1, HME HA JIEKAPCTBEHMA DPOAYKT 05. 07, 2016 AGpuuied 1g npax 3a mibKeKIOHEH pasTBOp paopewowse ie BOA Abricef | g powder for solution for injection Aankapsie Ne. 2. KAYECTBEH H KOJIMYECTBEH CLCTAB Bann daxon cemppxa 1,048 g uedoraxcum Harpuit (ceforarime sodium), exsnsancHTeH Ha 1g uedboraxcum, Adpiued cuppa 48 mg/g narpri, 3a IbAHMA CHHCBK Ha NOMOMIHHTe BeMeCTBa BHDKTe TOKA 6.1, 3. JIEKAPCTBEHA ®OPMA. Tipax 3a mioxexustonien pasreop Ban wna Gnezonsarr mpax 4. KRU AR 4.1 Tepamestaana noxasanns Tipnnara ce 3a nevenne Ha unipeKIUAK, MpHUHHEHH OT MYBCTBHTERHH KEM He-POTAKCHM .MuKpoOpraxHaMy KATO: © Cemruuenus; © Hiabexun wa auxaresuite metHula — ocTpy 4 xpoHMaHH GpoHxirn, GakTepHaHt nHeaMonmy, HixexTHpaHn Gporxuextasnu, GeslonpoteH aGciiec H chenonepaTHBHK HHOKEHH Ha rpbanMs Kou, + Hindexunn a otmenkreniara cHctema — ocrep H xpoHuveH MueTOKedpHT, WHETHT 1 acunTomaTHuna SakTepHypHa; . Hdexunm Ha koxkata 4 MeKHTe TRKAHH; ©) Hacbexuu Ha kocrire 4 cranure — ocTeOMMeNHT 4 CerrrH4eH aprpHT; © Axyiepo-runexonorwunn wibexumn ~ ras0Ro-BEsraMresa GOneCT; © HirrpaaGnommiai uniexwy ~ nepHTOHMT, MeKUMH Ha HuIBMMTE MmeTAA, + Tosopes, p cmyyante MpH KOHTO MeHHUWIMHORATa Teparlus € HENOMXOAAIita HK € He ROBENA oO oNaknanus esbexr, © Mesuirirr, enaoKapaue H apyra HHCpeKUWH HSHCKBAUIM NapeHTepaHo neweHMe H MpHUAHeHH OT HYBCTRHTERHH KM Ke*oTaKcHM GaxTepHH; . Jlaiimcxa Gonecr. TIpwiara ce 3a npe- x noctoneparueia npopW1aKTHKA pH NAlWeHTH, NOAIOKeHM Ma xupyprisant MITTepBCHUVIM, 3a KONTO € H3BECTHO MIM Ce MpeAMONara, de € HACTSMHLIA HIM € BLOMOKHA xonTaMHHauns. Tlevesmero c mponyxra TpsGea sia Gale B ChOTRETCTBHE ¢ HaNMORAMETE w/ATH 3a arTHOHOTHYHA TepamTHA. 4.2 Josmponka n naan na npuzoxenne AosupopxaAoonpovxara, natin NectoraTa na npiioxete tpa6se na GoaaT onpenenexH B sasoHMOCT OT TexecTTa Ha HHGEKIMATA, HYBCTBHTETHOCTTA HA MPHMHHTENE 4 CECTORHMETO Ha NAUMCHTA. Jlesenueto mone 2a Sie mivuupano H pent pesy:rrarure or Tecropere 9a GaxTepHasia ‘MYBCTBHTeMHOCT Ja ObyaT HANH. Bospacmuu Tipenopsswremata 2038 mpH neKH H cpeHo TemKH HHdeKuMtH € 1 g ABykpaTHo AHeBHO Tpe3 12-sacopH mHTepsamit. Tosara npy Texxs wnipexuuu Moxe aa Gee nosuuzena 0 12 g AHesHO, pasHomepHo pasnencHa B 3- 4 mpvema. TIpy mucpextumn, mpHuMneHH or 4yBcTaHTeTHH maMose Pseudomonas spp. € HeOGXOAHNO aMesnara j03a fa Gone >6 g. Heduampusna nonyaayua Tipenopbunrennata aHesHa nosa pH AeKH H cpesHo TexKH HAeKuHMH € 100-150 mg/kg, pasmencHa B 2-4 pasniomepmn 203m. [pet moro Texxn mipextata OSMKHOBeHO ¢ HeOGXOMMMA 03a OT NOPATEI a 200 mg/kg. Hosopodenu Tipenopssnressara aHeara nosa ¢ 50 mg/kg, pasmenesa 8 2-4 pasomepitH A03H. TIpH MHoTO TexKH HueKUMH OGMKHOBeHO Ce Haxara NpHIOKeHHe Ha 2038 150-200 mg/kg. Tonopes Eawoxperna aosa of I g, npHsloxkeHa MTpaMyCKyHO WAM MTpaBeHOsHO. Taxpuenmu c Go6pewnu yepencdanua Tlopanu ToRa, We mpoaykTéT ce enkmsHHpa OcHOBKO NlocpencTBOM excTpapenasIHH TSTHIIa MPH auMeHTHTe C TexxkH OBOpetHM yaPEkIAHHA € HEOGXONWMO KOPATHpaHe Ha osaTa (CKopocT Ha raomepyaua (puutrpanuas < mU/min = cepyMen kpeanuiHi npuGnucs#TenH0 751 jumol/) Cres nepaonataria waronapnaua o3a or 1 g, AHeaHaTa noza TpsGna ja Gane pemyumpata c % Ges TIPOMAHA B HecToTaTa Ha osKpaHe — MspsoHaaTHa no3a OT 1 g Ha BceKH 12 4aca cnenBa na Goae nawacrena na 0,5 g Wa pceKn 12 vaca; 03a oT | g Ha BceKn 8 vaca fa Gee peayunMpasta 20 0,5 g Ha Bcexn 8 aca; nosata oT 2 g Ha BcekH 8 aca, cBoTBeTHO 1 g Ha BCeKH 8 4aca. Kaxro npx apyrire naiweHTH, 0sHpOskTa Moxke fla HSHCKBA HONEAHHTEAHO anarrTApaHe H NUMBHAYATHOMpaHe B CLOTBETCTBHE C MPOTHYAHETO Ha HHChEKUNATA H OGWIOTO CELCTOAKHE Ha nauweura. Tlpedonepamusna npogruxaxmuca ‘Tosa 1 g uetpaneHosHo win HeTpamycKynHo, 30-90 min npem xHpypricana HHTepBeHLKE, Tlauenmu ¢ wepnodpoGnu yepencdanat He ce usucxsa koparmpane Ha nosaTa. Hawmn Ha mpanoxente Virrpamyexy:mo r miTpanentosto MpHToneHne Tipunara ce wirrpanerostio (Kato aHpexTHa HIDKEKKHA HAH Noa opmara Ha unbysriA) WH wumrpamyeKysni0. 3a ykazamia oTHoctio pasrbapauleTo ta NeKapoTBeHHa MPOAYKT NPeAM MpANOMeHHe BIDKTe TONKA 6.6. Has ua npurorasne Ha pasTsopa Humpamyexynno npunoacenue Cranpxannero Ha dviaKoxnTe AGpuued I mg ce pasrsaps upes paskramane, cho _16KO HETpAMyeKyAHO.Humpasenosuo npuroacenue 3a aupexria wHrpaBeHooHa MiDKeKWUA — cBABpKAHHETO Ha bnakoHHTe Apuued 1 g ce pasTBaps ‘upes pasictamae c 10 ml crepiina Bona 32 minkexuHiH, HeokexTupa ce B NpOBDKeHHE a 3 10 ‘5S muntyra. To ppeme Ha nocTMapKeTHHTOBH KaGmoneHHs ca cKOOUIEHH NOTeHUAMHO >2xHBOTOGACTpALlIABAll\A ApHTMUE MPH MHOTO MasTEK Gpoll NalIWeHTM, Ha KOMTO € npUOKeH eiboraxcnM 6xps0 MHTTpabeHoaHo Mpes UeHTpaNleH REHODEH KATETBP. 3a MerrpaBenoaHa MHdyaHa — chirspxanueTo Ha duiaxoHMTe AGpuued 1 g ce pasTeaps pes pasksiauiane ¢ Ha-Manko 10 ml crepwala Bota 3a HroKexIIMH H c7eq TOBA ce paspe:xa c 40-100 ml oT eaHH OT cneaHitTe HHGyaHOMHH pasTBOpH: 0,9% HarpHen xnopHa, 5% Han 10% raoxosa, 5% rroK03a H 0,9% HaTpHeS 2UTOpH, HATPHED NAKTaT HIM CTepHAHA BOA 38 MEDKEKLI. Hirpanenoatata madyara ce napsputina 3a 20-60 saytat. PastsopenHat 3a MIDKEKTHPAHE NPORYKT € CBE CDETIO AAT HK ABITT NO CBETHIO KeXAUGAPEH UBAT, B 3aBHCHMOCT OT KoRUeHTpallKsTa, HSTIONSBaEMs PasTBOpHTeN H YCIOBHATA Ha CEXPAHeHHe, TIpenopssa ce pasteopure sa ce npwiarat neqHara crieX NpHTOTBAHETO HM. AKO TOBA & HeBEIMOAHO, rpHTOTBeHHTe pasTBOPH MoraT a ce c>XpaltabaT 10 24 vaca npH TeMmtepatypa or 2°C 0 8°C (@ xiaqumHK), Tiparorsenure ¢ nmqoxann pasTeopit Ha AGpaued I g 3a siTpaycKyAHO MpWAoxeHHe Aa He Ce ‘pumarat meTpapexo3Ho! Teoraxcum ammnormixosian ne TpxGna 1a ce CMeCRaT B e”IHA M CITA CTPHELIOBKA 11H nepdysHotex pasraop. 43° Mpormponoxasanns Ledoraxcam e nporusonoxasast np# nauwieHTH cee: © CBPEXYYBCTEMTEMHOCT KEM LEGOTAKCHM W/H.TH APYTH UedbanocnOpHHOBH arTHOHOTHL; ¢mpemonmamn aabHnaKTHHEH peaKUHH MpH JleMeHHe c TeHHLBETHHODH axTHOKOTHUA - 'BB3MO‘HA € MPORBATA Ha KPKCTOCAHA CBPHXYYBCTRMTESTHOCT MEMIY MEHMLCTHEOE edanocnopi (Bx. Towa 4.4). Ledoraxcuu, pasreopert ¢ AHoKaHH HuKora He TpaGwa ja ce pH © mmtpasenoaHo; © pa newa na sispact <30 meceua; © pH nanwenra c anansieaa 2a CEpEXYyDCTBHTERHOCT KEM JIMJIOKAME HiIH KEM APYTH sOKAIHH anecTeTHUH OT aMMeH THN; © MaunexTH ove cupneyen GHlOK, KouTO HaMaT nOcTaBeH NeHicMeliKep; © mauiers © Texxa copediia enocrarsaHocr, 44° Crenuazmn npezympexctenna u npeanasun Mepn ups ymorpeta Anaipunaxmewny pear Hima choSwienus 3a cepHoaii, a 8 HKOM CHyHaH Hc cbarateH WSXOR PeaKuKH Ha CcepExtyscrawrenHocr (aitadpHaaKcis) NH MALWEHTH TeKYBAHH c HecboTAKCHM (Bx, TOMKH 4.3 4.8). TIpesit ncex# Hom xypc Ha eveHWe c Mponykra € HeoBxoRUMO Na ce cxbepe NompoGHa HAbOpMALHA 3a CBPBXYYBCTBHTEAHOCT, OcOBeHO 3a alepran KbM B-nakTaMHn aHTHOMOTHUM. [IpH Nowa Ha PeaKIIHH Ha CBpBXYYBCTRHTEMHOCT, NeNeHHETO TpsGRa Na Gone MpeycTaHOBeHO. TIpHIO-eHHeTO Ha ueOTAKCHM e CTPOTO KOHTPAHHJHUMpAHO MPH TALeHTH ¢ AHAMHESA 3a CBPLXYYBCTBHTCAHOCT OT Gup3 THN KeM wedarlocropAHH. [Ip CBMHeHHe 3a TakaBa ¢ HEOOXORMMO JIeKApAT sla IPHCEEre TTspBoTO NPHTO‘eHHe, 3a Na Moxke a pearHpa HesaGaBHo MIpH MosaTa Ha alta‘pi ‘Tif kao ChulecTBYBa KPLCTOCAHa CBPEXYYBCTBHTEMHOCT MET NeHMUAIHAH H oxono 5-10%, nedanocnopHi TpaGEa na ce HanONIBAT HOKTHONTEAHO BHAMATEAI ‘VIeprAWHH KEM NEHHLBLI, KATO e HEOBXOAHMO CTPHITHO HAGMOHEHHE MPH Tp! PeakuMitre Ha CBPBXUYBCTRUTEMHOCT (aHa*WIaKTHUHH peakIMH), KOHTO ce Ha ba Buga axTUGHOTHUA MoraT fla Genet CepMOSHH H OPH Gara. 3cma u arepeuuna npeducnosiun Lledotaxcu TpaGea 2a ce npwiara BHHMaTeNHO MpH nauKeNTH ¢ aneprHtiia NpeRHCrOSHUHA H Sporxnaria acrwa. Tepicxu 6ynosnu peaxyuy Caysan Ha TexkxH 6yno3HH KOOKHH peakuiMl, KATO chtiApOM Ha CruBBHC-/KOHCEE WK TOKCHEHA ‘ertiaepmania HeKporiHsa, ca cboSUIBBAKH pH ynoTpeGaTa Wa uempoTaKcHn (wx. TOUKA 4.8). Tlaunentare rpaGna 1a Gb1aT NOCKBETBAHH JA Ce CBBPAAT HesA0ABHO CHC CBOR TeKap NpeAM a NpOMBIOKAT JeHeHHETO, AKO Ce TORBST KOXHH WHK TMTABHYHH PeaKUMH. Cappxpacmene ua neyyecmeumemiu Muxpoopednigas Kaxro # npe apyrite tpoKocTIexTEpHH aHTHOMOTHLM, NeyeHHETO c LleOTAKCHM MOXE 1a penwasnka cepsxpacrenk Ha Candida u, ocoGeHo mpi npomBmKHTeTHa YnOTpe6a, BESMORHOCT OT ‘SBpEXpACTEX Ha HEYYBCTBHTETHH MUKPOOPraHHSMH OT rpynara Ha Enterococcus spp. Clostridium difficile. [lpn ann 3a cepexpactex crempa ja ce MmpexpaTi NPHOKeHHOTO Ha aHTHOHOTHKA H 1a Ce MpeaipHteme ceumdyenta Tepanias. HeoSxonHMa ¢ MepHoAHHa ONCHKA Ha CLETORHHETO Ha naunenTa. row 201 i 0. Tlo speme ta neyeHueTo WK B MEpBHTe CeAMMUH CHEN TIPKKMOURAHETO My More za ce pasBuTHe mceszomemOpaosen komm (Clostridium difficile ewspsano saGonapane (CDAD), npossaramo ce che CHMITTOME Ha Texxa Wim NepcHeTHpatia AHApHs. J[harHosaTa Ha TOBA PAIKO, HO C BRIMOKEH araen exog cocToanHe Moxe Ja Obne NOTELPHeHA eNAOCKOTICKA W/HIH XHCTONOTHIHO. Conpsanutte c Clostridium difficile saGoaasanua Morar aa npoTekar oT sexo 10 >xnBoTOSACTpAMABAINO, KATO Hali-TexxaTa (bopMa e nceBJOMeMG6paHosHia KosT. TlopaH ToRa € MHOTO BAXKHO /la Ce MHCIIM 38 TASH AMArHO3A MPH AUMEHTH, KOHTO MOMY'ABAT AMAPHA HO BPEME Ha WK Caen Revere ¢ HepoTAKcHM. ‘Ako ce Mlonlosnpa aMarHosara ricesnoMeM6paHoseH KOANT, NPHTOKEHHETO Ha UedboTaKcHM Tps6BA AA ‘ce mpexpata nesaGanio H na ce samosne nomxonama cneunbu4na arTHOHOTHTHA TeparAs, BaGorssarre cpppsano c Clostridium difficile mome na Gone NoanomoruaTo OT dbeKasieH sacToH. Visnomspanteto tia cpesicT#a, KOHTO NOTHCKAT NlepHCTaMTHKATA € KOHTPAHAAMEPAHO. oz Tlo Bpeme Ha teveune ¢ weoraxcum (Nono6KO Ha ApyrH GeTa-slaKTaNHH axrruGuOTUNH) Mowe Aa ce aneite NeskOneHMs, HEYTpOMEHMS H 11O-PA/IKO ArPAHYTOUPTOSA, OCOGEHO TIpH IipOITEDKHTEIHO saewenme. TIpy xype Ha sevenne Hansmurasam 7-10 HH ce npenopeusa peryaspeH KOKTpON Ha KppeHata kaprunia, ocoGeHO Ha pos Ha epHTPOUMTUTE, LeBKOUMTUTE H TPOMGOLUTHTE, KATO eveHnero cheqsa ja Gale npeKpaTeHo Nps Noswa Ha HeyTponteHas. CoOOUIENK ca H HAKOK Coy'aH a cosuHodimta A TpoMGourToneHHs, Gepi0 OGparuM Ces NpeKpaTHBAwe Ha NYCHHCTO, Tloxnanpany ca v cyan Ha xeMosHTititia aHeMHs (Box. TOUKA 4.8). Haaguenmu ¢ r6pera nedocmamnoem Tosera rpsGea na Geae KopHrmpati cilopen HANHCHEMH KPeATHNUAOD KIMPBHC (BX. TONKA 4.2). Heodxoaumo e nosiIneHo BHAMA:IHe MpH enHoEpeMenio TeveHKe ¢ HeGOTAKCHM H AMKHOCMAKOSLIE, mpoGeHxenny MAH Opyra HeppoToKcH4HH cpeacTea (Bx. To4Ka 4.5). [pw TesH MayueHTH TpaGBa 1a ce npocaenasa 6x6peuiata byHKUIL, KAKTO 1 MH NaLWeHTH B CTapYecka BRpACT H TAKHBA mpenxorxnaruo 646pesHo yaperkaaHe. Heapomoxewuwocm BUcOki 03H Gera-naKTaMHH aNTTHOMOTHUM, BKMONMTENHO M HetpoTaKcHM, Morar fa NpeaWsy ‘exedpanonatus (HapylleHne Ha CRaHAHMeTO, ASHOPMHM /IBHREHHS H KOMBY.ICHH), TaumerTn c Gx6pesHa HenocTaTBMHOCT (Bax. TOUKA 4.8). Tlaunenrure rpaGea na Goaar nocbecTRaHM fa ce cBEpRAT HesaGaBHO CoC CBO; 7 NpOABMHAT NeeHHETO, akO ce NORBAT NONOGHH peaKLIHH.‘Mpeonasnu mepxu npu ynompeba Tlo speme Ha rloctwapkeTHHTODH HaGmoneHHS ca cuOOUleNH NOTEHLIMAMHO KHBOTOSACTpAMIABALLH ApHIMHM MIpH MHOTO MaJIbK Gpoli naueHTH, Ha KOHTO € MIpHIOKeH UeoTaKcHM 64p30 HETPABCHO3HO Tipes UlesTpasieH BeHO3eH KaTeTEp. [perlopb4MTeNHOTO BPeMe 34 HIDKEKTHPAHE WK HEysMpane ‘TpaGpa na ce criaspa (Bx. TOHKa 4.2). Bwoxte TouKa 4,3 3 NpoTHRONOKasaHHa MPH WSNONIBAHE HA PASTROPH CHABPIKALIM NMIOKAHH. Expexmu sopry nabopamopuu uscnedeaniy Kakro # npx npyra ue*anocnopHl, NH BAKOM naNHeHTH JeKyBaHH c HebOTAKCHM € HAGMOTABAHO TosuTaBupane Ha TecTa Ha KyMGc, KOETO MOW M18 OKBKE BIKANHE H Ha TECTA 3a KPEBHOrpyNORA ‘eBeMecTaMoct. Tlo speme Ha nevetHe ¢ npomykra © BiaMoxHO GbanumnBo NOSHTHBHPANe Ha peaKKMATA 3a OTpeNENANE a ratoKosa & ypuuara Np HonOMBAKE Ha HecnenmpurmH MeTORM. TOBA We ce HaGMoRABA MM Onpenleratie Ha rimoKO2aT@ ¢ rmOKO20-OKCHARBEH CTeMMUYEH MTOR. Toon nponyxt chappxca 48 mg/g HaTpHi, KoeTO TpxOBa fla Ce MMA MpemBH pH MaLyHeHTH Ha NHETA.C KoHTponMpaH npHem Ha HaTpHih 45 Bsanmoneiicreue c Apyra neKaperwenm MpOnyKTH M APyTH opMn Ha BIaMMonelicTBRe Baxmepuocmamuuiu npodyxmu Ennospemento npaoxcenne ¢ OaxtepHoctaTHunn aHTHGaxTepHaTHM MpomyKTH, H&Np. TeTpaLvHTHHt ‘MW XIopaMeHHKON, BOM 10 AHTATOHHCTHMEH eeKTH. Vpunosypwiu cpedcmea MipoGeneuHa oxasea BIMAHHe BEPxy TySyHaTa eKCKPEUHA Ha NehOTAKCHM, KATO 110 TOSH HauHH ‘YBemtuaBa eKCTIOBHUMATA Ha NePOTAKCHM OKOMIO 2 METH H HaMasIHBA GKOPEYBINA KIMPEHC 10 OKOO TonopHHaTa B TepanesTHuHH 03H. Tlopai WMpOKAs TepanesTHNeH HEgeKC Ha WepOTAKCHM, He Ce Manara KOpeKiuH Ha o38Ta MH nanserTH c HoperanHa GLopesa yHKnis. BsaMosKHo € 1a ce ‘HATO KOPATHDaHe Ha JOtaTa MH NaUIMeHTH c GxGpeHO yepexnane (wx. TOK 4.4 4.2). Anunoznuxosudu anmuGuomur u Ouypemuyga Kaxro u py pyri uesatocnopan, uehoTaKcHM Moxe ja NOTeHLUApa HedpoToKcHTe eGOKTA HA HedpoTokcHMim ekapCTsa, KATO ANHHOTTHKOSAIH HAH MOMLMH AM'ypeTHLH (HAN. dyposeMua). IIpH ‘TesM mauneHTH OxGpesmara yr TpAGEA fa ce HaGmomaBA (Bix TOHKA 4.4). 46 Depruanrer, Gpemeunoct m kopmene Bpemewnoot ‘Besomachocrra a 1eeporaKcu He e YeraHoneHa npH Gpemesitn xen. Mpoy4saHnsra BEPXY 2kHBOTHM He MOKA3BAT MpeKH WIM KOCBEHM BpeAHH edpEKTH fo CTHOUIEHHe Ha PenpoAYKTHBHATA ‘Toxcwunocr. Bunpex# TOBA, Gave HAMA aeKBaTHH 4 Ope KOHTPOTMpAHK MIpOyuBAKUE pH Gpemenmn xeHH. Leoraxcitm npessanasa nmaueHTapHara Gapnepa. Tlopax Tosa, 1ecboraKcHM He Tpx6Ba ma ce TMpwara no Bpeme Ha GpemesHOct, ocoBeHO No BpeMe Ha ITSPBHA TPHMECTED, OCBCH AKO O¥aKBAHA Honsa He HAnBHINIABa NOTeHLWATHATe PHCKOBC. Kepmene Lledoraxcum npenniiana 8 MaliMuHHOTO MASK, NopaaH KOeTO He Morar ja ce HOKMONAT edbeKTH BEPXY ‘usonorusnara upesiia dopa Ha kEpMavteTo, BOReNIK No AHAHs, KOTOHMSALIHR OT APOXTETOROSHM ToOusnH H ceNsAGHLTHAHpAKe Ha HOBOpOZEHOTO. Tlopanu Tosa tpsGea na ce BieMe pelleHve NaNH 1a ce npexpara kepMeWero 1M Tepannsra, B3EMe NPELBHA NONIATa OT KEPMEHETO 3a AeTETO H NomaTa OT sJeYeHHeTO 3a MalikaTa.4.7 Edextu pppxy enocoGnocrra 3a mogupane m paGora ¢ MacaHm Tipnnoxeunero wa eoTaKcHM € cpEpsaHo c rlomsaa Ha samalibave, KoeTO Moke JA OBAMA Ha cmtocoSuocrra 3a mogmpane m paGora c MaLIHH. Bacoxm aoa wesporaKcts, ocoGeHO NPH NaUMeHTH c OxGpewna HeNOCTaTBYNOCT, MOTaT Aa NpMAMET. enutedaionamua (HapylienHe Ha ciaHaHMeTo, aCHOPMHM ABIOKEHUA u KOHBYaCHH\—X. TOHKa 48). Tlauestrure tpaGna na Goat noceReTRAHH a Ke MiooMpar WIM a paGoTsT ¢ MaMLMAH NpH NORBATA a WAKO OT TeIH CHMITTOMN. 48 Hexenaum nexapersenu peaxnun Hooxenanre peaxuntu, ceepsarn c npiiiomenuero na ueiporaxchm oOHKHoBeHO ce HaGmonasar ‘oTHOcHTeAMHO PANKO, KATO IO MPHELIHN ca Nex # Npexonny. BesMonsnt ca cnemHUTe HexkeNaHH peaxaos: ‘Cnetewo-opramnn | Mivoro sect | Yecra | Hexecrm ‘C nexespecTaa aecToTa (OT raacope evo) 1/100 | 1/1 000 zo <1/100) ANMSORTe AME RE 30 ome 1a Gye wanpanena <1/10) coutenka)* Vinbextnn Cynepangexunn (om. saspectantsat rouxa 44) Hapyens Tleakonen Heyrponeniax xpeora v minder Econnorema Arpaysouiroaa encrena ‘Tpomboueronennx (px. Tosa 4.4) Xemonnrrirana anew Hlapyrenr a peaxii Jarisch-Herxheimer | Anaghraxrisa peaxiinx cyasara cacrema ‘Auraoezem Bpouxocnasem Anadwacrisen OK. Hlapyarenna wa Topsone Taaso6onne ‘epptaa cucreMa (ox. Tosa 4.4) Samamnoct Enmedaronarin (1.6 apyieno cosnattne, ‘naTOrOrH MBWKEHUA) (wx. ro4Ka 4.4) ‘Copnesnin Apmiwnex cen Oxpsa apyurena Sonye wnipysun apes neHTpaen BeHOseH yarersp__ ‘Cromanin0-=pesnn Tapen Tazene apymenna Tlospeuane Boma n o6nacrra wa open TicebnomenGpaoxex om (ax. TOK Xenarooicrwapaw Tlosnivanane wa erarsr® (WonAKOTA © repymrenna ‘seprtoapoSurTe cxHt >eeatrenmnia) (ALAT, ASAT, LDH, rawa- GT whim arcana octparasa) wr Gnsmpy6rat Hiapyarena wa ‘O5piB Eparewa wyarrapopme xoxara Tpyparye ‘cunuIpow na Stevens- HoaKoxtara Texait YpraxapusHapymenua na Hawanazane Ha OvOpewsaTa | Mrepcrmumanen neppur GsGpewmre ymxaqiv/nownimanaHe a uxowtere moran peaTawma (ocoGeHo npx eanoppemensio npemmuceaxe a AMHHOTMHKOSHNA) ‘Oounn napymrenus | Mipu wmpange- Tpecka Tipe mirrpanyexyano megexri a rymto Bronamrenm peaxumns — | mpanoxenve (koraro acroTo wa purorcenue nacToTo Wa mmxexTapase, | pasTeopsT ebmepaKa Mpmnoxeune Boma n nsteroro knosHTenHO auaoKant): CHoTeME a wipxexTMpawe ueGur/rpomGogpneGurr eaKiwnn KEM HROKAIT * HOCTMaKETHHTOR OAT Jjarisch-Herxh HM Tips xesenne a Gopenvosa © sesMoxHO fa sesHinnaT Jarisch-Herxheimer peakina npes mmppHTe JH OT nesenmeTo. Te Ce HspasaBaT B NOBKUIeMa TeNTIepaTypa, Tpecka, TaBoGomHe H CTaBHA GonKa. Eni WIK rlopewe OT CEMHHTe CHMTTTOMH Ca GALIH HABMONABAHH CHEM HAKONKO CeAMHYHO eCHHE a riaunerrH c Gopennosa (Jlafincka Gonect): Koxext OBpHe, cbpGext, TPecka, EBKOTIEHA, TOKa‘BaHe CTOHHOCTHTE Ha YepHOMPOGHITTE CHSHMH, SATPYANEHO AMUIAHE, cTaBH AACKOMpOPT. Ho ‘M3pecTHA cTefieH TesH MpOABH ca CHeACTHHE Ha CHMIITOMHTE Ha 3a6OnABAHETO, 38 KOETO NAUWeMTsT Ce sexy. CeoSuapane Ha nonoanpain4 HersenaHn peaxtuMH (CroSntapaHeTo Ha NonosMpaHH HeXeTaHM peaKHH cren paspewasane 3a ynorpeGa Ha seKapeTBeHHA IMpOAYKT € BwmkHO, ToBA TOIBONSIA Ja NPOBIDKM HACMOJeKETO Ha CROTHOIIEHMETO NosT3a/pNCK 38 eKapcTaeHHs npoAyKT. OT MEMMUMHCKHTE CIEUMASINCTH Ce HSHCKRA fla ChOGUIABAT BCAKA onosHpana Hexenasa peaxuwa pes Harrantirenna aresnts no eKapersara, ya. .Jjawan Tpyes” Ne 8, 1303 Copies, rex.: 02 8903417, yeBcaitr: www.bda bg. 49° Mpexosmpane ‘Crutecraysa pick of oGparuma enmedatonataa mpi npHTOKeHHe Ha BUCOKH 03H Gera-naKTaMHH anrraGHOTHUM, B TOBA HHCHO H Ha We OTAKCHM. CCuvtrrosarre tia npeaosmpanee 20 roniaMa cTenem KopecrionsHpat ¢ npoduna Ha HexesiaHHTe Alekapeteen peaxtin. Tipu npexosupane, nevenneTo ¢ yepoaxckm TpaGsa na ce MpeycraHoRH M ja ce sanlowHe TOMABPHAILO eNEHHE, KOTO BKTIONEA MEPKH 3a YCKOPEHO EAHMMHMPAHE H CHMMTOMATHNHO eNCHHE Ha HeOeTaHHTe NeKapCTReHH peakuiMH (HAND. KoHBy-TcHH). Hama cnettHHHeH AHTHIOT. TlasMentre KOHMeHTpaUME Ka HedoTaKCHM MOTaT fa GeRAT HAMANIEH MocpeICTBOM NepaToKeaHa swanwaa WIM XeMonHAHaa. $. @®APMAKOJIOTHYHH CBOMCTBA S$. @apmakogunamnaan cnoiicrea @apnaxorepanearauia rpyna: Bera-naxramnn auruOnoraum, uespanocropany, ATC Kon: J01DDO1 Mexanwspm Ha nelicrane Lledotaxcm e Tpeto nioKoneHHe mmpokocneKTbpeH tecbanocnopHmos aTHGHOTHK c GaKTepHIUAZIHO aelicTaHe. Mexanvamtt Ha nelicrene ce ocbillecraasa pes HEXHGMpaHe GHOCHHTesaTa HA GaxrepHannara weTbuHa MeMGpaHa, ‘Mexanty tia peaneresrrioer PeaitcTenTHOcrra kbM WeOTAKCHM More Ja Ce /IBIDKH Ha MpOnyKUAs Ha Cera CmeKTSp, KONTO Morar edbeKTHBHO Aa xANPOMMAHpaT UedanocnOpHHTe, Ha KHAY suiawaTentia excnpecis Ha es¥nu or Tan AmpC, Ha Gaxrepvasiva Henponye! Mexanusyit Hla noMmeH edmtyKe,Fpanuyu na wyecmeumennocm Knmmnraorre Hops 1a MIC sa pasnensne wa sypcrautemn (S) natorenm or pesuctenTax (R) natores eriope EUCAST ca ance no-nony. Enponelicku KoMBTeT 38 Tecrnane na auTAMMKpo6uaTa wyBcreuTeamocr (EUCAST) Kaunasan nopwet na MIC (V1.1, 31/03/2006) ‘Uyserpmresen (<)/Pesucrenten (2) Enterobacteriaceae” v2 Pseudomonas = Acinetobacter - Staphylococcus* Benexka® Enterococcus - Streptococcus 4, B,C, G 0,5/0,5* Streptococcus pneumoniae 0.5/2" Haemophilus influenzae 0,12/0,12" Moraxella Catarrhalis Neisseria gonorrhoea 0,12/0,12° Neisseria Meningitidis 0,120,124 Fpam nezamusnu, anaepo6u - ‘Hesnaoso cpepsaki Hopmu! 2 SKAT SYBCTBHTeRKH HAH He HaITBAKO YyBeTAHTeIHM chopest TESK HOPMH. 3 Yyncrautenuocrra na Staphylococci xem wespalocnopwli ce pHnoKpHBa c METHUWLIMHORATA MyBCTBMTeNHOCT (c HIKMOYEHHE Ha Le*TASHAHE, KOHTO He TpAGBa fa ce HSNONSBa NH crawiokokori HHexumn). 4 Lllamose c MIC crofiocta Hat S/] HopMa ca MHOTO pelIKH WIH Bce Olle He ca CBOSLICHH. ‘Wacternduumpanieto W tectopere sa aktTHMHKpOGHa YYBCTBHTETHOCT pH TaKHBa HBONETH TPACDA LA Geaar NoBTopeHH H Ako pesysITaTBT ce MOTSSpAH, HOnaTET TpAGBa Ja Gene HINpaTeH B pehepentua aaGoparopiss. JoKATO HMA AAHHM 38 KAMHHNeH OTrOBOP NK NloTBEpaesrTe monary ¢ MIC wa IipHer#Te HOpMiK 3a pesvcTeHTHOCT (a HTamHk), Te TpAGwa fa GbIaT CLOG UIABAHK KATO pesHCTENTHH, ~- = TecTaane 2a 4yBCTBHTenHOCT He ce NpeflopE4Ba, Tbii KATO BANOBETE He CA NOIXOAAINH 38 ewene c TO3H Me;KKAMeHT. TE = Hama J0cTaTs4Ho JaHHH, Ye Te3H BH/OBE Ca TOAXOMALIH 34 NEYEHKE C TOSM JeKAPCTBEH poayr. RD = oGoctionant # noxyMerupan sani, wsnosseann or EUCAST sa onpenenste 1g Uyscreareamocr Yectorara Wa pesHcTeHTHocTTa Moxe a BapHpa TeorpadcKH H BEE BPEMETO 3a Hs simone. JloxamaTa witbopMauina 3a pesicTenTuocTTa e weNaTeMHa, OCOGEHO KOI Toxkn HHbeKIUM. Ta3H HEKbOpMaltAA NpeTocTaBA camo NDHOnWHTeNHATA REPOS MHKpOopranHaMuTe We Ob2aT HIM He YYBCTEHTENHM KEM eliCTBHETO Ha uemoTaK 8 ik a We