MMHUCTEPCTBO 3APABOOXPAHEHMA POCCHACKOM PEJEPAUHH HHCTPYKIMA 110 MEXMUMHCKOMY MPHMEHEHHIO JIEKAPCTBEHHOYO IIPENAPATA Tam-KOBH-Bax, KomGunupopansas eekropuan saxusia jis npopuaaxTuKn Koponapupycnoit HNdexuuH, BLISLIBAeMoll BHPycom SARS-CoV-2 | Vilanusit aexapcrsenmuiii npenapar saperuerpuposa no mpoueaype perterpaumn Npenapatos, mpemHasHatenHuIx fIa MpHMeHeHHA B YCAOBMAX yrpOIbI ROBHMKHOREHIA, | ROsHMKHOBeHMS H AMKBHAAMNH 4pesBEraaiineix cuTyaunii. Muctpykuus nonrorossena Ha OcHOBaNHN OrpaHMYentoro OGLeMa KAMHNYeCKHX AAHHBIX fo MpuMeHeHO |Penapara u Gyser xonoaMATKeR no Mepe nocTyHeHHA HoBLIX jaMHBX. TpuMenenne Npeniapara BosMoxHO TOKO B YCIORHAX MeRUUNHMCKHX opramaannii, uneromNX npaso OcyMeCTBART — BAKNMMONpOdNAKTHKY —-HaceneHMA = B-yeTaMOBAeHHOM |sakononatearersom nopaake — - MMH3MPAB POCCHH | JM ~ 606395-110820 Perncrpannonuniii womep: Topronoe naunenonanne: F3-KOBHA-Hax, Koummpooanian vextopuon eaxuutia nna npodunaKruKH Kopoxanupycuoll uibexunH, BbrsLIBaemoit Bpycom SARS-CoV-2 Mexaysaponnoe Henarentopannoe H.1H Fpynnupopounoe HaNMenopanne: Baxuna ana mpoduiaxruxn Hosoi KoponaeupycHoii unex (COVID-19) Jlekapernennas popma: pacteop 418 BHYTPHMbIMIeYHOTO BBeneHHLA Cocran Coctas na 1 nosy (0,5 ma): Komnonenr I conepaur: Alelicmeyiowee sewecmso: pexomOumautasie aneopupycrbie actaust 26 ceporuna, comepxanne ren Genka S supyca SARS-CoV-2, p komnuectse (1,00,5) x 10!! sactmu/nosa. Benomozamenbnoie eewecmsa: Tpre(ruapoKcHaMeria)amaHomeran -1,21 Mr, HarpHa xTopua- 2,19 mr, caxaposa -25,0 mr, Marna x0pua rexcarnapat -102,0 mxr, 3/ITAsMHaTpHeBas Come auranpar - 19,0 scxr, onncopGar 80 - 250 M«r, 3raHom 95% - 2,5 MEI, Bona Ana HABEKUDH 20 0,5 san, Konmouenr I conepaxur: Felicmeyrowee sewecmso: pexonGuuantable anenoupycubte vacTuuks 5 ceporuma, coneprxauune ren Genka S Bupyca SARS-CoV-2, w xonmuectse (1,020,5) x 10" yacrnu/gosa. Benomocamenouste eujecmea: Tpac(ruapoKcwimetHn)aMHMoMeTaH -1,21 Mr, HaTpHA xTOpHa- 2,19 mr, caxaposa -25,0 mr, Marana xnophaa rexcaruapar -102,0 xr, SIT AnmiarpHenaa comb aurnapar - 19,0 xr, nonmcopGar- 80- 250 m«r, staHos 95% - 2,5 me, Bona a HATBEKULA 20 0,5 ma. Onneanne: Kommonent I. Pactsop samopoxesutsi. Fpencraznset co6oii nioryio sareepaesiyio Genosaroro peta maccy. TMocxe pasmopaxnBanis: ognopoanbilt GecuseTHBili Wik c >XenTOBATSIM OTTEHKOM cHlerKa oraieclWApy:OUNlk pacTBOp. Komnonent Il, Pactsop samopoxennmii. Ipeacranaser co6ofi nnotiyio sarsepaenmiyio Senosaroro peta maccy. Tocne pasmopaxneannx: onHopoaNbi GecuseTHsili wai ¢ .KeNTOBATLIM OTTeHKOM chlerka onanecuMpyiounaii pacteop. OF “HUIS HM. He. FAMAMEM" (MMMHGAPABAXapaxrepuctuxa: Baxuuna nonyiena GHotexnosorMyeckum nyreM, mp KOTOpOM He Henlombsyetes Natorentbili aaa YenoneKa Bupyc SARS-CoV-2, [penapar cocront 13 2Byx KoMMOHeHTOB: KoMMiouenT I Kommouent I. B cocras KomnoneHta T BXOAMT pexoMOUHaNTHti aeHopupycHtill BeKTOp Ha OcHOne alleHoBupyca YenoBeKa 26 cepotuna, Hecytuit ren Genka S- Bupyca SARS-CoV-2, 8 cocras xomoxetita Il pxogiT BeKrop Ha ociione ateHoBupyea senopexa 5 cepotuma, tecytnit ren Geaxa $ supyca SARS-CoV-2. ‘Papmaxorepanestuseckas rpynna: MUBII-vaxuna, MI3IPAB POCCHH Kon ATX: J07B AN - 06395-10820 FOr TACOBAHO ®apmaxonorneckue ceoiicrsa | Batauua wHayuMpyeT (bopMHpoBaHHe FyMopaibHOTO H KIeTOUHOTO MMMYHHTeTA B OTHOWICHHH Koponasnpycuoii unbexunn, abrabmaemoii Bupycom SARS-CoV-2. Hwmynonornueckas obibexrustoct Vmynonormeckwe caoficrra | GesonacHocTs BaKHHL M3yYanit 8 KNHHMECKOM HecnenonaHHH y B3pocnbIx 30poBsIX nOGpoBOABUEB OGoero THOMA B BospacTe oF 18 0 60 ser: 9 ao6pononsuies Morya KoMnouexT 1, 9 - KoMMoHeHT lI H 20 - B pexuMe npaiim-Gycr. Uemyroreinocrs “‘ouennmamt no yposio crenuiseckux IgG-anraren x Genxy S xoponasupyca SARS-CoV-2 u supycuelirpammyuuHx anTHTen, a TAKE fo ObpaxoRanm chienmdusecknx T-xeanepabix (CD4+) # uxtoroKcuyecknx (CD8+) mumousros. OueHKy yponns creunduveckux IgG nposomHMt B cpaBHenHH ¢ HCXORHBIM ypoRHeM axTHTen (ao wmnyrnsannn). ¥ pcex yuacrHuKos HccHenOBAHA, HOnyyaBWINX Mperiapar, oSpasoRanice cheumpuveckie aururena. Ha 42 cyrku cpesmereometpmeckoe sHaYeHHe THTpa cocTaBiio ~ 14 703, np 100% cepoxousepeun. Tawxe na 42 cyrkH OT Havana BaKWMHallHit ® chIBOPOTKE XpoBH Bcex HOGponombiles AeTeKTHpoBaliLl Bipycueittpanusyioune axtTuTeaa K Bupycy SARS- CoV-2 co epenuum Turpom 49,3, AKTHBHOCTS KxreTOUHOTO HMMyHHTeTa OleHHBATH B TecTe muMdonponmepaunHCD4+ 1 CD8+, a TaIoKe lO Mpupocty KoneHTpatuH HHITepdepoua raMMa B OTBET Ha CTHMYAALMIO MHTOFeHOM (ramkonporens S). Vuoyunsauist penaparom [am-KOBHJI-Bax, psiseana chopwuposarne HanpsxeHsoro aNTHTeH-CreundutecKoro KAeTOYHOTO MpoTHBOMHeKuMOHHOTO —MMyiuTera y 100% AoGponoabuies (opMuponanne anTuren-cncumpuaubix KACTOK oGoux nonysauuit T ausbourtos: T xennepubix (CD4+) mT xunaepsix (CD8#) 4 noctosepHomy nopsuleHHio ‘cexpenu HOHy ). SauurrHoiii THT axTHTeM B HacToauIee spems HeNBBecreH. TlponomxuTembHocTs 3aHTEt wenapectia, KanniueckHe uccnenOBaHHA No HayYeHHIo SmuAeMuONOrH4ecKOH S¢bcexTHBHOCTH Me mposoguauce, Toxasauna x npHmenenmo: Tpopuaaxtaxa Hosoi KoponapupycHoit weextuan (COVID-19) y wspocabix 18-60 ner Tiporusonoxasanus: — TunepsypcranrenbHocrs x kaKOMY-lHGO KOMMOHeHTY BaKWHHBI IH BaKMHHEI, conepscamtell anaorMsiibte KOMMOHCHTEI; — DoKembie annepritieckne peaxunn B anramHese; — octpHle HndexunomnEre H nenMbexuMOHHBIe sa6oneRAHHA, OGocrpeHNe xpoHHyeckux saGonenennii — pakunuanmo mpowonst Yepes 2-4 HeneaN Tlocne BEIsAOpoRTeHHs AnH pemuccun. TIpx HetmKenurx OPBH, octpsix undbexunomnsix 3aGonenanuax JKKT. BaKIUMHAYHIO NOBOAAT Noche HOpMaHsauKH TeMNepatypst;, — Gepementiocrs 1 nepHoa rpyanoro BcKxapmansanna; — aospacr no 18 ner (s cwa3n c orcyrcrBHeM aaHHEIx 06 odexTHBHOCTH Ht GesonacHocTH) OrBy "HUM, Es Ho. TAMANEN" MMMHBPABA POCCIAM ‘=Tporsonoxasanis 114 swencnua KoMnonenta I] — DOKEABIE MOCTBAKUMHAMBHBIE OCTOKHENHA (aeduex TeHepanusopanHble alepruveckHe peakunH, c¥mppoxHbiit iTypa soe 40 °C H 1.2.) Ha BuexenHe KoMnoneHTa I BaKUAHE: NSARM POE AM 006395-i 10820 C ocropoxnocrs10 Tipu xpounueckux saGonenaHHaX neveHH H TOYeK, BbIpaKenterx Hapieihditlickll bynnuHn SHAOKPHHHOH CHCTeMbI (caxapHEtit AHaGeT), TaKeNBIX 3a6OsCRAHHAX CHiCTeMBT KPORETHOPE HUA, omiuienc, HHCyabTax u ApyrHx saGonenannax LHC, sa6onewannax cepneyno-cocyaucrol cHcTeMé! (litbapKTaX MioKAapAA B avaMHese, MHOKapHHTAX, 91WLoKapaMTax, mepHKapsurax, MullemiecKoHi GonesHn cepauta), NepBHYHENX H BTOPHIHEIX HMMYHONeDHUMTAX, AyTORMMYHHEIX sa6onenanHax, saGonepanuax serkux, acrme uw XOBJI, y mauvewtos c nuaGetom 1 MeraGonH¥eckHIM CHEAPOMOM, C A/LTePTHMIeCKHMH PeakUMAMH, aTONHell, 2K3eMoh. Mecra, re npoboaHTea BaKUMMALINA, NOTKHD GblTh OcHALLeNBI epeneTBAMH TIpOTHBOMIOKOBOI Tepanun B coorsetersun ¢ TipuKasom Munncrepcrsa snpasooxpaenua Pd or 20 neKabpa 2012 r. N 1079 «O6 yreepauennn craimapra cKopor MenMUMHeKoH MOMOMN mpi aniagunaxritiecKom Woke). B xen nponerenus paxunHauHH nalwenT nomKeH Gbrre ocMorpen Bpavom: oGssaTenBHBIM spnietca oBiHi OcMOTp Ht HIMepeHHe TeMMepatyps! Tena, » ciyyae eci Temmeparypa npesstuiaer 37 °C, naxumHanvio He MpoROnAT, Tpumenenne mpu Gepemennocr 4 8 rlepHon rpynnoro BcKapMaMBaHHS, Tipenapar npotuponoKasax pu GepemeHHOCTH HB MepHOn rpyANOrO BKApMIHBAHHA, Tak KaK ero odipexTHBHOCTS H GesonacHocrs B 9TOT nepHos He HayyanHce. Cnoco6 npumenenus H 10301 Baxunna npenwasHatena TomsKO JIA BHYTPHMBIMeIHOrO BBeHeHAA. Crporo sanpeuteHo BuyrpHBeHHoe BBeneHHe Npenapara. BaKUMHY BBOAAT B AeNBTOBMAHYIO MbIMILY (BEPxIIOIO TpeT Hapyxuoi nowepxuocTH neva). 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Tlocae peenenux naxyinue naqueHT NOwKeH HaXOAMTECA MOA HAGHIOAeHMEM MeRMUKHCKHX PaGorHHKos B Tevenne 30 mamyr. ‘Orby "HALISM 1M, Hud. FAMASIEM" MVH32PABA PoccunVudopmauna ana MeaHmmicKHx — paGoTHMKoB, —BLIONHAIOMINX _ naKLUMTtaMmO JiekapeTBeHibIM mperrapaToM: naHMetit neKapcracHstai npenapar saperHcTpupopatt 110 ocoGolk Mpouleaype PerHeTpaNit, B CBASH, ¢ eM HEOOXOAHMO yaenowAAre DeneparsuyIo cayHGY no Hamopy 8 cibepe anpasooxpantertia 0 KaxvIOM ¢bakTe IpHMeNeHiia jleKapcTBeHHOro nperapara nyrem BHecenua MAopmauuH B cooTBeTcrByoUteH it EFHC3 MiUN3/PAB_POCCHR Al - 606395-110820 COraACOBAHO TloGosnoe selicrnne a Hexenarenbibie abieHHs, XapakrepHbte ANA MpHMeHEHHA BaKUMHEL, BLIABNEHHBIE B paMKax KnHHMeCKHX HccneROBAHHi, a TAKE HCCMeLOBAHHI, APYTHX BaKLMH Ha OCHOBE allanOrMAHO! TexHonOrHdecKoit mnartbopsai, GuIBaOT MpeMMYeCTREHHO HerKoHl HAH cpemHell crenenn BHIPAKEHHOCTH, MOryT pasBHBaTSCa B Mlepabe-RTOpWe cyTKM Tloche BAKUMHaNHH A Paspeutaiorca & tevenme 3-x mocieayrouNx uel, Yame apyrux moryr pasputsca Kparkoppemenribte — oGuwe—(HenportomkHTenbubI —-rpunnonono6usti? —cummpom, Xapaktepuayiouutiicn o3H0GoM, TOBLIMIeHNeM TeMMepaTypsl Tena, aprpanrHeH, mnanrieii, actennel, oGuuMm HexoMoranHem, TonOBHOH Gombi0) H mecTHbIe (GonesHeHHOCTS B Mecte MHDEKUMH, THILePEMHs, OTeYHOCTS) peakuHH). PeKoMeHAyeTcA HasHAYeHHe HecrepoHNAEIX npoTMonocnammrensusix cpeqeTs (HIIBC) npH noseilieHH TeMmepatypsi ocie BaKUMHALNA, Pexe oTmevaiores ToumMoTa, AMcencHs, cIpKeHMe anneTHTa, HHorMa - yBemmuenne PerHonapHEx aHMtpoysioB. Y HeKOTOpLIX MalHeHTOB BOSMOKHO pasBNTHe annepruyecKHx Peaxunii, KparkoBpeMentioe MoBbIHeHHe yponHa MleveHOUNBIX TpaHcamMntas, KpeaTHHHHa WM kpearumdocoxitiaani 8 cbIBOpOTKe KPOBH. 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OTKIOHeHHS B Swen axaause mown: spHTpownTss B Move, Bombuinicte Hil saBepuiMaHc® BiXSLOpoBmeHHeM 6c3 nocneuctsnii (144 HA). Ha 42 news uccneaopanua ne sazepusmmict 31 HST (Hexon Guin vewsnecten sia - HA u wen mpouece esisnoposnenus - 4 HA) - na6opatopasie oTknoHeHHA ‘Ory "HALIM MM. 1.0. TAMANIEM" = MMH3I)PABA POCCIMMMIMMYHONOTHYeCKHX NOKaxaTeNeH, TO He HMeeT KIMHHNECKOTO sHANeHHS (He HYAMAeTCA npoReeHHH JOOAHMTeNbHBIX ANArHOCTHYeCKHX NPOUeRYp W HasHasieHHs Tepann).. Tlepexosuposka O cayyasx mepenosHposxi He coo6uasiocy. ‘Yuutsias, uTo OTMycK seKapcTBeHHOrO Mperapata JonycKacTea TONbKO Wid seyeOHO- TpounakTuveckux yupexwteHui, += CaM@_~—«BAKIMHANM = MIpOBOHTCR © TOBKO Kua nbUMpOBAHHBIM MERHUAHCKHM TlepcoHAIOM, PHCK MepeMo3HpOBKH KPaliHe HIE3OK. OgHako MOxKHO MpeaMOTOxHTS, 470 MpH cywaliuol nepegosMpoBKe BOSMOKHO pasBUTHE {YkadaHHEIX RIE TOKCHMECKUX H TOKCHKO-ANIeprHYeCKHX peaKiA B Gonee TaKesIOH creneHHK. ‘Cnenunnsecknx anraqoTos x mpenapaty He cyulectayer. 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Bauaume wa cnoco6uocrs ynpapasTs TpancnoprHLimMM cpeqcTBaMH, MexaHH3MaMHt Heccnegonaniia 0 H3yeHHI0 BIMAHHA BAKKMHEI Ha CHOCOGHOCTS ynpaBIATE TPacnOpTHBIMH cpencTBaMi H MOTEHUHANEHO ONACHBIMH MeXaHHSMaMHt He MPOBOHANCS. opma BumycKa Pactaop Jia BHYTPHMBUMTeMHOTO BBEMeHHA, KOMTOHEHT I - 0,5 nen/po3a + KoMMONeHT IT - 0,5 w/go3a. Tipu npowsnorctse STBY «HHLOM um. Hb. Tamanew» Muusapasa Pocenu (pumian «Menramam OTBY «HMIIIM um. H.®. Pamanew» Munsapapa Poccan): mo 0,5 ma (I 03a) kaxgoro KOMMOHeHTa mpenapara Bo ¢bnaKousi —elftpanbHoro crexna —mlepporo Tagpomutu4eckoro Kacca (rina 2R, 4R), repMeTH4Ho YkynopeHHEIX mpoOKawi H3 pes1Hsi, OGKATLIX ATIOMHMMEBLIMH 11H ANOMOTIACTHKOBBIMH KONNAYKANH. Ha dnaxonst naxqenparor oTHKeTKy H3 Gymarn mHcHeit no TOCT 18510-87 nan aTHKeTouHOi no FOCT 7625-86, wan oTHKeTKy 49 caMoKNemmeroca Marepuaia no TY 13.96.17-001- 90585582-2019 nam ananornatoro KavecTsa. 1 Gaakon Komnonenta I ¢ HHCTPyKMHeit TO MpHMeHEHHO NOMeNLaIOT B NAYKY KapTOHLyto 0 OCT 64-071-89 an nauKy H3 KaproHa Kopo6ouHoro Maps xpom-opsau nH A no TOCT 7973-89; 1 dpnaxon Kommonenta II ¢ HNCTpyKLMeH lo NpHMeHEHHIO NoMelaOT B naNKy kapronnyto no OCT 64-071-89 nnn B auKy 43 KapToHa KOpOGOuHIOTO MaPKH XPOM-opaai, HTH Anno FOCT 7973-89 Tipu nporsnoncrae AO «Bunnodapyo: Tlo 0,5 san (1 02a) kaxkuloro KoMnoneHTa npertapata » anys no ISO 9187 wn TY 9462-001- 53908805-2006 ua Gecupettoro crekaa 1-ro rHAponHTHYecKOTO Ksacca BMECTHMOCTEIO 1 MAC upeTHoii TOHKoii. Ha KaxkayIo AMMTYAY HaKMeHBALOT OTHKETKY. Tlo 5 amnyn Kaxuloro KOMMOHeHTa Mpenlapara NOMELIAIOT B KOHTYPHYIO AUEHIKOBYIO YIAKOBKY 19 neHKH nonMBMAAAXAOpHAHOL Tlo | KouTypHoit a4elikoBoli ynakopKe BMecTe ¢ HHCTpyKuHeli Oo NpHMeHeHMIO TOMeMaioT B nauxy 3 Kaprona mo TOCT 33781-2016. (OTBY "HALIM HAM, Ho. rAMANEM" ‘MMHBIIPABA OCCAYeaosus xpanenua: Xpain7s p sauumuenHom or cnera Mecte, npa Temneparype He BMI Munyc 18°C. He qonyckaetoa xpasiene pasmopoxextioro npentapara Gonee 30 munyr! pants B HenoctymHom suns neTeii mecre. Yeaosus Tpaticnoptupopanns: Tpanicnoptuponarne npenapara np Temepatype He BLue munye 18 °C. TIpustensim crtoco6 TpartcnopruposkH ¢ CYXHM sIbOM. Cpox roauoctm: 6 mecauen. He npumenars no ntetewenun spo TOMMY LDA POC ‘Yeaosna oTmycKa: 119 neveGuo-npodpanakTHyeckux, yapexrennii. Ill - 606395-110820 | JACOBA Mpowssoanress | CoraacoBano HanMeopanma 4 anpeca npowssoncrseHHBIX ToUlaxK npousBonHTens nexapeTecHiioro Npetapara: 1) @PBY «HLM um. H., Taanem Munsgpara Poccun (anna «Mearaman TY «HHU2M um. H.. Pamanem» Munsupasa Pocen), Poccus, 123098, r. Mockra, yanua Tamanen, a. 18. (sce crag mpousponerBa): 2) AO «Buniodapw, Pocena, 124460, r. Mockna, r. 3enenorpan, yn. Konctpyxtopa PycoKona, a. 3, erp. 1 (ounerka, poanus (nepsH4taa ynaKoBKa), ynaxonka (BTopHyHaa noTpebMTeNDCKAR ynlaxoska) Baaneneu peruerpanuonsoro ysocrosepenus/opramnanns, MpHMNMaroUIad npereHsHH norpeGuresta: OFBY cHaunonanbusiii Hcenenosatenscknit yep onieMMonorHH w MHKPOGHONOTHK HMeHH WoweTHoro akazemuka Hb. Tamanem) Muuuctepersa snpasooxpaiiesma Poccutickoii enepauun (OTBY Tunu6ypr AJ. Munsapaza Pocenn OF6y "HALDM YM, H.@. TAMANEM" MMH3DPABA Poccun