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KPATKA XAPAKTEPHCTHKA HA [IPOAYETA 1. HME HA JEKAPCTBEHHA TPOLYKT LIL 100 mg exhepsecuerrrit TaGrerist ACC 100 mg effervescent tablets 2. KAYECTBEH M KOJM4ECTBEH CBCTAB /TERHA ATEKUNA M10 NEKAPCIBATA [Reena aparmennarina a rtp ToaoreaeT | fouree 9. LOLOB', rarauonen RELLTAL L728 |oge5po8 Bn 1th me Beaxa eepaecuenrna ra6aerka chappxa 100 mg auerusuncrenn (acetyleysteine). Tlomouuin eutecrea ¢ wanectHo elicrene: cop6uTox Beska esbeppecuentia Ta6xerka cbabp:xa 75 mg nakrosa, Gesnonua 1 4,2 mmol (96 mg) Karpuatl. 3a mbanna covesk Ha NOMOMMHTe BeulecTBa BIDKTe TOUKA 6,1, 3. JIEKAPCTBEHA OPMA. Egepsecuentia raGnerea ALILI 100 mg epeprecuenrram raGnerex ca Germ, KpBraw TaGHeTKH, Ges HepaBHOCTH, MHPHe Ha KEIN. 4. KI AHHH 4.1 Tepanestaunu noxasauna Cexperoamruuto evesme ia OcTpH H xponMuH 6poxxonyaMoHapHH saGonaBANH, MPHIpY>KEH C Hapyuieno o6pasysale M MpeHoc Ha CeKpeT MPM BESpAcTHM, /OHOMINE H jlewA Ha BwApACT Hast 2 rOAHNH, 42 Jomponxa w nasun sa npaaoxem osponxa Caeaniara xosuponka ce nperioppysa 3a ALILI 100 mg edpepneouerrm taSnerkat: Bsspactun u jonomm wag 14 rome 2 esbeppecuenHn TaGnetks 2-3 NTH AHeBHO (cEoTBeTCTBAUYH Ha 400-600 mg aLeTHAMCTEHH AHEBHO). ‘Tea usonomu wa pespacr of 6 0 14 ronHaH 1 eepaecuentia Ta6nerka 3-4 meTu qHeaHo (cbotnereTBaMt Ha 300-400 mg aueTHAUHeTeHH AReBHO). Heua na sespacr or 2 no 5 rommim 1 expepnecuentHa ta61erxa 2-3 nbTH AHeBHO (cEoTBETeTBAMIH Ha 200-300 mg aueTHMUHICTeMH sHEBHO). Hawn na mpycxenue Ecbepnecuerrrumre ra6uierat ce npvemat pasTsopenn B Yallla Bova clea xpaHtene, Tiponminxsreanoct ma sevenuero AIL 100 mg esbepaecnentim TaGnerkn He TpsGBa 2a ce pHemat noneve oT 4-5 nH atexap. 43° Tporanonoxsanus ~ CBPHXIYBCTBNTERHOCT KEM ALCTHLANHCTEHHT HTH KEM HAKOS OT NOMOUIKHTE BEUIECTBA, HOOPOCHH B TOXKA 61. ~Texxko OGocTpaHe Ha acTMa -XPOHWHa s2Ba Ha ZBalageceTOTpBeTHHKa H CTOMAXA Tlopaan BcoKoTo chubpxKaHHe Ha akTUBHO BetKecTBO, ALILT 100 mg eepeecueHTHH TaGACTKH He TpaGBA ia ce ynorpeOaea npa eta non 2- rommmHa Bsapacr. 44 Cueunasum npeaynpexsenus m npexnasmn MepkH pH ynorpeba Muro pasiko ¢ cbo6ulaBavo 3a TEKH KOK PeaKUIH, KATO CHHAPOM Ha CTHBBHC-JDKOCEH H CHHAPOM. a Jlalien, chanenau\i nlo epeme c ynorpeSata Ha auieTHanMcTeHH. AKo GpnaT 3aGeamaNH HOBOBLaMMKHATH RPOMEHK NO KoxkATA H JWMrABHUTe, TpAGEA HesaGABHO 1a Ce NOTEPCH KONCY:ITANH C ekap, a MpHeMBT Ha aueTanuictenn Tpx6pa na ce npeycraHoBH. Heo6xoamso ¢ nosnmeno nHMMaHHe pH yilorpeSara Ha aNeTHAUNCTeHH TPH NAUMeHTH ¢ GpoHKHatia acta M mpi nauuesTH c anaMtteza 38 x38. Heo6xonumo e nosnineno BHHMaHHe MPH NalIMeHTH ¢ HeNOHOCKMOCT KEM xHCTaNHEN, TIpH TAKHBA auucHTH TpsGaa a ce ws6xrRa NPONBIPKHTEATHO JleveNMe, TH KATO aLleTHAUVICTeRH NOBMHABA MeTaGouIH3Ma Ha XHCTAMMHa H Moke Aa Mpe/USBHKA CHMITTOMH Ha HeNloHOCHMOcT (Hamp, raBoGonHe, BaSOMOTOPEH PHHHT, chp6ex). Beaxa esbepnecuienTna Tabnerka coubpxa 4,2 mmol (96 mg) Harpy. Tosa TpsGsa na ce uMa npeBAA Np AUWeHTH Ha HHeTa ¢ KOHTPomMpan MpHEM Ha HaTpHH (HUCKO ChTEpACAHMe Ha HATpHi/HMCKO ComeBA META), Tosu sexapcrnen npoaykt chappxa siakrosa. [TaunenTH c penki HaceneTBeHH mpoGaeMt Ha TanaxTostia HenoHocuMoct, Lapp naxTaseH jecMU WH FaKOKOSO-rarTaKrOaKa MaTaOCOpOUHA He Tps6a fa ‘pweMar Tosa neKapcTso. ‘Tosm aekapersen mpoaykr chabpaa cream OT cop6iTost. 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Peoxu ‘Ancnues, 6porxocnases — mpem Tip MalHeTH ChC CBPbXAKTHBH: Gponxwana cuctema, cTpaitauw oT Gpouxuania acraa Cromamuo-spesan | Hevecmu Cromarar, kopensa Ganka, ranete, mapymenns noppouiane K AHapHR Peoxu Avenencus ‘Hapymenus a ‘Fevecrmu ‘Vpruxapia, oOpis, aurHonespoTiien Kowara w moaKOxBaTA OTOK, cEpOex, exaastTeM reKau Hapyme yxoro | Hewecmu Tanarye w naGupuura ‘OGmm napymenuan — | Hevecmu Tpecka egextu aa mactoro na | C xeussecmua vecmoma —_| Orox Ha sHMeTO upuaoxenne Muoro paixo © eLo6ulanaHo 38 TEAK KOKHH peaKiTH, Karo CHEApOM Ha CTHBDHC-JDKOHCBH H TOKCHHA enuaepmasiua Hexponmsa, cBBnaZAMH no BpeMe c ynorpeGara Ha aLleTHAUECTeMH. B nosewero oT Tes CHY¥aH To CLUTOTO BPeMe ¢ MMpHEMAHO NlOHE OWE CAHO JIPYTO JIEKAPCTBO, KOCTO MOIKE sa € 3ACHLIHLIO ‘omHoaunue esbexTH BBPXY KOKaTa H THTaBHNTe. B cayuaii na nowropua nompa Ha sesHH no KOKATa M TAraBHUNTe, TpAGBa HesaGaBHO sa ce noTBpcH KOHCYITaUMA ¢ neKap, a NpHEMBT Ha AMeTHMUACTeHH TpxGRA sa Ce MpeycTaHOBH BeaLara. B nomssnene, mitoro panko ¢ cLoSulanatto 34 XeMOpArHH BBB BPESKA ¢ MPHOMCHHETO Ha aueTHAUNCTENH, acTHURO © peakHH Ha copEX4yscrBHTenttocT. FIpH pasTMYHK Mpoy'Batna € NlOTeSpreHa NOMMKeHA ‘TpoMGouprrHa arperauiua B NpHCbETBHETO Na auleTHAIHCTeHH, B HACTORUIHA MOMCHT HE € BEIMORKHO a ce onpentennt komamuHoTO sHaNeHHe Ha TOM daKT. ae Ba nexenana ui ‘Cro6utapaeTo na nozoaapann HexkenaiH PeaKuWH c7en paspewlasaxe 3a ynoTpe6a Ha neKapcTReHHa Npoaykr ¢ paxkvo. Topa noskonaba Ja NPORDIAH HAGMOMENKETO Ha CHOTHOINCHMETO Nost3a/pHCK 38 Jlexapereenna npoayKT. Or meqAUMHeKATe cneuanHcTH Ce HSHCKBA na CROOUIABAT BeAKa NOOSHpAKA nexkenalia peaKuaa "pes HauHonaTHa cHcTeMa 3a cbOGulaBaHe KeM HaIrbTHMTenMara arerunA nO sexapernata, yi. Jawan Tpyes* No 8, 1303 Coots, rea: +35928903417, yeGcaltr: www.bda.be 49 Tpeaosmpane Tlocera ne ca ckoSulapaiin cny‘iaH Ha ToKCHUO NpeosHpane ¢ MepopamitaTe TeKapCTBeHH ‘opMA Ha ayersuuutctenn. Jo6posonun ca tpeTapantH ¢ 03a OT 11,6 g AMeTHUMCTENH AHEBHO B NpORBNKCHME Ha oneve or 3 Meceua, Ges a ca HAGMOAABAHH HAKAKBH TEKH Henke-TaHH peaKiusH. Tlepopatin 03H aueTimuicrent 0 500 mg /kg TenecHo Tero ca ToHacsHM Ges CHMITOMH Ha HITTOKCHKALI. Crommonu na wimoxcurayan Tipeaoaupatiero Moxe na yonene 10 ToMALIO-spesit CHMNTOMH KATO raieHe, NoBpEulaHe H aMEpHs. TIpH bpNaverata CbilecTByBa PHCK OT CBPEXCeKpeItHT. Tepanesmaunnu mepeu npu npedosupane AKo e Heo6xoaHMo, B 3aBHCUMOCT OT CHMNTOMHTE, ‘ia sani 2a merpaseionHo mpiutoxetve Ha AUeTHUINCTEHH NPM Xopa B MAKCHMAIN AHe3H {§MpH nevenme na worToKeKauia ¢ apanieTamon, HrpaseHosHoTO TpHNOACHNE 1 10s KOHUCHTPalMH Ha AUCTHIIUMCTEHH BOA 10 YaCTHYHO HeOOpaTHMH ,.anadHrakToHEn pec pH opeupario nprnarane, 5. @APMAKOJIOPH4HH CBOHCTBA 5.1 @apmaxoqumamwunn cnoiicraa apmaxorepanestina rpyna: JekapeTnenst mpoayKTH 9a ZeYeHMe Ha KAILUA H MpOCTYAHN SAG OnABARIA; Mykomerant; ATC kom: ROSC BO AUeTHLILMCTeHH € NPOHSBOAHO Ha aMHHOKHCeNMHaTA LMCTeHH. AUCTHILHCTeHH jezicTBa ceKpeTOAMTHYKO H MpAABIEKBa cexpeTa B OGaacTra Ha pecnMpaTopHs TpakT, CHa ce, ve Toi parkLcBa cEEPABAMTE WCYNDWTHH MOCTORe MEKAY MYKONOMMIaXapHAHUTE BEPHTH W TOBA BOM AO AeNoAUMepHsHpaM embeKT supxy HK sepurire (8 riofisms cexpet). MocpenteTaom Team MexantaMH ce saMariiBa RHCKOMITeTa Ha cexpera, AvirepnaTHBHHsT MexXaHIEIGM Ha ALIeTIVICTeNH Ce OcHOBaBa Ha crlocoGHocrTa Ha Heropara peaKTHBHa SH Cpyna aa ce CBEp3Ba c XHMMYHM pasKaH H 110 TOSH HAYHH J1a TH AETOKCHKHpA. ‘Ocsen Toma, aljeTHAUNCTeHH AONPHHACK 3a MOBKUIABAHETO Ha CHETe2a HA MAyTATHOH, KOETO € BAKHO 38 evoxcnkawvrra Ha speaminre areHTH. ToBa OGACHABA M HeTOBH eIpeKT KATO AHTHOT Nia HHTOKCHKALIEA € napaueramon. 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Emonunupane PapMaxoKiHeTHMHH npoyuBaHua Ha MiFTpaBeHiosHO NpHAOKeH AUeTHTUNCTeHH NoKsaBaT pasnpeestenne oF 0,47 Vkg (o6mo) wax 0,59 Vkg (penyuupan), uiaaMeMiixT KAMpoHC © ony chotnetHo Ha 0,11 Vh/kg (o6u0) m 0,84 Wh/kg (peayuspar). EsHMMHaLMOHHKST omysKt iTTpabenosHo npwstoxexue e 30-40 MAHYTH, NpH KoeTo exckpeuMsTa cnenBa TpHdasHa Gera m Tepautamia rasa~pasa). Auermmuctenn npemmnapa nnayenrata H ¢ OrKPHT B KpoBTa OF MamHaTa spss. Hama Hebopmanis ‘omocno exckpeusixra B xDpMaTa. Hawa zanan 9a rlopexennero ia aueTHTusIcTeHA CrpsMo KpBbEHO-NosbsHATa BepHepa MPH xopa. 53° Tipexkamnmmn aannm sa Gesonacuocr oer H eKETI¢pHMEHTH ¢ KHBOTHH OCTPATA TORCHMOET € HHckA. 3a sHeNeNIETO Hla MpeosHpave BYDKTe TONKA oT 49, Xpowmna Toxewunoet Tipoyspaniis npr pasnnuiin xHpoTINICKH BILLOBE (TUTEX, Kye) ¢ NPOABIDKHTENHOCT No AHA roAHHA He noxasbar naTonOrHtiH MpoMelH. reHeH HEH He ce ovaxsat wyrarenmu eexta na auermucren, Peaysrrarire or in vitro Tect ca orpHulaTentn. He ca npovexaatu npoy'Banua 38 TyMoporeHiis NoTeHLMial Ha aueTHALWeTeHI, Penpoaykrsia toxewuwocr ‘He ca naSmozasaud Manhopmanun npH npoyssanHs Ha eMGpHoTOKcH™HOCTTA NpH Saul H TLTExORe. Tipoyssarnixra Ha Gepruinrera, nepHlaransaTa H nocTHATAINara TOKCHSHOCT cA OTpHUATEAHH. AuerwmumcreHa npeMuvasa MalleHTaTa pH TunsxoRe H ce OTKpHBA B aMETHOTHNHATA TeTHOCT. Kouuewrpauusra Ha meTaGomra L- usieTen b nranexrrara n geTyea jo 8 vaca cilen nepopatio UPWIOKEHHE € TlO-BHCOKA OT ILIAIMeHATA KOMUeHTpALAR NpH MaiiKATA, 6. @APMALEBTHYBH AHHH 6.1 Cnucex na nomouquure Beuectaa AIL] 100 mg edpeprecuenram TaGaerKHt Tiwwonena xicenma, Gessonta Harpues xauporenxapGonat Herpwes xapouar, Gessonen Matusron Jlaxrosa, Gessonia Acxop6utiona xvicexnna ‘Herpes tompat Baxapae natpatt Apomar na kumuna “B” (Chinepya namin, MasTTOReKCTpHH, FIOKOHONAKTOH, COp6HTos, cHMHUHES AMoKeHA, KoOHTeH GesBoneH, MaHHTTON) 62 Hecnemectamocra Henparoximo 63° Cpox na roanoet ‘Ty6u: 2 roam Camera: 3 roauun 64 Cuenuannu yenonna ua cuxpanenne Ty6u: Ja ce cexpanapa nog 25 °C. (Coxpansnatire 1yGara nursTHo sarsopera, 2a 28 npesnasire oT aaara. Camera: JJa ce cbxpanana nog 30 °C. 65 Bua coqupaanue ua onakoskara. + Ty6u or nommnpormien, sersopent ¢ nonteTmieHona aanyulaska che cyuures (MONeKYAHO CHO) + SareuaTann cameta, Hanpanets or tpHeaofinio ¢ponwo (naMsTHupaia aulyanuneea Xapriis) Bynope onakosku: ‘Ty6n: 20 eeppecuenran Ta6aerKH Camera: 20, 40, 50, 80, 100 espepnecuenran raGnerKst He scx siioge onakosku Morar a Ovnar nycHaTH B nponaxGa. 6.6 Cnenuaamu npeanasna mepxn apu usxeupaane Hama cnenpaian usucKsanis. 7. TIPHTEXKATEJI HA PA3PEIIEHHETO 3A YIIOTPEBA Sandoz dd. Verovskova 57, 1000 Ljubljana Croseeme 8 HOMEP(A) HA PA3PEUIEHHETO 3A YIOTPEBA 20140342 9. HATA HA ITbPBO PA3PEHIABAHE/TIOJHOBABAHE HA PA3PEMIEHUETO 3A, YHOTPEBA 14/11/2014 10. ATA HA AKTYAJIM3MPAHE HA TEKCTA 10/2014

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