3BMPEH U3BELUTAJ 3A OCOBMHMTE HA NEKOT 1.MME HA SIEKOT. CnacmeKe cbopre 5 mg ra6netn, 2. KBANMTATMBEH M KBAHTHTATMBEH COCTAB TROSPIUM CHLORIDE 4 Ta6nera coapxn 5 mg Tpocnuyy xnopig, Tomoua cocrojm: naxrosa Movoxigpar. 1 ra6nera conpxct 78,7mg naxrosa MoHoxngpar. Ocraatute noownn cocrojkn ce HaBeneHH 80 penot 6.4, 3.@APMAUIEBTCKA @OPMA Tabnem TaBnerure ce Genn go cxopo Genu, oxpyrnnt M paMH co saKocenH arn 4.KTMHMUKM TORATOUN 4.4 Tepanestexn wnanKaunn Tpocnuys xnopwa e Myckapukcen peyenTopeH aNTaroHMcr. Toj awa enaaMonieT Ko ‘mejcTeo aps ashure mycxyni, Tpocnayse xnopng ce KopucTa 3a nexyearse Ha + byniuwonanen cnasaNe Ha masiara Myckynatypa Bo ractpomHTecrAMannnTe aTHWTa, KONNAHOT Meyp, KOMGHMTE NaTHUTa H YpOreHTANHHOT TpaKT, * nocroneparveen cnasam Ha masHara myckynatypa Bo ractpoulrectuwanHnTe arma, xoMHHOT Meyp, MOMYAMOT Meyp H ypOreMATANHHOT TpaKT, + arolicka Kesosapxanoct wiunn sroneexa ypiHapria copexsenunja « HeonxonHoc 2a OfeHbe 80 ToaNeT Koe TO MOE fa Ce NojaBH Kaj naLIMeNTH CO NpexyMepHo aKTHBeH MoNeN Mey—p (Ha Np. WAMONaTCKa Mnh HeBpoNoUKA "NpexymepHa akrieHocr), 4.2 Hoamparee w naunn Ha ynorpeGa Mpenopavanara aneswa Aosa vaHecysa 1 Ao 2 TaGneTH TPA naTH Ha feH (uO entiaxso Ha 15 n0 30mg Tpocnuyse xnopwa Ha eH) nn 4 TaGneTH ea nara Ha ROH (wo e enwaxso wa 40 mg rpocniym xnopwa Ha nek). Maxenmanwara qeascnena aHeeva nosa usHecysa 45 mgFlaunetTa co 6y6pexio owrerypaise: oj nauwess co cepncato penanho oueTyeaise (knupenc Kpearimnn <30 lina), "npenopawanara AHeBHa 02a vsHecyea 20 mg enHaul Ha jleH npen crmene, Gnacwexc Ype6a Aa ce seta co valua Bona BapeM exen Nac npen o6pox MotpeGara 8 nponouipavo nenysaise Tpe6a fa ce npoBepyea Ha penosin wuTepeann of 3-8 meceun Gracnexc He Tpe6a na ce ynorpe6yea raj agua non 12 ron nopagw HegocraroK wa onaToUN 2a Gesbeqnoct W edhwwachocr. 4.3 Konrpannannaunn jrnasueke dopre TaGnernTe He cwear Aa ce ynorpebysaar raj nalinghTH co nostra none NTMENOCT Hal TpOcrMyM anOBNA MMH HA Gx Koja noMoUKa cocToja ra exor. Flexor we tpe6a Ao ro semaar naywesTa co cepHosua xpoHnuNa unpnamaropna rayron ea na Gonecr (ynueposen konnrac, Kpowosa Gonect), TOXCHeN weraKoron, aykow co TeceH aron, TaxvapuTMnja w mMacrexuja rpaBue, fener We cee A Ce Aasa Wa nalweNTH co ypuNapHa pereMpla W nayreHTH co ‘PepHoaHo OurTeTeHa penania cbykKunja KOM uMaaT noTpeGa On xeMonWiaruas [iepoAw anor po] NogaTOUM WTO C8 ontecysaaT Ka Gesbexvocta W ecpmachocra Ne Toca xnopia va Aue, RoUa NOR 12 roRMNN He cweaT Aa TO NpmuaaT O89) nek 4.4Mepra Ha npernaannaoct u noceSun npeaynpenyeaia RoceGva npeTnasnweoct @ nompeGua aj NALNCKTH co MexaHiN crevooa wa FomnaneTectavannuTe narmuTa KaKo WTO @ nunopHa cTeHo3a, Kaj naumeNT co Toncabia peTenunja kaj KOM nocTow prim on peawayanna ypuNa (xa np Gonna ceog bos wa npocrara), xepHna wa aujacbparwara (xnarye xepria) m peconyneos S2ocbanntc, Hapyuryeaisa a ABTOHOMMHOT HepBEH cHCTeM, Kal neamerme akon Ges0To cpueGuerwe He © noMeno (xunepTMpounnaam, Coneer. ma kopowapHara Miron senownyearee wa Tepanvjara TpeGa fa ce HeKyar oprancgITe. npitwnn 2a reer pbekBeunja, cpuesa cnaGocr, Gonect Ha Gy6pesie, nonwumona x ‘weber writ TyMopit Ha ypunapHuTe narHusra,NoceGvo eHiMare TpeGa a ce nocseTH 2a BpEMe na HiTpaDeHCKO neKyEaHse co ‘TPocnHYM XnOpWy Kaj NocTapH naLWeHTH co cpLiesa cnaBocT M saBomyBaive Ha Gene apo6oan, Barna mncbopmaynja sa Nexon on cocrojaute Ha neKor Flexor conpier nakrosa woHoxmapar Mauve co perky HaCneAHM npoGneMn 20 cave a HenoAHocnMBocr Ha ranaxrosa, Lapp makrosa AecpMUMT wn rnyro30. FanakrosHa manancopnusja He Moke na ro ynotpebyeaar o80j nex 4.Siinropaxunn co Apyru nexoen unn apyrH opun wa mHTopaKinja Votospetienara ynorpe6a a Tpochiys xnopia co amaHTaais, TpMuKrweonn NTARENPECHEM, KARMA, AASONAPAMIA W AHTAXACTAMUHMLIA MOMe fia To sronetan HTHxOnHMeprHSHHOT ecbexT Ha choMeKaTéTe neKOBM, Ucrospewenara yrorpeGa Ha Tpocnuym xnopHa,_co Gera-anpeneprisin peyentopin ATOHNCTA Mowe fa ro sToneNM TaxnkapAMNMOT ecbexT Ha OBME Nexo, AsiereoTo Ha nponmerurTe nexoeM KAKO WTO @ MeTOKTONAMIMA NOME pa oTeycTayea npH vcToBpemeKa ynorpeBa Ha Tpocniyw xnopun, Eunejia Tpocraym xnopua woxe aa enwjae eps racrpousrecrmnankiOT MoranuTer M Cerpeurja, ancopnusjara Ha apyrM McTospeMeHo ynoTpeGeHN neKoBH MOM® aa Ce amen Merospemenara ynovpe6a Wa ryap, KoMecTAnOn 1 KONECTHpAMKN MONG fa ja Hawanw ancopOuvjara Ha Tpocnuyst xnopia M nopanu Toa ucToBpeMela ynoTpesa ha wane ‘eKoBH He ce npenopayyea. 4.8Bpemenocr w naxraunja BeaGeanocra u ecbvKacsiocra wa Tpocniym xnopwA He e yrepaeKa xaj 6peMeNn new, ‘Tpocnym xnopwa tpe6a na ce nponhuysa Ha Gpewenn xeHH camo sora ToTenuvjanwata KOpWCT @ noroneM on pHaimkoT. Tpocnuiym xnopHA ce noKaxano feKa Ge wonawyea 80 MFIEKOTO Kaj CTaopUNTe Ho He © NosHaro Aan TpOcKMys xnopI ce WanaNyes 80 Maj¥HHOTO MreKO Kaj MeHATe. TloTeHUMjanHieTe HeraTHBKM nejeTea aj AoetwnisaTa He Ce noataTA. Zaroa, Tpocrmym xnopHA TpeGa Aa ce KOPUCT co Npernasnasocr kaj wenn wiTo Aojar. 4.7. Bnujanne spa cnoco6wocra 2a aoselwe HnM pakyBaibe co Maun YnoTpeGara wa TposniyM xnopHA MOKE fia ce nospse co nojasara Ha Bvayent vapyuyyeaica wro woxat aa ja oulerat nepibopmancara npn sosewe, Cenax, wnuTyBaieara Ha napaMeTpHTe KoM ja Kapaktepyanpaar cnoco6Hocra sa yuecTeo vo coospaiajor (npewssHocr 80 erayenna opvenraunja, KoKetTpaunja, npernasnueocr woTopHa KOOpAMHaUIja W peaKuija NM CTpeCHA cHTyaUW) He noKaKAne HuKaKON ‘AejcTea Ha tpocniym xnopua,Alokonky ce nojasar susyenh wapywysarsa, nayneNTHTe TpeGa fa ce BOsApxAT On Bo2eibe MT paxyBaibe co Mam, 4.BHecaxanu pejorea Chopen Yecrorara Ha nojaeysaise, HecaKanuTe jejcTea ce knacdbmypann no ‘bravia cucrent ( enopen MeDRA knaciepaxaunja) KaKo: MWory weeru (21/10), wecra (21/100, < 1/10), nomanky wecra (21/1000, < 1/100), peren (21/1000, < 1/1000), muory perm ( < 1/1000), sectora Wa nojagyeaise He Mowe fa ce onpeni on pacnonomusnte noparoun. ‘laBapamopucku ucnumyaaiva: Peru: sronemesn spenvocra Wa TecToBHTe sa yxKuvjara Ha UpHNoT Apo6, Coyesu napywyaana Flomanky wectw: raxnkapanja Pern: taxnapiruvja Henoskarn: (we moxe ja ce onpeaw on pacnonoxusute nogarouM): Gonka Bo rpaawe, Hepyuyearea Ha wepenuom cucmem Yecta: maso6onra npocnenena co samop, Busyentu Hapyuyearsa ecru: napyuiena eusyeria axomonaunja, Henosnar: (We moxe ga ce onpenw on pacnonoxuenre nogarouM): saMareH BMA, mwaprjaca, Pecnupamopiu, mopaxannu u Medujacmujanku Hapyuyearsa Flomanny wecrw: ancnneja, Tpocnuym xnopng moxe ga ja Hamann cexpeunjara Ha 6poHxrjansnor MyKyc. Facmpouxmecmusaniu napywyearsa Muory wecta: cyea yera Mectu: cromauna Gonka, ranewe, avjapea, HanyeNocr, ancnencuja, KoHCTHNaYHja, Tpocniym xnopHa Mowe fa npenwsbnKa racrpo-esocparvjaneu pecbnyxe w sa 10 Hamann wsnawyBaisero Ha nnyaKara, Pevannu u yourapnu Hapywyeara Yecri: HapywveHo npasHelse Ha Mo4KMOT Meyp (cosnaBaibe pesMayana ypuHa), peTenuna Ha ypunara,Hepyuyeatea va koxama u nomKoxHomo mxueo Flomanky wecti: ersanTeMa, cysa Koxa, Tpocnnyse xnopHa Mowe fa ro HaMann ébyAKWHONHPaeTO Ha NoTHITe KNeSAM. Onwimu Hapyuyeaiea u Hepywyearea Ha mecmomo Ha ynompesa Yeotn: samop, Hepyuyeatea wa umyonoumuom cucmem Henosnarm: (He mome #a ce onpenw of pacnonoxente nogaTouN): aKacbAnaKTHNin Peakynm, axrMosnem, 4.9Mlpenoauparee NpexymepHn AO3M MOMe Aa npeaNsenKaaT KnHKWKA chika Ha AHTHXONANeprHNeH ‘CHapoM BKNYSYyBajiN BHyNeHN HapyWIyBatsa, TaxHKapaja, yea YCTa K UPEeHHNO Ha koxara, Aloronry © nopeSHo Moxe fa ce AagaT napacuwnaToMAMETAYA KAKO wo ce apesTepanek HeocTarwan ww cbHsocTHrMnt, Flumokapnit MOM® a ce asa noKano Ha nayneHT co maykoM. Taxnkapaujara Mowe a ce TpeTupa co v.8 Gera-Gnoxaropn, S.@APMAKONIOWIKM NODATOUM 5.4 @apmanounnamnja ‘®apmaKorepanescxa rpyna: ypuHapHn cnasMonieTHun ATC xo: GO4BD09 Tpocnuym xnopwa e KeaptepKa aMoMMyM Gaza, To) npwnafa Ha mycKapHNcknTe Peuentop akraronnews. Herosvor Haun Ha AejcraO e cnHeH co To) Ha arponias. Toj & Komner#THBeH aHTarOHNCT Ha aYeTHAXONAK M QpYTK MycKapMHCKH aHTaroMMCTH, ajpepojaTHo HecenewBHn Myckapnickn peuentopi Mi M Mz Hajsaxsioro alirumycxapiicro ejcts0 Ha Tpocnmym xnopd @ NeroBoro Ccnasmoninvo nejcre0 Ha masHire mycrynn 5.2 @apmaronunoraka AncopSuuia ‘Tpocnuym cna6o ce ancop6pa on ractpountecTakannire narnura nocne nepopanka ynorpe6a, MakciManniTe cepyitckn xoHyeHTpauymn ce NocrHrHyBaa of 4 90 6 Waca no Repoopanvia ynotpeGa. Bopacnonoxsisocta € oxony 10%. Bvopacnonoxusocta Ha ‘TpocniyM xNOpHA ce HawaryBa CO CHMYNTaHO BHecyBAKLe Ha xpaHa, ocoBeHO co xpavia co ronewa Macnenocr 80 conpynHara.DucrovGyuvia Bonywenor Ha AvcrpH6yumia vaHecyea oKony 3952140 Ine nepopanva osa Ka 20 mg Tpocnayw xnopwa. Tpocniym xnOpHA nopaRM cBOuTe xWApOdHNHM cECjcreA He ja RPeMKyea TPaNMuaTa Ha KpBTa GO MOJOKOT Ao sHaYHTeNHO HiNBO. TnaoMa porencxor cepsyeaise @ 50-85%. ‘Mera6onugan MeraSonvawor wa Tpocniym xnopHa He @ UenocHo yrepiieH. Bo Man npouenT Tpocniyi xnOpHA ce MeTaGONHaHpA NpeKy WHTOxpoM PAO ensmMuTe (< 5% penannia excrpeunja). Hajsaxnwor nar cenak Ha MeTa6onisam © ectep xwaponisa Ao Senauniiia ercenma Koja ce Konjyrupa co rnykopmla KNCeRMHa 2a cosnasaise He ‘cnupoantoxon, Enuuniaunia loseke on 80% of nosara Ha Tpocnuym xnopna ce Mecbpna npety cbexanvure, Floronewuor Aen on Aosara wa ancopSupannor rpocnym xnopiia ce wesbpna MeweMeHeT npeKy akrMBHara pexanHa TyOynapKa cexpeunja. Man npouent na Tpocnuyst xnopia ce nojasysa eo ypriara Kako cnupoanwoxon. Kaj nauwenTu co ceposio penanno oumreTysaise (CLer< 30mifnin) Guna sa6enexana AononnuTenka casa Ha enmunnayyia (oKony 33h), AUC 0-00 Cmax Ha TDocniy xnopna One sroneMenM sa 4 nary u 2 natn coomBeTHo, cnopeneHo co aApasin nia a voTa Bogpacr nocne nepopanio AosHpaive, He nocTojar nogaToUM 2a MiTpaBeHoN ‘Tpocnnya xnopHa. HawanysaiseTo Wa osaTa Hmm nponoHrMpalseTo Ha uHTepeanoT Ha Aosara ce npenopayysa Kaj nalvieHTH co peHanNo ouerysaixe. Gapmavownnermmara ta tpocniym xnopin He @ Ucrpaxysania Kaj nauenTH co cnaGo Ao ymepeHo penanno ourrerysatve (CL cr 30-80mi/min) Bospacra 4 wapywyeaisara Ha xenapor He anujaat eps cbapmaxokmetikara Ha TpOCMHyM X/OpHA HA KNMHHMKH HaAeH HaANH, a NpHNaroAyBaHeTO Ka AOSaTA He Oe cuera 3a HeonxogHo. 8.3 Npenxnannuxn noparoun 2a curypHocta Nperanimuwrre nogaToun He noKaxyeaar Hokoja noce6Ha onacHocY 3a woBeKOT Bp CcHlosa Ha KoHBeHUoHaNHuTe vcTpaxyeatta 3a Ge2GenHa cbapMaKonoruja, nosToperia Osa TOXCHNHOCT, TeHOTOKCHNMOCT, KApUMHOTeHINEH NOTeHLUWjaN, TOKCHMMOCT Ha Penpoaymuia. Vorpanysarara wa npeTiniHnuka aKyTHa ToXCHHOCT TM noKaxaa cneaHHEe SHaL Ha TpyeWee: TOHOKTONMNHM HanaAH, TpEceibe, Ujanosa, aTaxcja W xunanrecilaVecrpanyaatnara a cySaxyria ToxcusHocT co TpocniyM xnopig He Nokaxaa npoweKt 80 GvOXEMNCKHTe, GHSOMOUMUTE, AHATOMCKHTe MW XNCTONOUKUTe NapaMeTpH 60 opranuTe Ha xuBOTHMTE KOM Ce TECTHpAaT, Tonrorpajoro nexysawe He noxaxa jeKa npenMaBHKyBa HMKAKBM MuKpO-ANH ‘MaKpockoncia npoMeHH KON npeAMsBNKyBaaT RecbeKTH WITO Ce npennWyBAaT Ha NeKOT 6.@APMALIEBTCKM NOPATOUM 6.4 Tincra na excuMMMeHCM: KonlonAHa akxngpHaHa cna, MnKPOKPHCTANHA Lyenynosa, nueHiveH cxpo6, nakrosa MoHOxMapar, MarHesHyM cTeapaT, Tank, (E553b) 6.2 Vixomnarn6unnocra He noctojar 6.3 Pox na ynorpe6a 5 ropnmn A Hawni a wyoaiee Tlexor ce wyea Ha TeMneparypa fo 25°C. 5 Npupona u conpxna Ha naxyeatsero Bnucrep naxysaice (anylonwja PVC cbonnja),xytwja co 20 raGners (2 Gnncrep naxyeaisa x10 ra6neva) 6.6 Ynarcrea 3a ynorpeGalpaxysaree He noctojar noce6ii yenoen. 7. TOAATOUM 3A HOCHTENOT HA PEWEHVETO 3A NPOMET Jlex Cronje JOON, Nepo Hakos 6p.33, Cxonie, P. Makenonnja 8. BPOJ HA PELUEHMETO 3A CTABAHDE BO NPOMET 8. DATYM HA MIPBOTO PEUIEHNE 3A CTABAIbE BO MPOMET 21.08.1997 rogua 10. DATYM HA TOCHIEQHATA PEBM3HJA HA TEKCTOT Hoemapn 2015 roaniaTipea ynorpeGa Ha neKor BHAMaTeNHO NpONMTal ro ynaTcTBOTO. © Yyeajme 20 ynamemeomo. Moxe6u Ke mpeba a 20 npowumame ‘noemopno. ‘© Axo uname dononnumenu npawiates, o6pameme ce Kaj Bawuom sneKap unu cbapmaueem, * Oeoj nex Bu npenuwan Base nusno u He mpeGa da um 20 dasame Ha Opyeu nuya, 6udejku moKe da uM Hauwmemu dypu u aKo HusHUME cumnmomu ce ucmu kako Bawume, S| Ynarcrporo 2a naywenTor compan: 1. mo npemcmaeyea Cracuexc u 3a wmo ce ynompebyea 2. Uimo mopa da suaeme ped da 20 ynompebume Cnacwexc ‘3. Kaxo da 20 ynompe6yeame Cnacmexc 4. Moxsu necaKanu dejomea 5. Yyearbe u pox xa ynompeba Ha CnacmeKc Spasmex/ Cnacmexc 0,2 mg/6 ml pacrsop 2a nijexruparbe TROSPIUM CHLORIDE ‘Axrupuara cyncranunia e Tpocraym xnopna, Flomowmi oyncraxumn: HarpHys xnopia, paspegeHa xnopoBonoponwa KrcennHa (sa pH nonecysatee). soma sa mvjenu. Viwe appeca Ha HocuTenor Ha opoGpeNneTo 3a cTaBaibe BO npomer: Mek Ckonjo ooen, Tepe Hakos 6p.33, Cxonje, P. Maxenonnja Vine W anpeca Ha nponsBoquTenct: Lek farmaceviska drusba d.d., Verovékova 57, TeyGreana, Cnosernja 4. Lito npetctasyea neKor Cnacmexc 3a uiTo ce ynorpe6ysa 5 ml pacteop 2a mujextapaise (1 ayn) conpxat 0,2 mg Tpocnuyss xnopi, Conpyuia va naxysaisero: Kyrwja co 50 amnynin Tpocnuym xnopng npunata Ha rpynara neKOBH Hape4eHH aNTHcnasMONHTHUM (nIeKOBH ow Ja Wawanyeaar NanwaTocra Ha maaHuTe Mycxynv), Ce Kopwotn 3a: = onecysaie Ha eHgocKonckHTe Mm cbyHKMONANHHTe wicnMTyBaiba Ha ractpouyTectananaure naraura,~ Rekyeaiee Ha cbyHkuwonanin noctonepaTBHM cnaoMH Ha MasHara myckynarypa 80 racrponwrectmmannuTe naTAUiTa, wonsHOTO kece, KOMKNTe aTnwsra u yporenurannnor cHcTeM, 2. lro TpeGa na aHaeTe npen na ro ynotpeGure Cnacmexc Homojre ma ro ynorpe6yaare Cnacmexe: ~ 2X0 cre anepriwni (KunepeeHaiTABHH) Ha TpochHyM xnopIIG HMM Ha GuNO Koja ‘coctojka Ha neKor, ~ ako wMiare cepvioata socnanntenia Gonect Ha upesara (ymuepoaen KonuTHC, Kponosa Gonecr), 7 2kO ware ToKcHeH MeraKONoH (npeKyMepHo npoumpeHo AeGeNo upeso), = ako nae rnayxow co sarsopen aron, + ako mare Opa u Henpasiinen cpyes pram (raxnapurtavja), ~ KO nature on Mujacrennja rpasHc (eBpOROLKG Hapywysaice Ke ce Maknebectapa co myckynna cna6ocn), * ako nature of ypumapHa peTeHuvia (sanpuKa Ha ypHaTa) uni cepHOsKO Sy6pexno owreryease Koe nwa noTpeGa of xeMonniannsa, Cnacmekc He Tpe6a na ce nasa Ha aeya nomnagi on 12 roan, Bugore noceGuo summarennu co Cnacmexc: ~ ako uMaTe MexaHMNiKO CTeckyBaibe Ha racrponATecrManHaTe naTHuTa (Ha np. ‘nunopka creHosa - cTeckyBarke Ha OTBOpOT Ha HaNesOT oA CTOMaKGT), > aKO HiMaTe ypurapha peTeHynia (Ha Np. sronemena npocrara), = ako miare xepHuia Ha zujadparmara ~ ako narute oA pecryxcen esoaruruc (socnanekne Ha esodarnankara enysHiya nopagi racrpyurara kvcernta), + ak0 naTHTe on dyHKuMOKANHO NopeMeTyBaike Ha ABTOHOMHVOT HepBEH cHCTEM, ~ ako Muare npexymepHa Tuponawa akruBHocT (xHnepTapoaNsaM), KoponapHa OScrpyrnja, KoHrecTuBHa cpueBa cnaboct, ~ KO Mare OuTeTeHa ynKunja Wa YPHHOT APO unk cnaBa, ymepera no Cepuosvo ourreTeHa Gybpexva pynmnja (engeTe ro Aenor: “Kako pa oe ynotpe6ysa Cnacuexc’) Nipea sanovnysaise Ha neryeawsero, nekapor TpeGa a ja cxnyyn MoxwocTa of ‘Opratickx nPHinki 2a NecTO ypHHHpalbe, cpueBa M GySpexta BonecT, nonnauncula likcbexui nn TyMop Ha ypuHapHuTe narmusa, Floce6xo shumarne Tpeba Aa ce nocseTH 2a Bpeme Ha MHTpABeHCKO neKyBaibe co Tpocniyst xnopg xaj nocTapH nauneNTH co cpyesa cnaGocT M saGonyeaise Ha Sennte Apo6oau, Somatbe na Cnacmoxc co xpana u co HaniToK Xpaniara He sniljae Ha pejcrBoTo Ha CnacMexc nxjenunure, BpomenocrCosemysajme ce co Bawuom nexap unu cbapmayeem nped da sememe Guno KaKos 0K. Doxonky cre Gpemena ynorpeGara Ha Tpocnuym xnopwg He ce npenopayysa. BawnoT ‘nexap fe ogny4n gana Heroeata ynorpeba e HeonxonNa. Doewe Cosemysajme ce co Bauuom sexap unu dbapuayeem nped Ga sememe Guo Kakos He ce npenopauyea ynorpe6a Ka tpocniyi xnopi 2a apeMe Ha noetee. Bnujanno eps cnocoGHocra sa sosetbe HTH pakyBase co MaLIMKM YnorpeGara Ha Tpocnnym xnopHa MOKe Aa ce NOEpLe co eNSyENHM HepyLiyeareA KOR Ione fa ja Kapywar ecbrxacnocra 80 cooGpaiajor. loxony ce nojasar, He TpeGa a soatre unu fa parysare co mau. Baxcnn micbopmaumn 3 HeKoM cOcTaBHK KoMnoneHTH Ha CnacMeKc Osoj_nex compan nomanky on immol (23 mg) Katpuym Ha 6 ml pacrsop sa imnjextupaice T.e On Momeno fa ce KaKe "Ges HaTpHyu SeMaiee na apyrn nexoBn Be monmue qa uwate 80 ain neKa osve ykamyeaiba MoxaT fla ce oAKeCyBaaT M Ha COnMe NpORIBONH UITO CTe rH 3eMArIe BO MAHATOTO MK Ke TM JeMaTe BO MAHMA. Be monnue na ro wacbopmupae Bawvor nekap uni cbapmauest ako 3eMare, WM AKO neonamia cre semane BMI Koj APYF eK, AYPU H OHNE KOM He ce Ha eKapcKn PeUeNT. Coseryaajre ce co Bausor nekap npea a nowHete Aa ro ynorpe6ysate Cracmexc, AOKOny cToBpeMeHO seMare Ouro Koj OA HaBeAeHUTe NeKOBH: = amaiTaniy (ce KOpACTH NM neKysarse Ha TlapxmHcoBa Gonecr), = Tpvuyxnnann aTugenpecnsn (nexosn sa nexysarbe Ha Aenpectia), = sags, qusonmpamug (ce KopwCTaT sa eKysarse Ha Henpasnnen cpus puraw), = akTinocrammnnys (neKosH npoTas anepryja), + Gera-cumnatommmerayn (neKOBM KOM OGHNHO ce KOPHCTaT 3a NeKyeaKe Ha actwa, cpuiesu Gonecrs, npoGnewn co owMTe, saTHaT HOC), ‘Meroxrionpamng (nex npoTHe noepakaise). xpejin Tpocnuym xnOpI MOXe fia Bnjae Eps racrpontTecTHHaNKaTa NORBIOKHOCT cexpeuwja, ancopnuyjara Ha Apyra wcTospeMeHo ynorpeGeHH neKoBH MOXE fla ce vomens. 3. Kaxo aa ce ynorpe6ysa Cnacmexc Crporo npwapmysaire ce KOH ynaTcTeaTa Ha nexapor. floswre He cMeeTe Aa mH enyeare nnn nexyBarseTo Ma ro npeKnHyBare Ges sla Ce nocoBeTyBaTe co neKap. Cnacmerc 0,2 mg/S mi pacteopot 2a usjexTupaise © HameHeT sa uHTpaBeHoKa ynorpe6a. Vnjexuujara tpe6a aa ce aqmusncrpHpa OaBHo. PacTeopor sa wnjexruparce© GesGoeH, Guictap, npakrisHo Ges suANWBN HanBopeWKH wecTHNKM. flocTaneH € 80 ‘alinyria 9a enwoKpaTHa ynoTpeGa Tosnpawero © wHAMeNAyaNKo, 80 2aBMcHOCT OA noTpeBuTe Ha na\MEHTOT, Tipenopavanara qoza vaHecyea 1/aunyna Crackexe ga qo TPM nara Ha neH. Pacreopor TpeGa fa ce Aat ynotpe6a, co KopvoTewe Ha cTepinen uinpmy M wrna sa enHa Tlauynenta co 6y6pexno ourrerysaibe: Kaj nauweTh co Gypexto oweTyBaibe ce npenopayysa HaManyeaibe Ha qozaTa Mri npononrparse Ha miTepsanoT Ha AosupAibe. Ynorpe6a xaj neua Cnacmeke He Tpe6a na ce ynowpeGysa kaj neua non 12 roan, nopann HenocTaTOK Ka onaroun 2a GeabeaHocTa m ecbuxacnocTa. ‘Axo umame enevamox dea ecexmom Ha Nexom @ npeMHozy cuseH Unu npeMHoey ‘ona6, nocosemyeaime ce co Bawuom sexap unu cbapmayeem. 4, Moxtn HecakaHn pejcrsa Kako u cume nexoeu, CnacweKc Moxe da uma HecaKanu dejomea, uako mue He ce ‘nojasyeaam xaj cume nayuenmu. Cnacwexc woxe fa npenwssika cepwosHi aneprickn pear ‘Axo 3aGenexwre GAMO Koe Of CReAHMTO HecaKanM AejcTBa, BeAHaWl npecTaHoTo co 3eMaibeTo Ha NeKoT M 3a MCTOTO BeANaU! MaBecTeTe TO BawMOT NeKap Mn ‘oneTe go ypreHtHoTo oAAeneHNe BO HajGnucKaTa BonHHua: = HeHanelHH npoGneMH co AnWeHLeTO, S6opyBAHLeTO H rOmTTAKLeTO, + oTexyeaibe Ha ycnmtTe, nMueTo # Bparor, + ahawnTenia spTornaanua hn ry6eibe Ha cBecra, = vewlaibe H wowN Ha Kona, Vissecrere ro Baumor nexap To © MOKHo nocKopo ako sa6enexTe Guo KOe OA, ‘cneaiure Hecaxann gejersa unn cumnroMn’ Muory ¥ectn necaxann qejcrea (ce jayeaar vai nose“ on 1 on 10 naywenrH) = oyga yora, ect Hecaxann asicrea (ce jasysaar kaj nowar» 40 nayrentw = rmaBo6onKa co saMop, = wapyuysaize Ha BvsyenKitTe npucrocoBysama (npoSneMH co fnepaibe Ha ‘npeamerure mHory GnutcKy), = Gonka 0 crowaKor, + ragere, + Aljapea (nponwe),= nopyetocr, = HenaroaHocT 80 cromaxor nocne o6 po, = xoncTanauja (sane), = nopemeryeaise Ha MoKpelseTo M nowarKy wanauyBawe Ha yprMa of ‘soo6uuaeHoTo, = Tewxorvja unit Gonka npm morpetee, = onurra cnaGocr. lomanky vecTu HecaKann pejcrea (ce jasyeaar vai nomanky on 1 on 100) = Opa cpues putam (TaxnKapavia), = TewKoTHja 80 anuerseTo, + exsairema (acu), + yea Kowa, Pore wecaxann aeiersa (ce jaeyeaat kaj nowarny on 1000 nauvenTa) = 6p3 M Henpaaunien cpues pirTae (TaxnapwTMnja), = sfonemenn epeavocTs Ha aHanusnTe Ha bynKujara Ha UpHMOT AOS. Tpocnuym xnopna MoMe fa npenwsenka Gorka 80 rpaniTe, saMareH sMA pouMpyBaiee Wa SeHMYNTe, BOCNANeNMe Ha esocparvjankaTa cnysHnya nopani pecbnyke Ha racrpHnara kuCeNHHa, a TO Hamann vanawyBarLeTO Ha NnyHKATA, fa TO WxwOvpa usnauypaiseTo Ha cnyaTa 80 pecnupaTopHHTe naTHuiTa M fla ro Hamann Synuwonnpaisero Ha noTHuTe xntesnM ‘Axo npumemume Guno Kakeu HecaKanu dejomsa Kou He ce cnoMeHamu 60 o¢a ynamemeo, Be Monume da 20 uxqpopmupame Bawuom sexap witu drapmayeer. 5. Uysaibe Ha Cnacmexc JSlexor ce yea na Termeparypa Ao 25°C. Tlexot ce ya Ha MecTa HenocTanHn 3a Aeua. Pox Ha ynorpe6a Tlexom He cee da ce ynompebyea no damymom wa ucmexom Ha porom Ha ynompeba lumo © waeeden Ha naxyearsemo. Hawne na wanaBaise Ha neKoT Jlexor moxe fa ce ynoTpe6yea calio 80 sapascrsena oprannsalyia atym a nocnequa pesuauja Ha BHaTpeuMoTo ynaTcTEO Brampewnomo ynamcmeo @ odobpeno: po] Ha ono6perne 28 crapaibe Ha neKoT BO npoMeT:Mpednoz mexcm sa dononumentia HanenHuua Vime Ha nexor: Cnacmexc pactsop 3a uijexrupatee 0,2 mg/5 ml Cocras: § ml pacreop conpxw 0,2 mg Tpocnuym xnopMA Tlanysaice: Kyruja co 50 craknenn amnynu x 5 ml Hast ha ynorpe6a: Npem ynotpeGa Ha nexor BHAMaTenHO npounrajre ro npunoxexoro ynarcTBo Bawa go" Mpouaeoauren: Lek farmacevska druzba d.d Jby6reana, CnoseHnja Hocuren Ha ofoGpekie 3a cTagatbe Ha nekoT 80 npomer: Mex Cxonje DOOEN, Mepo Hakos 6p. 33, Ckonje, P. Maxenonnja Haumn wa usqasaiee: STeKoT Moxe fa ce NpUMeHYBa camo BO 3qpascteena oprannsaunija (3) Haun Wa uyearbe: fla ce usa Ha Temnepatypa fo 25°C Tlexor Tpe6a fa ce Ya HanBop on AocbaT Ha neua po) m ary Ha pewieHve 3a crapaibe 80 npomer: Cepucia 6poj EAN Kon: