KPATKA XAPAKTEPHCTHKA HA IIPOJLYKTA. L90P007S7 76 | Axcen 5 mg raGnerist BESHATHP- £8 164 -5- Accel 5 mg tablets ‘Axcen 10 mg taGner«n 29.01, 200 Accel 10 mg tablets 1, HME HA JEKAPCTBEHHA 1POLYKT 2, KAYECTBEH H KOJIMYECTBEH ChCTAB Beaka TaGnerka Axcen 5 mg cbaeprKa 5 mg anstoaumian (amlodipine) (kaTo amsionunnion Geswtar). Beaxa TaGnerka Axcen 10 mg crarepaca 10 mg anstoxunun (amlodipine) (Karo amsionmninnos Gest). 3a moma crMCEK Ha HoMOUIMHTe BeuLeCTBa BHOKTe TOHKa 6.1. 3. JIEKAPCTBEHA ®OPMA TaGnerxa Axcea 5 mg: Ta6nerkite ca kppran 4 6ern, ¢ aMaMeTbp npHOsMsHTeaHo 8 mm. Axcea 10 mg: TaGnerkute ca KpBIaH H GesH, ¢ JeMMTeNIHA YepTa ENHOCTPAHHO H AMAMeTEp MpHOTHBHTETHO 10,5 mm. TaGnerwara Moke a Gwe pasmtenena Ha paBiH 03M. 4, KJIMHW4HH AHHH 41 Tepanestwann noxasanna Xnnepronns. Xpormnta craGnama crenoxapans. Basocnacrwyna annua (Ha Prinzmetal). 4.2 Jlosmponka a nasun na mpaaoxenne Tosuposxa Bospacmnu OGuualinara Havana 03a NH XHMepTOHHA H cTeHOKapAMA e 5 Mg ANIOAMNHH BEE MIHEBHO, KATO Moxke Ja ce YBeNHH 0 MaKeHMasIHa 03a OT 10 mg enopen TepaNeBTHsHOTO NOBAMABANE Ha NaNWeHTa. Tipx nauveHrn ¢ xHMepToHHA aMcIOAHNHH ce HoTlonsBa B KOMOHHAILNA c THASHLAEH AMypeTHK, aaxha-GaoKep, Gera-GnoKep WAH HEXHOWTOP Ha aHTHOTEHSHH-KOHBepTHpAMLMs CHSHM. IIpH CTeHOKAPAHA ANLTOANMHH MOKE AA CO MSTIONSBA KATO MOHOTEPAMMA HAH B KOMGHHALWA ¢ APYTH ANTHCTEHOKAPANH JleKapCTBCHH NPOAYKTH pH NaLWeHTH CK CTEHOKAPAMA, KOSTO He Ce MOBMHABA OT HATPATH WHIM ChOTBETHH 03H GeTa-GaoKepH. He ce vianara Kopekuiia Ha 20saTa aMIORHNHH MpH EHOBPeMeHHO MPHTOACHHE ¢ THASHANH AMYPeTHNH, Gera-GnoxepH M HHXHGHTOpH Ha aHrHOTeHSHH-KoHBepTHpAlLIMs CHSHM. Cneunanin nonysausn Heduampuina nonyaayua Heua w ioxoum ¢ xunepronns Ha eespac or 6 20 17 roawuy, Hpenopyurteniata arTHxsMepreHsHBHa Tepopasa 03a npH NesMATpHYHH NaUIMeHTH Ha BEspacr 6 — 17 roaMHH € 2,5 mg eHOKpATHO Havana 03a, THTPHpaHa BNOCNECTBHE AO 5 Mg EHOKPATHO AHEBHO, ako cnen 4 cenMMUH ye axenanoTo Kpbsno Hanarave. JlosM wa 5 mg ;HEBKO He ca npoyYaHH NpH NesWaTpHYNH ‘roux 5.1 15.2). Alewa na sespacm nod 6 zodunuJhunesar ann, Hayuenmu a cmapvecka evspacm AMGIOANMHH, HSNONIBAH B CXOAHH OSH MPH NaMWeHTH B CTapHeCKa BEIpacT M MpH NlO-WaAAH NaLWeHTH ce onaca envakso 06pe. IIpH nauwenH » crapyecKa BYspacT ce MpenopE4Ba HOPMaLIeH PeokHM Ha OSMpaHe, Ho MOKAUBaHeTO Ha 1038Ta, TpaGea J1a ce MIpaBH c BHHMAHHe (ByDKTe TOUKH 4.4 H 5.2). Tlayuenmu c 66pewno yependane TIpomennre 8 naasMeivte KOHLCHTpaUNH Ha AMIORNTIMH He ca 3aBHCHMH OT cTenciTa Ha GuGpesHo yopexutaie H 3aroBa ce npentopbusa oSHYalita 2OsHpOBKa, AMAOAHNHH He Moxke a ce AHATUESHpA. aipuenmu c wepnoopobno yepeocoane Tososuar pexun pH naulHeHTH c JIeKO J10 YMepeHO YepHoApOGHO ysPexAAHe He € YcTAHOBEH H 3aTOBA wsOopeT Ha 03a TPAGBA Ja Ove HaNpapelt BHAMATeNHO, KATO TpAGBA MA ce SanowHe OT Hali-HHCKaTa BEIMOKHA 03a (BiOKTE TOYKH 4.4 H 5.2). DapMaKOKMHETHUHHTE CBOFICTHA HA AMIONMMMH TIpH TexKO ‘epHoApoOHO yapeauiane He ca npoy4Barn. Tipu naueHTH c TexKKo 4epHo”poGHO yapexkiaHe TpAGBa sla ce sano4ne c Haii-HHckaTa jlo3a H sla ce THTpHpa GaBHo. Hawnn na npwtoxenne 3a nepopansio npanoxeHne. TaGaerkHTe TpaGBa Aa ce MpHeMaT ¢ Walla TeNHOCT (HaNp. Yama BONA), HesABHCHMO OT XpaHeHHsTa. Equospemeniusr mpvem ta rpelinbpyt 11H Ha cox or rpeiind)pyr He BaMae Ha neHiCTBHETO Ha AMAOAHT. 43° Tpormponoxasanu: Axiom e npoTHBortoKasan ripH mauutestTH ¢: © CopoxayscroHTerHocr KbM aNJIOANTHH, AMXHAPONHPHAHHOBH MPOHSBOAHH HIM KEM HAKOC OT oMouutTe BeutecTBa, HSGPOEHH B TO4Ka 6.1. © Texka xunoronns © Illox, pxmountesio kapanorenter wok © OGerpyxusss Ha waxosa Ha sna Kawepa (Htanp. BHCOKOCTeNeHHA aopTHa cTeHOxa) © Xemonnnaniriia necraGiuia eupaestia HenocrarbuniocT cae Hi apKT Ha MHOKApHa 44° Cneunaann npexynpemsem jorpesa MW mpeqnasum mepxu mp) He ¢ yoranosesa Gesonactiocrra n eikacHocTra Ha aMOAHMMH TIpH XHMepTOHHYHH KPHSH. TlaunerTH cbc cepaesia HenocTarEaHoct Tlaunennute cx cppaeuia HexocTarbuHocT TpaGBa ja ce seKysaT ¢ BiManne. TIpH xKarocpouHO aaiteGo-KoHTponMpalto Mpoy'BaHe MPH MAUMKEHTH ¢ TexKa cHpeNHa HenOcTarb4HocT (Kae no NYHA OT w IV), cboGuenata Yectora Ha GenonpoGeH OTOK € M0-BHcOKA 3a rpymara, neKysaHa ¢ AMTOANTUH, B cpapnienne ¢ ruiaueGo rpynara (birare TO¥KA 5.1). Baoxepi Ha KATUMeBHTe KaHaIH, BKMOWHTETHO aMONMNHH, TpAGBA Aa ce waNOTBAT ¢ NOBHUIeHO BHHMANHe MIpH TaMeHTH Che SacTOfina CHPeHa HENOCTATBHHOCT, Thit KATO MOTAT Jia NOBMUaT pHcka OT GeneUIH CHpaesHO-chAOBH CBOHTHA H cMEpTHOCT. nonpeGa npH nayweHTH ¢ yapesteia YepHompoGHa Tip nauieHrH c yapeneHa NepHoapoGHa dyHKUM nONyARHBOTET Ha AMUIOAKNKH ce YaWDKABA, a ctofiniocrire Ha AUC ca 1l0-BHcOKH; He ca YeraHOBeHH NpenopBxH 3a OsHpane. 3aTOBA aNzORTAH TpAGBA 2a ce sano4ne c Hall-HMCKaTA 03a M a Ce MPOSBH BHHMAHHE, KAKTO 8 HA4ATOTO Ha JIeHeHHETO, Taka H MPH opnutasante 1a Ao3aTa, TIpH naunerTH © TexkKa YepHompoGHa HeADCTATHUHOCT MORKE ja Ce Ha ‘THTpHpanle Ha 03aTa H BHHMATENIHO MOHHTOpHpAKe. ‘YonorpeGa npH nauwenTH B crapyecka BEapact B crapyecka s»spacr nosvusenneTo na n0saTa TpaGea ja crasa ¢ BrHManHe (ByDKTe TONG}Tlaumentu c 6x6peuna Henocrarsunoct Tipu Taxnpa naunertH Mowe a ce npHaarat OGuyaiiHTe 203K amaonHnuH. TpomenuTe 8 naasmeHiTe ia Ha aMVIOgHTINH He ca cBDp2aHH CBe CreneHTa Ha GLOpeHHo YeperKave. AMIONHNHH He ce AHATHSHpA. Tomoumu peurectsa Tos sekapeTseH npoxykt cburbpxa no-Maixo or | mmol Harpuii (23 mg)» TaGaerKa, T.e. ce CMHTa, Ye He ceuaypxa Haru 4.5 Biaumoneiicrone ¢ apyru ackapernenu npoaykrn m apyru opmu Ha paanmogelicraue KTH Ha APYTH JleKapeTBEHH MPOAYKTH BUPXY AMTOAMTIN CYP3A4 unxu6umopu EnnospeMmenoro npiioxenme Ha aMnoHTHH cK CHIH HM yMepeHH CYP3A4 MixxHOMTopH (npoTeasHHt MixHGHTOPH, AsO MPOTHBOTEGHAHN CpeneTBa, MakPONWAM KATO epHTPOMHINKH HTH KNApHTPOMHLHH, BepaniaMHn WAH AWLTTHadeM) MOXKE a OBENE 10 SHAYHMO YaeTHYABAHE Ha CKCMOSMUMATA HA ANJIOAHTTHE, KoeTo a NOBMIM pHcka OT xunoTOHHS. KinHHUNaTa 3HaYHMOCT Ha TSH ¢apMakOKHHETHYHH BapHALiHH Moxke Aa € MO-HspaseHa NH MauINCHTH B crapyecka svapacr. Tosa MOC a HATOKH KAMKHYHO Mpociessnane W KOPeKUAK Ha 1osaTA, CYP3A4 undyxmopu Tipit catiospemenrio npanoxenne Ha HsBeCTHH HHAyKTOpH Ha CYP3A4 muiasMenara KOHUeHTpaLHA Ha anogHnAH Mo%ke ta Bapupa. [lopaitH Towa, KpBBHOTO HassraHe TpAGBa na ce MpocaessRa H sla ce OOMHETH aajanTupane Ha j03aTa KaKTO NO BpeNe, Taka H cule EsIHOBpEMeHeH TIpHeM, OCOGeKO CBE cA CYPSA4 MHLAYKTOpH (HANpHMep pHdaMMHIH, ADIT KattTapHOH). He ce npenopousa ynotpe6ara Ha aMnogunun ¢ rpeiindpyT HH coK OT rpelindpyt, Thi KaTO NpH HAKOH NauweHTH GHonaNN4HocTTa MOxe Ja Ce MOBMINH H ja jOBENe JO 3ACMIBAHE Ha AHTHXHNepTeNSHBHHTE eer. Hanmponen (unqsysua) Tip axuBorHn ca HaGmonasann aeranna KamepHa HOpHAALHA H CEpMeMHO-cChnOB KoNaNc, CBEpsAHH C XMMepKAIHeMHA Ce MPHIOKCHHe Ha BepanamMHT M METTpaBeHOseH naHTponeH. TlopanH pHCK oT XMMepKAIHeMHA ce npenlopeysa sla ce ¥3GRrBA eRHOBPeMeHHOTO MpHIOKeHHe ¢ AHTArOHMCTH Ha KasIuMeBHTe KaHQIM KATO AMJOAHTH NH NauMeHTH, NpesIpasTOOKCHM KOM MAIMTHeHA XHMEPTEPMHA HM ‘pH OBnansBaHe Ha MATHTHeHA XMMepTepMHs Etpekru a aMogunutt Bepxy ApyrH JeKaperBeHH Tlowwxasamva xposnoTo Haaarane edeKT Ha ANJOAMMMK SACHUIBA NOHIDKABAMLMA KPHEHOTO HANATAHe ether Ha apyru seKapcraen cpeacrsa ¢ anruxuneprensuBeH edexr. Taxpomunye CotecTaysa pick OT MOBMUCHM HBA Ha TAKpOsIMMYC B XPHETA MPH EAHOBPEMEHHO NpHAOKEHHE C ANLIOAHNHH, HO ¢apMaKOKHHETHUKUAT MEXAHIETEM Ha ToRa BIAHMoneHiCTAHE He € HANWIKO NpoyueH. 3a na Ce HSGerHe TOKCHMHOCT ¢ TAKPOAMMYC, MPHAOKEHHETO Ha AMJONMIMK Ha TAUHEHT, sIeKYBAH C TAKPOAMMYC, WoNCKBA NpocHeAABAHE Ha HHBATA Ha TAKPOMMYC B KPEBTA H MpH HEOGXOAMMOCT, KOpHrHpanie Ha O3aTa va Taxposumyc. HuxuGumopu na npomeun, mapeemen 3a panasuyun (mTOR) VisuGroprre na mTOR xavo eupomiye, Tevcnpommmye 1 eveponmmye ca cyGerparn na CYP3A. Awuionninun e€ cna6 wHxuGutop Ha CYP3A. TIps enospemennara ynorpe6a Ha mTOR wi AMIOAHTINH MonKe a NoBHUNH excrosHUHATA Ha MTOR wuxHGuTOpHTe. lucsocnopun He ca nposexnanm npoyusanns 3a slekapcTbeHH maauMogelicTBHR ¢ KNOCNOpHH 1 Sapasn o6posonun HIM NH APYTH NonyZALHH, ¢ HoKMOYEHNE Ha NaLWEHTH C GE6pesHA 3BETO ce HaGMOgaBAT NpoMeHLIHEH NoBMULeHHA (cpenHO ¢ oT 0% no 40%) Ha Hali-MNCKHTe KOHUEHTpALH wa wiksocnopiit. TpaGea 2a ce OGMHCIM MOHMTOpHpaHe Ha HHBATa Ha WHKAOCKOPHH MpH MaNHEHTH C GxOpeuna rpanicrnarrauns Ha TeyeHHe ¢ ANOAHMHH, a RosaTa Ha LKIOCHOpHH TpABBA Aa ce HaMANH copes HeoGxoxHMocTra. Cuweacmamun EnvospemeHHoro MHorokparuo npiitoxeHne Ha 10 mg auuioaunue m 80 mg cHmBacTaTHH € AoBeTO 20 77% TOBHUeHa eKCNOSHUME Ha CHMBACTATHH B cpaBHeHHe Che CAMOCTOSTENHO NpAIOKeHMe Ha CHMBACTATHH. Tipy naumerm, npHemau asioaMMIMH, sata Ha CHMBaCTaTHH TpaGBa fa ce orpaHiH 0 20 mg AHEBHO. B xaHHnun npoyysanna 3a ssanmonelicTeHa aMsIOnHTMH He MosAHABA dapmaKoKHHeTHKaTa Ha ATOpBACTATHH, AMTOKCHH WAH BapibapHH. 4.6 Pepruamrer, Spemennocr u KEpmene Bpemenioer BeionacHocrra Ha awionumus py Gpemennn xen ne e yeranionena B npoyspanns mpi 2kHBoTHH NPH BHCOKH J103H € HaGmOAABAHA penpoxYKTHBHA TOKCHUHOCT (sHDKTe TONKA 53). ‘YnorpeGara npi Gpemennioct ce npentope4sa cao Koraro sancea no-GesonacHo asrTepHaTHBHO TeNeHHe H Koraro 2aGonsnaHieTo HOCH MO-FomM puck 2a waiiKarra H dberyca. Kepmene AMs0q1HTIMH ce ekckpeTHpa B KEpMata np xopa. Yactra or posara Ha MalikaTa, NlOmy4eHA OT KBPMAXeTO € wouneaena ¢ uHTepKsapritieH aManasoH 3-7%, ¢ MaKcHMyM 15%. EdpexreT Ha aNJoaHNHH BEpXy KbpMayerara He € H3BecTeH. PeuleHHe ATH Ja ce MpOsBIDKH/ MpeKBeHE TeparnnaTa ¢ AMIO/NHH TpaGBA 1a ce maeMa KATO Ce HMA NPe/BHA Nomara OT KYpMeHeTO 2a jeTeTO H NONATA OT TepanHsTa c AMIOMMMHL 3a atixara, eprusurer Tipu akon nayHerry, xexysann ¢ GxoKepH Ha KaTuHeDHTe KanATH ca cboGieHH OGpaTHiMH 6HOXHNMEIHH NpOMeHH B rHaBHUKaTa Ha crepMaTosoHATe. KaMHMuHHTe JAH ca HeNOCTaTEAHH M10 OTHOWIeHHe Ha norenmMamina eexr Ha aMnonHMMH BEpxy deptHmTera. TIpH enHo mpoyyeaHe MpH TIEXOBe ca YetanoBeHn nexcaann eeKTH BPXY MbAKKHA depTHsTET (BHATE TOHKA 5.3). 4.7 Egextu supxy cnocoSuocrra 3a mogupane m paGora ¢ mamnnm AMUIOAMTIH Moxke la MORAMAE B Ma:IKa 10 YMepeHa cremeH Ha cnlocoHocTra 3a wloduparie H paGora c Mami, Ako nauHeHTHTe, NpHeMauLM AMORHTHN, CTpalaT OT saMaRHOCT, raaBOGorHe, YMOpeHOCT Hat TaneHe Moxe Ja G7 yapeteHa cnocoGHocrra na pearupar. IIpenopEuBa ce NORMILIeHO BHHMAHHE, OCOGEHO B HaaoTo Ha eNeHHETO. 4.8, Hemenanu ackaperseum peaxuun OGo6menne wa npodiia na GesonacHocr Hali-vecto coSutananuTe HexKeraHH PeaKUIMH MO BPeMe Ha eYEHHETO Ca COMHONEHTHOCT, 3aMARHOCT, TaapoGoane, nanmirayih, 3avepeaBaHie, KopeMa Goutka, raiteHte, OTOWNH Ha riteseHHTe, OTOK H YMopa. TaGamven ennco. uM HaGmogasann caw ca AOKNAMBAHH cremMHTe HeMeTaHH jeKapeTBeHH peaKLWH npH YnorpeGara Ha AMJIOMMNKHH CbC CaleMHaTa YecTOTa: MHoro 4ecTu (21/ 10), Yecru (21/ 100, Ho <1/10), Hex Ho <1/100), Peak (21/10 000, Ho <1/1 000), Mroro peakn (<1/10 000), ¢ HeHsBecTHa 4 He Moxke Ja Ghyle ycTaHOBeHa OT HaIM4HMTE aHHH). Tipu. peako rpynmparie » aapicHMocT OT ecTOTaTa, HexxenaHITe ‘eKaperseH peaKutn HHEsxONMII pes Ho OTHOUIENHE Ha THIXHATA cepHoaHocr.Cucmema, opean, Kaac Yecmoma ‘Hencenana nexapemsena pearyus Hapywenur na xpoema wu auwdnama | Muoro peaxn — | Jleakousrronenus, TponGounTonieHia cucmena Hapywenua na unynnama cucmena ‘Muoro peaxn | Aneprnwnn peaxunn Hapywenua vd ~—-memaGoxusma wu | Muoro peaxn | Xunepramxemnx | xpanenemo Tlevcxuampuinu napyueniaa Hewecra Bescbiine, npomatia 8 HacTpoeHMeTO (BK. ‘Tpesoxnoct), Aenpecus ean OGepKanocr ‘Hapywenua na nepsnama cucmena Weer ‘Ceiuimsoer, sanaanocr, — rapoGomHe (ocoBexo w HavanoTo Ha ue4eHMeTO) Hexeor#t ‘Tpemop, aucreysi, cHHKON, xinoecresna, napectesHst Muoro pean | Xunepronna, nepudepia Hesponarvia CC wemspectua | Exerpanmpamnao Hapymrenne ecrora (Ounn napyuenua ecru Hapyuienns wa spennero (BkmounTemHO anmuionns) Hapywenua na yxomo u esmpeunomo yxo_| Hewes ‘Taearrye ‘Kapouonocuxnu napyiuentn Wecrm Tlasmrrannn Hexecra ApHTMHa (BkmounTeNHO OpaquKapans, KaMepHa TaXHKapAMA M_ mpencEpaHO rbokaeHe) Muoro pean | Hibapxr na mnoxapsa Backyaapnu napyucnun Weer Bavepaapane wa HUET Hewecra Xunorowns. Muoro peak | Backysurr ‘Pecnupamopnu, epeouu w meduacmunainu | Neetu ‘Auenwes mapyuena Hevecra ‘Kamuraua, pax Tacmpounmecmunania napywenica ecru Bonku 8 KopeMa, raneHe, aMcnencus, npowana 8 pene byHkuan (exsowrrennio anapua H 3arieK), Hewecrn Tlospbuiane, cyxora B yerara Muoro penx | Tlanixpearut, ractpit, xunepniasa a enue “Kenamo-Gumuapru napyuenua Muoro peaxn | Xenavwr, _xcurTeHMua, nOBMUNeHHT ‘epHonpoGHN eHsHMH* ‘Hapywenua na Komama u nodxoocnama | Hevecra ‘Anoneuss, nypnypa, oGesuperasarie Ha moxan KoxaTa, XHMepxHApO3a, CEPGEX, OGPHB, exsanrTeMa, ypTuKapna Muoro penxn | AnrHoenem, — epHTema —_ wysrrmiope, excbonmarunen aepwari, CHnapom Ha Cruppxc-JbKoHncbH, oTOK Ha KeHHKe, orouyscrawtennocr C newsnecria Tokens emiulepMasiia HexpOnHa ecrora Hapywenua na aycxyano-ckexemnama | Yecta Tlonysane a Taesenmre, MycKysHH cucmena, cvedunumemama moa u xpawn, kocmume Hevecra Aprpanras, waar, Gonkn 8 rspba Hapywenua na Goépeyume uw nuxounume | Hexecta Hapymienna 8 ypanps Typ momaya no-tecTo ypHHMpane Hapywenua na —_penpodyxmusnama | Hevectw iwnorentiocr, raiexo) ccucmena u zepoama i O6uyu napyuenua u edexmu na xacmomo | Muoro wecrn | OroK {‘na npunoowenue Weer ‘Yopa, acrenua Hesecrn Boaxn = ~——srepanre, ——_Gomka, Hepasnonoxenne Hevecra Tlosamasane Wa Ter0T, NORMOKABAHE Ha seraoto CroGuiapane Ha Nozo3mpaHH Hexke IM peakUH CroSutananeTo Ha TOQOSHpAHM HEKeIAHH peaKLWIM caren paspeumaBaHe 3a ynoTpeGa Ha AeKapeTBeHHE NposyKT € BwKHO. TOBA MOsBONABA Ja NPOABORM HAGMOAEHETO Ha ChOTHOUIEHHETO Nlowsa/ PHEK 3a ekaperseHHs npoaykr. OT MeAHUMHICKHTe cremHaNHCTH ce HaHCKBA 2a cEoSulABAT BeaKa nonosMpana Hexeriaiia peaKiua Hpes HaLIMOHANHaTa CHCTEMA 3a CLOGUIABAHE. Vonbannteana arenmna no sexapersata ya. lanai Fpyes” Ne 8 1303 Coda Ten.: +359 2 8903417 yeGcaiir: www.bda.bg 4.9 Tipexosmpane Onursr ¢ npestamepennio npenosupante mpH xopa e orpannien. Cuwnmoneu Hasmnire anim npeanoaarat, e mpenosmpalte © BHCOKH 03H MOXKe Aa TOBE 0 MpeKoMepHA nepHdepia BasoaMAaTALINA H BePORTHA peduieKcHa TaXHKapmus. CROGUIARAHO © 3a H3pazeHa H BepORTHO NpOMBIMAHTEsHa CHCTEMHA XHNOTOHHA AOCTHTaUlA NO H BKINONHTESHO WOK ¢ (parasteH HSXOM. Tlewenue KawinHo sHauuMa xunoToHs, Nopam npexoaMpane c AMIOAHNMH, Haara akTHRHO NOMIDpKAHE Ha bynKunaTa Ha cEpreHHoceTOBATA CHCTEMa, BKINONMTE:IHO HECTO MPOCKEAABAHE Ha CEPACHHOCEIOBATA H AXaTeMHaTa PYHKUAS, NOBAMANe Ha KpaliHMUUTe, coleNeHe Ha WNpKYAaTOpHH OGEN H AMypesara. 3a snscranoBasane Ha CLAOBHA TOHYC H KPDBHOTO HaIATAHHe Morke sla ObAe OT Nossa BASOKONCTPHKTOP, pH Yenloave, He HMA NpoTHBONOKaxaHHs 2a ynorpeGara My. KasHes rKOKOHT, MHTpAREHORHO, MOKE a € OT nnomsa sa npeooaapane Ha e*exrtte or GxoKaara Ha KAMUWeBHTe KAKA. B HskoM cyan Moxe Ja € OT noma crowamHa npoMuaka. 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HaGmosasana e Ro-ronaMa BapHaGHAHOCT Ha eKCnOSMIMATA MeKAY HHAMBMAHTe. CroSuleHHTe Aa NpH AeuA non 6 FOAHHH ca orpanuNenH. 5.3. Tpeakamnuann aanum 3a Gesonacnoer PenponykTHsia ToKcHuHOCT PenponykTHBH npoy4saHHA NpH TLXOBE HM MHIIKH NOKASBaT SaKBCHABANe Ha AaTaTa Ha parKaaHe, YAWDKeHA MpomWDKHTeRHOCT Ha paxraHeTO H HaMAeHa 2KUSHeCHOCOSHOCT Ha NOTOMCTBOTO TPH 03H TpuGmusHtento 50 nbtH NO-BHCOKH OT MakcHMANHHTe MpenopLAHTTEAINH OSH pH Xopa, HB4HeNeHH Ha 6asa mg/kg. Hapywenus Ha WIMTeTA Hama eext sepxy beprwmrera Ha IUTbXOBe, TpeTHpaHH c aMLIOAMTMH (MbAKH — 64 AHH Mo KeHCKH — 14 AHH TipH onmoxsaHe) B 103M 0 10 mg/kg/aeH (8 M.TH* NlO-BHCOKH OT MaKCHMasIHaTa NpeniopEuHTetHa 3a ‘xopa 103a or 10 mg Ha Gasa mg/m’). 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TIpoy'sanna 32 MyrareHHocT He nokazeaT slekaperaeHo OGycnOReHH epeKTH HATO Ha reHHO, HHTO Ha XPOMOJOMHO HBO. *yoxmenena 3a naunerrTH ¢ Tero 50 kg. 6. ®APMAUEBTHYHH AHA 6.1 Cmesx na nomomuute pemectoa Leaynosa, wuxpoxpreramia Kanes xwnporenociar, Geaoren Harpues nnwectex rmoxonar (run A) Marnesnen creapat 6.2 Heewamectumocra He e npunoxnno. 63° Cpox ua roanoer 3 rommnn 64° Cnewnasun yeroous na coxpanemne Jlekapersennar npoaykt He HSHCKBA HAKAKBH CreUHasIHH YesIOBHA Ha CEXPAHEHHe. 6.5 JJanun 3a onaKkosKata PVC/PE/PVDC-a1ymunnesn GanrepH. Bpoii 8 ontakonxa: 30 taGnerk, 6.6 Cnenuasnu npeanasuu mepku npy waxeupasue/n paora ‘Hawa cneuwasnn wsHicKBanns. 7, TIPHTEXATEJI HA PA3PEUIEHHETO 3A YIOTPEBA Medochemie Ltd., 1-10 Constantinoupoleos str., 3011 Limassol, Kump 8. HOMEP(A) HA PA3PEIIEHHETO 3A YIOTPEBA ‘Axcea S mg: Per. Ne: 20080045 ‘Axcest 10 mg: Per. Ne: 20080046 9. ATA HA ITbPBO PA3PEIIABAHE/IOJHOBABAHE HA PA3PEUIEHHETO 3A YIIOTPEBA ‘Zara na mspso paspewasane 3a ynorpe6a: 14 mapr 2008 r. Zara Ha nocsieaHo nonHonseane: 15 cerrremepx 2011 r. 10. JJATAHA AKTYAJIM3HPAHE HA TEKCTA 10/2020 10