KPATKA XAPAKTEPHCTMKA HA IIPOAYKTA 1, HME HA JIEKAPCTBEHHA NPOAYKT A6puxopr 0,25 mg/g Kpen Abricort 0,25 mg/g cream 2. KA4ECTBEH H KOJHYECTBEH CbCTAB 1 g xpeM cumopaca 0,25 mg dryouHononon aueron (fuocinolone acetonide). Bel Hic 1 g Kpem cbaupxa 50 mg nponwnenranKos (E1520), KouTo ca exeHBanenTHH Ha 750 mg B Ty6a or 15g. 1 g kpes ceapza 1,8 mg MerunmapaxumpoxcHOews0aT H oKono 0,25 mg nponmamapaxnapoxcuGensoar (siiHONeH B cpcrapa Ha Kcanndan 15). 1g pent ceaeprxa 30 mg WerHito# ankoxon, KONTO ca eKEMBaneHTHH Ha 450 mg B TyGa or 15 g. 3a MAHA CHMCEE Ha TOMOMIAHTE BelllecTBa BuDKTE TOUKA 6.1. 3. JIEKAPCTBEHA ®OPMA __. eee Eee VISTIDAHYITENHA ATEHUMA 10 EKAPCTBATA pari vapaemopuerina Wa ADOGHNTA-TAOGHI® T 4. KIMEMUHE ABBE 4.1 Tepanestauna noxasai Jloxanan wewudexrupann nepmatoaX 1 BLaMaTeHUa, NpHIPy>keHH OT cBpGEXk M aneprHyHH MpoMeHH fo KookaTa Karo: ~ _Dlepsarirs (korrraxten, aroniruen, ce6opeen, uiicexTeH); - _Exsemn (aneprirana xowrraxria); - Eprrema myntudopne; = Jiynyc epuremarosyc; = Tleopuaaue aynrapue; - — Tluxen py6ep maxye. 42 Josuponka u nauH wa nputoxenne Tiponyxrst ¢ npeawasuaven 3a noKaHa ynorpesa. AGpHKopr Kpem ce npunara KaTO Mariko KoMHHECTRO OT MpORYKTa Non ¢popMara Ha THHBK HAM ce pwaara BUPRy sacerHaTHA YuACTBK 1-2 MATH AHeBHO, B 3ABHeMMOCT OT Te:keCTTa Ha Sa60NABAHETO. Oxoomenute 4acTH ce OOpEcBat, 3a MA Ce OCHTYPH AAPEKTEH KOHTAKT c ACaHITTE. Ja severe Ha ncopHasMe WK Ha TPYAKO HoAABALIUE Ce Ha AeYeHHe RepaaTosHt MoraT 2a ce voTions8ar 4 OKTYSHBHM MpespEskn. Te ce cMeHAT 3-4 METH AEBHO HH TO-¥eCTO, HO NpeWeHKA Ha snexapa. IipH mpoasa Ha pesucTeHTHOCT HAM JOMBINMTeAHa UNeKuME TpAGEA Aa Ce NpeKparH ‘MgnomaBaHieTo Ha OKTYSHBHa NPeEpEIKA M 2A CE TIPOMBOACH sIeYEHHETO ¢ MOMKOMKIO epencreo. ge ‘He ce mpenoppyna neyenve, no-nporwoKHTeAHO OT 2 ceAMHLA. ASS ; s Bupxy stmueTo npomummxurresHoctra ta neveneTo ¢ | ce”IMHIa caNo B cay‘ait Ha ‘HeoGxomHMocT. ooe 1 : StansTleqnarpusia nomyaaus Tlpogy«rer we ce npunara np aeua nox 2 roa#Hm, a npH neua Hal 2 TOME ce MpHnara ¢ NOBHIeHO BHHMBHNE EINK TLT sWeBHO BLPXY MaRKA KoxAIA NOBEPXHOCT. 43° pormponoxasanns AGpuxopr xpem © nporupontoxasaHt mpi: © COPEXNYBCTANTENHOCT KEM AKTHEHOTO BEINECTBO HAM KEM HAKOE OT OMOWIHNTE BELMECTBA, ma6poenn 6 TouKa 6.1; ‘Mop6vaiH, papauena, pySeoma H pyrH BHPYCHH KOOKHH 3aGonABAHHA, MHKOSH; ‘© axite pyzrapne, posauies, nepHopaten zepmaTH, 44 Cnenmam He ce npenopesna npoemacrrenvia ynorpeSa Ha mponykra Hay 2 cenmumys. Tipit npomEaDKHTeTHO jneyeune HapacTna pHoKbT OT panRriMe Ha HeskenasttTe peakUMH H cHCTeMHH etext. TipH Neue exop6usixTa € Mo-TonaMa, 2aTOBA Te ca HAOeHH tia NO-TOREM PHCK OT TKO#EA HA CHCTEMHHTE epexrit ua Koprakocrepowuae. Tipanaraneto na npoaykra sypxy Knenasmtre TpaGsa na ce wa6arBa nopanH onacHocT oT BroMlABaHe Ha CbIMBTCTBAUM KaTapaKTa 4 TayKOMa, Spumeanu cmyujenua Tips cucTemHo H sIOKanHo IpHTOREHHE Ha KOPTHKOCTEPORITH ca BBSMOXHH CBOGLICHMA 3a SpHTENHH CMYUIEHHA, AKO MpH NaUWeHT ca HANMLe CHMITTOMH KATO 3aMEEHIEHO 3peHHe WIM jpyTH 3pHTesHH CMyUICHHs, aUIMCHTDT TpAGBa 2a Gore HacoveH 3a KONCYMTAMAR C O*pTAMONOT 38 OHEHKA HA [BRIMOXHHTE MPHMHH, KOMTO MOAT Ma EKAHONBAT KATAPAKTA, PayKOMA HH PesIKH 3a607RBAHHA KATO eHTpasa ceposta xopnopeTHHonaTis (L[CX), 34 KOHTO ce ChOSuLABA GiTeM CHTEMHO H OKANHO wenonsBatte Ha KOpTUKOCTepOHAH. TIpwnara ce ¢ nosmieHo BHMMAHHe NpH NaUMeNTH CEC CENLeCTRYBAlNA ATpOOWA Ha NOAKOAHATA ToKAH, Ako ce HsnlomsBar OKAYSHBIIH MpeEpLAKH HH Ce TPETHAT roneMM YHECTEID OT KO‘kATA CbILECTBYBA OnacHocT oT yaeaM4aBane Ha CHCTeMHaTa pesopONHA Ha NpORykTa H SACHIBARE Ha cHeTeMHMTE My egexm. Tlomouti seutectBa TapaGenu (wemut- u nponumapaxudpoxcuGensoam) Morar a npwunssr aeprisin peaximan (seposTuo or sa6apen THN). Tponurenenuxon TponaneHrinkoa moxe fa MpHYHHM apasHene Ha KOKaTa. Hemuioe arxoxon Moxe 2a npr noKani KOxEM peakipur (HAN. KOHTAKTEH 2epMaritr. 4.5 Baaumonelicrone ¢ apyru aexapersenm MpomyKTH H apyTH hopMH Ha EsaRMogelicTEHE Hana gan sa yorasionen seKapcTaet ssanMonclicraus. Bumpeks TOBA No BpeNe Ka NeysHMeys, auctor He tana ace naxctep cpeutynapniena x 2pyrH saGonasarnn, ocoGen pxoi poayxrst ce npianara wa O6WMpHH MIO. / Y,4.6 Bpemennocr m xepmene Tlo ppeme 1a 6pemermioct H KepMene a ce HaGarea npHtaraxieTo Ha mpoaykra, ocoGeHO NPONRUAHTEsIHO BpeMe, B FONEMH KONHNECTRA H BEPXY OGIIMPHH MOBBPXHOCTH. 4.7 Espexra nepxy cnoconocrra 3a moupane m paGora ¢ maunaH TIpwnoxexuero na AGpHKOpr KpeM He Bue BBPxY clocoBHOCTTa sa mlobupaue Ham paGoTa © Maun. 48 Hexesann sexapersenn peaxnnn Pestome na mporpaia 1a Gesonacuoct Tipx npoxsmxwrenio npiiarane ua QiyOWMOnoH MOraT ja ce MORBAT axHe, cTepoMma NypHYPa, aTpodHa Ha enisrena H NoAKoAaTa THKAH, CyxOTa HA KoxkaTa, JeHTMeHTaLUAA, CTPHE, ‘TeNleaHrHexTasHn, epHopalen AepMaraT. Koraro npoayxrsr ce npiara BEpxy METepTpHrHMHO3HA MH dulexcopHa NOBSPAHOCT MMH BEPXY “TuueTo, Tesi MPoMeHA MoraT a Ce MOMYYAT H 3a 1O-KPaTKO BpeMe. Tipu npunarane pypxy Rrenawrre Moxe 2a ce pasane kaTapaxa ¥ rayKOMa. 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Hapywenus ua xoocama u nodkoocnama mvxan Crewspectia wectora: aks, cTepowaHa nypnypa, arpodus te enurena MW lonKOmGIATa THK, CyXoTa Ha KOXATa, eMHTMeHTALUAS, CTH, TeleaHTMeKTASHH, NepHOpALIEH. epMarat, ypTHkapHs, MaxynonanyaoseH OGpus, sowasaHe Ha cemecrayBam 1e3K. 06 onosupail Heakesarn CsoSumazanero Ha noao3HpaHH HexeaaHH peakuMH cieR paspewasane 3a ynoTpeGa Ha jeKapCTBeHIA poayKT e BaxkyO, Toba NO3BorABA fA NPOALORH HaGaOAeHHETO Ha CLOTHOWeHHETO Nomsa/pHCK 3a RexapeTBetiva mponyKt. OT MeqMUMHICKHTe CHEMMANNCTH Ce HSHCKBA Ja CROCUIABAT BCRKA nonosMpana HexenaHa peaks pes MsrrbaHuTenHa arenas no nexapersara, ya .Jlamss Tpyes” Ne 8, 1303 Cosua, rex.: 02 8903417, yebcaitr: www.bda.bg. 49 Tipexosmpane 7 oe anwar HaGmonasannre npu npenoaMpanie cHNMTTOMH cEBNANaT ¢ onHeaHMTe Tlo-rope oa ‘nexapernen peat, oc0GeH0 pH To-TpOnTnxarTeMHO evene W ph MPH eS a TUIOU. xe \ VG ‘Noo2 a5. @APMAKOJIOTHYHH CBOHCTBA 5.1 @apmaxounamnaan cuolicra apmaxorepanesrirana rpynia: Kopraxocteponau, zepxaronoriann mponyxri, ATC xox: DOTACO4 AGpaxopr cearnpixa dutyoumtonoHos aiteToRn, cHHTeTHYeH KopTHKOCTepOWsL OT rpynara Ha onyopmpansTe npeamyaonioHH. ‘MexaniispM na Jelicraie H (hapMakonMHaMiraHi ebeKrH Tipu oKanHo npwaoxenme, diyouMHONOHOB alleTOHNA npHTexKaza OCHOBHHTe GbapMaKOROTHMHHt exbexta Ha KopTHKocTepOMmtTe - nPOTHEOSESNAMHTe:IeH, AHTHAIEPrHNEH M AHTHEKCYAATHBeH. 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Enna Ty6a 6 kaproena xyrH. 6.6 Cueunasam upeanasan mepku npu wsxBypanue x paGora Hama cneunanin snexsanna, Hewsnonssannar nexapcraet npouyKt 11H OTTAZBSITe MaTepHAsIM OT Hero TpaGBa Aa Ce HSXBEpAAT B CROTRETCTaHE ¢ MECTHNTe HOHCKBANKS. 7, IPHTEXKATEJI HA PA3PEIIEHHETO 3A YIIOTPEBA ‘Tena bapwa EAI ya. ,JlioGa Benwuxona Ne 9, 1407 Corps Bunrapna 8. HOMEPA HA PA3PEUIEHHETO 3A YIIOTPEBA Per. Ne 20010715 9. ATA HA ITBPBO PA3PEMIABABE/IOJHOBABAHE HA PASPEDIEHHETO 3A ‘YDOTPEBA Zara ua mpeo paspeumasase: 21.06.2001 r. Tara na nocaeswo noaHosasarte: 03.01.2012 r. 10, ATA HA AKTYAJIM3MPAHE HA TEKCTA 05.01.2021 Noo 5