KPATKA XAPAKTEPHCTHKA HA HPOYKTA 1. WMEHA JIEKAPCTBEHHS IPOXYKT Texcxeronpoent Carsios 25 mg rnmmpani raG1erKH Dexketoprofen Sandoz. 25 mg film-coated tablets, 2. KOJIMYECTBEH H KAYECTBEH CBCTAB Equa asMupana TaGnerka chaprxa: yeKckeTonpodext tpomeraon (dexketoprofen irometamol) 36,9 mg, Koifro chosereTBa Ha fexckeTonpoden 25 mg. 3a MANNA cHUCEK Ha NOMOMHHTe BemlecTBa BYOKTE ToHKa 6.1. 1H JTEKAPCTBEHA ®OPMA usvmpasin ta6nerKH. Beaw, apoiino warskiaan, IWMIMIpHYHH TAOTETKH ¢ esIMTeNHA Yepra H rpasupaH Name ,DT2” oT ennara erpawa, TaSnerknre Morat fia Geaat pasieneun Ha ABC PABHH 03H. Pasmepn na raGnerkara: 3,9 mm x 9,3 mm_+ 0,3 mm. 4. KIMHWYHH JAB 4.1 Tepanestay noxasanus ‘Cnromaraiio newenie Ha 2teka 10 yMepeHla Gorka, Kato MYCKYHO-cKeneTHa GoaKa, TPH AHEMeHOPER H 386060. 4.2 Josnponxa x nagme na ynorpeba ‘Tosnponna Bospacmmu B sapcMoct of sna H chtiata Ha Gonkara, mperioppunTensara Osa € 12,5 mg wa Bcexs 4-6 aca aH 25 mg na sexu 8 vaca, OGmara AHeBNa nosa He TpaGsa a ramsHulasa 75 mg. Hemenaere texapcrnenit peakiyan MoraT a Gogar WaManeHH KATO 3a KOTPORHPAHe Ha CHMITOMHTS Co ynorpeGapa BtaMoxto Hali-HvlcKaTa eipeKTHBHA 1038 38 BLIMOXHO Hall-KpaTLK CPOK OT BpeMe (BX. TOHKA 44), Tlexoxetonpopent Canizos ne e npemHasnaven 3a npoaoxuTestia ynoTpeGa H NeYeHHeTO TPAGBA AA Ce Orpanuun B cHMITTOMATHUHHR MepHOd. Teduampiora nonynarys Tlexckeronpodex Tpomeramon He e npoyupal MpH ella H }oHOUIK. CnegoBaTemHo He ca yeTanoReHM Gesonachocrra 4 efbexTHBHOCTTa My B Ta3H BEapacroRa rpyna H ToH He TpAGEa ma ce Mpitnara pH eu M ronoum, Cmapyecxa sespacm TIpw nauserrTH B crapecka BESPACT Ce NpenlopbuBa eHeHHETO Za 3ANOHE ¢ HHCKA Tpanuus Ha yozaTa (oGua nHeBHa 03a 50 mg), losara Mowe fa ce YBenuH 20 Tero} TonynallHs CAMO Cle] YoTaHOBABaHe Ha O6pa OOula NOHOCHMOCT.Yepuodpo6uo wapyuenue Tlaunertu c sexo ao yMepeno Hapyutena YepHonpobuia SyYHKUWA Moxe ya 2arTOuHAT ACYeHHETO C PenyuNpanH jo3M (oGma yHeBHA AO%a 50 mg) Ha GRAAT MpOCTEAARAKH BHUMATETHO. JleKCKETOMpOEH Cantos He rpsOna a ce wsnoasea mpM nauMeHTH C TeAxKo Hapyutena ¥epHoapoGHa GYHKLME. Bebpewo napyuenue Haarnara nosa Tpa6na xa ce peayttapa ao 50 mg o6tta aHcRHa 203a mpH nauMeHTH ¢ exo HapyLicHa GrGpesna dbymnnia (xpearanMHos KaMppHe 60-89 ml/min)(aiDK 7.4.4). HexcKeronpoden Caxiz03 He tpaGea 11a ce HoMON3Ba TIpH TaANMeHTA ¢ yMepeno 10 TexkKO HapyeHa GEEpeNHa dyuKtHR (KpeaTHnHAHOB ICLApEHC +559 ml/min)(s10x 7.4.3). Hasina npwroxenne ‘Ounnpainrre TaGnevkH TpxGBa sa ce MormEMLAT € AOCTATEAHO KOTHYecTEO TesHOCT (Hanp. eaHa waUa oa), EAHOBpeMeHHOTO MpHIOAeHHe ¢ xpanta 3a6aBA CKOPOCTTA Ha AGCOpSUNA Ha TeKapCTHOTO (BK. TONKA 5.2), caenonaresno » exysait a OcTpa Gonnka ce npenlopysba NpHlo‘eNHeTO sa cTaBa Hali-wanko 30 MuiyTH npeaia xpanene. 43° pormponoxasanus Aexcxeronporex Canyos ne rpaGna ja ce npisiara B enermre eaysran: * TaNWeHtH, CEPEXHYRCTRNTETHH KEM Ak THBHOTO HeMtecTEO, KM ApyrH HCTIBC Wilt HSKOM oF TOMOUHHETE BEULeCTHA Ha MpOLYKTa, HB6pOEHH B TONKA 6.1 + maunerrm, npi KoHTO BeulecTRa che CKOMHO 7eHicTAHE (HAN AuCTHUICAMMUNLIOBA KHCEAEA HIE pyr HCIIBC) npenmssuxear npucrsna wa acta, 6porxocnasbM, OcTSp PHHMT WIM MpHUHABAT ABATHH MOAT, ypTHKAPHA HK aHrHOHeBPOTHYEH OTOK + wonecTan boroareprasut Wa oTOTOKcHYIH peak TO BpeMe Ha TeveHHE ¢ KeTONpOden HAH nOpare + austen ¢ altaaniesa 5a cToMamHo-speneH KPHaOHs.THS WIH nepchopAUEL, cBYPIAHH ¢ MpeNxoHHA ‘Tepaniia ¢ HCTTBC + anMeHTH c akrHBHa nemTHtna ima/cToMaLIHO-4pemeH KPBHOMIMB HH aHAMIESA 3a CTOMAMIHO- 'NpeBHo KBpReHEe, pasmaBanaHe HK TepshopaLia + manseHT# ¢ xponnsnta aucnencHs + manwetri ¢ apyro axrupHo KBpBeHe HH apyr 3aGoABanHs, cBEpsatiH c KDpBeHE + mausenTH ¢ Gonecr Ha Kpott rarm ymteposett KonNT + raunenmi ¢ Teaka eopeuia HegocTarssnocT + TauseHTH ¢ yweperio 70 TexKo Hapywena SEGperma pyukuns (kpeaTHHHHOB KIMpuUC <59 ml/min); + nauvenru ¢ rexko Hapywiena Yeptloapobua dbynKun (peaysrar 10-15 1 Child-Pugh) + manner ¢ XeMoparuunia xwaTesa H jipyrH HapywenHa B KoaryaaunaTa + TannenTn ¢ TexKa sexnaparauns (B pesy:TTar Wa MlOspMilaHe, THapH HI HewOCraTEHeH NpHeM Ha ‘TeunocTa) + To Bpeme Wa TpeTKa TpHMecrEp oF GpeNeHHOCTTa H nipes MepHona Ha KBpMeHE (Bx. TONKA 4.6) 44° Cnenwasnn npeaynpexenna m upexnasum Mepku mpi ynorpeda Za. ce npunara ¢ noBHIeHO BHHIMaHKe TH nauMeHTH c aHaMHe3a 3a aleprHann CLcTORHILA. ‘TpaGba na ce v2Garea ennoppenentio npinioxenne Ha Jlexcxeronpodext Cantos ¢ sapyr HCTIBC, DBkmOsHITEAO CeneKTHBH! HEEXHGHTOpH Ha UKKIOOKCHTeHaDA-2, Hexeaanre aexapersen peakurta Morar aa Guat HaMa:TeHH KATO 38 KOHTTPOAMpatte Ha Cl ynorpeSiaa sbaMOxKHO Hail-MMcKaTa EbeRTHBHA 1038 3a BLIMOAHO Hail-KPATBK CpOK OT HW mo-nomy nocoxeHHTe PHCKORE, CBRPAAHM CHC CTOMALIIO-4PERKUR TPAKT H CBPACHHO-CCromaumo-upesia Gexonacnioct Cromaumo-upesert KpiEoHB, sana HAH Tepopauus, KOTO Moke Ha ca c GaTaTeH HIXOI, ca cboGurasann mpm ynorpeda Ha BcHaKH HICTIBC no acsko speMe ta e4eHHeTo, ¢ aH Ges npesynpemurenti CCHMNTOMIT UT TPpenIHIeCTRaUIA aHANTHEZa 3a CepHOSHH CroMAlINO-YpesHtH HLAUEHTH, TIPH BESHAKBAHE Ha CTOMAILINO-NpeBHO KBPSCHE HAM YaMepaLtNs Ho epeMe Ka Tepants c [leKcKeTonpoen Carros newenHeTO ‘TpaGwa ja ce npeycTaHORH. PHCKKT OF CTOMAMIHO-HpesEH KPBKOMSIME, 38a HAH NepOpalLAR ¢ T10-BACOK py yaemu4apaHe so3ara a HCTIBC, mph namserTH c atantiesa 3a 5384, OcOGeHO aKO € YoTOKMEHa C xpbaows:1HB 11H Tepdopauiss (Bx. 7. 4.3) 1 MIpA CTapyecKa BRApACT. Crapyecka peapact Tanwenture » cTapsecka wbspacr ca C MO-BHCOK pHeK 3a HoKesiaN peaxustt KbM HCTIBC. OcoGerio cToMalHO-4peBcH KPBBOHSIHNB H MepHopanna wonke Ja ca darastn (Bx. 4.2). Tes naunonTH TpAGBA Aa SanowhaT AeHCHHETO c BRAMOAKHO Hali-MMICKaTA 1034. Kaxro npit norsk HCIIBC, npean sanoupanie a evenie ¢ aeKcKeTonpodpex TPomeramo” TpAGBa a ce posepi 2a HaaHHe Ha ex0arHT, FaCrpHT W/HNH NeMTHHa ABA, 3a.na Ce MOICHTYpH ROGpo O61 ‘cperommie Ha nannettta, [lauseHTH Che CTOMAULHO-speBHM CHMMTOM HK aHaMe3a 3a CTOMaIIKO-YpeBtt Hapyuenna TpaGra 7a ce mpersiegat 3a xpanfocmHnaTesMit HapyUleHHA, OCOGeHO CTOMAIITHO-HpeBHO KEPBEHE, HICTIBC spsGna a ce npwnarat BHANaTeNHO MpH TaUMeHTH ¢ akaMHe%a 3a cTOMaNINO-ypesHH saGonBaHS (ymeposent kommt, Gonect xa Kpon’), Toil Kato THXHOTO sa60AHAHE MOXKE sa Ce OFOCTPH (1x. TONKA 4.8. Kon6imupavara Tepans ¢ nporekTiBHH siekapcruenn ripoayKtH (anpMep MHZonpocTOn LIK ixxHGHTOpH Ma TpoToHHara moMNa) TpsGRa 1a ce ANAT TIPEAIRAR MH TesH MALINEHTH, @ CBILIO H TPH NallWeHTH, pM KOMTO ce Havlara KOMOWMMpatia TepaNH ¢ MHCKH O34 ALETHNCAAMUMLIOEA KHCETHEA HK APYTH sleKapeTBeH NpoAyKTH, 3a KOHTO HMA BEPOATHOCT Jla NOBHIAT CrOMAIHO-"peBHHLE PHCK (BK. TONKA 4.5 no-nony). Tlanwerni ¢ arasaiesa 2a cTOMaMIHO-upeBia TOKCHUHOCT, O€OGeHO & crapHecka BLSpacT, TPAGBA sla cboSutabat 3a BCeKH ReoGwiaeHt CTOMALIHO-NpeneHt CHMIITOM (OcoGeHO CTOMALIMO-UpeweH KPEBOH3AHB), ‘ocoGeno m Ma¥anuure eramtH Ha aeveHHeTo, TIpenopmusa ce NoBHINEHO BKHMaHHE IPH TALLHEHTH, KOHTO NpHEMaT EHOSPEMEHHO seKAPCTBA, KONTO Morar a ysennuar piicka OF KEPBeHe, KATO repopacTHH KOPTHKOCTEPOMIN, ANTHKOAFYAHTH, Ham. aphapHi, ceneKTHEHH HEXKGHTODH Ha OGpaTHOTO saXBaMlaHe Ha CEpOTOHTHNA AK ANTHTPOMBOUNTH ReKApCTBA, KATO ALICTHLTCAMHIUUIONA KHCEMHHA (BA. TOUKA 4.5). Bu jacwocr Hanexea ce nosuilieno pineanne npH nalmenrH ¢ vapyulena 61Opewa yakuns, TIpH TesH nanmeHTH npwtoxennero Ha HCTIBC moxe 2a n08eae 0 esrotavane Ha GeGpesniata ynxunes, sanpuce Ha ‘TeNHOCTH # OTOUK, Hanara ce CbilIO NOSHINEHO BHIMARME H NPM MAUeHTH Wa jAMypeTHAHa TepaTNA WK, np Tes, KOHTO MO>KE Jla PASBHAT XHTIOBOVTEMH, FOPAUH NOBKILIEH PACK OT HEGPOTOKCHAHOCT. Tlo apeme 1a stevenneTo TpsGna la Ce OCHrypH AOCTATBHEH MpHeM Ha TeYHOCTH, 3a fla Ce NpenOTEpATH exnapaTauva H BBsMOKNa acowApaka NosHuieHa SyOpe4wa TOKCHIBOCT. Kaxro npu scx HCTIBC, moe ja ce nopnurar niaaMenitte Hea Ha ypesra x xpeaTamana. Kakto mpi ApYTH MEXHGRTOPH Ha MpOCTATNAHNHHOBHA CHTTeS, MOKC Jd ce MPOABAT HEACTAHH peakunU OT CTpAHA Ha ‘Ss6pewnre, Konto 2a ZoRenaT 20 FIOMEpYOHEOpHT, MTEpeTHLUaAICH HeMppHT, GDOpewwa nanwiapHa Hexposa, HepoTHieH cHIIPOM H OcTpa Gudpestia HeRocraTBANOCT. Tlauwenr 8 crapsecka skspacr ¢ no-sepoatHo a crpaiaT oT wapymiena Go6pewa Gym YepuogpoSua Gesonacuoer Wsuckea ce 1osuuiexo BHHMaKHe pH HauKeHTH ¢ HapyueHa HepHoupoGHa ysTlogoéxo 1a apyrt HCLIBC, nexapernoro sia ce npearseitka mpexoHo steko yaearenme Ha HAKOH ‘uepHoupoGii4 napamerpA, KakTo H 3HauirestHO yoemnuenne tia SGOT H SGPT. B enyuall a sHawnTeaHo yaeamenne ta Tesh cTOMIHOCTH, AeHeHHETO TpAGBA 2a Ce MpeycTAHOBH. Tlaunetna 8 crapyecka Bespacr e no-neposTHo aa crpaar or Hapyiienia HepHoupoSha dpynKuns (Wx. ToMKA 42), Crpaestio-chi0Ha m MoxeuHo-crytoBa GesonacHocT Hsncxsar ce noAxonamo NPOCAeNsBAHE M ChHETH 3a NALLHEMTHTE ¢ AAMHe3A 3a XHTEPTOHHA W/HTH MeKa.O _yMepenta copes HejOCTaTBSHOCT, HeoGxojMMO € CrIELMaAHO BIHMAKKe MPH MACHTH ¢ aHaMHesa 3a Cepacuito saGoamnane, ocoGcHo npn Te3H ¢ HpesXOAHH erMsoAH Ha C“pACHHA HEOCTATLATOCT, TBit KATO MOxKe la HMa TIOBMLLIEM PHCK OT TIPesISBMKEAHe Ha CepsLesHa HelOCTATDYHOCT, Toi KATO Ca COOLABAH aaTepAcae Ha TeNHOCT H OTOK BRA APHAKA c sIeweHe ¢ HCIIBC. asinine or cmmasiin 4 eniiaenHonormnn npoysania noxasear, ve ynorpeSara Ha HaKox HCTIBC (ccoGeHo Boe BiICOKH 103H H NH mpoaBsLAGITEsIHO MpHLTOAEHHE) MOE 2a Gbsle CBLPIAHA C JIeKO TOBHUNEH HCK OT aprepiamil TpOMOOTHMHH HHAHAEHTA (HANDUMEP MUOKApAeH HHKpapKT WK HxeynT), Haws OCTATENHO AHHH, 38 18 Ce HOKTUONH TAKE PHCK MPH AeKcKeTOMpoden TPoMeTaNo. Caeaonatento, manent ¢ HeKoHTpompara xuneproHKA, 3acToiiHa cEpsedia HeqOCTATLHOCT, YerTanosexa Hcxemuuna Go7ecT Ha cEpueTo, saGomABaKle Ha MepMepHHTe apTepHUA H/HIK MOSBIHO-cbAORA Gonect rpaGba sa ce stexynat ¢ ZekckeTonpoden TpoMeTaMon caMo c:1eH BHHMATETHA MPeuCHKA. Tipenenkara TpsGea aa ce npaai mpest sanoyeane Ha ABATOCpOHHO Teen fia NAUHesTH ¢ PHCKOBH aKropx 3a cepueuHo-ceaOBH MALIACHTH (HANp. XHNepTOHHs, xHMepTIMHTENMA, 3axapeH ANACer, ‘ToTIoHONTYMICHE). Bewski necenextusan HCTIBC morar aa mxHOnpar tpoMGountHara arperanna H sta yawsokat BpeMeTo Ha Kopsctie upes MiXHGHparle Ha NpocrarsasHAORaTa cHHTesa. Tlopatn TORA, He Ce NpenlopeHBa TpMAOKEHHETO Ha AeKcKETONPOdeH THOMETANON MPH NALLMEHTH, KOHTO TIONy:aBaT APYTH eKApCTBA, TOBAHABAINM XemocraveTa, KATO BapKpapHEL MAH AIpYTH KyMapHAH HLH XertapHH (EK. TOKE 4.5). Tlauwenrure » ctapyecka BEapacT € nlo-BeposTHO Ja eTpAJaT OT Hapyulena chapeHtTO-chaIoBa hYHKUNK (BK. Touxa 4.2). Kon peaxwnn CepHosin KOXXHM peakUMH, HAKOH OT TAX ATATHN, BRTONHTETHO eKCHOHATIBEH HEpMaTHT, CHLPOM Ha Crapene-Jbxonicbi W ToKCHHa eniLlepMasHa HeKposT3a ca CBOOMABANH MHOTO PRIKO BEB BPL3KA C pmaoxennero Ha HCIIBC (1x, rouxa 4.8), Hartervta, He paCkBT 3a Te3K peakwutn mpi nanwenrrute Hall COK 8 paHeH €Tan OF KyPCa Ha Ne4eHHETO, KATO B NO-FoWMA HACT OT CITYMAHTE, HaATOTO Ha PeaKuMHTE € Iipes apBn Mecen or neHeHHETO. JlexckeTonpodeH Cano TpAGBa Ja ce MpeycTaHoBH MpH TepsaTa posea Ha KOKCH OBpHB, MYKOSHH TeSHHE HATH NPyT NPHOHAK Ha CBPEXNYBCTRHTEHOCT. ‘Tpyra ubopwanmo OcoSeno BHHMAHME ce WaHICKB mpm NatiKe:TH C: = _BponeHo HapymcHHe B MeTaGomaNa Ha HopOHpHiNTe (MaNp. ocrpa MTepsnTerTHa NOPHUPHA); = mexiiaparanns; = _aKpextno een ronama onepauna, Axo mexapar npeuett, te © HeOOXOHMO NOADIDKHTeAHO TeHeHHe © eKeKeTOMpodenl, TPASEA pe) ce npocaensBar vepHonpoOHara n GzSpeusata YHKUMA M KPEBHATA KAPTATHA. ‘Texsc octpa peaktun Ha capExuyserauTesHocT (Hamp, aHadbwnaKTHen WOK) ea HaGsOnAF peak cayyan, Jlevennero TpAGea Ja ce npeycTatonn pH MEpBHTe NpHSNALy Ha TEKHcepsxuyscrenremiocr cnea npuem Ha Jlexckeronporpen Cariao3. B sapicuMocr or cHMMTOMHTe, BCHIKH HeOSNOaHMH MeaMUUTHCKM MpoweAypH TpAOBA la Ce MIMLNNPaT OT MEAHLMNICKH CHeMLAHCT. Tlanmeisra ¢ acta, # KOMOMHALINA C XPOHHYEH PHEHT, xDOHHYEH CHHYSHT H/H Rasen nomMTO3a, ca HEMMOKEHH Ha BMCOK Pick OT AleprMm KEM alleTHUICAMUUsIORA KKCEMHHA H/staK HCTIBC, oTKOAKOTO ocTanariara 4acT or aceneHneTo. IIpaoxeNHeTO Ka TON steKapeTBEH MPOLYKT Moxke fla NPeAWIBHKA AcTMaTHHH MpHCTEMTH HAH GporrxocnaseM, OcOBeHO TPH MauIneNTH, ATepruSHH KEM aueTHTeAMHUATOBA kwcenmna wat HCTIBC (Bik, TouKa 4.3). To wakmovenne, papHuera Moxe fla NoBReME 0 CepHOSHH KOAKHO HAH MEKOTEKAHHO MHCDEKLHOSHO yexoutnenne. Jo MoMenta He Mone 2a ce Hakmoun, 4e HCTIBC sonpunacat sa e:tourazane Ha Tesi arbexuni, Topaz Tora ce mpenopsusa na ce HaGarea MpHnoxenHeTo Ha eKcKeTonpompen TPOMETAMON B cayvait va napmyena Texcketonpodent tpomeramon TpaGaa sa ce npitiara BHHMaTE”HO MpH NaNHeNTH ¢ xeMonOCTHEHH Hapy eit, CHCTENCH MIYMc epuTeMaTOnEC HuIH CMEceHa CRENMAINTETHO-TEKaHHa 6ONECT. TlonoSto wa apyr# HCTIBC, jtexexeronpoent moxke a Macknpa cHMMTOMHTe Ha HEKeKLHOSHH saGonapanus. Degwarpyyna nonyiayns Besonaciara ynorpeGa npu tia w oHowln He e yerawonena 4.5 Jlexaperseun w apyra ssanmonelicrans Careanite ssanmonclicrans ce oTHacsT To IpHHIIIN 3a HecTepOHAHHTe MpOTHBOBKsnAMHTETIEH cpencTsA (HCIBC): Ko HH, KONTO.He ce MpenopHBaT + pyri HCTIBC, sxuowrrenno sucoxt 2osu canmumaarH (23 g aHesHo): eAHOBpEMeHHOTO Mpioxenue Ha uakonko HCTIBC Moxke Aa yaeni¥ pucka OT CroMamIIHO-4peBHa 5388 HAH KPHEOHETAB MocpeaCTHOM cHHeprHven e*bexT, + aurruxoaryzasris: HCIIBC nosnuianar erpexra Ha repopasiuitre altrHxoarysiaitt, KATO ManpaMep sapapun (sx. TouKa 4.4), nopain BHCOKa cTeneH Wa cBBpSBAHE c MulaBMEHHTe NOTEMHH Ha JleKekeronporpen 4 MiIXHOHpake Ha TpoMGouNTTHaTa yHKUW H yapexdaHe Ha cTOMAUZHO-4pesHaTa suraprita, AKO KOMOHKINpAHOTO AeNenHe HE MOXKE Ja Ce HBGerHe, € HEOGXOAHMO CTPHKTHO KAIMHENHO HaGmogenve H npocnesimnane Ha KaMMIEHUETe MapaMerpH: + -Xeftapwin: nosmurer puck or kepaee (nopaan wixtGupane Ha TpoMGoweTHaTa dyHKuMS H -yepexkaaie Ha croMauiHo-spestara 1Hrannua). AKO KOMOMMMpAHOrO TeNerHe He MOxe sla ce usGerHe, © HeoGXOsHMO CTpUKTHO KAMKHUKO HAGMOREHHE 1 TIpOCREsMBAKE Ha KIKMMHMNTE NapaMeTpH; + KOpTHNOCTEPOHINE: HOBHINEH PHCK OT CTOMAMIKO~Ipenra SBA HIM KPBEOHSTHB (Bx. TONKA 4.4). + amrait (onacatio € ¢ Haxonko HCTIBC): HCTIBC nonmuiasat isara ta JIMTHh s KPBBTA, KoHTO MoraT 7a OCTHTHAT TOKCHUHH CTOfiHOCTH (NlonMxcHO GBOpesHO HaTDHBAHE Ha sTHHA). CrreAOBATEATIO TOSH Napamersp Tpa6aa sa ce rpociteasna Mpy sariownatte, alarrripane H MIpeyeTaHOBABAHE Ha JleveHHeTO ¢ exeKeronpoper; + Metotpexcar, npiiaraH bs BHCONH so3H oT 15 mg ceaMMNO HAH HoBeHe: sacHTeHA XeMaTOTOTHHa TOKCHNOCT Ha METOTpeKcaT MocpenCTBOM NOKIOKeNiHe Ha GLOpewnHA MY KMpHHC OT pormpossanavrestan cpeacTea mo npuuuniT, + xuIaHTroH H cynouaMnas: ToKcHHOTO AelicTaMe Ha TESM BeMiecTBa MOKe a Ce SACHA Kon6urawm, xonro yanexaar npeanaann mepxn + amypeTint, mixnGuTopu Ha aurHoTeHsMH-KouBepTupantia exsint (ACE), atrrHGax AMHHOFAMNKOSHAM H aNTarOHHCTI Ha aurHoTexaun IT peuenTop: HexeKeronpoden Mo edextire Na AHypeTHWHTe H aMTHXHMepTeNsHBHHTTe neKapcTea. [IpH HAKOH Tau GoGpesnia Gyseuda (Hamp. nexiapaTupawl NauMeNTH WI MaUMeHTH D crapyeckaxapyurera Gu6pessia yHKas), eAHOPeMeHHOTO MpHAOKene Ha neUlecTBA, HOTHCKALIH uwknooxcurenaaara w ACE uHXHOMTOpH W1A aHTHOTeHDHH II peuerTOpHH aHTArOHUCTH MOxke sa oResIe 0 JOMEANHTEAHO HapyUICHHs Ha GLOpeHHa GYHKUUAE, KOCTO OGHKNOKEHO € OGpaTHMo. B cayywai Ha KOMGHHHpaHO MpesInicHaHe Ha JexcKeTonporpeH M AMYPETHE e KAKO 1a Ce OCHTYpM au1eKBATHO XWJIpATHpAHE Ha NAIWEHTA H Aa ce HicteNe GSOpesMaTa GYHRIHA TIPH 3aMONBAHE Ha sleweHHero (Bx. To¥Ka 44); + -weToxpexcar, npyraran 8 HieKH 03H, no-Manko or 15 mg ce”MUTHHO: XeMaTOAOTHsIHaTa TOKCHUHOCT a METOTpeKcat ce YaclutBa pes NOHIAKeHIMe Ha OOpeNHUA MY KAMPENC OT NPOTHBOBBSNATHATEAMHTE cpeacTea ro mpanuin. Exkeceammatio Hocaensanie Ha KPDBHATA KApTHHA pes Mpeara ceAMMUA Ha KomOmnmpanoTo seveHwe, ZacHieHo HaaoseHMe MIpH HasMNIe ZOpH Mt Ha TeKO YEpeRAANE Ha GrOpesara dytnuiiA, KAKTO KE MPH NaWEHTH B CrapyecKa BEpACT; + renToxenspruii: nopnuen puck oT Keppene. [lo-akTHBHO KANTIHAHO HaGmMONEHHE 1 110-HECTO WaciieABaHe Ha BpeMeTO Ha KLPBEHe; + augoByaant: pueK oT noBHwanaHe Ha ToKCHYHOCTTA HEPXY epHrpOUATHATA peAMUA HOCpereETEOM aeHcTBMe BEpxY PeTHKYTONNTITe C BLIHMKRANE Ha TekKa aHEMHR etHa CeAMHLYA Cie SAMONBaHe Ha HCTIBC. Mponepxa sa miteara xpoena kaprania m Gpos Ha peTHKy.TOUMTHTe emMa 10 ARE CesMHIH cea sanlo¥ave Ha newenmeTo ¢ HCTIBC, + eyabamatypetinn aexapersa: HCTIBC morar sia sacar xanorixeMmanins edpeict Ha cymanarypelinire nexapcrna tocpestcTHOM H3MecT#aHeTO HM OT MecTaTa 38 CBEDSBAHE © TuiasweHiere npoTenaH. 2. 50 ce HMA nIpeaes + Gera-Gnoxepn: aevenHeTo ¢ HCIIBC Moxke sta OHIDKH aHTHXHMepTeHSHBHOTO HM ZeiicTBHe mocpeneTaoM HinxUGHpatle CHHTesa Ha mpocTarnaruuantTe: + umknocropn 4 raxpounye: Hepooxciaoctra Mo%ke Aa ce 3aciuin ot HCTIBC, rlocpexcrwom MeaHMpali OT npocTarnansuMnnTe edekr BEPXY GEGpeuTe. [To BpeMe Ha KOMOHHHpAHO neHeHHE apsGaa aa ce wscnensa GEGpeunara yHxis; + tpomGomerHun: nosMuier prick oT xEpaeste; + aimmponGounrita sexapcrua 4 cerexTHaHl HAXHOHTOpH Ha OGpaTHOTO 3aXBalilane Ha CepoTOHNHa (SSRD; rossatent pcx oT cromamo-apebHo Kepaere (Bx. TONKA 4.4), + npoSerenmia: nasmennre KOHUEHTpALINA Ha NeXCKCTOMpOdeH MOE Ja Ce MOSHULAT; TOBA naauMoseficTaHe MOxe 2a ce ABJUKIE Ha HHXHOMpane Ha MACTOTO Ha ObGpewara TYSyzuIa CeKpeLAA H Na FaroKopottowaTa KOHIOTANHA H Ce HOHCKBA AuaNTTHpane Ha AOBATA Ha JleKeKeToMpodent Carn03;, + eepaeuna raukoswu: HCTIBC Morar ja yeearuar niaaNenata KOHUeHTpAUMR Ha THHKOSARHTES + saienpneror: nopaiH TeoperHsHHE prick OT MpoMsa B edpeKTHAHOCTTA Ha MHLpeNPHCTOH OF MIXHOMTOpHTe Ha TpOCrarIAHAMHOBHs cures, HCTIBC He 1paGsa a ce wanomsear noBede or 8-12 SIH Crea NPHIOKEMAETO Ha MapenpHCTOH: + ximonoHOBH anTHGHoTHMn: OTUETHTe TIpH AxMBOTHH NOKAIBAT, Me BHCOKH 03H XHHONOHH 8 xomGnnantix ¢ HICTIBC Morar 2a ysemuuar packa OF mpoxBa Ha KOHBYACHH. 46 Deprauter, Gpementiocr m kEpmene Texoxetonpodent ¢ nporusonokasart pes TperH TPHMECTEp oT GpeMeHtHocTTa H MepHoa Ha KEPMetHE (BK, ‘Towa 4.3) Bpementoct WiaxnGupanero Ha npocrarianantonus cutres Moxe Ja Happesla Ha GpemenHoctra WiaH enGpvonasmorolberanworo passiTve. JlaHHH OT enleNHosOrH4HH NpoyBaHHs Nlopaxiat GesmoKoHcT#O OTHOCHO noBHMeN PACK OT aGopr H OT CEpTEUHA MaTHopWaLIHE H racTpOCKNBHe che: yroTpeGara Ha HIEXHGHTOPH Wa MPOCTAP-IAHIMHOBHA CHHTES B paHHMTe CTanHM Ha BpenenwocTra, AGCOMOTHAAT PHCK 38 ‘erara ewsptuocr. B slomuatene KbM TOBA, YeeMHeH GpoH cmyyaH Ha paxtALHH BHO BUHOUHTeTHO KAPAHORACKYTapUH, ca CbOOMEHH IPH 2KMBOTHH, MIpHEMALIH HEXHOMTOpE HapocrarnaiqHHosua cmrTes M0 Bpeme Ha opranorenesara, BenpeKi ToBa, pH NpoysBanis MPH AHBOTHTE, ‘Ha KOMTO ce MpHara seKeKeTONpo*eH TPOMeTAMON, He Ce HAGIOTABA per|pOAYKTHBHA TOKCHYHOCT (BH. Towka 5.3), Tlo BpeMe na MpSHS H BrOpHs TpHMecTsp He TpxGsa Za ce pea zeKcKeTONpopeR TPOMETaMON, OCBEH ako IpH KATEropHUHa HEOGXOAMMOCT. AKO Ce HacTara TIpHADKEHNE Ha jeKcKeTOMpohen, TpomeTaMos Ha xeH1a, KOSTO Ce OmMATHA ja tAOPEMeNEE HIM € B MIEPBM WH BTOPM TPAMECTED OT Gpemennocrra, nosaTa TpaTsa Ma € BREMOKHO Hall-HHCKA 3a BRIMOPKHO Hafi-KpaTko BpeMe. TIpwroxkesmero na wtocnOwTopyre a npocrarnanaHHosHa cmtiTe3 NO BpeNe Ha TPCTHA TpHMecTEp OT Gpememoerra More sa npn = Ha deryca: +“ Kapanonynwynapna ToxcHsocr (npeactespemenno sarsapatie Ha ductus arteriousus GenoapoGHa xunepromna); + GaGpeuna ancdysKnHR, KORTO MoxKe Ja Mporpectpa jlo GuEpeHtia HeTOCTATHAHOCT HLTH XO ‘oalHroxapoaMEosa. = Ha Malixara W HoBopozeHoTo, 8 HaKpag Ha GpemesHoeTTa: + BeposTHo yanubkanane Wa BpeMeTO Ha KEPBENe, aHTTH-AarperanteH EpeKr, KOATO MOE AA Ce TIPORBH OPH H TIpH MOTO RHCKH 03H. + nonvickaHe Ha poWIAHTe KOHTpAKUMM, KOETO BORN 0 3aGaBRHE HIM YIBIOKABAHE Ha ‘YOHANAN BpeMe Ha PaxVIAHE, Kepmenie He ¢ wspectno nam aexcxeTomporpent ce excKpeTHpa 8 KEpMaTa. Deprumerer Kakro npw apyrure HCTIBC, ynorpeSara a aexexeronporpent tpomeramon Moke sta Hapywint peprivuirreTa a 2keHiara H He ce nperlopeusa npit Ket, KOHTO ce omtTBaT na saGpemenest. IIpw skentH, KOHTO HMaT sarpyanenis pH 3a6pemenssate Ham KoHTTO ce WacTesBaT 3a Gesnsiozve, Tps68a jta ce OGNUCIH peycraHonsBake Ha sleKekeTOnpodbeH TPoMETaMo 4.7 Bgext upry cnocoGuocrra 3a mogupane paGora ¢ Mammnn Jlexckeronpoder TpomeTaMon More 2a Ok@kKe J1eKO WIM YMepeHo BUMNAHHE BLPXy chocodHOcTTa 3a Uodpupane wit paSora © MaUIMHH, nopaZi BaMoxMOCTTA a NPenHOBHKa 2aMARHOCT HI CLAMUBOCT. 4.8 Hexenann xexapersenu peaxuun (CroSmasainre B KAMHHUHHTE MPOYYRAHHR HEXETAHH PeAKLINH KATO TIOHE BLSMOKHO CHBPSAH C eKckeTonpodex TpomeTaMON, KAKTO M ChOSINaRaHHTE HEENAHH PEAKMH CAE MYCKAHETO Ma rlasapa Wa ekekeronpodot ca npeacrasckn no-tony 8 raGmHnta, KATO ca KacH>HUUMpallA NO cHICTeMO~opraHieH K7ac H pasaesiett no YectoTa: ipa oxasarure kareropun YecTora e HamossBatia CHeHaTa KONBEMUNA: Mnoro were (21/10) ect (21/100 a0 <1/10) Heuecta (21/1000 10 <1/100) Peaks (21/10 000.210 1/1000) Muoro peak (<1/10 000) CC wemsnecrua yectora (oT HaTHHHHITe AAEM He MOXE ja Gbae Hanpaneva oueHKa) ‘Cucremo-opranen Kae Meera Hevecra Peaxn Hapyureuua ua xpeera m awmguara cucrema Hapymenus ua umyunara ‘Cron wacucrema TIapHERCA, PeaKu, BT anagunaxTinien, 10K Hapymienus na wera6oansma ‘Anopexcnn 1 xpanenero Teuxmann napyuienus Vincownnna, “tpevoxHoc Hapymenna na neponara TaasoGonue, | Mapectesus, cucressa sanastiocr, centixon connoneHTHocT Hapymenus wa owmre Sawrreno spenme Hapyuienus wa yxoro « Bepruro iya m yuuwte AaGupanra (Cepaeunm napymenms Tasnnraunt Taxneapins ‘Ceto8m wapymienna Savepaseane | Xuneprouua | Xwmorouns Pecnuparopnn, rpbana # Bpaaunnes Bporrxocnaseat, Mesmacrunaaun Hapymenns auction Cromamino-spenni Tanere wean | Tactpa, Tlenmenia aoea, | Tlarxpearar Rapymenna ospeuiare, xoncranauns, — | xpbBosimn Gomka kopema, | cyxoraayerara, | wm awapis, qaarynenuus — | nepdopaune wa suenencna nentHsta 9382, (ex. TouKa 4.4) XenaroOuanapnn napymennn ‘Xenarar Xenaro- nesysapan Hapyurenns “Hapymenns na KoxaTa O6piB Vpruxapas, | Cunapom na nogkoxWaTa TKAK axe, Stevens Johnson, ‘yaenwseno ToKowsHia wnorsnane | enuzepwasria lexpoaiHsa, (camapom Ha Lyell) auronesporuuen. Ook, OOK Ha mayeTo, peaKuyant Ha syscrmmrestocr oe cueranta, pypurye Hapyuenun wa wyeny.ano- Bonka 6 repoa exeaerHara cacTeMa H cxequTeanrra rua LL Hapymtenna na GeOpenure w ‘Ocrpa Hegpar win nukowEnre muruma GxGpeuta Hedporasen Henocrarsunocr | cHHLIpOM = Tlonmypna Hapymenaa na Hapymenne 1a px supowznoqmrennara Mencrpyamina cncrema w repnara 86.7, pa -apyilenHe ZR SOMET npocrarara //y-—~ ‘OGmiw wapymicnns m epexra ‘Ywropa, Tlepudepery/ = Ra MACTOTO Ha MpHUIOKCHNE Go:ia, ore ELEacTenna, Brpucane, oma omnaawanocr, Hocaeqpanm ‘Oraonentin 6 ngcneaBaua Ha ‘epHoupobrara py wien (Crowammo-4pessn: Haii-Nectute HeaxenaHit peakUHN ca comamiHo-spenin. Moxe na ce HaGtlonasat enmita aa, epopauvia HaH CTOMAMINO-SPeBeNt KPEBOHSIME, NOHSKOa c arateH wXOR, oCoGEHO B cTapyecka suapact (mk. ToxKa 4.4). Caen mpilogenne ca chOOmanaHH Tazene, NOBPBULARE, AHApHA, quuarysenuts, xoHeTHNAUNE, AMEneTICHR, KOpeMH GonKa, MesieHa, XewaTeMe3a, y-1Uepo3eH CTOMATHT, OGoctpante Ha Kost Han Gosect Ha Kpon (wx. Toxka 4.4). [fo-paziko € NAGmOAaBAH racTPHT. Orox, xinepromns H cupmesma negoctarssHocT ca cuoOulanalH BMB BpBaKa ¢ Tepantis ¢ HCTIBC. Kakro npa apyra HCTIBC, staMoxvo e sia ce nposar calenHMTe HexkenantH peaKKM: AceTTrHveH MEHMET, xoliro Moxke fla BRSHIRKHE MpeMMHO MH TIauHeHTH CBC CHCTEMeH YHYC epHTeMavoaee HAH CMeCeHA CheMHMrTento-ToKanta GonecT; XeMaTONIOFHYHH peaKitMA (MYPHYpa, aMutactHta H XeMOUTMTHUHA AKeMUR H, PATKO, ArpaHysIOMlATOsa H KOCTHO-MOSbHH XMMOTLIEGHR), By.nostit peaxian, nksuountenio Cituapos Ha Stevens Johnson wan Toxcitta emirepsatia neKpomttsa (ounoro peak), Kiunnsnn npoydpatis H eriinenmosiorieny sanmM MoKasBar, 4e ynoTpeGara Ka tiaKoHt HCTIBC (ocoGerio BBbB BHCOKH J103H H TPH MPOALUKNTEAINO NPHLLOATCHHE) MOXKE 1a Ce CBDPrKC ¢ s1eKO NOBHLICH PHeK OT aprepraman TpomOorsrannt RHCURAeHTH (Hamprsep, MHOKApZeH HeKbapKT WAH UNey:TT) (Bx, To-KA 4.4.). 6 11a rlonosupant Herc “aku (CroSurasatiero Ha nonoauparn HemenaHH peaKuNH cnet paspetanante 2a ynoTpeGa Ka seKapcreeHHs pouykr e saxno. Tosa Noseons¥a Aa MPOABURH HAGTIONEHHETO Ha ChOTHOLICHHETO MO:134/pHCK 3 nekapcrnenys mpoxyKr. OT MemMUMHeKHMTE CHeMMANMCTH Ce HSACKRA 2a ChoGuABaT BCAKA NOOIMpaKa HexeaaHa PeakUMs upes HALHOKAMHa CHCTeMA 3a ChoStLaBane KeM Hismmunirestara areHys 0 exaporsara, yar. ,Jlancais Fpyen" Ni 8, 1303 Cosas, ren: +35928903417, yeGcaitr: www.bdabg 4.9 Tpesosmpane He ¢ ussectia catmowarosorvirra fipi mpeaosmpane, CxomHH 1eKapcTBeHH nponyKTH ca npeaMBBHKBATH cromauino-4penimt (nompsmane, attopexci, KopeMtta GonKa) H NeBpoxorHMHNH Hapyuteting (COMMONeMTHOCT, sepruro, saryGa Ha opHenTanv, rnaBoGozTHe). Tips carywaet WH npekoMepen pHeM, HesaGaBrio TpaGwa ja ce aaNlONHe CHMMTTOMATHTIHO eHeHHe B 3aBHCHMOCT OT KAMHHHOTO CHCTORHIMe Ha traliueHTa, AKO ca NpHETH TloBeue OT S marke Or BBapacTeH WAH JeTe & PaMKHTe Ha e7HH aC TPAGBA Aa ce NPHAOKH aKTHBEH BUTTEH. Aexoxeronporpent tpomeranton Moe Ja ce oTCrpantt Ypes AHaHBa, 5. APMAKOJOPHYHH JAH 5.1 Dapmaxommuamwnn cnoiicrsa apwaxorepaneariana rpyna: Hpovamosxanamstenia u atapeaMaTasni mpo:yKTM, He: TIpowsnoatin wa mpormoniona xricemania ATC xon: MOJAEITTlexcxetonporpent tpomerano7 € TpoMeTaMerannHoga cost Ha S-(+)-2-(3-Gerrsounpent) ponHowoBa RUCONMHA He AHATTETHUHO, NPOTHBOBEIILAHTEsIHO H SHTHNHPETHYHO AeKAPCTBO, KOETO MPMHANTERH KEM rpynara Ha HecrepowaHitre npoTHBoBEaniamitrestiH cpeacrsa (MO1AE). Mexainsbe Ha gelicTane Mexaiianor Ha 1elicTBMe Ha HeCTepowIiHTe MpOTHBosBsTIAsMTesIHH CpeACTBA ¢ CBBDIAH ¢ NOMMOKABANe Ha cHHTesa Ha HpOCTaTiaNAMHHTE Npes MHXMOMpane Ha KackadaTa Wa HMKGTOOKCHTENAsaTa, CrewacbHsHo ce vuixnGupa MpespeuiaHero Ha apaxiloHoBaTa KnCeHHa B UME enOMepoKcHAN, PGG2 « PGH2, Koro npoayunpar npocraraarumtt PGEL, PGE2, PGF2am PGD2, Kakro # npocrawaktun PGI2 4 tpomGoxcarn (TxA2 w TXB2). Ocpent Tosa mxnGupanero na curtTesa Ha Mpoctarnananitre Mo%e fa sacerne pyrH MeavlaTOpH Ha BBONATEMHETO, KATO KHEAHH, MpCAMSBHKRAMIKH KOCBEHO sHICTBHe, KOETO MOKE fa ODAC AHTHBHO KUM MAKOTO. Papmaxommanvstn eer Tipu excnepumertH py aciworiy it np Xopa e AeMoltcTpApAH, He ZexcKeronpodex HasHOMpa nefiersieto Ha COX-] COX-2 Kam cHoer n Gexonacuocr Kannwsnorre npoy4eanis, nporeena npn waxonko Sonkonst Mozena, Aemontcrpupar e”peKTHBHOTO OGexGananamo jelicTBHe Ha AeKckeTOTPojek TPOMETAMO;. B HAKOH NpOYRAKHR HaNaToTO wa anarer™mnioto Aejicrane ce npoxBaRa 210 30 MYTH Chel MPHIOKeHMTETO. AnaAerHMHHAT eIpeKT € & npomsmxwremHocr or 4 20 6 aca, 5.2 Papmaxoxnnerusmn ceolicrsa AScopSuns Caren nepopanio mpitoxeHne na jeKeKeTonpo(peHt TpoMeTaMOx MpH XOpa Cage C8 NOCTHTA Ha 30-Ta MITA (B ananasona 15 - 60 ManyTA). Tips estwospementio npuioxenie c xpana AUC He ce mpomess, asnpeKH 4e Cayx Ha HeKCKETOMpOdeHt ‘TPOMETaMO Ce NoHoKaRA H CKOpocrTa Ha abCcopGUIE ce 1aSaBs (yBEMTIABA CE tay) Pasnpenexenute Bpewero na noay:susor boa asava a pasnperesenve # 1a evMMUHHpAHe Ha eKeKeronpodpeH TpoMeraman ¢ choTBeTHo 0,35 Haca m 1,65 aca. Kako mpi ApyrH sleKapeTsa c BHCOKa erent € mmasmenutte nporenin (99%), oGeMr Ha pasnpenenenie © epeato 01 0,25 Vkg. ‘caspapane Tips cbapMaxoximerita npoyseanna ¢ MEOroKpaTHO npisIOweHHe ce HaSsnonaBa, ¥e AUC (nuaomrra roa kpusara) cxlen MocmeTHOTO MPHLAOAKEHHE He Ce paUIMUaBa OT MOsTyWeHATA CiTeA esIHOKPATHO MPHIOCHME, KoeTO HloKa3na, He HAMA KYMYZIMpaHe Ha AeKapeTBOTO. Buorpane: 1H emMMMEMDAR Crea npictoxenwe ta aexcKeTonpoijen TPOMETAMOsB yphHaTa ce OTKPHBA camo cHattrHoMepa S-(+), KoeTO noKassa, He pK XopaTa He ce HaGmIONABA MpespEilake & eHaHTHOMEpA R-(-) Ocuosinar nar wa eammnHupae Ha neKckeTOmpodeH € ¢ rUOKYPORHAHa KOROTALULA, NocenBawa OT Hesroupane npes Ge6peunre. 5.3 Mpeaxaummnn aamnm 3a Gesonacuocr TIpeaotiruusre aati He noxaspar cneuHguieH pHEK 2a XOPATA, KATO Ce OCHOBABAT Ha KOHBE! acre qBaHH 3a Ge30MacHOCT, TOKCHHHOCT MPH MHOTOKPaTHO MpHAOXKeHHE, reHOTOKCHHHOCT, Penpoaykrusia TOKcHHHOCT H wMyyHOMapMakostorH. [IpoBeAeHHTE BLPXY MHMIKH H MaiiMy’ 22 XPORHSHA TOKCHMHOCT ca NOKANAH HABO Ka mHNCa Wa MEAKEAHK peaKiLAH npHH3 mg/kg‘OchosHitre Hexe:Tatin peakunl, HaGmoqanaHl MPH BHCOKH 103K ca GHLIM CTOMAINHO-NPeeHH epOsHH M 38H, KOHTO Ce pasBMBAT 8 SABLICHMOCT OT AosaTa. 6 @APMALEBTHUHH JARHE 6.1 Canes a nomounmte semectaa (Copuesina na taGnerkara: Hapesirario nuuecte, Mupoxpucrama ueryn0sa, Harpnes wamecter raukoxar, Taumeponos ancreapat (OSsupka na raGnerkara: Xnnpomestosa (E-464), uration auoxent (E-171) Maxporoa 400. 6.2 Hecnsmecrumocrn Henpnzoxuno. 6.3 Cpox ma roauocr 2 roan 64 — Chenwa.in yeropus Ha chxpanestne Hla ce coxpansna non 30 °C. Banerepure ja ce coxpatianar # Kaprowenara KYTHR, 3a la ce MpesnassT OF coeraunta. 65 Bua w cbanpaanne wa owaxonkara TaGaennutre ce npeiarar 8 Onutcrepy (Ganctep or PVC-PVDClany sue). Duamupann taGaerKH TeKexeronpodert Catiz03 25 mg - 10, 20, 30, 40, 50, 500 gmmpaxn TaGaereH B onaKonxa. He scnukit siose onakosku Morar a Gxaar nycaTa Ha nazapa 6.6 — Cneuna.anm upernasun wepku mpi HaxeHpasute paGora Hevanossannsr seKapcrsen npodTykT WM OTTianbuHiTe MaTepHaan OF Hero TPAGEA Za Ce HSXBEpAAT B ‘COTBETETHE € MCCTHHTe HSHCKnaIt, 7, TIPHTEXKATEJI HA PA3PEIIEHHETO 3A YIIOTPEBA, Sandoz dd. Verovskova 57, $1-1000 Ljubljana Caowenus 8. HOMEP(A) HA PA3PEUIEHHETO 3A YIIOTPEBA20130406 9. JATA HA ITBPBO PA3PEMIABAHE/TO/HOBABAHE HA PASPEIMEHHETO 34, YHOTPEBA 18/11/2013 10. JATAHA AKTYAJIN3HPAHE HA TEKCTA 04/2016