KPATKA XAPAKTEPHCTHKA HA IIPOAYKTA 1. AME HA JIEKAPCTBEBHA TIPOAYKT ‘Auerusax 500 mg Ta6nerKu A0000764 Acetysal 500 mg tablets R6/HIT fab het 25, 02, 2001 2, KAYECTBEH M KOJIMYECTBEH CbCTAB. Berka TaGnerka chappxa 500 mg auerncanmuuutosa xucesuna (acetylsalicylic acid). 3a IBIHMS CHHCEK Ha NOMOUIHHTe BeUtecTBa BYDKTE TOUKA 6.1. 3. JIEKAPCTBEHA ®OPMA. TaGnerka Kpsran, apofinommexsan TaGnerku, ¢ 6x1 Hin nowTH Gan uBsT, mMaMerEp 12 mm, ¢ HaznHe ~~Acetysal 0,5” or eanara crpatia. 4. KJMHH4HH AHHH 4.1 Tepanestuann noxasamms. Aueriicanmuuionara KHCeIHHa npHTeKaBa aHAITeTHSHO, AHTHTMpETHYHO K NPOTHBOBESMATHTEATHO aielicTeve, Mpunara ce 2a cuMmroMaTHHO eveHHe Ha BEAIAMMTEsHM, MpOCTYsHH H APyTH CECTORHHA, MPHIPYAEHH 1eK JO YMepeHt GoaKOB cHHAPOM H/nAM eGpHsITET: © mpocrysta u rpm; © rnano6onne; © _spemenno oGnexuapave Ha GonkH w MyckysITe H craBiTe, GonkH B rep6a, sleka aprpuTHa Gonka; 46060n; Mentetpyanin Gok. 4.2 Josmponxa m na4un na npnxomenne oampoaxa Teouampwwna nonyaayur: ‘Auernsar 500 mg TaGnevkH He TpaGsa fa ce npHzara npH seta Ha BEspact Ao 16 roAMHH, OCBEH MPH creunbitann noKasanna (nanp. Gonect Ha Kasasaki). Hayuenmu 6 emapuecka svspacm TIpwainnica na Texka GxOpesna nam YepronpoGHa HenocTaTBNHOCT ce npentopEusa oGuyalinaTa 03a aa eapacrun, Bespacmuu, oxmowumesno nayuenmu 6 cmapuecka eespacm u deya nad 16 200%: Tlo 500 ~ 1000 mg eatioxpaTio mpes 4-8 waca. Maxcuwannara snesna 03a ¢ 4 g, paseseHa 8 ones npnem. Noos 1 0900308Hawi wa npwioxenne Tlepopanio npiinoxxene ‘TaGnerkure ce mpneMar npes ycTara no BpeMe Ha xpaveHe WK HENOCpesICTREHO CEN TOBA, © snocraTosno KoAHYeCTBO TesHOCT. 43° TIpormponoxasanns. © Ceppxaysctairentoct KBM alleTHICATHUNLTOBA KHCEZTHNa, KEM CbEAHHEHHA Ha CcanHUyTORATa KHCETHHa HIM KEM HEXHOMTOPH Ha MpOCTarsAaHAMH cHHTeTasATa (HAN. HAKOH nauweHTH c actwa Morar fla ony'at MpHCTEMM HIK Sary6a Ha CESHAHHe) HAM KLM WAKO OT omouttHTe BetltecTBA, H36poeHH B TONKA 6.1; © Axia yi1H axiamiesa 3a peuanenpamia nerrrasna 36a W/iKTH 838A Ha CTOMaXa/KEpBEHE OT TacTPOUHTeCTHHAIHHE TPakT HIM PYTH BHVIORE KBPBEHE, KATO MOSEYHOCHOBM KPBBOMSAMBH Xemoparnuna haTesa; Koarys1aLIMOHH HapyIMeHNs, KATO XeMorpHsN H TpOMGouMToNeHHA; ‘Tesxko YepHonpo6Ho Hapyurente; Texxko 6s6pestio Hapyurenie; ‘Ties 03H > 100 mg no epee Ha TpeTHa TpuMecTBp oT Gpemenmoctra (Bx. TouKa 4.6); Merorpexcar, wanonspax 8 03H > 15 mg/cemMmno (Bx. ToAKa 4.5); 44 Cnenman mpeaynpexzenua u npeanasuu mepku mpm ynorpeGa Aueruicasmuwiosa kucesuHa ce npenlopeusa 3a ynorpe6a NpH BESpAcTHH H 1OHOUIM Ha 16 rOAHHM H nopeve, Tosi sleKapcTBeH MpOAYKT He ce npenlopbuBa 3a ynoTpeGa NpH AeUA/OHOUM 20 16-ronMMHa [BLOpACT, OCBEH AKO O¥AKBAHHTe NOASH KastBMILIABAT PHCKOBETe. AuuericamMuiionara kicenHHa Moxe Ja Owe OTKMOYBA GaKTOP 3a pasBHrTHe Ha cHApOMA Ha Peli Imps HskoH neua. (Chmectaypa nosnent pick oF KpunoHE iE, ocoGeHO Mo BpeMe Ha OnlepaTHBHH MpOueAYpH HAH c.1e ‘Towa (OPH H pH HesHasITTeNHH MpoUesypH, KATO HanpHMep excTpakuns Ha 386). Ja ce usnONsBA C TOBHUEHO BHUMAHHE MIpeqH OepaTHBHA HaMeca, BKTONHTeTHO eKcTpAkWMa Ha 346. Moxke a ce HAIOKH BpeMEHHO MIpeKpaTaBAHe Ha eeHMETO, Aujeruncanmuiuionara kicenHHia He ce npenopsa no BpeMe Ha MeHoparis, THif KATO Moxe a YYeHIIM MeHCTpyasIHOTO KEpBeHE. Auerancanmiionata kicemia TpaGRa 1a ce HstonsBa c MOBHILIEHO BHHMAHHE MpH cay¥an Ha XHMepTOHHA H KOTATO MAUIMEHTHTE ca c aHaMHeSA 3a CTOMAMIHA HAM AYOACHAMIHA A3BA HK ETIHSOAM Ha kepnene, HAM mpoBexknar Tepamns ¢ alrTHKOarY.TaHTTH Tlaunernire Tpa6na 1a choGutasat Ha AeKYBAlNHA CH TeKap 3a BCH'KH HeOGHMaiiHM CHMETTOMH Ha kopsente, Ako ce HaGmonanaT racTpoMHTeCTHHaIHO KEpBeHE HH Y:AtepALINA, TeNeHHETO TPAOBA 2a ce mpexparn. Aueriicanmuuiosata KicemHHa TpAGBa 1a Ce HSTIONSBA C NOBHINCHO BHHMAHME MPH NaLeHTH ¢ YMepento yepenea GxGpewtia waIK NepHonpoOHa dbyHKuA (NPOTHBOTOKAsAHO € AKO € TeXKKa), WIM pH JexWIpaTHpaHH nanHeHTH, TBH KATO ynorpeOara Ha HCTIBC Monke 2a noBene 0 BrouIaBaNe Ha GxOpewnata gynkuna. [IpH nanHeHTH che c7a60 HIM YMepeHO HspaseHa YepHOAPOGHA HeOCTaTBYHOCT TpxGEa sla Ce MpOBEAULAT peOBHO HEPHONPOSHH hYHKUNOHAAHH TECTOBE. Aueriicanmuvionata KHCETHHa MoxKe Ja NPOBOKHpa NoxBA Ha OPOHKOCHAsEM H ACTMaTHYHH, pHCTEITH HAH APyTH peaKiUHH Ha CAPBXYYECTBHTENHOCT. PHICKOBH (PakTOpH Ca CbillecTByBallia acTMa, ‘ceHHa Xpema, OHTA 8 HOCa HIK XPOHHMHH pecrIMpaTopHH saGonaBAHHA. CBuLOTO Ce OTIIaCA H 30 NatweHTH, pH KOHTO ce HaGmONABA AneprHMsHa PeaKWAA KEM AIpYTH BeUteCTBA (Hamp. KOKHH peaKuii, cBpGex HIM ypriikapHa) ‘Noo3 2 20219104B peaks earywan cen ynorpeGa Ha alleTiIcanHUWNI0Ra KHCERHHa ca HASHONABAHH TERK KOKHM PeaKHMH, BKMONHTENHO cHHIApOM Ha Cruppitc-/bKoneH (Bx. TOUKa 4.8). YnorpeSara Ha canHMiIOBA KHCemMHa TpAGaa fla ce MpeycTaHOBH TPH TTBpRA Tossa Ha KOXKeH OOpMB, MYKOSHH JeSHM WIM APYTH Mpwstauut na cBpExstyBcrBHTesHOCT. Tlaunermire p crap'ecka ppspact ca No-HYBCTBHTeHH KEM HEKeAHHTe sIeKapcTBeHM peaKUHH Ha HCTIBC, sktounTesHo aleTHrIcaTHusuIoRa KHCeTHHA, OCOGEHO KEM CTOMALIIHO-YPEBHOTO KEPBEHE H nephopauna, KoHTO Morar ja Gener darantin (8x. TosKa 4.2). TIpH nauveHTH B cTapyecka BL3pacT He ce npenopasna npostisoxHTesIHO NpHTOKeHHE. Koraro Ce HBHCKBA MIPOTBIDAHTEAHO sTeHEHHE, auneriTHTe TpaOea ma ce npersesciar penoBH0. Ennoppemertioro seveHHe ¢ alleTHicaTHUMi0Ba KHCesHHa H /IpyrH sekapersa, KOHTO OKA3BaT RIMSHHe BBPXY XeMOCTaIaTa (HAN. AHTHKOATY:AHTH KATO RapdapHH, TPOMGOITHYH H alTHarperaitr cpestcTBa, MPOTHBOBLSNAHTeNHM JeKapcTBa H CeNIeKTHBHH HEXHOHTOPH Ha OGpaTHoTo 2axBalllaHe Ha CepoTOHHHa) He Ce MIPeMOpEYBA, OCREH MPH KATerOpHYHH TOKAsaHHA, TH aTo Morar sla NOBHUIAT PHCKA OT KPEBOMSAMBH (BX. TOUKA 4.5). AKO KOMGHHAMINATA He MoxKe fla ce waGerve ce npenophuna BHHMATETHO HaGMORABAHe 3a NPHSHAIM Ha KBpBEHE. TIpenopsuna ce noavieno BHAMAHHe MPH NalINeHTH, KOHTO E”1HOBPeMeHHO MpHEMAT seKAPCTBA, KONTO Morar a TIOBHINIAT PHCKa OT YatlepaLins, KATO Nepopani KOPTHKOCTEpOHLAH, CesIeKTHBHH MixuGuTOpH Ha OGpaTHOTO saxBamlaHe Ha CepoTOHHHA H Jle*bepasHpOKe (BX. TONKA 4.5). Tipwiowena 8 HHCKH 103M, aeTMTCATHNVWIOBATA KHCENHHa HAMANSBA EKCKpELINATA Ha NHKOMHATA xniceawna, Topann Tosh (axr, pH MAUeHTH ¢ NONHDKeHa eKCKPeUNA Ha MHKOUHA KHCeTHHA MOE 2 ce HaGmonasat npHcTEMH Ha Noaarpa (Bx. TouKa 4.5). Tipu npexosmpane ¢ ayeTHtcanHuninona KHCemmHA 4 yrioTpeSa Ha cynbaniarypelinM nposykrH H MHCYAHH MoxKe Aa ce MOBHLIM PHCKET OT xHTOrAMKEMHR (BK. TONKA 4.5). TIpoxsinkurreniara ynorpeGa Ha ananreruun (> 3 Mecetia), ¢ NpHLlOZeHHe Ha BCCKH j1Ba AHH WAM nO- eCTO MONE fla NOBENE 0 rnABOGOMHE HH AO BAIOMABAHETO MY, AKO BeHe CbinecTBYBA. TuIaBOGOAIME or capexynorpeGa ta atianreTHuM He TpAGBA a Ce sIeKyBa ¢ NOBHUABaHE Ha o3aTa, B-TAKHBA cyan ynorpeGara Ha anareritin TpaGpa Jia ce npexparH cen KoHY.rTauts c s1eKap. Tipw manera, crpanauun or sedpaur 1a rm0Kos0-6-*pocipar nexwiporenasa (G6PD) 8 TexKa ‘opm, auerancanauninosara KHCEMHHA MOXE a MPEmWSBHKA XeMOMHSA HIM XeMOMTHMHA AHEM, @akropire, KOMTO NOBHINABAT PHCKa OT XeMOTHBA Ca HANPHMED: BHCOKH 103, TPECKA WIM OCTPH smnpexun, (Cimtecraysar HakoH xoKasaTescT#a, 4 lekapcTBa, KOHTO NOTHCKaT WHHK:TOOKCHTeHAs0- NpocrarnansMHOBATa CHHTESa MOTAT a YBPENAT KCHCKHA ShEPTHUINTET, KATO OKAKAT BAAHME BBPXY onynauusra. Tona e oSparHMo npH rpekpatanane Ha seveHHeTo. Tpontxuresara ynorpeGa, ocBeH Nox jekapeKH KOHTpon, Moe ja One Bpenta. Ips nepeneTupante Ha cHMntomHTe e HeOGXOAHMa KOHY:TTALINA € AeKap. ‘YnorpeGara Ha auerMncanMuuIopa KHCEAHHa He ce NpenopyyBa Ha NauMeHTH, BAKOHHApAHH HACKOPO petty RapHitesia nopasiH HoBMIeH PHcK OT pasBATTHE Ha cHHApOMa Ha Pei. Tlomairre 4 puckonere or npiiioxeHHeTO Ha alleTHLIcaHUNIONA KHCeTHHa TpsGsa na ce OOcwKZIAT H TNpH naUMeHTH, CKTOHH KBM AMCTIeNCHS HAIK exc aAGONARAHNA, JACKAL FacTpOMNTECTHHATHATA siurapnua. OcoGenio BHMMaHiHe npH ynorpeGara Ha jekapcrBOTO HaHCKBaT cysanTe c sex 110 epenHo TeakKa\ > \\ ‘cppaetna HenocTaTBHHocT. ‘Noo3 3‘Tou stekaperaen mpoaykr cbirspxka no-Manko or | mmol Harpuii (23 mg) Ha TaGnerKa, T.e. Moxe sa ce Ranke, Me MPAKTHTYECKH He CBITEpAKA HATpHIL 4.5 Bsaumoneiicrome c apyrl xekapersenu mpoaykTH m apyrH opma na Bsanmoneiicraue TporusonoKasaun koMGunauH ‘Memompexcam (usnonzean 6 003u > 15 mg cedmuino): Tipu konGummpane 1a meTorpexcar m aueTHacamHiaiona KHCemIHHa ce 3acHiTBA XeMaTonorHena ‘TOKCHYHOCT Ha MeTOTpeKcaT, Opal HAMBIRBAHE Ha OBOPeYHUS KIMPRHC Ha MeTOTPeKCaT OT auericanuuunosara Kucera. Ero sailo, enHospeMeHHata yrtorpeGa Ha MeToTpeKcaT (8 03H > 15 mg/ceamuua) ¢ aueTHicaTMuntoBa KHCesAHA € NpoTHBOTIOKASaHA (BX. TOUKA 4.3). KonGunaunu, Konto He ce npenopeanat Ypuxosypusnu cpedcmsa, nanp. npobeneyud (Canmuytravire anrraronupar eexra Ha npoGeriensa. KonGuiaunsra TpxGaa na ce wsGarsa. KonGuniaunn, mpi wnsro a ce HaVcKRA MOBMIUIeHO BHUMAKHE Amuxoaeyaaumu, nanpusep KyMapun, xenapun, 6apdapun Tlosmunext puck or kepaene nlopag mixiOupante Ha TpoMOowTHaTa YHKIUAR, YapeExIIAHE Ha “Mrapuuara Ha qBaHasleceTONpHCTHHKA H HBMECTBAHe Ha NepopasnMTe AHTHKOArY:aHTH OT MecTaTa WM 3a CBupsbane c mlasMenMTe pores. TpaOBa fa ce NpoctensBa BpeMeTO Ha KBpBEHE (BK. TONKA 44). TpomBoyumnu anmuaepecaumu (nanpunep kronudozpen u dunupudamon) u cerermusnu wexubumopu a o6pamuomo saxsayane na cepomonuna (SSRIs, xamo cepmparun wu napoxcemun) Tlosnutex pick oF cTOMauIHO-upesHo KEpBeHe (Bx. TONKA 4.4), AnmuduaGemnu cpedcmea, nanp. cyadbanurypeiinu npodyxmu Canmuanatire Morar sia YCHAST XHTOTTHKeMMUHHS e”heKT Ha cy-WpaHHtypeliHHTe NPOAYKTH. XHMOTAKEMHMCH e*peKT. lucorcun u mumuii ‘AueTiLIcaTHuionaTa KHCeNHHa Hapyuiana Gu6peunara exckpeuMA Ha AMFOKCHH H JHTHH, KOETO ‘Bon 0 NOBHUIeHH NaasMeHH KoeHTpauu. [IpH sanoyBarie H MpeKpaTaBanie Ha eHeHHe © aueTwmicamuiiona KHCesIMHa Ce Tpenopbusa NOHMTOHHI Ha TuAsMeHTE KONLIEHTpALWMH Ha AMTOKCHH H sIHTHIi, Moxke Ja Ce HANOKM KOPEKUMS Ha O3aTa. Flupemuagu u anmuxenepmensusnu npodyxmu HCTIBC morar na Hamaaiar axTuxnnepreHsHBHns ecbexr Ha JMypeTHuMTe H JIpyrH anrraxuneprensieHn cpeacrea. Kako H mpi pyrite HecTeponsNH npoTHBOBLsTamMTeNHM cpeneTBA eAHOBpeMeHHOTO NpHorKeHHe C ACE-HHXHGHTOH NOBHLNABA PHCKa OT OcTpa OrGpesna HegocTaTBHHocT. Tuypernu: Pack ot ocrpa 6x6peuna Hexocrarb4HocT, NopatH HaMatenara roMepysna wTrpanHs [BCIICNCTEHE Ha NoHKeHA GEGpeNHa NpocTarsIaHsMHOBA CHHTeSA. B HaYarOTO Ha sAeHeHHETO ce peniopb4sa XHApATANA Ha NALIMeHTA H MpOCHEnBAHE Ha GHGpeMHaTa YHKUMA. Kap6oanxuopasia wecuGumopu (ayemasoranwo) Morke s1a onene 10 Texkka alHsO%a H NOBHIIeHa TOKCHIHOCT BHPXY LleHTpANHATa HepBHa cHCTeMA. ‘Kopmuxocmepoudu 3a cucmemno npunocenue TipH enHospemesio npHIOxeHHE Ha alleTHLICAAIMIVLIOBA KACEAMHA H KOPTHKOCTEPOMAM MORE 21a Ce OBHUIM pHCKBT OT FACTPOHHTECTHHAMHA yaINepaNHs H KEPBEHE (BK. TOHKA 4.4), ‘Memompexcam (usnonsean 6 dosu < 15 mg/cedmuya): Tipu KoMGuimpaneTo Ha MeToTpeKcaT H alleTHUIcANMUIATOBA KHCeAHHa MO>Ke 1a Ce YBeIMYH XeMaTONOTHHA TOKCHSIHOCT Ha METOTPEKCET, NOpaAH HaMAnaBAHE Ha GKOPEMHIR KIMPEHC Ha MeToTpeKcaT OF alleTHLIcaTMUMTORATA KiCemMHa. TTo BPeMe Ha ITBPBHTE CeAMMIH OT EHEHHETO C ‘Noo 4 2ontbt0sKoMOnHaunsra TpaGea Ja ce nposexar execeAMMMINH NpOBEPKH Ha KpBsHaTa KapTunia. TIPH HaH4HeTO Ha OPH ciaGo HapyuieHa GEGpeuna d)YHKLMS, KAKTO H MpH naueHTH B CTapyecka ‘Bbapact TpsGea sla ce mpovene sacweno HaGmoneHHe. Apyeu HCIIBC Tlopsimen pick oT ractpoMHTecTHHaZTH YallepauitH H KBPREHE NopanH cHHeprMuHH e”heKTH. Llurxocnopun, maxponunye Ennospemeniara ynorpe6a Ha HCTIBC # wirkiocnopat HH TaxpomMye MonKe Ja YBeRHUH HeIhporoKcHMHHA e*beKT Ha UMKSIOCHOpHH H TaKPOHMyC. B cay4ali Ha ennoBpementa yroTpeGa Ha ‘Tea cpencTBa H anleTHUTcamHNITOBA KHCeTHHA ODOpedHaTa yKUNA TpAGBA 2a ce HabMORaBa. Bampoam AueTHcaTMMIOBATa KHCETHHA MOME a HaMa:TH CBLPSBAHETO Ha BAsIMpOAT Che CepyMHHA aGyMUH, M10 TOM HAMHH JAA YBEMHMH CBOGOHHTE My MLIASMeHH KOHIICHTpALIH B PaBHOBECHO CECTORHHE, Penumoun Camuuzavire Hawasasar ceupapaneTo Ha dbenMTouH ¢ ruasMentia anGyMAn. ToBa MORE Ja 1OBETe 10 NOHIDKaBaKe Ha OGUINTe MuIasMeHH KOHMEHTPAUIMH Ha GeHNTOHH, HO ce semana cBOGOMNATA ébpaxuns a cbermToun. Heceppsanata KOHUeHTpALHA, cTenOBATeTHO H TepanleBTHAHHAT eXeKT warmexaa He ca 3Ha¥HTeNHO MpOMeHeHH. Anwoxon EqnospemeHHoro npwioxeHHe Ha anKOXO. H alleTHLICATMMJUIOBA KHCeMMHa YBeHYABA PHCKA OT CTOMAUIHO-HpeBHO KEpBeHe. 4.6 @epranrer, Gpemennoct m kepmene Bpemenmocr Zlosu om 500 mg duesno u no-sucoxu VinxnGupaneto Ha npoctarnanamiosara CHHTesa Moxke sla Hwa HeGnarOnPHATHO BIMAHHE BEPXY Gpemernoctra Wain eMGpHoiperarioro passirrHe. [arti OF endtemHoslOTHKHM MpoyHBAHAR ‘OKaSBaT MOBMULEH PHCK OT CTIOHTAHEH AGOPT M pasBHTHE Ha CEpIeHHM MasIbopMaLMH cae ynorpeSa Ha HHxHOMTOpH Ha NpocTarTaHAMHOBATA CHHTesa B PAHHTe MeceuM Ha GpeMeHHocrTa. ‘AGcomtoTHnsT pick 3a pasBiTHe Ha cEpeHHoceAOBH Ma:KbopMaLIMH HapacTBa OT r1O-MamIKO OT 1% 0 oKon0 1,5%, Cuntra ce, He pHCKST ce YResHHARA ¢ NlOBHUIABAHE Ha losaTa M NpOMRIDKHTERHOCTTA a zevenme, [ipa wnBOTHH, NpHAaraHeTO Ha HEXHGHTOpH Ha NPocraraaiaHHOBATA CHITEIa MOKE Ja ROBesIe 0 Npe- M NocT-HMMLAHTALOHNM 3aryOH H 210 eMGpHopeTaneH seTamTer. B AoMAHEHHE pH KMBOTHH, MOMYSHUIM MEXHGHTOPH Ha NpocraraHyUHHOBATA CHITESA B MepHowa Ha OpraHioreHesa, ce HaGmonapar no-HecTo ciyHaH Ha paxii4Hit ManOpMALlMH, BKsIOYHTENHO CbpEMHOCE.IOBH. Auerueammunosa KHcemHHA He TpAGBA Ja ce MpHara No BPeMe Ha MLPBHA H BTOPHA TPHMECTSP Ha GpemenHoctra, ocneH B city'all Ha KaTeropHHia HEOGXORMMOCT. Ako aueTuncanuuiuiopara KHcenHHa ce MpAara MPH >keHH, KOHTO ce ONUTBAT Za 3aGpeMeHeRT, HUH NO BPEME Ha ITEPBHA H BTOPHA TPHMECTHp OT GpeMeHHOCTTA, NOSHTE TPAGBA a Ca BBSMOAKHO Hall HHCKH H MpOABIDKHTEMHOCTTA Ha YOTPEGA BEIMOHKHO Hail-Kpatka. Tlo apeme Ha tperua TpHMecTEp Ha OPeMeHHOCTTa, RCHYKH. HHXHOWTOpH Ha MpocTarnaHIMHOBATA curesa Morar ja wanoxar dperyca Ha: © kapauonymMonania ToKcHuNocT (c npexkneapemeHHo 2aTwapaie Ha ductus arteriosus passiTue Ha GexoapoGHa xnnepreHsia); © GrOpeuna anedynKuns, KoxTO Moxke Ja nPorpecupa 10 Gubpeuna HegocrarBHHOCT & ‘oamroxnapannnosa. Malixara M HoBOPOeHOTO, B Kpag Ha GpeMeHHocTra Ha: ‘Noo 5 26210104© siaMoxto ysWuDKABAHE Ha RpeMeTO Ha KBPREHE, adrTHArperaHrTeH exbeKT, KOHTO MORE 1a Ce INpoasH Opi HIpH MHOTO HHCKH 03H; © noTHeKaHe Ha MaTONHHMTe KONTPAKIUHH, KOETO MOXKe Ja 3a6ABH HIM YATRKH Npoweca Ha pavanate. Crenonareano ynorpeSara na aueTWICamMULAOBa KHCemMHA B AHEBHM 03H OT 100 mg H NO-BHCOKH No BpeMe Ha TpeTHs TpHNeCTEp Ha GpeMeHHOCTTa e MpoTHBONOKAsaHa. Kepmene Casuitarire a Texnirte MeTaGOsINTH Ce eKckpeTHpaT B KBPMaTa B MasIKH KoHUeCTBA. Thi KATO 10 cera He ca HaGMORABAHH HEAKETAHH JeKApCTBCHH PeAKUMH Y HOBOpOReHOTO KpaTKocpo"nATa yoorpe6a B npenopnuranire jo3H He HOHcKRa npeKpaTanate Ha KKpMeHeTo. ITpH mpombDKHTesIHA ynorpe6a /nia npHnarare Ha N0-BHCOKH 203M KUPNeHETO TPAGBA ja ce MpeycrTaHOBH. 4.7 Esbexra supxy enocoGnocrra 3a modupane m paGora ¢ mamma He ca nposestenm npoyspaniia 3a eeKTHTe Ha auleTHICanMLuUIOBATA KHceNIHHA BLPXY criocobHocTTa sa worupante H paGora ¢ wauniHHH. Karo ce uwar npensiiy dbapmakorHHaMHunuTe cpoficTBa H HexenaHHTe JeKapcTBeHM peaKLMH Ha AUCTHICATHUNLIOBATA KHCETHHA HE Ce O4AKBA BIMAHHE BEPXY PeAKTHBHOCTTa H CMOCOOHOCTTA 32 uroxpupanie 4 paGora c maui. 48 Hexeranm nexapersenn peaxuin Hexenanure 1ekapeTaeHH peakiqin ca rpyniupaHi mo cHcTeMo-opraHHH Knacone. B paMKute Ha cicTemo-opraHnre wiacoBe “ecToTaTa e onpesleneHa karo: MHOTO 4ecTa (21/10), HecTH (21/100 20 1/10), wewecrs (21/1 000 20 <1/100), penikH (21/10 000 0 <1/1 000), meioro peak (<1/10 000), ¢ HeHBBecTHa YecToTa (OT HATHUHHTe AHHH He Moxke a 6tye Hanpapena oueHKa). Hapymenus na kpora | Yecmuc waumpuata cietema | Tlosntutetta cknonnocr KEM KEpBEHE, Peowu: TpomGourronesus, arpanynowTosa, arutactHuna aveMua. CC neussecmna wecmoma: ayant na kupperie ¢ yirbinkeHo BpeMe Ha KBpBeHE KaTO eMHCTAKCHC, eppeve of nenuTe, CHMrrToMiTe MoraT s1a NlepeHcTHpar 3a nepHon OT 4-8 aun cen npexpaTasanie Ha eYeHHeTO ¢ aueTHNICATHUNLIOBA kucesmia. B csetcreue Ha TOBA MOXE 11a HMa TIOBHIIEH PHCK OT KBPBEHE nno speMe Ha xHpyprisiait poUesypH. (Comectaysauto (xemaremesa, MesieHia) HIM OKY:ITHO CTOMALLHO-4peBHO open Morar Ja 2oBesaT 0 xensIORe*MLUATHA aHeMHS! (NlO-YeCTO MH 1n0-BHCOKH 103). ‘Hapymenns na Peonu: umynniara cuctema Peaklinit a cBpExNYBCTOHTEAHOCT, aHTHOCAeM, asleprHYeH OTOK, AnadpHIAKTHHIH PeaKIUAH, BKATIONHTENHO LOK. Hapymenns na C meussecmna wecmoma: meraGoauaMa ‘Xunepypukenus. xpanenero Hapymenus wa Peru: Heppuara cucrema ‘Mnrrpaxpannatia xemoparnia C mewssecmna wecmor TapoGonne, sepraro. ‘No03, 6 20210104:Hapymienna nia yxoro m | Cwewssecmna wecmoma: aGupunra OrenaGpante Ha caryxa, THENTYC. ‘Ceaonn napymenua | Pedxu: Xemoparnuent sackyar. ‘Hevecmu: i MeamacrHma.tint Puaurr, anenies. napynieni Peowu: BpouxocnasbM, acrMaTituitt MpHET IH. Hapymenus na Peoxu: pempoaykrupuara ‘Menoparus encrema m reprara Cromammo-spesum Teemu: wapymenns Awenencus. Peonu ‘Texbk cTOMAlIMO-upeneH KPBBOMSIHB, raneHe, NoBpbitaHe. C newssecmna vecmoma: Cromauina nam syonenasina x36a H nepdopaun. XenaroGnamapan ‘Cneussecmna wecmoma: napymenus, YepwoxpoSwa HenocrarbaHoct Hapymenus wa xoxara | Hevecmu: mnoakoxnara Texan — | YpTHKapHa. Pedxu: (Cuapom Ha Crussic-J>xoHcEH, cHipon a Slain, nypnypa, eprtema HOROGYM, epiTeMa myaTHGhOpMe. Hapymenus na (C newsaecmna wecmoma: GxGpenmre Hapywiena 66peuna yun nmkownmre mrama CroSuanane Ha nonosmpann nexcesaHn peaKunn CeoGutananero Ha No_OsHpaHit HexeNaHH peakUWMH cies paspelaBane 3a yrorpeGa Ha NeKaperBeHHs Mposykr € BaxkHO. ToBa NOIBOsABA Ja NPOTBIDKH HAGIIOACHMETO Ha CLOTHOLIEHHETO TO3a/PHCK 3a slekapeTBeHiis nposykT. OT MenMLIAHCKHTe creuvaTHCTH ce HaMCKBA a CbOCUIABAT BeaKA nogosipava HexezaHa peak pes MsibaHiTesHa areHUMA No JleKapcTBaTa, y2. ,.lawan Tpyes” Ne 8, 1303 Codua, rex.: 02 8903417, yeOcaiir: www.bda.bg. 4.9 Tpexosupane Bonpeki ue cbulecrayaar 3Ha4uTenHH HirrepHILWENAYATHN RApHALAH, NOE JA ce MpHENe, He ‘ToxenuHara 03a € oxos10 200 mg/kg np s»spacti 100 mg/kg npx cua. Jleranwara 03a auieTisicanuiiiona KuceaHia e 25-30 g. ThasweHH carmuyanaTHH KoHUeHTpanun Haz 300 mg/l noka3eaT HasMHne Ha METOKCHKALUS. FLiaaMeHH KOHUEHTpaNHH Hazy 500 mg/l MpHt BEspacTHM H 300 mg/l px eua OGHKHOREHO ROAST {10 TeKKA TOKCHUHOCT. TIpexosupantero more sa 6ble BpeaHo 3a NauMeHTH B cTapYecka BLSpAcT H OcoGeHO 3a MasIKH JEU (TepanestH4Ho npenosHpatie WIM YeCTH CALyYaliHH HETOKCHKALIMK MoraT fla Oslar daraTHH). Cinarrrow mpi ymepest mroxcuxani Tuiryc, cayxonn Hapyutents, rianoGonHe, BepTHro, OOLpKAHOCT H CTOMALMHO-4peBitH CHMITTOMIE (ragene, nospsutare M Gonka p oGmacrra Ha Kopema). 'No03 7 20210104. 7Cunmrromi mp teaxkn HtToKcMKaM Cunrromite ca cmepaaiit Che cepHosHO Hapyliapane Ha KHMCeTMHHO-aIKaAIHHR Galan. Thspsonayasio ce Ha6monasa xunepscHTAantin, KOTO BOAH 10 pecnAparopHa astkaztosa, TlopaH TOTHCKaHE Ha JUXATEMHHA HeHTEp ce pasBHBa pecriMpaTopHa alwwtosa. B AOMHHEHHE BEIHHKEA MeraGozHTHa auHui0sa BoTeACTBHE HAMHIHETO Ha COHUVLAGTH. ‘Toil karo HHTTOKCHKaLHATa MPH MasIKHMTe ella HeCTO Ce OTKPHBA Ha TIO-kECeH eran Te OGUKHOBEHO ca BoveToRHHe 1a aus, (Ocsest Tosa Morar fla Ce NOSBST CreMHHTe CHMMTTOMH: XHMEPTEPMHA H TOBHIEHO HSOTABAHE, KOETO BOA AO OGesBORHABAHE: YYBCTBO Ha GesnOKOHicTBO, KOHBYACHH, XATHOLMHANAH H XHNOTIMKEMEA, TloTHckaHeTo na HepsHara CHCTeMa MOKE JA NOBENE s1O KOMAa, CEPHIeHHOCE;O KosIANC HAH pecmiuparopest apecr. Jlevetne na npenosupaneTo ‘Ako € MpHETa TOKcHHHa 03a ce HSHICKBA XocrHTTamHauH. B cnyyait na yMepenia HITOKCHKALA ‘TpaGea na ce npeMsBHKa NoBpbinane y NauHeHTA. Axo Toba He ¢ ecbexTHBHO mpes MBpBHA Hac Crem Nor-TbULAHE Ha SHAMMTeAIHO KOAHYECTBO OT eKapcTBOTO MOKe A Ce HANPABH CTOMALIIHA MPOMHBKA C:1eN KOETO a Ce MPHTOKM AKTHBEH BLEeH (aacop6crr) # HarpHes cysbar (naKcaTHe). AKTHBHHAT BEITeH MOXKe 2a Ce MpHmara KaTO enHOKpaTHa 03a (50 g'sa Bbspacren, | g/kg TeNecHO ‘Tero 3a gere ao 12 roam). Aakastnsnpa ce ypanara (250 mmol NaHCO3, 8 npoxthinkene Ha pH vaca), karo ce poBepaBaT cTofiniocrite 1a pH » yprnara. B cayaaii na Texka HHTOKCHKAMAA Ce npemnoNHTa XeMOmNAAIHSa, Tipwrara ce cnnrromaritano esene. 5, ®APMAKOJIOPH4YHH CBOHCTBA 5.1 @apmaxoanuayarinn cBoiicn apmaxorepanesriana rpyna: JIpyrH anaireTHi H aHTHMHpeTHIEH, cATHUNLAOBA KHCeNH H nponponni, ATC kon NO2BAOL AnnirrpomGormunn cpencrsa, HixnGuropn Ha TpomGousTHara arperaua ¢ HSK. Ha XenapH, ATC Kon BO1ACO6, Mexainsa a nelicTane AuieriuicaTMUHIOBaTa KHCEAMHA NPHHALIEKN KBM rpynara Ha HecTepoMAMITTE nporueopsarammrenin cpercrea (HCTIBC). liprrexasa avanreTH4Ho, aHTHTIMpeTHNHO H NporHposssnamreno neficTane, AueTHTCATMULAOBATA KHCeAMHA HMA NOTHCKaIO AeliCTBHE pes AIeTHAALIMS Ha eHSHMa NHKCIOOKCHTeHaNa, KATO NO TOM HAM MHXHOMpa CHHTESATA Ha npocraranann E>, npoctarnanann pu TpomGoxcant Az. AtieriuicaTMuisionata KHCesHHa HHXHOKDa akTABMPAHeTO Ha TPOMGOUMTHTe: KATO GAOKMpA ‘TpOMGoUNTHATA LIKTOOKCHreHAsA NOCpEsICTBOM ALleTHLIHpalte, TA HITXHOHPa cHitTesa Ha TPOMGoKCaHt Az~ QvsHonOrH4HO AkTHBHPALiIO ReMLeCTBO, KOeTO ce OcROOXK:AAKA OT TPOMGOWWTHTE H KOTO Hpac ona npit yeaonntenmaTa tia aTepomaTositHTe s1esHH. VuxGupanieto Ha cunresa ta TXA-2 € HeOGparHMo, Tait KaTO TPOMGOWTHTe, KOHTO HAMAT 421pO, AMAT crlocoGHocTTa (nopaaH s1HNIca Ha cNOCOGHOCT 3a NPOTeHHOB CHETeS) fla CHETTeSHpAT HOBA LUMKNOOKcHTeHasa, KOATO € aeTHAHpaHa OT aLleTHWICANMUIOBATA KHCE:THHA, TIpwzaranieto ta MHoroKpaTHH 103M oF 20 70 325 mg BoM AO HHXHONpane Ha eHSHMHATA aKTHRHOCT 0 30 0 95%, Flopaan Heo6paTHoro ecTecTEO Ha cBEPSBAHeTO, etheKTET NepoHcTHpAB MpOsTRIOKHHE Ha XUHEHHA UMKKN Ha TpOMGoUNTa (7-10 HH). HNXHOMpaUAAT edpeKT He Ce SMepriBa MIpH MIPOAIUKMTE:IHO sTeMEHHE H EHSHMHATA AKTHBHOCT NOCTErIeHHO 3am1O4BO OTHOBO cze}t OGHOBSBAHE Ha TPOMGoUWTHTe 24 J10 48 Naca cea MpeKECBaHe Ha TeYeHMETO, AueTHACATHUNLIOBATA ‘Noos 8 20210104xvicenmia yawoxana BpemeTo Ha Kupaene cpeaHo ¢ oxo.10 50 s10 100%, Ho Morar 1a ce HaGmoxanaT PaLMHSHA MEKAY OTAENITE HHANBILA. 5.2 @apmaxoxnueruumn enoiieroa AGcop6una Crea, nepopantio npitoxenie, alieTiuicanmumtosaTa KHcesMHa OBp30 M HSLUUIO ce aGcOpGupa OF cToManHONpeDKs Tpaxt. OctloBHo Macroro Ha abcopGuHs ca mpoxkcHMamiHTe OTHeMH Ha THHKHTE ueppa. 3Ha4uHTetHa YacT OT losaTa, OGaYe, ReYe e XH/IPOIMEHMPAHA 0 CAIMUMIOBA KUCETHHA B "upeptiata cetia 10 BpeMe Ha npouleca Ha aGcopSupane, CrenerTa Ha xHapomisa 3aBMCH OT crenleHTa na aGcop6uns, (Crea mpi Ha rnaHo Ha aueTHsIcaNHIHOBa KHceTHHa TACTPO-pesHCTeHTHH TAGNETKH, MAKCHMATHH TnaIMeHH KOHIeHTpANNH Ha ALIETIUICATMIULTORA KHCeNUNA H CAMHUILIORA KHCEsIHHA Ce ROCTHTAT choTneTuo cen 5 aca W 6 vaca. AKo TaGneTKiITe ce MpHeMaT ¢ XPaHa, MAKCHMAHH nuIasMeHH KOHLeHTpalIMH Ce jlocTHraT NpHOAMBHTeAHO 3 Yaca MO-KPEHO, OTKOIKOTO MPH NPHEM Hal rastHO, Pasnpenenenne AlleTHLICATMUMIOBATA KHCEAHH, KAKTO H FAaBHHAT MeTAGOUT CANHLULTOBA KHCeTHHA, Ce CBbP3BA B TonaMa cTertelt ¢ ruiaaMeHTe npoTeHHH, raBHo ANGYMHH, H OBp30 ce pasnpesiens BEB BCHYKH YaCTH a TanoTo, CreneHTa Ha npoTeHHHOTo cBBpaBaHe Ha CaTMUMNOBATA KHCEsMHa € B CTPOTa 3ABHCHMOCT OF KOHUeHTpaLIMTe Ha CAAMULTOBA KHCETHMHa H aNGyMuH. OGembT Ha pasnpenenenne Ha auerumcanmuuuiosara KucenHHa € oxox0 0,16 Vkg TestecHo Terao. Cannuwiosara xuceauna GaBH0 ‘auyaupa B cHHopHantiara TeNHOCT, npeMuHana rutaueHTHaTa GapHepa M ce ekckpeTupa B KEpMaTa, Buorpanes AuleriicanMusuionata KHCemHHA Gep3o ce MeTaGONHSHpa 0 camMUWAIOBA KiHCEAHHA ¢ Ho:yxHBOT 15 30 anya. CanHunsosara KHCemHHa BTOcmenCTBHE Ce NPespBita OCHOBHO B FAKKHH H KOHOTATH Ha THOKYPOHOBATa KHCETHHA, CKC CHEM OT FeHTHSHMHOBA KHCEAHHA. EnuHnaiHonHaTa KHHETHKA Ha CATHUHTOBATA KHCeATHMHA € OI03ABHCHMA, TBii KATO MeTaGOMHINTLT & Orpanisien OF Kantawurrera Ha YepHonpoOmnTe eHsHMM, [opal TOBA, ETMMHHALKOHKHAT NOY KHBOT appa H € 2-3 vaca clea npweM Ha HHcKH jo3H, 12 4aca crea MpHiarane Ha O6MualinTe ananrerusnn joss W 15-30 4aca cxen BHCOKH TepanesTH¥HM 03H WEIH HIFTOKCHKALIA. Enumunupane Cammunnopara xnceania 4 HeliniTe MeTaGomTH ce exckpeTpar npeaUMHO "pes 6OpewHTe. 53 Ipeakannn aanun sa Gesonacnocr Tipeaxammannar nposbia na Gesonactocr a auleTHAcaTMUMAOBATA KiCesIHHA © HO6PE AOKYMeHTHpaH. Tipoysnara c >xHsoTHH noKassar, Ye cammunLAaTHTe He YapexxaT Apyr opran ocpen GLOpeuue. IpH Mpoy¥naHHs c norExoRe ca HAGMONABAHK *peTOTOKCHNHOCT H TepaToreHHocT cates MpwlaraHe Ha AUIETHACANHUNAOHATA KHCEAHHA B 03H, TOKCHHNH 3a Malikara. Knunmaara stia4HMocT © HeMIBeCTHa, Thi KATO JOHTe, HANOTIBANH B NPEAKTHHHYHHTE MpOy4BAKMR, CA MHOTO 110-BHCOKH (vali-manko 7 mori) or MakcHMamiuTe npenopDuNTesHHt 1O3H 3a OCHOBIIHTe CLPACHHOCE OBE MHHKANDEH, AUeTHLICATHIATORATA KHCETHHA € TPEAMET Ha LMPOKH NpOY'BAHHA TIO OTHOUIEHHE Ha MyTareHHHTe H KapuHHOTeHHH e*pexTH. PasyaTaTHTe KATO 110 COvAT, He HAMA 3HAMHME MpHSHALA Ha MyTareHHH WIM KapUAHOTeHHH ehEKTH MPH MPOYYBAKNE C MHLIKM M TLTBXOBE. 6 ®APMAUEBTH4HH AHHH 6.1 Cnneni na nomomune Bemrectsa Lapesisno ninuecte ‘Noo3 9 202t0104Harpyes unuecrex riuxonar 6.2 Hechsmectumocrn Henpaoxamo 63 Cpox ua roauoct 4 roawen 64 Cneunasuu yeaoous na coxpanenne Tia ce esxpatiasa ron 25°C. 65 Busan chepmanne na onaxopkata Tlo 10 TaGnerku 8 Gancrepa or npospayno, GesueHo PVC/AI donno. Tlo 2 Gnuctepa 8 Kapronena KyTHA. 6.6 Cnennasnn npernasnn mepkn npu HsxBEpasie m paGora Hama cneunamii WSHCKEaHH. Hetsnomapannst nekapereent MpOnykT HH OTTIATBYHHTe MATepHALTH OT HeTO TpAGBA sa ce MSXBEPAAT B CROTBETCTBHE ¢ MECTHHTE HOHCKBAHHA 7, MIPHTEXKATEJI HA PA3PEUIEHHETO 3A YIOTPEBA ‘Tesa @apwa EAJL ya. ,Jlko6a Benwaxosa" Ne 9, 1407 Copa Buarapus 8, HOMEP HA PA3PEMIEHHETO 3A YIOTPEBA Per. No 20000692 9. ATA HA ITbPBO PA3PEUIABAHE/TIOJHOBABAHE HA PA3PELIEHHETO 3A YIOTPEBA Zara na mppo paspeuranane: 01.05.1984 r. Tiara Ha nocieaHo noaHosaBane: 29.04.2011 r, 10. ATA HA AKTYAJIM3MPAHE HA TEKCTA 05.01.2021 ‘Noo3 10 2oztbios