KPATKA XAPAKTEPH( HAT L. HME HA JIEKAPCTBEHHA IPOAYKT Merponnaaio. #.5. Bpayrt 500 mg/100 ml nnysnoneH pastBop Metronidazol i.v. Braun 500mg/100 ml solution for infusion 2. KAMECTBEH H KOJIMYECTBEH CBCTAB [saqpnmitenda arenunh fo fexapcraara | lentes 00 TI 1 ml pastaop cptspoxa 5 mg merpoxnnazon 100 ml pastnop ckarspxxa 500 mg merponuziazo1 Pespaxionia he 7 7 Tromoupu sexyecmea: pone, S026 27M 10 1 ml pastaop cbanpxa (2206 c0mue Ee f Harpuep xnopua Tam CORR ee Aunarpue hochar zoxexaxunpar 1,5 mg Codnparcanue na exexmponumu (na 100 mi): Harpuii 14 mmol Xaopast 13 mmol 3a IBAHNA CHHCBK Ka NOMOMTHHTe BeIEcTRA, Bx. TOHKA 6.1 3. JEKAPCTBEHA ®OPMA Hucysnoner: pasreop. Tipospayen, Ges{peTeH HTH sICKO ACHITEHHKAB BOCK pasTBOP: 4. KIMHM4HH JARI 4.1 Tepanestaana noxazanns Tlevenie v npodwiaxrika Ha HitbeKWMH, IpUMHHeHH OT HYBCTAUTENEH Ha METPOKIAs01 MuKpoopratiaM (ipeauuMHo anaepoOHH GaKrepHn). 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TIpa ewecemm aepoGnit n ariaepoGHn unibexu, & AOMBICHHE KAM MeTpOH ce wanox3nat anTHGHOTANN, NOAXOAAIUK 4a seeHKe Ha aepoSua HUpexts Merponmasoz un, Bpaya 500 mg/100 ml.HMpodusaxrroro npitomenve BHHATH NOKasaHO MpenM OnepaTHEHA HaMeca ¢ BHCOK PUCK OT anaepoGra undbexuns (rHHeKoNOrH4HH H BLTpeKopeMHH Onepallnn). Odmuamure yrasanus 3a npaswanara ynorpeSa Ha anTHOaxrepuaiiM arentTH TpxGBa 2a ce ana npesaH 4.2. Josnponxa w naam Ha npHTOKeHHe Zlosara ce perysmpa copes HEAMBHAYATHOTO HlORIMABAHe Ha MaMeNTa OT TepaLiAsTa, velinava/tieronara BBapact H TesIecHO Terv0, KAKTO H cnOpen RIVA H TeKeCTTa Ha sa6onapanero. Tpa6na ja ce cnespar ceHstTe OpHEHTHPOBEAHH 03K: Bespacmnu u ronowi Tlevenne na anaepoun mibexunet ‘Obwaiinara ao3a ¢ 1500 mg (300 ml) npes mpBHa eH Ha neseHHe, NocneTBaHa oT 1000 mg (200 ml), npwaowenn karo emHoKpaTHHt 1O3H upes cneBamTe EH. Asrrepaarusno, 500 mg (100 ml) Morar 2a Gxuar npHsaraxn wa BceKH 8 vaca. TIpa MesUIIWHHCKH oKasaMH HaToBapsama 03a oT 15 mg/kg TenecHO Ters10 (TT) Moxe 7a ce mpwiara & HavaioTo Ha JeIeHHeTO. Tpomantentoerra Ha neveHrero 3aBHCH OF Herobata e*peKTABHOCT. B noneteTo eyaHt sleweGen Kype oF 7 un € AocTaTBUeH. [Ip KTMHHTIHH MOKaSAHHs JleveHHeTO MOXe 11a TpOAbIPKM H sles TOIH epoK. (BrK. CbINO TOAKA 4.4), Tpodpusraxrica cuejomepatuana nexus, mpHunuera amt Caxrep Hu: 500 mg, Karo MpHoxeHKeTO MpHKUMOBa OKOTO EHH Hac MpenH XUpypruveckara Manunyzanua, Jlosara ce noptapa cnes 8 #16 aca. Tleduampwina nonynayua Hevenue na anaepoGun maexums * ena ua seapact > 8 come 40 12 roma: OSuraatinara yHeptia 03a ¢ 20-30 mg na kg renecHo Tero AHeBHO Kato emoxparia slosa 10m pasvienena Ha 7.5 mg Ha kg TeecHo Tero Ha BceKH 8 aca. Fsennata 03a moxe 1a Gwe yeemHera 10 40 mg Ha kg Tenecho Ters10 B 3abHeuMocT oT TewecTTa Ha HieKUNLTTa. * Tena na sespacr < 8 cemmnun: 15 mg na kg renecno Tero muestto KaTo enHOKpATHA sl03a HENH pasvieneHa Ha 7,5 mg Ha kg tenecko Termo wa ncexs 12 ¥aca. * Tip nosopoaexn c recranmonta sspact <40 ceavai, Harpynpane Ha METPOHHA30: MORE 41a Ce MONYSH pes IEpRATA CesIMIIA OT IKABOTA; HOpAth KocTO KOMUeHTpalusiTa Ha MeTPOHH A011 B CepyMa € LOGE Jia ce KOHTPo.Mpa ce HAKONIKO AHH sIeNeHHe. Tipomparantesmocrra Ha neveHHeTo OGHKHOBeHO e 7 HH, ‘ewe wa wwapact < 12 ronment:20-30 mg nia kg rexecwo rerxo Karo eanoxpatia 03a, mprroxena 1-2 vaca mpeni xupyprvsreckara MaHHITy TaN; * — Hosopozenu c recrayuonna stapact < 40 cemMartt 10 mg ua kg TenecHo Ters1o KaTo enHoKpaTHa Osa, MpHAIOKeHa MperE xupypreieckara MaxMMTy:TaITHA. Tauuenmu ¢ 6e6pe%na nedocmanrsnocm Hanansmane Ha jlosaTa He e HEOGXOANMO, BX. TOUKa 5.2. Tlanjuenmu ¢ uepuodpobua nedocmanrunocm ‘Teil Karo pH TekKa YepHOApOGHa HELOCTATHHOCT WsasMeHHAT NONYACGBOT © YAWOKEH H TaasMenuaT KMpBuc ¢ 3a6aBeH, 4a MallveHTH ¢ Texkka YepHoupoGHa HeqocTaTBHHOCT Ue ca HeOGXOAHMH 1O-HHCKH 03H (BrK, TONKA 5.2). Haunn na upaaoxenne Wumpanenosno simnane. Cenpprxanneto na enna Gyrunka TpaGsa 1a ce pulee GaBHO MHTpaBeHOSHO, T.e, MaKCHMAIHO 100 ml 22 He 10-Manko oT 20 MultyTH, Ho OGuxHIOBeHO 3a HoBeHe OT 1 Hac, Merpongasox un. bpays 500 mg/100 ml moxe camo 7a Obsle paspenen MpeaH MpHTOReHHe, ‘pes OGABAH Ha NeKapeTREHHA MpOYKT KBM HOCEM paxTBOP 3a BEHOSHO NPHIOAHHE, KATO vanprep 0,9 % natpres xiopust wud 5 % rmOKOaeH PasTBOp 3a ReHOSHO BIMBAHC, Hastiaenure saeaHo c MeqNKaMeHTa axTHOHOTHI TpAGBA Ha ce MpwIarar OTAeHO. 4.3 Tpormponoxazanus Tipu cBpbXx4yBCTRHTeTHOCT KLM MCTPOHHMIA307, KbM JIpyFH HHTPOHMHUIa30N0BH NPOH3BOHH HAH KEM HaKOe OT MOMOMUHHTe BeMeeTBA, 4.4 Cneunasimn npeaynpexsenus 4 mpegiasun MepKn mpi ynorpe6a Tipn narmenry ¢ Teck YepHoapoGHM YBpexNAHUS WH Hapyiueka xenonoesa (HAN. TpanyouMroneHHs), MerpoHHiax0n TpsGBa Na ce MpHara CAMO aKO OvAKRAHATA NONT3a {CHO npesbsxoxna HOTeHIMaILAHTe PHCKOBE. Tlopant pucka or promanane Ha CBCTORHETO, METPOHIUIA30x TpAGBA Na ce HSTONSBA H MpHt TAUHEHTH ¢ AkTHDIH HTH XPOHHHH TOKKH saGonmRaNHA Wa lepubepHara WIM NeRTpAITHA HepBtia CHCTEMa caMO ako OvaKRAHATA NlO‘Tia CHO HIpeRLIXOANA TOTEHUMATHHTE PACKORE Konsyncusua repuone, muoxronyc u mepuibepxa HeBpomarHs, KATO MocmemHaTa ce € xapakrepa2upaita npeuiMHo ¢ HaTpBMBaHe WM TapecTesHH Ha flaeHt KpaitHHK, ca choOmasaHH pH nanventH, 7exysan ¢ Metpounason. [losaata Ha anOpMaIHH HeBponorH4HH CHMITONH MaHeKna 6tpsa oueHKa Ha CLOTHOUICHHETO MoMsa/pHCK pH MPOBTKaBAHTe Ha sIeeNHCTO. B cayuaii na TexKH peaxtitn Wa capsx4yncTBHTemHoct (AanpuMep anadpwiaxTH4eH 110K), aleyennero ¢ Merponmaasoa u.s. Bpays 500 mg/100 ml rpsGxa ja ce npexparH HesaGaBHo H fla ce 3alowHe YTBRPICHO CHEMIHO eYEHHE OT KRAILAIpULIpAHH MEMIANCKH CheNMasIAeTH. Texxka nepeHeTapaiia HapHs, NosBIZTA ce mo BpeMe Ha teveNHe HH mpes OCH: CCoaMHILH MOXe Ha Ce ABAKH Ha IceBAOMENGpaHO3eH KOMMT (B NOBEIETO Cny' clostridium difficile), wx. ToxKa 4.8, Tona “peso saGonaBalie, NpoBOKMpan auTHOHOTITAOTO TeYeHHe, Moxke sa GbE KHROTO 2acTpamanamo Ha Har: TOAXOAAMO NeyeHHe. AHTHNepUCTAITHIHH sleKapCTREHM NPOAYKTA He TPsTlpomtmxwrenzocrra Ha neYeHHeTo ¢ MeTpOHAa30N HIH APYTH seKapeTBeHH cpeyieTsa, ChAEpAAMIH HHTPORMALIASONN, He TpAGBA na HanBuuasa 10 AHH. Camo B Hs6paHH enews Cyan 1 ako onpentesieHo € HeoGxosHMO, eYeSHHLAT NepHOA Moke na SBME YABIMKEH, TPHAPYAEH ¢ MOAXOAAUIO KAKHHUHO H aGopaTopHo HaGmoseHHE.TloBTOpHOTO eweHHe TpAGBA ‘na Gunle orpanteHo ZOKONKOTO € BLIMOKHO H CAMO B CENCE MONGpanM cny'AHt. Orpanirietnara Tpa6na na ce eEOIOnaBaT CTporo Opa BESMOXHOCTTa OT pasBUTHE Ha MyTareHHa akTHBHOCT OT CTpalfa Ha METPOHHWAsONIa, KOTO He MOE 1a OBNe HsKMO'EHA Che CurypHocr, u nlopayia oTGesLrsaHOTO YBeNHYABAHe TeCTOTATA Ha OMpesIeNeHE TYMOPH pH ekentepuMexta ¢ xHROTHH, Xenaroroxcumocr mpi nanHeHTH ebe cHHApoM Ha Cockayne Caysanr na Temxa xenatoroxcnsnoct/ocrpa YepHoapoOHa HeAOCTATBHOCT, BKIMONHTENHO H cnysaut ¢ aranen H3Xon ¢ MHoro Grpso HasaO Cie” SanOuBAKE Ha JIeYeHUe NpH HalWeHTH CEC cunmpom wa Cockayne ca NOKTaIBAHH 32 MPORYKTH, C6IGPKAIIH MeTPOHHIAON, KOTATO Ce Mpaaarat cueremno. Tipu Te3H Nonys1auHa MerpouHAON He TpAGBa na ce HaNION3Ba, OcBEH AKO ce cunTa, ve MomsaTa HANIBHMTaRA pHCKa H AKO HsIMa anTepHATHBHO TeyeHHe. Vscnensanns na sepHonpoGHara SyHKilus TpsGna Jia ce HSBEPINBAT HenlocpencTBeHo Mey awaT0TO Ha TepaMHiaTa, Mpes UsuOTO BpeMe H CHIEN Kpad Ha NeeHHeTO, AOKATO YHKMUNTA Ha ‘Neprmis p06 € B HOpMa, HI AOKaTO He GEAaT RocTHrHaTH GaxoBHTe crotiHocTH. 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[opanit TOTEHUMAM 3a TEXKa TOKCHYHOCT H CMBPTHOCT, CBBPJAHH ¢ HOBMINCHE TLIaIMeHH HABA Wa Sycysnpan, extoppemenmo npuoxeHHe c MerpoHHMason TpxGBa 1a ce HIGATBA, Carbamazepine (Kap6amasenun) Merpommuson moxe ja novHcHe MeraGom#ana Ha KapGamasentt H a TOBHMIM TLIasMeHHTe KoHeHTpalHH KaTO TlocmeNHUA OT TOBA, Cimmetidine (Lluemudun) Exuospemeso npATOXeH CHMETHMMH MORe 1a HAMA eIMMMHHpaHeTo Ha METPOHHIASOA B HAOAMpAHH CHYsAK W BHOCTEACTBHE ja OBeNTe No NOBHMIEHH CepYMEH KOHUCHTpAKHH Ha Merpormaasos. Tpomusosavameunu steduxamenmu Haxou anTuGnormua Morar B HSKHOMHTENIHH cy4aH 7a HaMansaT e*eKra Ha MpoTHBosa4arbunuTe MeHKAMeHTH 4pe3 MOBTHABAHe GakTepHATHATA XHAPOMTHIA Ha CTepOHLAHH KOHIOTaTHCB YepBaTa H M0 TOIH HAHN Ha HaMaslaRaT peaGcopOMasTa Ha HeKOHIOrHpALH cteponan. 3avoBa MacaMeHHTe HHBa Ha akTHBHHITe crepowAM HaMatsnaT. ToBa HEOOHIAHHO BIAHMOACHCTBHE MOXKE Jla Ce HaGMORaRa TPH %KEHH C BACOKA EKCKPeUWs Ha CTepOHAHH KOHIOTATH 4pes 2:rbeKaTa. 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Tumut Eatospementioto npkioxeHHe Ha MeTpoHHiqax07 c HTHeBH comm Tps6pa ma crapa BHHMATeHO, 3allOTO ce HAG TIOMABA NOBHIABAHe Ha CepyMHaTa KOHUeHTpalwa Ha THTHi Ha ona na retenne ¢ Merpomunasos. Mycophenolat mophetil (Muxorpenoram sodemus) Bemecrsa, xowro nponensr cromaiHo-«pensara (htopa (Hanpumep axTuGuoTHUM) Morar ja NOHIxanaT opasHaTa GHOMAMHMHOCT HA MPOAYKTH Ha NUKOpeHOOBATA KucesHHa. [IpenopbyBa ce BHUMaTeTHO KAMHHIHO H JlaGopaTopHo HaGmoseHHe 3a HAMHIMe Ha NOHNKER MyHocynpectBent edeKT Ha MHKOeHONOBATA KHCemMHHA To BPeME a eHOBPeMeHHO NeyeUHe ¢ mpormpopsananHTesinH arerrH, Phenytoin (Benumoun) Merpongason notucka meraGostH3Ma Ha EmHOBpEMeHHO MpHIOKeH (pEHATOH, Te. HaasMenara KoMMeHTTpanns Ha dpeHHTOHH ce NoBHuIaRa. Or xpyra crpatia, eibuKacHocrra Ha MeTPOHTAI0 HaMANIABa MPH exHOBPeMcTITO MpHTOKeHHe Ha PeHATOHE. Tacrolimus (Taxponwyc) ExuonpemeHto IpHnoxkeHHe ¢ MeTpoHHAasON Moxe a TORHIIM KOHLIeHTpanMATe Ha ‘TakponuMyc B KpbBra, [pesmonaraesuaT MexaHH3bM ¢ TOTHCKaHe Ha 4epHORPOOHHA MeraGonus0M na TaxpoaHMyc upes CYP 3A4. Kpubiute spa Ha TaxponuMyc 4 GEOpewHara bynruyia rpaGs 1a Oban nposepanaHH YecTo H NO3aTa KOpATHMpava CLoTBETHO, OCOBeHO CEA, sanoubane WH IIpeKparasare Ha sleveHHe C MeTPOHEIA90N MPH MALIHeHTH, KOHTO ca craGimHsHpannt Ha pexkiM © TakponuMyc. Apyrn opmn na psanmoneiierane Aawoxoa TIpnemor na ankoxomm narirky TpsGna sa ce HaGarua 10 RpeMe Ha TeyeHHeTO C MeTpoHUza20.1, Thi KATO Morar jla Ce HORBHT HERMAN PEAKUHM KATO CBETOBEPICK 1 TospBiliane (acy mpupam-nozoen edvex). 4.6 Depraaurer, Gpementoct m KEpMene Konmpayentyua npu moore u orcenu Bx. TouKa 4.5 ,.mpoTHBosauarbuHn seKxaperBa”. Bpenesnocm Besonacnara ynorpeGa Ha MeTpoHHj1a301 10 BpeMe Ha 6pemenHocT He e Gua noPFagsMHE "0 7. JeMouctpupaita. OcoSerio npoTuBopemBH ca CbOOUIeHRATA 3a YNOTPeOA TO BI Spementiocr. Hakont npoy'paHHs ca NlocouHLIN yrem4eHa YecToTA Ka mano ekchepuMeHTH ¢ xXHBOTHH, MeTpoHHZasON He e MOKazait TepaToreHHM exbexTH[pes nepsua tpyacersp, Merpornason H.8. Bpaynt 500 mg/100 ml rps6sa na ce ynorpe6sna CaMo 3a JICHEHHE Ha TEXKH XHBOTOSACTPAllaBAM HUEKUMH TIP OTCECTBKE Ha 110-GesoracHa atepuaruna, TIpes propia a TpeTHs Tpamecrsp, Merpostizazon u.n. Bpayx 500 mg/100 ml MoxXe a Ce HSMIO-T3RA H 3a TeYeHHe Ha APYTH MEGPEKUMH, AKO OYAKBAHHTE HOWSH OT HeTO HCHO TIpestaxonctar nesKakcen BRIMORKCH PUCK. Kepuene Toil Kato Mctponiason ce CexpeTapa B KBpMaTa, KBpMeHeTO TpsGpa 1a ce MpeKBeHe 110 BpeMc Ha nevenuero. Cie MpHKMOUBANE Ha sIeeHHeTO ¢ METPOHHLA30N, KBpMeHETO He TpaGwa Ja ce sns0SnoBsza mpemH ja HoMHHaT OMe 2 - 3 AHH, NOpAAM HNFOTO APeMe Ha TIOTYKHBOT Ha MeTpOHEL@I0N. Pepmurumem Jianesar naman ramen 4.7 Egexrn supxy crocoGsocrra 3a modupaue # paGora ¢ MammHuHt opm xorato ce w3no.a3ea cope ykasaIHsTa, METPOHHNAION MORE /la NPOMeHH peaKuMtHTe Taka, Ye cnocoSHocTra 3a moMpane WIK paGoTa c MaILIHH Ja e Hapyuena, Topa e oute 110- custo Hspaseno B KOMOnHaNHA ¢ ynoTpeSaTa Ha AIKOXON. 4.8 Hexesanu sekapersenn peaxnam Hexenamrre peaxuni ca caspian npeqHMKo c MpostbunKHTeNHa yrloTpeba WIM BUCOKH 203M, Hali-ecro namonananure peaxnum BKMOUBAT raleHe, NPOMEHeHA BKYCOBH YeetaKH H PUCK oT HeBporiaTHs B coy¥ail Ha MpoABMKUTeTHO sleveHHe. TIp aozHoTo u3Gposware 1 3a OnMcalHe HectoTHTe Ha HexeTAHUTe peaKUMH, ce ynOTpeGABAT ‘neque TepManin: Mroro uecru : = 1/10 Yecrn 2 1/100 .n0< 1/10 Heaeeta — : = 1/1000 0 < 1/100 Penk: 2 1/10000 0 < 1/1000 Muoro pemxs:< 1/10000 Herssectna :“ectorata we moe aa Gaze onpedestena or HannsnHTe ZaHHH Ungperyuau u napasumosu Penk: Tenuranam cynepunexnan ¢ Karuna Muoro penku: IIcennomem@pano3eH KONMT, KOHTO MOXKE /la Ce HOSBH HO BPeMe HH CTE TeMeHHe KATO TEXKA YMOpHTA AKApHA. 3a MOAPOOHOCTH OTHOCHO CeMTHOTO esenue, wx. TouKa 4,4, Hapywenua na xpooma u awnipuama cucmema Heuceta: Hamann Gpoit neskomwrrn u TpoMGowHtTH (:Tenkorlenns, rpaxyTouNToneHHs H TponGoUHTOTIeHHA) No BPeMe Ha sleNeHHe C MeTpOHHIA30s. Muoro peaks: Arpaiy.ionnTosa, anmactuana aiemust Pegonwoto wscneneane ta 6pox KPEBHH KIIETKH € 2QNbIDKHTEsIHO 110 RPEMe HA TPO; pmnoxenue. Hapymenua na wsynnama cucmemaHexecrn: —_Jlexw 0 yMepeHH peakuHH Ha cBPEXYYBCTBHTETHOCT, HANPHMEP KOXHH peakunn (5x. ,Hapymenun na Koscama u nodkoocnama noKan” 110-10NY), aHTKOeeMa H sleKapcTaeHa TpecKa. Muoro pejicn: © Texkki Ocrpi CHCTeMHH peaKIIHH Ha CRPEXUYBCTAHTENHOCT: aHadHTAKCHs 10 anawaaKraved 0K. © Texken KoxkHH Peaxuu, BDkTe Hapywenua Ka Kooicama u nodkoocnama MMtekant” 10-0. ‘Texsrre peacunu nastarar HesaGauua repantentwunia naMecs. Trewxwotu napywenus Heseert: — Crctosnus nia oSpxantocr, panapasiiTemiocn, Aempectia Hapyuenua na nepenama cucmena Hevecru: — TnanoGonne, cactoseprex, chiLaHROCT HAH GeacbitHe, ATAKCHS, MHOKTOHYC H repsone, nlepuibepHa HesporaTHs, ManMipectApauta ce xaTo napectesHs, GostKa, yeetante 3a rpaniana koxa M M3TpbrBawe Ha xpaittMUHTe. Hewssectun: Enuesaionaras. Jlexysanuar nexap TpsGva ya Gone HesaGanuo ysenOMeH MPH TlosDa Wa rEPYOBE HAH TIPHSHALH a repubepua HeppomaTus Hm enuebanonaTHs. Own napyuenua Hesecru: — Hapyresa sputenua ocrpora, mmionus, MHOmH. Hewssectua: Oxysorapasina kpisa (wsomapann enya) Crpoeuu napyuenun Mroro penxu: EKG npomenu Kato nitocka T-pain, Cmomauno-xpesnu napyuenua Hesecrn: — Tonpsmare, ranene, zapys, rsocHT H CTOMaTHT, opmrsaue c ropsHB BKC, TeMECT B eMluracTpHYMa, HLOBAUTaHe, 2ary6a Ha ANIETHT, MeTaeH BKyC, OOTOKER eam, Apcdarns (npurmnena ot epextite Ha meTpouHAMON BBPXY HeHTpamHara Heppita cuerema), rasxpeatHr. Hewsnecrna: Yepnodpobno aexvanu napywenus Heyer: AMopMamHH cToMTHOCTH 1a YepHOpOGHH ewaMMH H GuTEpyOHR Heuspectna: Xenatur, acsnrennma Hapyurenua 4a Koxcama u nodxooKenama moran Heuecra: — Aneprirann xox peaxn xaTo capex, ypTHKapua, epaTeva mysrnopme Muoro peau: Cyiutpom wa STEVENS-JOHNSON (waoampaiH cboOMIeHHA), TOKCHaHa ‘enuepManna Hexpommsa (H30THpan chOOMICHHA). Tlocxeaumre ane peaxuun HastaraT HezaGanna TepaneBTHaHa HaMeca Mycxymio exenemnu napymenua u napyuenie na evedunumensama mxart Hewecra: —Aprpanras, mnamria Bobpewu u nuxounn napyucenia