNa Ce YBCHMARA B AMKAIHA YPHHA; KAOTHHTET BEPORTHO Hawanasa aGcopOunirra, Tlausetrire TpxGza na ObuaT CeBeTRANK JA He MpHEMAT eMHOBpEMeHHO aNTHANAA, 38 Ja ce HGerHe NpexTIeBpeMeHHOTO OcBOGOAABAHE HA TeKAPCTBOTO. Aumubaxmepuannu cpedcmsa ‘Tokcsmocrra Ha cyaonamnayTe Mowe sa ce yaennH, Luxnocnopun Eqnospemennara ynorpeGa Ha ubknocriopxy a HICTIBC moxe aa qoveye s10 MOBHMeH puck OT ‘uuiknocnopmnosa Hedporoxcatniocr. Anmuenemunu Merokionpamma sacwnsa edpekrure a atleTHsIcaluIiwiopara KHCeNMHa 4pes yBeNHHARAHE HA ‘oxopocrra Ha a6copGunsra. JTesxompuenosu anmaconucnu Tlosnmasa ce nnaswetara KonlieHTpawvix Ka 3abupayKacr. Tecmose sa dynxyusma na ujumosuduama aces AueTHAcAMMMHIOBATa KHCEAMHA MORE a NPOMeHH pesysTTATHTE Ha TecTOBe Wa GYHKUATA HA murTosHataTa aCIE3a, 46 @eprusmrer, Gpemennocr # kEpMene Bpemenmoct Hucku d03u (20 100 mg na den): Kanawsnire npoyyeatiag noxaanar, ue osm 10 100 mg Ha eH, 3a orpannNena yrotpe6a B AKYWepCTBOTO, WBHCKBaILA creMMATHSHpAHO HaGmONEHHe, ca GesonaCHH. Zoosu om 100 00 500 mg na den: ‘Hima 1octarpsHo IcIMHMYeH OKT no OTHOMIeHHe Ha FaNnOATRAHeTO Ha slo3H Has, 100 mg Ha AEH AO 500 mg quesHo. Ero sauio, npenopexre no-AoMy 3a 103M oT $00 mg AHeBHO H No-BHCOKH ca NpHIOKMMH CbuNO H 3a TOSH 1O20R HUTepBAL, ozu.om 500 mg na den uno-sucoxu: ‘HaxuOupanero va cutrresa wa MpocrarnaHaWHH Moke la ok@Ke HeOaroNpHATTHO B: Gpementoctra wink emOpHonanioro/eranoro pasbrTne. Janmure or er 3chempanna NoKa3Bar MOBHILeH PEK OT CHONTaHEH ABOPT, KAKTO H OT CEPA ractpocxwsa cae HaNOA3BAHE Ha HHXHGHTOP Ha NpOcTaraHAHHOBHA CHEN GpemenviocrTa. AGcommoTHNAT pHCK OT CEpENHOCKOBH MAT opMaLIHH cefh 1% no oxono 1,5%, Casra ce, He PACKET ce NOBHMABA yaenHUaBAHE HA NOsATa H NpombmDKHTeHOCTTA Ha eHeHHeTO. FTloxasavo e, ¥e npwloxeHNeTo Ha HiXMOMTOpH Ha MPOCTArNaHAWHOBHA CHHTES PH AHBOTHH BON Ao nosmmenia npe- u nocTHMNAaHTrauHoHHa sary6a K eMOpno-deraren neTamuTeT. B xombanenie, ToBnitienTe YecroTH Ha paan4HH MasIPopMallHH, BKIOMHTETHO CEpAeYHOCE.ORH, ca CHIH HOKAAABAIH NPHKHBOTHM, Ha KOHTO © OMA AATEN MEEXHOHTOP Ha NpOCTArnanAHHOBHA CHITTES 10 BpeMe Ha rlepHozta Ha opravorenesara. AveTHTCATHUNLIOA KHCeTHHa He TpxOBA Ma Ce AaBA NO BpeMe Ha ITbpBMA H BTOPHA TpHMeCTSp Ha EpeMeHHOCTTa, OcREH ako He € AGCOMOTHO HEOBXOAKMO. 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Seprumrer He ca nposexranu KOTpONMpaHH NPoy'BAHNA Tio OTHOWeHHE Ha NOTERIUAATHHE edeKT Ha alleTHcaTMuNTOBaTa KHCeAHa KOpKy depranaTera. 4.7 Edexru sypxy enocoGuocrra sa modupaue u paSora c mamunn AueTacammuyiosa kucenHHa He NOBTHsBA CNOCOGHOCTTA Sa Wloupave HmK paGora c ManIIME. 4.8 Hexenaum texaperocun peaxnun Herxenauvte nexapcrsen peakigAH ca rpynupaid ps3 OcHOBa Ha cHCTeNO-OpraHHHTe Knacope. B PAMKHTe Ha BCEKH CHCTEMHO-OpraHeH Kilac wecTOTHTe ca edpuHApaH KATO: MOTO HecTH (21/10), ecru (21/100 20 <1/10), weer (21/1 000 0 <1/100), pean (>1/10 000 20 <1/1000); mexoro peaxu (<1/10,000), ¢ werssecrua vecTora (He Mowe fa Chae OMeHeNa OF HAMMSHHTE aH). Hapymenus na xpoora u ammiuara cucrema PeOku: TEKKO KBPBEHE, KATO HANPHMEp CTONAIINO-"peDeH H BLIPeYepeNeH KPPBOAATED. CC neussecmna vecmoma: nopuiie# PHEK OT KuPREHe, YRIDKARAHE Ha BPEMETO Ha KBPBEHE, ‘TpomGountoneni. HaGaronanano ¢ kepsette, nanpunep nepHoneparHetia XeMoparns, XeMaTOM, el yporeniranio Kepsene, Kepaciie OT BeHuUETe, Kapscticro mome sta 20B¢ne 10 OCTPA JIM XPOHHMHa AHEMH HlOpAn KP} xerasonedMUHTTHa aneNa (HANPHMeD B peay.nTar Ha OKYSITHH MUKPOKP xapakrepysupamis ce ¢ aaGoparopHH H KIMI MpHSHALH Karo cat XeMomHTHuHa aHEMHS MOXKE /la C2 I1OABH IPH NaHeHTH ¢ rmoKo30-6-pocdar AexHporenasen (G6PDD) acspuuwrr. Hapymenua wa nwynmara cucrema PeOku: peakiy Ha CEpEXYYBCTRHTENHOCT, XapaKrepHs¥ApalllK ce c aGOpaTOpHH H KAMHALIH NNpHstiaLy, BKAMONDAILA: aNIHOEIEM, KOOKTIM PEAKING, OTOK; TEKH PeAKKHH Ha CBPEXSYBCTBMTEAHOCT, BKANONMTENHO aNadpNAKTHYEH WOK. Hapymenus wa meraGosimsma u xpanenero Mnozo pedxu: xunornukemua. (Cepaeunn napymem C newsecmna Yecmoma: peaxnn Ha cepExtyncrenttennocT, xapaKrepHsHpailt Ce ¢ s1aGoparopH [KTMHHUHH MpHSHAL, BIOHONBAUK: KAPAHO-PecnHIpaTOpHH HApyUICHAL, Oroum, xanepronna H cepacia nenocrarsAHocT ce CkoBuiaBar Be BpDaKa c HCIBC, BKMOMUTETHO pH J1eveHHe ¢ alleTHcanMTORA KHCETIA, Hapyuienna a meppara cncrema Pedxu: Te2kKO KbpBCHE KATO BETPeHeperieH KPBBOIINE (OCOBEHO NIPH NALMEHTH ¢ HEKOHTPOMHpAHa XunepTonns W/WH No BpeMe Ha eNHOBPEMeHHOTO MpANOXeHHe Ha alTHKeMOCTATHLI), KOCTO B ommeann cay4an moxe na Gisle NOTEMUIMANO ONACHO 3a BOTA. C newseecmna vecmoma: CbeTORDPTEK H LYM B YUIKTe, KOTO OOHKHOBeHTO ca CHMITOMH Ha nnpenosnpaue. (Cromammo-spenaa napymenus ‘Yecmu: aucnencna (KHCenHHH, razene, NOBpEutaHe) H Kopemtta Gosia. Pedku: mxsnanenue Ha TaCTpOMITTECTAHAIHHA TpakT, CTOMAUINa W/HLTH AYOHeHALIHA 36a, MHOTO PAAKO BOReMIM AO racTpoMMTecTUHAIEN KPEOOMTHE H NepsopaNys, XApAKTEpIApAUH Ce ¢ KAMHHMHH H JtaGopaTopHH npustau. PecnapaTopan, rpsaNH M MellMacTHRasMH mapyment PeOku: peakiluh Ha CBPEXNYRCTEHTEAHOCT, KapAKTEpIBApALN Ce ¢ nAGOpaTopHH M KIMMEL pusiaig, BxmouBaIIH: acTMa, GpoHKocniasEM. ‘Xeuaronsnapun wapymenus PeOxw. npexonya YepuoapoOHa AWcipyHKIWAS ¢ MOBKIENM TpalicaMHnaaH. Cneuscecmnaecmoma. 4e puOApOGHA HEAOCTATRANHOCTS cHHApOM Ha Pea. ‘Hapymenus ua xowara u noakexuara TeKan Mnoeo pedku: 6ys03ie peak, BKmMOYUTERHO CHHIpOM Ha Stevens-Johnson # TOKCHYHA eniaepwasia HeKpommea. CC newssecmna wecmoma: peakuwil Ha CBpEXYBCTBHTEAHOCT, XapAKTEpHSMpAllld CE € KIMHHUEH TIpyaHaun, BRIKOGBAULH: OOPHB, yprHxapns, cLpOexc. Hapymenna na G.6penure m muKownmTe mETHOLA Myozo pednu. napywiena Ss6peuna dyHKuMs, ypaTHH kaxbHn B GxOpeuurre. Hapymeuus ma penposykrunmara cucTemMa H rSpAaTa Peak #? menoparw. a or aH ‘Cro6urasaniero ua nogosupan Hexe-iaun peaKuiHH cnen paspeuianane 3a ynorpedag Mpoaykt ¢ Baxno. Tosa nossoamBa 2a NpomRIDKY HaGMO/EHHETO Ha CLOTHOMEHHE Hlexapersexita nporykr. OT MeqAMMHCKHTe crenHaNHCTH ce HaHeKBa 2a cbobujapal Nogosnpavia Hexkesiana peakuns 4pes Hismssrnrreana arenuus no nekapcrsara ya. »Jlanan Tpyes” No 8 1303, Cons Ten.: +35 928903417 _yeGcaltr: www.bda.bg 49° Tipexosmpane Tipesosupanero npu nauMeHTH 8 HanpegHalta BESpACT H OCOGeHO MH MANIKH stella HBHCKBA ‘cheqanHo BHNAHHe, TBH KATO MPH TESH MaLIMeNtTH TO MO>Ke sa Ce OKaDKeE dparasHo, Tlopaw HHckara 03a Ha ANeTHIICAIMIUKTOBATA KHCENHHA, CY4aliHOTO TIPeLOSMpaHe Ha TOS JexapeTseH MpOyET e Mannko DeposTHo, HaposoTo normsulaHe Ha rosiaM GpoH TaGeTKH MOme Za OBCHE HO TOKCHTHH HBA B KPHETA, KOCTO MOXKE Jla Ce CHYYH H CBC 3AKBCHEHME OT NoBeHe OF 12 aca. Tlormtmane 1a rose 6poii cromammo-yeroii4HBH TAGACTKH MOXKe JJ NOBERe HO O6pasyBaHe HA used OT SatetieH TaGaCTKH 8 cromaxa, KofiTO € TPYAHO sla Gee NpeMaxHar. Cunmrromn (Cuntrromue Ha mpenosupane o6HKHOReHO ca: IIyM B YUINTE, XHNEpREHTHAALMs, Tpecka, raeHe, TOBpEINAHe, 2aMBEIEHO speriHe, rmapoGoaMe, saMalinane, OGEpKBaHe, HApyIEHHe 1a KUCENHEHO- anKaTHHa M ELeKTPOMMTEH GaTaNe, XHTIOFNHKEMHR, KOKHH OOPHEH. B cayuaii wa octpo npenosupane, Morar na ce Nosua JesMpHyM, TpeMop, Sayx, HSNOTABAHe, ses6yaa H KONA. CasmMuwiaTHOTO OTpaBaHe OGUKHOBEHO € CBEPsAHO ¢ WiasMeHHTe KOMMeHTPALIAH > 350 mg/l (2,5 mmol/l). Tloneveto ewmprin cyan Ha BespacTHM ce HaGMORABAT MPH NAMNeHTH, HEETO KonucHrpauvi nansumiasar 700 mg/l (5,1 mmol/l). BAWMHMHK 203H OT NO-Mamko or 100 mg/kg, € MaIKO BEPORTHO Ja NPHUMHAT cepHosHo OTpaBRHE. ‘Cecetiata pecnupaTopna ankanosa n MeraGoaHTHa auNA03a, ¢ HOpMalIHO HIM BHCOKO apTepHasIHO pH (Nopsaniia Wim HamaneHa KonMeHTpauHa Ha BOLOPOAKE HONK), € OOHMaliNa npH BE3pACTHH WIA Aeua fa BLapAcT nay NeTHpH ToRHAN. 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Envwiitupaitero ce yeenasa upes aikanusHpave Ha YpHaTa, KOeTO ce NOCTHTa pes npwnaraHie Ha 1.26% narpuen 6uxapGonar. TpsGsa na ce cnem pH va yputiera. Kopurupa ce MeraGonuruara ‘auigoza c uitrpaneHosHo npHnoxene ta 8,4% pasTeop Ha HarpHien GaKapGonaT (naii-nampent co pozepavar neara Ha cepyMHua Kasi), xunokalHeMHsta TpsGwa sa Ghile KOPHTHpala MpenH Ja ce ‘ane Harper Gikap6oHAT, sailloTO akamMsupaHeTo Ha ypHHaTa MOKe sla Gwe Mo-MasIKo edhe aKo nnasMenuTe HuBa Ha Kama nanwar non 4,0 mmoV/. Popeupania aAypesa He TpaGos, wonomsba, Toi KATO TA He NlonOGpaBA eKCKPeMBEATA He CASIAMUETHETE HM MODKE JA 0 Genompo6ex otox. Xemoamamsara e severe Ha HGop 3a TEXKH OTpaBAHHA H-TpaGa Na ce MME I ‘C niaaMen KoHeHTpaWAH Ha canimuitaT > 700 mg/l (5,1 mmol/l) Hak mpl no-#AG CBEpBANH ¢ TeAKH IOIAHMHEH HIM MeTAGONHTHH (byHKuM. ITawvseerr om 10 HH He Mat yBenHYeH puck OT CAIMMWIATHA TOKEMHHOCT M MOTAT JA Ce HYAUANT OT AMAIMGA Ha No-pavieH eran. 5. @APMAKOJIOrM4HH CBOHCTBA 5.1 @apmaxoqmnamauan ceoiicrsa ‘apmaxorepanestisna rpyna: mExHGuTOpH Ha TpoMGouuTHaTa arperatuA, ¢ HSKMONEHHE Ha xenapnn, ATC on: BOLACO6 Auieriutcanmuiiosara KHceaMHa € HeO6paTHM HHXHONTOP Ha UHKNOOKCHTeHaaTa, KATO MEXHOMPA ‘cumTesaTa Ha npocraraHan OT apaxnaonona Kicen#Ha. Tos MeXAHASBM € OTTOBOPEH 3a poTHBOBESMaAMTeAHOTO, arminHpeTHHOTO H antasreTHHO jeHicTBHe. Hall-vaxnnar ecbexr oF alieTWicaNMUATOBATa KHCeTHHa MpM HCKA 1038 oT 75-150 mg e MuxnOmpaxeTo Ha cHHTesa Ha TPOMGoKcaH A2, chemMHeNHe, YBenHYaBallo TpOMGOUWTHATA arperauna 4 cBnoBOTO sanyusane. HixxHOupaneTo Ha TpOMOOUNTHATa NURTOOKCHTeHasa BOAM 0 Hamaianavie Ha crlocoSHocrra mM ja arperupat. ‘TpomGoustHara arperanut e ocHoven mpoutec, Koitro onpenlens nocreneriHara creHosa Ha KopowapHuTe apTepHH MH HCKeMMUHa GomecT Ha cEplieTo. 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Taka nvckuTe 03H aleTWICAMHUWIOBA KHCEsIHHa Mort fla NeHieTBAT NO-ed/eKTHBHO, OTKOKOTO TO ToneMHTe, KATO MpHMMHABAT H TIO-MAIKO HEAKENANM PeaKLDIN. Exenepumenraiii jai riokaspar, 4e uGynporben Moxe ja uixHOWpa edbexTa Wa HcKATa 1038 aNeTWTCATHUNIOBA KHCERHHa BEPXY TPONGOLMTHATA arperalilA, KOTATO ce MpHaraT eRHOBPEMEHHO, B eao npoyueane, Korato equHH4na no3a H6ynpoder 400 mg ce npHeMa & pammarTe Ha 8 aca TMpeHH WAH ® panne 1a 30 MiBHYTH HenIOcpesICTHENO Cue IIPHEMA Ha ALLeTHVICAAMUHLIOBA KHCEHIMHA, (81 mg), ptsHuKea Hamanspane Ha exbexra Ha allerWicaTMuyutopaTa KHCesIMHa BEPxY OGpasynanero Ha TpoMGoKcaHt win Ha TpoMGoumTHata arperaux. BomIpeKH Tosa, OrpaHMNcHHATA Ha TeSH AHH NecHrypHoctra oTHOcHo exeTpanouaWyirTa Ha ex Vivo RAHKHTe B KAKHHYHATA NpAKTAKa O3HAYARAT, Ye He Morar jia Ongar HanpaBeHH KATETOpHMH saKMONCHHA 3a penOBHATa ynorpeba a Hynpoden, H He Moxke Ja ce HMa NABH HUKAKLE KNMHMSHO SHANHM BepostTeH epexr npH ciywaiinaTa yrioTpeGa a n6ynpoden. 52 @apmaxoxunerwana cnoiicrsa AGcopouna ABcop6unaTa Ha aneTHNCAMMUHIOBA KHCEsIHHA OT CTOMALIHO-YCTOHSMBH TAGRETKH MAIKO Co paszuuana B cpasieHine c KoNReHUMouamrTe cbopmn. Ta 2arnouRa B pasuTe Ha 3-6 waca cnen Mpiiarane na neKaperBoro, KoeTO AOKaSBa, He MOKPHTHETO e*bexTHBHO Su1oKHpa pasnianssers JleKapcTBoTo B cromaxa, Tlakonara 1iasMena KoHUeHTpaulta ce Homysaza cite oKONO 6 waca H e epeaHO eromallHo-yeroitauen TaGaeTKH 6,72 ngiml 3a 75 mg cromauito-ycToH4HBH TIpwcterevieto na xpana 8 croMauiHo-4peBnns Tpakr 2a6ans abcopOuusTa, HO ‘SuouanHunocrra na aueTHacaTHuTosaTa KHCENHHA, 80-100% or nornnmarara noxa auerwicanuusiona KceaHHa ce abcopSupa OF CTOMALIHO-speBHtAs ‘tpaxr. Pasnpeneneune ‘AueriuicaustonaTa Kuce.tHtia 65ps0 H eKCTEHSHBHO Ce pasMIpe esis B TIOBCHETO OT THKAHHTE 1 ‘TenecHHTe TexnocTH, OTHocHTeMHaT oGem Ha paarpeviesteHKe € npHGnNsHTENKO 0,15 - 0,2 Vkg m ce yBenuuasa 32¢nHo c yBesHtaBaHe Ha CepyMHara KOHLICHTpALIHs Ha WeKapCTBOTO. TIp6araureatio 33% ot xexapcrsoto ce cBEpssa ¢ mpoTeMMHt npH cepyMHa KoHeHTpaLHA oT 120 ng/ml. Crenewra na Gesrrb4no ceppasaie Ha NeKapCTBOTO 3anvicH OT KOHLLEMTTpAuHsTa Ha anGyMnHa; 'Up 3paBH AOGposonu TO HaMaNIABA SaemHO C HAMANABANeTO Ha KONLCHTpALWATA Ka aNGyMvAA. Tipu 6x6pea HeyocrarsuHocr, no apeMe Ha CpeMeHHOCT M NipM HOBOPOAEHH, CBBP3BAHeTO HA ANeTHACATMENLIOBATA KHCETHHA C TLTASMEHITTE MPOTEMHK HAMAIABA He CAMO B PesysITaT Ha XHmoanGyMuneMHa, HO H TOPAIM HATPYTBAHE Ha CHOFEHHH BCUIECTHA, KOHTO HSMECTRAT JIeKaPCTEOTO OT MECTaTA My 38 CBEPSBAHE ¢ MPOTeHHHTE. Buorpanctbopwauns Auerivicamnyiosara KucenHHa ce MeTaGommsHpa 4acTHIHO NO Bpeme ha a6copOunaTa. TosK Mpowec ce HOEMpUIBA How BLa;etiCTBNETO Ha eCTepAgA, TAABHO B MePHHS NPOG, HO CBIMO Taka M B KPBBHAR CepyM, epHTPOWHTHTe H CHHOBHAIHaTA TeHHOCT. 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