Thiopental

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KPATKA XAPAKTEPHCTHKA HA TIPOAYRTA, L HME HA JEKAPCTBEHHA MPOAYKT MiSHIbSIHMTENHA ATEHLMA 0 NEKAPCTBATA Tuonenraa Cantos 1 g npax 3a mibKeKUMoHeH pasTBOp Thiopental Sandoz | g powder for solution for injection 2, KAMECTBEH H KOAHYECTBEH CBCTAB | 090500 Beexn duaxon cearwpxa I g-THometran narpuit (thiopental sodium). 3a MAHA CTIHCEK Ha NOMOUMUHTE BeUIeCTBA, BIEATE TONKA 6.1 3. JIEKAPCTBEHA ®OPMA TIpax 3a mioxeKunonen pasraop, cyxa cyScramunia c wcrreMHKaBo-Gaa UBsT.. 4. KIM AHA 41 Tepanestum noxasanna Bosexnane 8 oOua anectesHa Kparkorpaiitia anectesus Henogapaut ce na severe enmenrH4en craryc - cbeToanHe ¢ ronemn npHnaxount (status epilepticus- grand mal status ) 4.2 Jomponxa u nas na npwroxKenne Tuonenran Moxe Ja ce npitara caMo of slekap-CneUMaTHeT No aklecTesHOstOrH HH creunta MeaMUUIHa pH NOAXOAAULK 3a UesTTa yeTOBHA. HeoGxoNMO € fa ce npocsIeARBAT AAESHENNETE byneiuin (EKT, xpbano naxgrave, nyacowa oxcumerpia). Ha pastionoxenme TpxGea sa Hota OGopyswatte 3a NOsLIBpAkAHe Ha Cyp.eUHHTe H JUNXaTETHHTE (pyHKUMH (OGzMUIBAHE). inanswaynaviara nova THonenran nappa sHasirresno. Jlosara TpsGea ta ce peryanpa & sanneHMocr or epexra (nprtiauit tia OSuta anecTesHa) npentopBkHTe Mo-slOAy sla ce HaTIOAIBAT CAMO KATO pbxonoscTao. Toit karo THOMeHTa HAMA OGesGostaBaLl eXbeKT, OHKHOBEHO € HEOGXOAHMO OMbtNHTesIHO Mpiutarane Ha ananrerHuut (ONOWAKH) pH Gta anecresHa, ‘Twonenras ne pxGea Ja ce mpiitara noBTOpHo HAN KATO HAdy3HEA (¢ HrAZHONeHHE NpH eruuteNTHNeH crarye) nopaain pick or kyMy.aauus. MakcuMaswara slo3a He TpsGRa j1a npesniniana 1000 mg. Breeocdane 6 o6a anecmesust Heo6xommmara 1034 € nponlopunonata na TeroTo Ha nauuenta, 3a moneaviane 8 anecTests, OOwMaiinaTa 2o3MpoBKa ¢ 2-5 mg/ke. 3a npasiuoTo OueHABAKE Ha NyRCTBITTEHOCTTA KEM THONEHTA € NpeNlOpHuHTEAHO sa Ce haGmonapar peaxnuntTe Ha NauWeHTa KbM TecToBaTa 03a (25-75 mg npHt BEspacTH) B NpoxDKEHHE na 60 CeKyHIN, MIpesiH Jia Ce MIDKEKTHPA 11O-BHCOKA A034, unkompatinua anecme set HeoSxonmMara sloxa e nporioputonasiia na Terioro na nauerra. \ 3a spucaatie B anlecreais oHuaiiHaTa oHpoBKa e 2-5 mg/kg ‘3 atys\O\ Henodaseay ce na xewenue enurenmuven emamye Tipit naunenr e HeKorrpomupyeMo cocrosnie ¢ rosie npuniaxwuun (grand mal status ), ‘THOTIEHTAN MOrKe Jla Ce MPHTOXKH KaTO Kpallilo epesteTBO ¢ Lien alecTesHA. Jlosata saBHeH OT 2xuBHeHIITe HloKaaTeNIH, HO OGHKHOBEHO e B ropitre TpaHHLUL Ha OROBHs METTEpRAL. TIpenopasa ce sta ce aanioune ¢ 5 mg/kg Tenecko Tero Karo Havaa 03a up EKT Konrpon 1H BrlocHeeTBHE ja ce MpsLrarar ome Ho 1-2 mg/kg TexlecHo Tero KaTO Gortye O3a Ha BCeKH 3-5 MHHYTH 1oKaTO ce HocTHrHe ps3Ko NoTHcKane Ha EET 3a 5-10 cexyus. Cex oKo.10 30 MIHYTH Moxe sla ociestBa HiIpy3Hs1 Ha 5 mg/kg TeeCHO TersIO Ha BCEKH Hac, KATO Ce srtom3Ba 110-¢:1460 KoHLeHTpHpaH pasTBop (aLDK T.4.4). Cres KATO ce MocTHrHe saryGa Ha cb3Hanine npriaranara 02a More Ja ce Hamat 10 1 mg/kg Tenecko Tero. Cte KATO MpHCTBITBT OTMHIHE, TIperlopHuNtTento © MHtpysiTA Ja ce MpobIHAH 3a ote 12 waca mpesH 2a Goule mpeparenta, BpeMeTo 3 BLICTAHOBABAME INe Ce Y:KbIDKH. Tlosuposka 2a nayuenmu ¢ 6v6pewno yepemcoane He neoGxoavmo peayunpatte Ha 103aTa npr auMeHTH € sleKo 10 yMepeHo GBOpeuHO yaperKutaHe. ‘Jlosara Tpa6va na Gre HaMaienia pH ManlHeHTH € TeKKO GROpesHo yapexaHe, ZTlosuposxa sa nayuenmu ¢ uepnodpobuo yepecdane He ¢ neoGxonnmo peayuuupante Ha 1024Ta IPH MaLeHTH € sleKO 10 yMepeHo YepHOIpOGHO yepexciane. Jlosara rpsGna Ja Ghite HaMleHa TIpH MalLeHTH € TexKO 4epHOAPOGHO yepenciane. Teouampuina nonynann Mankwe jtetta OGHKHOBEHO Ce HyK1a8T OT NO-BHCOKH {03H THON cppacten ae6nT H Gops0 pasnpestesterHe. 3a nosoposten (0-27 sw) ce npenopbuna noauponka or 3-5 mg/kg, Jleua Ha msapacr or 28 HH 10 23 mecena ce nyaaat oT 6-8 mg/kg Testecuo Tero. Ocrananre ena 1 fonountre oOHHainO HVAT HYAa OT CbUNITE LOIHPOBKE Ha kg TeslecHo Ters10 KAKTO HIpH BRApACTHHTe. ‘1 HOpasIM TEXHHs No-ronsMt Tosuposxa 2a nayuenmu 6 nanpednaia sespacm OGnKHOBeHO ce NpHsArA O-HHICKA J103A 3a BHBEAUIAHE B AHECTESHA IPH BHIPACTHH HaMLMeHTH (wai 60 roamuina sEspact) Tomuposxa npu nayuenmu, stoynompeGasaugu c arkoxon wnu napwomugu Tipu nawienTH cic cHHa 2aBHCHMOCT KBM aTKOXON WIM eKapeTBA, Moxke sla Gwe TpyaHO a ce AOCTHYHE OGULA AHECTESHA CAMO C THONCHTA H 1a BLSHHKHE HYAMa OT JOMBIHHTECH AHCCTETHK, Jlosuposxa 3a nayuenmu coc samivcmacane “Tpa6sa na ce va npesBHtt, We APH NAUEHTH cKe AaTTUCTIRAHE MOrKe Aa.€ HeOGXOANMA NO BHCOKA 03a 4a BbBEAAHE B OCA aHecTesHA. Tlosuposka 3a nayuenmu cred npemedurayua tert o6wa anecmesua Tlpu npemeankupanit # anecTesnpann pes nocaesuiTe 36 aca HallHeHTH, Moxke sla e locTaTBIHa nno-HMeKa jlo3a THoMeHTaN 3a anecTesHA Havwun na npuroowcenue (eure m.6.6) (Camo 3a HHTTpaseHosHa MIDKEKLNA. 43 Hpormsonoxasanns Capuxsryacranresniocr koM THoneHTas Ht apyrH GapGuTyparH Muacrenus rpaaie Crarye acraarikye, pecnupatopxi Hapyuiets, Teakka ueries (nopacit GpowXoKonCTpHKTHAHHs epeKT Ha THOMeHTAA) Zlexonnencnpava cpaewiia HeOCTATRAHOCT, TekKa KapAOMMONATH, CRpeNHIH apHeTMItH Ocrup muoxapaen mubapxr Texpk 10K Octpa vepHospo6na nopiupin Teakka meraGomrra suee>ynkiia Ocrpa irroKcHKaLits c a:1KOXO:, CBHOTHOPH, AHAATeTHUM HK NeHXOaKTHBHH slekapeTBa 44° Cuennaann npeaynpeatenns m npeanasin mepku mp ynorpeba Tlekapcrnenusr npoaykt TpAG8a Ja Gwe npiutaral camo or crieunasINeT, sanosMar c TEXHMKHTE Ha anecrens Topaan puck or norickane Ha aMNaTenHara dyHKIUA H CHpleNHaTa JeliHOCT, NpHsiHeHH oT GHpsa ibKeKTHaHe HIME BHCOKA 103A, TpsGHa ja Ha HeOGXOmHMATA eKHIHPOHKA H sleKapcTea 3a creLIHO ‘obaMIBaHe H pecycuirTaNHs (BibK 74.8). [uXaTenTe rrsTuIA TpAGBA 2a ce NOATEpKAT CROOK no oGwsaiTHHa Has (NosMIKHOHNpane, MirTyGauUHa). Txanna u endomema nowocuwocm ‘Toxarnata 1 ewlorenara nonocHMOCT Ha HiDKeKUNOHHHTe GapGirTypaTH He e 20Gpa nopan BicoKaTa asIKALIHOCT Ha pasTBOpa. HepnumareaHoro mirpaaprepHactHo npiviowkeHHMe Ha THONeHTaI BOM BeAHAra 0 aprepmaneH casa H Moke Ja MpHUNH TpoMGoxa ¢ rHocseRana raxrpena. Beswara TpsGea ja ce npestnpreMar -Mepki 3a nporiposelicrane, Hamp. G7oKaIa Ha GpaXHanA TEIEKCYC, BLBEKAAME Ha NPOKAKH HI AWLIOKAUH Hpe2 MIETpaaprepHauIHa HICKEKLINK Ht ELHOBPEMeHHa AHTHKOATY.TALNA. Henusareavoro apancHo3io MiDKeKTHpane MOXE Jia NPHYNHN MHHOrO GoslesHeH HepHT. B TaKbB cayuaii ppxara TpaGea aa Gbe HMOOHAMSHpana H 2a ce HanpasH on 3a acnMpupane Ha WOKEKUMOHHMA pasTBop ‘pes MocraseHara Karosta, Morar Ja Goat WsMOASBANH CHILO BABAHIT konmpect. [lpi mioxekTupane Ha 11o-roleMH KoMYeCTHA, MOTaT Ja ce HBTIOTIBAT MposyKTH, noanomaranui zuxpysusera (xnastyponnasa). TpxGea Jia ce H¥OKeKTHp—A fOsIKOKHO HBOTOHHYEH. wanonornuen pasTBop, 2a 1a paxpesi parrROpa Ha THONEHTALT, NPOHHKHALT & THKAHTA Visrrpanenosiara mivkeKUWIt MOXKe Jia OBede 0 3avepAABANE Ha ChslOBATA MHTHMA, CCOGEHO pH Gopsa mioKeKuNa B ManKrTe nett, [IpH (Ho-TeARKH CTYaK TORA MO%Ke ta NpHUAHH TPoMGodp-IeGHT. Brsnasienieto Wa HitTHMaTa € CBEPsaHO ¢ GoaKa H Morke Jia Ce HBGErHE KATO MIEKEKUNIATA Ce NOCTABA B nlo-ronewtre cbl0Re. Cheyuannu apynu nauenmy HeoGxoanmo € nosmiseto Bitsanne mpi: = MauneHTH B Hanpeanata sespact = KoMMentcmpana cEpaeuta Hegocrarwuntoct = Koponlapiia Gostect Ha cBpucro (KBC) = xportirina oGerpyxTuBtta GexoapoGna Gosiect (XOBB) = Gporxwana acta = ximopoewis = GuGpesna nesocrarpsnoct = NepHoapo6a HenocTarbunocT = aapenioxoprixama Hesoctare = cence ~ — wyexyana anerpodia BapGurypanire rlonpxasar uepeSpatnara nepdysi H BOUT 10 Gypso H 3HauHTeAHO NOHIKABAHE Ha mitrpakpannazmoto naziaranie. Ero 3auto € HeoOXOsIHMO MOBHIeHO BIMaNHE MPH NaLHeHTH ¢ MosbuHlo yapexctane nopaliN BRsMOKHa xHMOKCHA Ha LIHC. f Enwn dutaxout (1g) eesxepaka so 4,87 mmol (112 mg) arpa Heo6xosuMo e BIHMaHHe MpHt NaNHeHTH Ha KOHTposMpatia Ha Harp Mera, Hecvamecmunocmu u pasmaopu ‘Tnonenraa © xHMHveckH HecbBMeCTHM c pasTHOPH c HHIcKO PH 4 OkHEAABALUH petLecTRa H 3aTOBA ‘Takuma cyOcTaHUMnH He TpaOBA Ja Ce MEDKEKTHPAT EAHOBpeMerHO IH jla ce eMecRaT Hecbamectimit ca KOMGHnauHHTe ¢ aMMIKALINH, MeHMIUUIKHN, ebaroCrOpHNH, Ko.LeHH, edpespit, Mopepitn, cbexotiasiin, cykcaMmeroHti H-TYGoKypapi, Zia ce vanonsear camo npscHo npurvTsenu, GueTpH pasreopu. B caywail Ha Hero pasrpapane Ha €YXOTO neMLeCTBO IWIN TOMBTHABANE Ha MIDKEKUMOHKHA pasTBop, TO! He TpAGwa ja Ghine HaNO:TABAH B nKaKbs casa (810% 1.6.6) 4.5 Bsanmogeiicraue ¢ apyru aekapersenm mporykTH m apyrn dpopmu na Bsammoeiierone TpHt eantowpestenno npiutokenne Ha THOMeHTaI HJIpyrH sAeKapcTReHH NpoxyKTHM € weHTpa.ten Aempecinent efpex, Harp. HesponeNITHL, AHKCHOAHTHLUL, CeaTHON NpoxyKTH, axtrHLAenpecastTH, CcbitoTBopH, cenaTHBHN aHTTHXHCTAMHM, AMECTETHI, OTMOHLLHN AKALITETHU H HpoTHBOrspHOBL aekapeTBentu npoayKTH, edlexritTe HM ce MOTeHUNpaT tanMHO, ToRa HRHCKBA NO-HHCKH 03M Ha THoMeHTA: B HAKOH Cay4aHt AAKOXOALT ChILIO MOE a NOBAMAE eeKTa Ha THOTIeHTAA, Karo waso peuteeTsata, HitXHGHpauut HakoH “tepHoapoGHn ensHMtH (MurTOXpoM P450, ocoGeHo # ‘osm caysait wsoersHm ILA) Morar sta yitbookar H 3aciUgT exbexTa Ha SapGuTyparure W rlowoGwuTe Ha GapOwryparn weutectBa. Bap6uryparure namaranat exbexra na nekapersa, MeTaGonHMpAMH OT HepHOAPOGHTE MEKpOsOMEH e16Hstn (Hanp. CreponaHH XopMoHH, XOPMOHAIHH KOHTpAlLeMTHBH, JUUKYMapO.TOBH aMTTHKOALY.IaNtTH, rpHseodysiaity, dbenstaGyrason, dbeHasoN, cbenHTONH 1 T.H.) upe? eHRHMHa HILAYKIWNS. ‘Penoruasmmure (Karo 1opnponasi) H pesepman saciLBaT GparuKapuera H xMnoveNsHeTa, nnpeausenkani oF THonetTa. DeHorHasiMHe Morar CLO a 3AcHLAAT BRAGYAKTE NpOABH 1a ‘wonenras. XnmoreHsustnar exhext Ha THONeHTaLIa Moke sla ce oTeHLIMpa NpH KOMGHEHpanteTo My c apyrit aMrxnneprensmnnn ares, ACE wirxiGutropH Gera-GaokepH, KaktO € TPMMMK.AMIEI anruaenpecanta, MAO amxnGuropu 1 anrnmenxorumt. Meroxaonpanma saciisa espexra na THoneHTan H Taka NowKaBa HeOGNoAMMaTA jlo3a THONeHTAA. Jlelicrsnero 1a THonetran ce HoreHuuipa OF BAANpoeBA KueeAMMA H ce yHILKABA OT ‘rpanucammnpoxinn. Beuiectea, KouTO ce KONKYpupat ¢ THOHEHTas 3a CBEPSBALIN MecTa ¢ MutasMeHtTe NpoTeHHK, nanp.cyadonasman, Morar a 3acHIAT exhexta Ha THorTeHTaA H HeOGXoAUMATA 02a 2a HHTYKUN ‘rpaGna ja ce nasa “Aneriuicasmmmionara kutceamma 1 upoGemenmt svat BiicoKa cTeriel! Ha cRypsBane € MIasMeHHTE pore H cbullo Morar jla sacs e*pekra Ha THONEHTAL Anmmogucinn woxxe sa axraronsonpa eiperra Ha THomenraa ‘Toxcwuoctra tia Mevorpexcar ce yeitisa or THomeHTaa. 4.6 — Depruanrer, Gpemenuocr m kupmene y ; oo | Tlo ppeme na Gpementioct Tonentan Canutos He Tpa6sa sa ce nIpHaara, OcBeH AKO € aGCOmMOTHO neOOXosHMO. TpiitoxKeHara 03a TpsGea Ja Ghte MHHHMALTHA Ha He HatBHUIaBA 250 mg. ‘Tuonerrras npemmtiasa nzauestraptiara Gapwtepa. He nlontnana Tonyca tia Spemenmara Marka. ‘MakcuMasiit KonLeHTpaLMH Ha THOneHTad B ITBNHaTa BPbs Ce AOCTHMrar 2-3 MMHYTH cate sirTpanenosto mpicioxkene. Axo ce HS110s138a NIpH THHEKOTOTHMIIH OnepAltHH, THOHeHTAN MOE Ja MpHAHN HoTHEKANE Ha LLHC a HoBoposieHoTo. Kupmene Konuerrpaunire 8 waiiaiioro se1aKo ca HMekHt, AOPH H TIpH MIpwtaratte Ha BHICOKH JO3H THONeHTAM. Tlo-BHCOKH KPbEHHE KOHeHTpALHH MOAT fla Ce AOCTUTHAT NPM KEPMaYETATA OTKOAKOTO pH TeXHATE Maiixit nopai Hespemiix MeraGoznseM. KnpMeniero TpsGna a ce rpexparH 8 npostmrKenme 1a 36 aca exten outa aHecTeata ¢ THONEHTAA. 4.7 Edextu sxpxy enocoGocrra sa modmpane m paGora © mama ‘Til karo Tuonenrast Cani203 nonansna nicHxoMoTopHitTe YHKINH 34 OKOIO 24 Haca, NaUMEHTHTE He ‘rpaGea 1a uodbupar WIM paGoTaT ¢ MALIK pes TOSH NepHos. 48 Hexeaanu aekapersenu peaxnun Hesxenairre peaxunn ce kxaciopmupar criopes opraninitre cHCTeMH H YecToTa KaKTO cx1e,Ba: MHOTO ssecta (1/10), sectu (1/100, <1/10), Heer (>1/1000, <1/100), peau (>1/10000, <1/1000), sttioro peaxit (<1/10000) Hapyurenma na umynnara cHereMa Hevecmu: acieprwsinin peakusit, anarprtaruelt Wok ‘Muoeo peOwu: Wa eAMHIMIKH CLOGUIEHH 3a CiIYMAK Ha HMyHOXEMOIHTHUHA atten ¢ GoOpeua negocTarsaHoeT Tlewxnsnn Hapyutenna Mnoeo wecmu: coxysane (¢ HenpnaTHo yeeutane), ey*popirno HH anesbopuitio Hacrpoete Yeemu: 3aMasnoct, OOwpKAHOCT H AMHESHA cilen OGUIATa aHecTesHA Hapyuienia wa wepanara cuetema Hevecmu: snowonnn Muoco peoxu: wa cami cbo6uleHx 3a eyNan Ha Napasina Ha paca eps (Cepaeuno-cij108n apyurenia ‘Mnovo wecmu: no epene Wa BHReK ANE B OGtA aHlecTesHs perhteKTopHa TaXHKapAv, Gpaxnkapans, prrratta, Hastasapane Ha copes eGHT H chad Ha KpEBHOTO Hatarane. CrenleHTa Ha TesHt HeKeAaH PeaKUHHL 3ABHICH H OT CKOpOCTTA Ha HiDKeKTHpaKe. BpaankapaNsTa MOKE Ja Ce HOBAHAE © arporms. Hevecmu: noamuapave va xpysnoro natsrane Pecruparopiin, rpbjtit MeAMacTHHia Ha Hevecmu: Kamina, Kixaie Peoku: Aapunrochases M GpoHXocnaseM, OcoGeHO MO BPENE Ha BLBCAKAAHE B aHlecTEIHA Jlapmurocnases H GporxXocnas6M Morar ja BBSHHKHAT, aKO NapacuatnarMkowara cHeTeMa & noTHeHara no-MasIKO OT cHMMAaTHKOnaTa cHeTeMA (IPH Mpiviarave Ha arpor). Bypsoro Bpexciane 11K npezoaMpane Moxke sla OBesIe JO LeHTpasiHa pecrmpaTopHa jenpecus anes Yi Hapyurenna ua GuGpeunre u nmkowurre mruua ff 2/ C neusgecmna vecmoma: wawaziena Gv6pesHa pyHKUNA, a MPH BHCOKH 103M ~ NOmHyp! Cromaumno-upesnn napywienns Yecmu: noctonepaTusuo raeHe H nospBulane Hevecmu: xwauane Hapyuienia Ha enJoxpunnara cicrema nH MeraGosuaMa Yecmu: notpbttbalte Ha MYCKYJIMTe, TpelepeHe H XHNOTEPMHA MOraT a BLSMNKHAT BBB pasaTa Ha ppactanonsnane H cule oOulara anecTesHa Muozo peoxu: Mazwrnena xuneprepwnt Hapywienia na Korkara 1 nloiKoxHara TBKAH Peoxu: exairtesa, fyprypa W yprukapHs OSuu1 Hapyurenns 1 ecbexTH Ha MCTOTO Ha NpHTOKEHHE ‘Mnoco vecntu: 10Ka1H0 yepekaane Ha Cha H BBANALTEHME Ha CyAOBATA MHETHMA, TPOMGodpsIeGETT Lop 1 npx npeuraxo HitrpaneHoao npHsioxeHHe Ha pasTROpH c HOPMALIHa KOHIEHTpALINA Moxke 1a Ce Hogan Goska Ha MACTOTO Ha MpHLIOXeHHe. Hirrparenosnoro mpiiioxeHe Ha 0-KOHILeHTpHpanin pastopH MOXE sta ORe:Te 10 TpONGodpsIeGHT. Henpasiwioto mrrpaaprepianio mibkekTupante Ha THONeHTa:I OTKIONBA Be,IHAra ChAOB CHAE H Moxke sia HpHSMHH TpoMGosa c mociteaBaMa FaHrpeHa. [IPH TakHBa catyHaH € HEOEXOSLHMO sta ce npeanprieMar niexaGanHo nocnesimant MepKiH, HaNnp. GxoKacla Ha GpaxvatHus ruteKcyc, MiFrpaaprepHasinit HIDKEKLNM rIpoKAHE LIM AVIOKAHH HIM CBITETETBAMHA AHTTHKOArYAALINA. 4.9 TIpexosmpane Tpexosupaniero ce xapaxrepitupa ¢ noTHckante Ha pectiupatopHire H copsteuHo-ceaoBuTe ¢byHKLUNH AAO eTeNeH Ha PecrHpatopen i WUNPKY:IaTOPEH apecT ¢ MOG-AEABAULN CHMTTTOMH Ha MHOK. Jewenue na npedorupane TIpeanpuema ce cunmrromaritiio slevetiie Mpi HirTerRHBHO JeKapeko HaGmoeHMe ¢ Mo;LTEPAaNe Ha -xiGHeMHTE TOKa3ATEH, NOLTPKAHe Ha CbpACIHO-CosOBATA GYHIKUN (_EGHT, KaTeXOTAMUHH) 1 perrrivtanuiera. EauMuiupariero Ha THOMeHTaN Moxke Ja Ce 3acHLIM 4pes ShopeHpana LHypesa, neprrtonieaiia Hastioa HAH XeMonHaLTHSA. 5. MAPMAKOJOPHYHH CBONCTBA in cBoiicrBa 5.1 @apwaxoam apmaxorepanesrisitia rpynia: GapSuryparn ATC kon: NOLAFO3 Tuonenrras Cantos e wirrpanenorent GapGutypon atecrernk ¢ yatpakeco scfiersne. Toit He nossnaBa Gouikosava 4yBcTBiTTeAHOCT H HoWMUeTTHBHHTe pedreKcH. AtiatreTuunHst My epeKT € CBEP3AH ¢ eropirre anecreruni cnolictka. Mycky.Mara penaKcauna Ce MpoxBaBa caNO pH AOCTHTaHe Ha amosiGoxa antectesis. THomeHrrat noHicKaBA HHTPakpaHHaoTo HaLaraHe. Monexy:Hiirt MexanitseM Ha eiicTBHe Ha THOMeHTaLT € BCE Olle HeHarTBAHO HBACHEH, Anecrerimnr my eexr ce Atk tia nOTHcKaHe Ha HeBpoHaTHOTO BEAGyATIEHNe, OcHOBHOTO MaCTO Ha sLeiicTBHe € TaAMYca, KBETO BEIXOAULOTO MpestaBaHte Ha ApAsHeHteTo € HOTHCHATO B petukyziapHara cbopMaluia, Taka Ye CHTHAINTE HE ce NpetaBAT KbM MossiHara Kopa. B pesystrar Ha ‘nelictaneTo Ha THoneHTaA ce Ha6moxanaT NoBHIABAHE Ha LepeOPOBACKY.1apHlara PescTeHTHOCT H ocieslwalto NOHIDKaBAHe Ha LlepeOpaTHHs KPBBEH MOTOK H Ha LlePeSpattA KPLACH OGeM. 5.2 apmaxoxumerunn csoiicrsa SaryGara wa cesrianne Hacronna 30-40 cexytuin exes iv. npHuioxenme Ha Zo3ara 3a O6tua attecTestA.._\ TIsaGounnara ia anectesnara Moxke 11a ce 3acHAH & cHeaBauutTe 40 ceKyHAH. MIpoawiaRHTennocTTa \ na aclicrane 5-10 munyru ¢ pyscranonspane cae 10-30 wumtyTH. Flepuoster Ha nomesta anectesia 5-8 simnyrn, Pasnpeaenenne 84% or Tuonenraa ce esepinar ¢ niaaMemre npotenun, [upsonayatHoro painpexenenme nia cySeTanunsra e rxanio 8 A0Gpe nepdysuparn oprans (MoxBK, CEplle, 4epeH sApO6, Gan p06). Caeaina 6vp30 npepasnpenenenne, 1aBHo 8 MyckyaHTe. PaplloBecHe MEY HitBara B ILIaSMaTa HB Myekyatre ce 2ocrura 15-30 manyru cae mioxexusisTa. [poswoxterHocrra Ha anecresuara 3aBIICH OcHOBHO oF NpepasnpestesICHHETO OT MOIHKA KEM MycKy:utTe. HlopaaH HHeKaTa crenteH Ha Nepiy3ia B MacrHara TEKAH, PaBHORecHe Ha KOHLeHTpaLutre B nlasMaTa M MacTHaTa TLKaN ce octura ees 1.5-2.5 aca, MeraGoausnxt MeraGomupa ce raasio 8 4epHns 4p06 1 B Maka cTeneH B GuGpewste H mMoxBKa, 10-15% or axTHBHOTO RewlecTBO ce MeTaGomMOHpa ta BeeKHK Hac. 3-5% ce aecya+pypmpar slo nesroGapouTan, Koliro cpio HMa axeeTeTHTHeH eter. Eamsuusnpane Basnioro ocroGoxsanane or MacTure ena onpesiena ckopoctra Ha eaMMMnHMpane Ha THONeHTAN. Eanniiaunorierr nonyanipor cea exnoxpario nittpaseHoasio mpiutoxkenue e 6-12 4aca. Tlopa.an Gypsoro My npepasnperenenme, NostopHara HiDKeKUHA THONHTAN BoAH jo No-BAGOKA nposwsoxrrestna aviectesi, 5.3 Hpeaxammnu ramus Gesonacnoer TIpH narexone it siMUKH, AoxHBOTHOTO NpHLIO-KeHHE Ha GapCHrTypaTH npestnostaraeMo ce cwEpsBa c OGPOKANECTBEHH WHLIK S:IOKAYECTBEHH TYMOPHH KETKH B MepHHA APO. BunpeKn omeret 8 NposwnKeHHe Ha AeceTHLIETHA B AHATOCpONHOTO AeHeNH ¢ GapSHTYpaTH, nce OMe AHNeRAT AOcTOBEpHH AHH, KOHTO Ja HlOTEDPART CHTYPHHA KanUeporeHeH etPEKT MPH MOBEKA, BHHIPEKH HE JiMa OnncaHH OTeAHH CHTysaH Ha NepHOAPOGHH TYMOPH Cale ThAITOTpa‘lHO TeeHHe ¢ NepopaTH GapGuryparn. PenpodykTHBHa TOKCHMHOCT Howe be ‘OKaRaTeNICTBA 3a TepaTOreHeH eheKT KAKTO NPH NPoy'BAHH pH rpH3aH, TAKA H mpi ernseatnoorvsn poyani np Hogexa (exenosN no wpeMe Ha rprie d weceta oT. GpeMmennocrra), CuvirroMn Ha OTHeNaHe ca HaG.0aBAKIK MHpH WOBOPOLeHM, Ha sHHETO Mali € GHLT nprtoxeH THoTeHTaL. 6 ®APMANEBTHYHH ABH 6.1 Crnevx na nomouunre nemectBa Hawa Taxnpa, 6.2 Hecpsmecrumocrm = : nnauneutecrs. syyccr¢ partnopit cHexo pH H OK eae eae " Fae min, tuecpalocropHHH, KOEHH, ebeapun, 1 ca KOMONHALMBTTE € ANIM cesar eorsasn, eyxsaMerou TyGoxypapin (ox 48) 63 Cpox ma roanocr : NS) taNe\ 4 roam 6 64 Cnenmaann yeronus Ha coxpanenne \ : ; | \ 4 fe 2a ce eexpaniana npit tennieparypa noa 25 °C. Zia ce evxpatiaea B6e BRHUIHATA OnAKOBKA, 3aULTEN OT cBETANNA. Toronnar pasrop moxke a ce Cuxpansba Hsia ce WBHtoM3Ba 0 6 Haca rIpH TeMmepatypa 25°C HH s10° 24 waca npn temmeparypa or 2°C 10 8°C (X7AAHUHK). AKO FOTOBNAT pasTBOP NPOMEHH UBETA CH, He ‘rpaGna 1a Goae WsowsBaN. SS anuu sa onaxonxara ‘Onaxonkn or 25 m 50 dyaKont. He ncwuxi aiiose onakoaki Morar a Gwaar nycHaTH 8 mponaK6a, 6.6 Cnenma. WH MIpeAMasHM MepKA MPH HSXBLpasIe H paGora Pasreapane Haii-oGuo ce npenopauna 2,5 ~ 5% pasruop wp vo. 3a niOweKtU, HaoroMMKH ea 3.4%-re poANH pastaopit He ce npenopb4sa H3nos3RaHeTO Ha ApyrH pasTBopHTenH (NaCl, raoKosa), Tit KATO xiinepronwunitte pasTopi Ha THontertran Caiios Morar ja npHannT GosiKa, Hounesanane a KonLeHTpaunure 3a KaMMHUHA ynoTpeGa: wuewrpauin | Konuevrpauuia (mg/ml) | HeoGxoaunw konnwecrsa Twonenran (g) | Bona sa wirxexunn ee (ml) 25 25 10 40 5.0 50 Lo 20 Pastuopire He chimhprxaT KOHCEpHaHTH H ca npenWAsHaYeHH 3a HesaGasHo MpHAOHEHHE Jla ce npwxarar caso npacHo npurorsenn GnetpH pastsopu. B esty4aii na HerNo pasTBapAHe Ha ChiLpARANHETO HK NIMTHOCT, pasTHOPHT He TpAGHA Ja Ce MpHLAArA pH HHKAKBH OGeTOsTeNCTHA Ako pogaTa 3a HIDKEKUMH noMBTHee cae HOGaBaHeTo Ha THoneHTad Cantos, pasTBopoT He TpAGBA la ce MHDKEKTHpA. 7, TIPHTEXKATEJI HA PA3PELUEHHETO 3A YIIOTPEBA Sandoz GmbH 10 Biochemiestrasse, 6250 Kundl, Avi pHs 8. HOMEP HA PA3PELIEHMETO 3A YIOTPEBA 20010824 9, ATA HA ITBPBO PA3PEWIABAHE/TOJHOBABAHE HA PA3PELIEHHETO 34, YTOTPEBA mmupeo paapeuranane - 24.07.2001 noanopaBane ~ 16.10.2006

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