KPATKA XAPAKTEPHCTHKA HA IIPOJYETA 220 OL-O > BEL AMTLE -GesCs 1. WME HA JIEKAPCTBEHMA IIPOAYKT Oe -1 Be Teran 10 mg/2 ml winkexunonen pastsop Degan 10 mg/2 ml solution for injection 2, KAYECTBEH H KOJIM4ECTBEH CbCTAB Beexu 2 ml mokexumonen pasrsop (1 anya) chtbpxat 10 mg MeTOKHOMpaMHsloB XH/IPOXTIOPHL (saro monoxnapat/Metoclopramide hydrochloride (as monohydrate). Beex I ml mroxexunonen pastaop ceirepxa S mg MeTOKIONPAMHLAOB xHpOXAOpHL (KATO Mowoxuapar)/Metoclopramide hydrochloride (as monohydrate), 3a manus cnviesk Ha NOMOULHHTe BemecTBA, BUDKTe TOUKa 6.1. 3. JEKAPCTBEHA ®OPMA Vinxexuwonen pazreop (Gucrep Geauneren pasteop, Gea npaxrHueckn 2aGenexHMH HacTHLU). 4. KIMHW4HH AHH 4.1 Tepanestmanm noxasai Brspacrua nony:rauns Tlerav¢ noxasax np msapactun 2a: = TIpodwaxruka ta nocroneparnato raene w nosppuane (post operative nausea and vomiting, PONY) - CuMromarisino ae4eHHe Ha raleHe H NOBpBULAHE, BKIIOHTETHO rasleHe H NoBpBUaH, NpeaMsBuKaHO OT OCTBp MUTpeHODeH MpHETN - Tiporpunaxruka Ha raieHe M oBpEulaHe, npeAMsBHKaHO OT sTBYeTepanHs (radiotherapy induced nausea and vomiting, RINV). Heawarpuana nony.anns eran e noxasan npx zeua (Ha sespact or 1-18 roast): = kato BTopa sIMHHA Tepamus 3a NpeoTBparasane Ha 3aGaBeHO FazeHe M NOEpBURAHE MPH xumnorepana (chemotherapy induced nausea and vomiting, CINV) = 3a leveHTHe Ha ycTaHOBeHO NocTonepaTHBHo raene M nospbuasie (PONY) kato wropa HHH Tepars. 4.2 Jlosuponxa u wayun na mpuazoxenne Pastsopsr MOxKe 1a ce NpWAra HHTpABeHOIHO HIM HITTPAMyCKy/THO. Hirrpasenosture 103m TpxGea na ce npuaarar Karo Gasex Gostyc (sa He no-masiKo oT 3 MHHytH). noxKasai rc 3a npodwaxtaka Ha NocTonepaTHBHo rajiene H nospeutane (PONV) ce npentopbyBa e; or 10mg. fig 3a cuwmromaru4no seveHue Ha rajteHe H NlOEpBuaHe, BKOUHTENHO rateHe H noBRE HPeAHSBHKAHO OT OCTEP MUTPeHOSEH MPHCTSM H 3a rIpoxpHcTAKTHKA Ha rasteHe HTH peaHsBHKaito oT eHeTepanus (RINV): [IpenoppsnresHata enna 03a © 10 ‘TPH MsTH AHEBHO.Maxcuwasnara npenoppsnrrenia nHeata yoza © 30 mg wun 0,Smg/kg TenecHo tern0. TIpoxwoxiremtioctra Na inbkeKUMOHHOTO ReYeHHe Tpa6Ba sia GENE KOAKOTO ¢ BESMONHHO MO-KpaTKa H ‘TpaGpa 2a ce NpeMMHe KEM TlepoparIHO WIM PeKTANHO sIEMEHKE BESMORHO Hall-cKOPO TIpenoppurrremaara 03a € or 0,1 10 0,15 mg/kg TeecHo Terao, MpHnaraka AO TpH TMTH JLHeBHO Hpes WHTpABeHOSEH IT Ha BEREKHANe, MaxcHmasnuara 03a 3a 24 Haca ¢ 0,5 mg/kg TesecHo Tero, ‘Ta6svmua sa nosmpaste Buspact Tenecno rerio Hosa Weerora cas 1-3 rowan 10-14 kg Img Ho 3 mena auenno 3-5 roamna 15-19 kg 2mg Ho 3 mer queso 5-9 ronmnu 20-29 kg. 2,5 mg ‘Ho 3 mera aeeno 9-18 roxmen 30-60 kg S mg ‘Ho 3 111 anesno 15-18 roan Han 60 kg 10 mg ‘Ho 3 mera aeeHo Maxcumasnara npomssokmresitocr Ha evenne € 48 waca ta neveHne Ha YcraHoReHO rocTorleparHBHo rane H riospsmuane (PONV). Maxkcnmanuara npopmxnrenHoct Ha zcucHHe ¢ 5 AHH 3a IpewoTepaTasane Ha saGapeno razene H opptulasie npu xAMHOTepanusa (CINV). (Cheumanan nomysa Cmapuecka sespacm Tipu naunentH 8 crapyecka ssspact TpxGea 2a ce OOMHCAIH HAMAIABAHE Ha NO3aTa, 8E3 OCHOBA Ha SuOpeunara n vepHonpoOHaTa hyRKUHA H OSUIOTO CHeTOSHHe, Bebpeuno yepesedane: Tipu nauwerru c 66peuno saGoaseane B TepMutianeH craail (kpeTHHHHoB kmHpBHe < 15 ml/min), sinentara s103a TpaGna na ce Hanami © 75%, Tipw naunerrmn ¢ ymepeno 10 Teaxko Ge6peno yapensane (KpeaTHHHHOS ApeHC 15-60 ml/min), osata TpaGna aa ce Hamam ¢ 50% (mk. TouKa 5.2). Yepuodpobno yepencdane: Tipu naumerrru c reaxko YepoapoGHo yapercaate, aoxara TpsGsa 1a ce naman c 50% (ss. TONKA 5.2). Treduampuxna nonynayua Meroxsonpami € npotisonoxasaH npH euia Ha BE:3pacT nog 1 rogHHa (Bx, TouKa 4.3). Hawn na npatoxesine: ‘Tpa6sa aa ce crasaa MunMaren enrrepsam oT 6 Yaca MEXTTY MBE MpHAIODKetHe, NOpH B cya Ha OBpBUaHe HH OTXBEPAAHe a OsaTa (BK. TONKA 4.4). 4.3. Mpormpomoxasar a Zleran e nporasonoxasan npa nanuentH che: - CapbxstyBeToHTeAHOCT KBM AKTHBHOTO BEUIECTHO HIM KBM HAKOC OT MOMOUIHHTE BEMIECTBA, y6poenn B To4Ka 6.1 ~ Cromalmio-spepio KupscHe, MexaHHaHa OGCTPYKLA HH CTOMAIIHO-"peRHa. Tuy AMUASTA Ha CTOMALIHO-"peBHIa MOTIUINTET NPeACTABIABA pHCK. = Tlorsspnen 1m noxosupartbeoxpoMotuToN, ropayM plex OT TexKH XHED ~ Enarencus (nosmurena vecrora a wiTeHsHTeT Ha npucrsmire) ~Bonect wa Flapxiicon~ KonGwnrauma c nesoaiona wm nonammneprisin aronncrs (wx. rosKa 4.5) - Vapecrita auamnesa 3a MerxemoraoGmHemi cenpaana, ¢ MeToRTOMpaMHal wan zedmuut Ha NADH usrroxpom-bS. - Tipiioxene npx zeua ua Buspact nog | romWa, nopayH NOBHWeH PHCK OT eKeTpantHpaMinzHH napymens (ax. rouKa 4.4) 440 Cnensam upeaynpesvieuwa a upeauasna mepka py ynorpeGa Hesponorwsm wapyusexia Morar na Hacrbnsr excrpamupaMMums HapyuienMa, ocobeHo pH seus H MilautH XOpa H/HUTH KOTATO ce variowspar BHCOKH 03H. TesH PeaKIDIH HACTENBAT OGHKHOBCHO B HAYANOTO Ha /ICYEHHETO H MOTAT a HACTeNIaT cen enHOKpaTHo MpHowenHe. FIpHeMa Ha MeTOKTONpAMHx TpxOBa fa ce MpeKparie esaGasHo w cayuall Ha excrparmpaMw”HM CHéMnrroMH. TesH expexTH KATO LpstO ca HamTBsINO OGparHmH ‘Chea IpeKpaTaBalle Wa NEYEHMETO, HO MOTAY sia NALIOKAT CHMITTOMATHAHO HeHCHHE (GeHZORMAseITHIH pH Jena With aerTHXOTMHeprHHHIH aFTHNEapKMHCOHOBH /leKapCTHeHK MpOAyKTH MPH BB3paCTHH). Bpenepis metepsas or nove 6 aca, nocoveH 8 TouKa 4.2 TpsObA ja Ce CHIE MERAY BCAKO INpWAOKeHHe Ha MeTOKTONpAMI, OPH B CAYall Ha NlOBPSULAHE M OTXBEPAHE Ha AOBATA, ¢ eA Ja Ce waGerne mpenosupane. Tipostesoxwremioto neveHie ¢ MeTOKNONpAMHA MORE 1A HPHYHEM TapaMBHa MCKHHES!R, NoveumasmHo HeoGpaTHMa, OcoGeHO NH nauMeHTH B cTap4ecka PEspacT. JleuenueTo He TpAGBa 1a aqpuurasa 3 Mecela, NOpajlH pucka OT TapAMBKa AUCKHHESHK (Bx. TO¥KA 4.8), JleseHHeTO TpsGBa Jia Ce MpeKpaTy, ako BUSHUKHAT KIHHMMHM MpHDHAllA Ha TapAMBHa AHCKHHESHA. Tipe xomOmiaunis na weTORTONpaNHLy ¢ HeBporeTalih, KAKTO K MIpH MOHOTEpATINA € METOKTONPAMH, ce croSmtana 3a Hesponermycn MamHTHEN cHHApoM (wx. To¥KA 4,8). MeToxTonpaMna TpsGea 21a ce pe Hesa6apto npH BLSHHKBaHe Ha CHMITTOMH tia HeBposIenTHeH MATHTHCH CHHAPOM H TpAGRa a ce sanoune nomxonmio neYenne. HeoGxonMno e 7a ce NOpXOATIA CbE CHIELMANIHO BHUMAHHe MPH NAUMEHTH ¢ TOs UIEACALIM eppororiram saGonsBaHH HW NpH MauertTH, KOHTO ca GHUIH NeKYBANH C IpyrM neKapeTsa ¢ ueHTpanKo AelicrsHe (Box, ToUKa 4.3). (Cunrromure na Bonect na Tlapkicox Morar 2a Gsaar oGocrpeHit or MeToKTONpAMH.I. ‘Merxemorio6imemns ‘Crobuaza ce 3a MeTxeMOrOGHMEMMR, KOATO MORE 21a € cBEpSana c nedmunT Ha NADH wtoxpos bS pexyrcrasa. B rakyba cirysan MeTOKTONpaMHA TpAGsa sla ce cMpe HesaGanHo M38 TOCTORKHTO M ‘TpaGna 2a ce npeanpremaT MOIXoAAMTH MepkH (KATO HaIpHMep JIeCHHE C METHTEHOBO CHILO). Crpnesna Hapymennx ‘Hania ca cboSureria 3a cepnosi Heaxenatta peaKlINH OT CrpaHia Ha CEpreHHO-cbjOBATA cHCTEMAa, BRTMOMBAUIK CLY'aH HA LAPKYATOPEH KonaNC, TeKKa SpamlaKapaHR, CrMpanc Ha copaesiata nekHOCT A ympoxanane na QT uirepsaa Galen npWomeHHe Ha MeTOKIONPAMH PE HEDKEKTHPAHE, OCOBCHO ‘pes Mirrpaneniosen mb (Bx. TOsKA 4.8), HeoSxoammo e crensas1Ho BHHMAFMe, KOTaTO Ce Mpwiara MeTOKIONpAMHT, OcOGEHO ped WoTpaseHOseH TT Ha BBBEXTIANE, Ha NONysALME B CTapMecKa BRAPACT, Ha MALWMeNTH C HApynteHa CBpAcdHa NpoBopMMocT (sKTIOUNTEAHO yiTwHKeH QT MHTepBall), MalMeHTH C HEKOPHTHpaH ‘eeKTponHTeH zACCanaHe, 6patHkapaHa H TakHBa, rIpHeMallM ApyrH wekapeTsa, 3a KOHTO ce 3Hae, He yabsoxasat QT muTepeana. = Hirrpasenoatre nox, ps6xa 2a ce npunarar Karo Gasex Gonye (3a He 10-Maa est HaMA/IABANE Ha pHCKa OT HEXcHAHH peaKiyH (T.e. XHNOTOHHA, akaTH3HA). Bu 1060 lelpi naumerm ¢ 6s6peno yapexnante HH ¢ TeKKO NepHoRpOGHO yapexTANe, Ce MpenlopENBa haMasapane wa jo3ara (sx. TouKa 4.2). 4.5 Baanmoneiicroue c apyri aexapernewa mpoxykra n apyrH Gopma Ha ssauMogeiicrame Tpormsonoxasanu komGunanin Jlesonona roma onaMMHepritsHH arOHHCTH METOKIONPAMHA MMAT BIQHMeH ANTAFOHMSDM (BX. rowxa 4.3). Kom6ananun, xouro tpaGna aa ce warner AAKOXONST NOTHUMpa cenATHBHHA edeKT Ha MeTOKNONPAMHA. Kom6nnanna, konto TpaGea ja ce amar npeqeHa Tlopaan npoxmnerusnns ebext na McToxtonpanin, aGcopGlusra Ha HAKOK jleKapcrsa Moke Zia Ce TIpOMCHH. Anmeconaepeuu u mopqnmoeu npoureodn Anruxoamseprauurre 4 MopbHHOBHTe lepHBaT MOraT 7a MMaT BIAHMeH AHTArOHUSbM C MeTORIONpaMi1o OTHOUIENME Ha MOTHIHTeTa Ha XpavOCMHaTenHAs TpaKT. JTlexapemea, nomucxauju yenmpasnama Hepena cucmena (nopdusosu npoussoonu, ankcuoaemu, cedamuenu HI aumeucmanunu, cedamusnu anmudenpecanmu, GapSumypamu, xionudan u nodoGwu) Cenarmaunre eek wa ekapcreara, NOTHCKaLIIH HeHTpaTHaTa HepaHa CHCTEMA H MeTOKIOpAMHI Ce noreHumpat. Hesponenmuyu Metoxionpamma Mowe 2a ua auTiseH edbexT ¢ pyr HeEpoxenTHUH 110 OTHOUIEHHE Ha ‘BLSHMKBaHeTO Ha ekTpamupannrHH HapyiteHus. Cepomonunepewinu nerapemsa Tipaioxenneto Ha MeToKnonpamm cbc CepoTOHHHeprHyK exapcrsa, Karo Hanpawep SSRIs Moxe ‘Ra TIOBHIA pHcka OT CepoTOHHLHOD CHIpOM. Flueoxcun Meroxtonpamia Moxe 7a Haman GHoHANHUKOCTTa Ha AurOKcHH, H3UCKBA Ce BHMMATE-THO ‘MpOCTeARBAHe Ha MHASMeHATA KOHUCHTpALNNN Wa AMTOKCHE. Huxxoconpua: Meroxionpamm nosnuiasa GHOHANIIHOCTTa Ha MEKIOCITOPHN (Crux ¢ 46% H excriosmnttrta ¢ 22%). Visucxea ce sumaresvo npocnenasane Ha xasMeHaTa KOHLEHTpaMlAs ta UMIOCNOPHE, Kawnusmure nocaencrsns ca Hescitt. ‘Musaxypuya u cyrcamemonuyss iroxescrupanie na MeToKsonpaMna Moxe 2a YabDRH NPOMDDKATETHOCTTA Ha HeEpoMyeKy-7RAT Gnoxaga (pes mixnGupanie Ha MLraaMeHara xomlMHecTepasa). Mong CYP2D6 wncxuGumopu “Hipara Ha excriosHinex Ha MeTOKOMpaMHL ca HIOBMUNeH, KOTaTO ce MpHUNara 3aenKO c MOLLE CYP2D6 minxi6etTopm kato manpuwep dayoKceTHH H napoxceTHH, BumpeKn 4e KMITAHATA SHayMMocT € HeRcHa, NamMeHTHTe TpsO5a ma ORAaT HAG MOAABAHH 3a HEKEAHM PEAKWI—— Toil kato JJeran nlosuapa BpemeTo wa nlacax Wa Xpanara H M0 TosH HauHEE CKOPO more 1a € HeoGXOaHMO Ja Ce KOpHTHpa AosaTa Ha NepopaluiTe aNTHAHAGETHH HncyTHa ripH maumeHTH c sHaGer. 4.6 @epruanrer, Speneunocr m kupmeneBpemestiocr TonaMo Koauectao ait npH Gpenteinn xxetm (Hoxon nH Tioneye oT 1000 exenosHuAH) He noxaaBa MandopMarHBiia TOKCHAHOCT, HHTO (eTOTOKCHSMHOCT. MeTOKTOTIpAMHL Monke Jia Ce NpHAaTa No Bpeme Ha GpemeHtiocr, ako € KAHAHYHO HeoSxoasMo. [Topanx dbapmaxonorHannTe cBolicrea (Kar0 Apyru Heeporenruu), 8 cnysall Ha npuoxeHHe Ha MeTOKAONPAMHA 8 Kpax Ha GpemeHHocTTa, He Mowe a Ce HSKGHONH ekcTparlMpaMNleH CHHAPOM TIpH HOBOpOneHOTO. YniorpeGara wa Meroiionpamita 8 Kpax Ha GpeMeHHOcTra TpaGsa na ce HsGarea. AKO Ce mpHara MeTOKIONpAMH, ‘TpaGna aa ce npeanpHeme HaGmozenHe B HeonaTaMNHa nepHO. Kepmene Meroxonpana ce exceperupa n xepMara a Hicka crenen. He Morar 1a GrAar waksuoHeHH HeokesIaHH peaKLMH pH KepMavero, ITopazi TOBA, METOKTONPAMHA He Ce npenopEsBA NO BpeMe Ha xepuerie. TpxGna 2a ce OGMMCIH cimpatie Ha METORIONpAMIA pM KePMEIH eH, 4.7 Banaune pupxy cuocoSmocrra 3a modmpane # paGora € Mal Meroxaonpamist Moxke sta MpHMHTHH CbRAMBOCT, SAMASHOCT, JMCKHHESHA H AHCTOHMA, KOTO MOE [A 3aCerHE SpeNHETO H CbINO sla HapyuIM CrlocoGuocTTa 3a wiodbupane M paGora c MALIA. 4.8 Hexenaum aexapcrsenm peaxnan Yecrorara Ha HeskenanuTe peak ce onpenesa cue caeaHHTe AedpHHALYEH: Muoro sectm ( 1/10), Yecta © 1/100 0 < 1/10), Hewects (= 1/1000 no < 1/100), Penn (2 1/10 000 20 < 1/1 000), Moro pesixn (< 1/10 000), C nesemmectua vecrora (He Moke a Grate onpeneteHa oT namuueTe 1aHEH) Cuctemo-opranen wiae | Yecrora ‘Hemesann xexapersenn peaxunu ‘Hapymienna ua kppara w anménaTa cncTesa ‘Henspecrnia wecrora. “Merxemora06uiieMilg, KOTO Mo‘Ke Aa e CEUp3atia ¢ Heqoctarunoer Ha NADH watoxpom b5 peaykTasa, ‘ocoBerto mpu Honoponentt (ax. TONKA 4.4) CyndxemornoSienas, ocHosto nH ‘eTIHOBPEMCHHO NPHNOMEHHE Ha BHCOKH 1O3H ekapeTBerty MponyKTH, ocpoGoavianalla capa | Cupaeamm sapymenna Hevecra ‘Bpanmeapana, ocoGeHo np witpasenostin opm Hewapectsia wecrora (Cupaewen apecr, HACTETIT CKOPO Glen HEKEKHORHO Mpioxenne, u Moxke 2a € Noculenean cxlen 6panuKaprus (Wx. TouKa 4.4); ArpHoneHTpuny.tapes 6:10K, cHHYCOR pec, ocoGeno mpy HiTpanenOsHMTe ‘bopMe, YIBTKEH QT mrreppan enextpoKapanorpama, Torsade de Pointes: Hapymieuna wa ennoxpuuniara cucrema* Hever “Amenopes, xumiepmponaxranesta, Pea Tanaxropea | Heusnectua yectora TunexomacTus ‘Cromammno-spepun napymeninn Tuapian ‘ebexrh wa mucToro na npunomeane Acrenna. ‘Hapymesus wa uaynuara cucrema Heuecra ‘Capexuyscraurennoct ‘Hewsnectua yecrora ‘AuadHiakTauna peakiia (BK00" anapwraxTH¥eH wioK, ocoGeHo npal spopminHapymenns: Muoro seer Comnonenrnoer Weer “ExeTpannpamnaqin Wapyiienis (ocOGeHO NpH seta W sia xopa W/ntnM KoraTo Mpenope¥HTeMara 03a € ‘anBHMeHa, AOpH chen MpHAOAKCHME Ha eAMNNH 2038 ‘oT nekapeTBoTO) (8x. To¥Kka 4.4), Tlapxunicomnot, AxaTaans Hewectw ‘Tuctora (okmounrenio spurenuu wapyuienna oxytorupia kpina), JucKHNesus, TIOHIDKeHO HHBO Ha oxsHanMe Peaxa ‘Konsyncum, ocobeno Tip nativenrH ¢ enmurericHa HewseceTna vecrora ‘Tapanena IHCKHHESHR, KOTO MOK a TlepeMCTHpA NO [BpeMe sa HAH cole MPOBDAHTETHO HeYeHHe, ocobeHO ‘MH nalwdesrTH B crapyecka BLapact (BK. TONKA 4.4), Hepponerivien manuriien carapow (Bx. TouKa 4.4) Henpecus Xamouarianin ‘Crcrosnme na oGspkanocr “Xunorowas, ocoGeno npy mtpasenosnure opm Tllox, eHnKon cien MroKeKUMOKHO npHtOKeHME, Octpa xmnepTouMa mp niauuteHTH c eoxponounToM (19K. ‘Touxa 4.3); MpexoAHO HOBHMIAbane HA KDLBHOTO uaaarane * Hapyurenex wa enJoxpunnara CHeTeMa 00 BpeMe Ha NPRWDEHTETHO eNeHHe, CBEDSAHH ¢ _xuepnpostakrusieMns (aMeHOpes, FaNaKTOpes, THHEKOMACTHA). Creanite peaxius, NOHsKora CEMpsaHlt, HACTBIIBAT No-HECTO, MPH MpHIOKEHKE Ha BACOKK NOGH: ~ ExcTpanapaMiiiuit CHMMTOMH: OCTPS AVCTONHX H BMCKHHCSHR, NApKHHCOHOS CHILAPOM, aKBTHBHA, Opi eaeg MpHIOReHUe Ha EMMA 10Sa OT MeKapCTREHHA MpOAYKT, OcoBeHo MPH ACUA HM MUTA xopa (x. ToMKa 4.4). = CoiIHBOCT, HOHHKEHO HHBO Ha CbsHaHHe, OFHPKAHOCT, XAMOUMHALAH. CroSuabanec 11a MOnOSHpaHH HExesaHH Peak CroSmapartero na nonOSMpAHH HeAKeNaHH peakuHH cslen paspeliaBane sa yROTpeGa 1a TeKapCTBHHA poaykr ¢ paxkno, Toa nosnonana a npostiokH HaGmoseHHETO He CbOTHOWeHHeTO NON3a/pHCK 38 sleKapeTseHia MponykT, Or MeNMUAHCKHTe CEANACTH Ce HSHCKBA a CROOUABaT BOAKA nono3Mpalia HeXeaHa peaKuMa Ypes HalthoHamHa CHCTeMa 3a cRoGuLaBANe KeM VsmuuicrenHara areuuia no aekapersara, ya. ,.lawsn Cpyes” Ne 8, 1303 Compas, rest: +35928903417, yeGcalir: www.bda.bg 4.9 Tipenoampane Cammrown Morar na #acrsniar excrpanmpammann HapyIneNMa, CEHLIMBOCT, NOMHDXEHO HHBO Ha CHSHAHHC, oGpkaHtocT, XaMOUMHAILHH H KapOHOpECTIEpaTOpeH apect. Qunanapane BB cay"ali wa exctpanypamwita cHMIITOMH, CBBp2aHH HH He ¢ peTOSHpAHE, sTeeHHETO € CaMO_ cummromarisnio (GersoavasenMa MPH Reta WiKTH AHTHXOTHREPrHeHH AHTHMApKHHCO) ‘TeKapcTechy MpoayKTH npH BESpACTHH). B aabucHMocr oT 1ommiiraa cTaTyc, ¢ HeOBxoAHMO OCEINOCTBABAHE Ha CHMITTO? mpomsinxsrtenso npocreasae ia expaesio-cononEra n Gexonpo6sara PyHKIUS |5. @APMAKOJIOTH4HM CBOHCTBA 5.1 @apmaxoamuamnanu cnoiicrsa PapsakorepanesTisia rpyia: TekapeTBa mpH SyHKuHOHATHNA CTOMAMIHO-ypeBHH HapyenAs, mnponysicnn ATC xo: A03FA01 ‘Mexauitsea Ha neficrane 1 dapMaxonmiamirsHH eexTH MetokstonpaMHa IIpHTexkaba KAKTO XOTHHOMHMETHYHM, TAKA H JOMAMHHepTHTEH CBOiCTBA. Metoxionpamny e WeHTpalieH JonaMHnoe axTaroHucr. TIpHreskaka 1 niepHibepHH XonMHeprH4tA eexra. Meroxaonpamnn wa anruemeraien ebext 1 ycwina MOTOpiKara Ha TopHara HacT OT CTOMAUITHO- ‘pesuna Tpaxr. YeemuMapa aMILiMTyA#Ta M MpOsBOKHTEAHOCTTA Ha C30‘parcaTHUTe KOHTPAKINH, yeennuana ToHyca Ha yomHHs evo%parearien cépAUKTep KATO NpenoTEpaTana BPEIAHETO Ha Xpaia OT ‘cToMaxa u YBENHUABa H AMTLIUTYATA HA CTOMALLKUTe KOHTpAkUM H TOHYCA Ha CTOMAUIHATA Myckynarypa. Taka yiecttea KanpamnaveTo Ha CTOMAXA, PellAKCHpa MWIOPHHS cibHHKTED H YCHLIBA Nepicrairtukara Ha TeHKOTO 4eps0, YCKOPABAHKK NpeMMHanAHETO Ha xpaHara. Metoxaonpamna npemmiasa npes kppsHo-mosbsHara Gapaepa n GilokHpa NonaMMHOBHTE powerTTopit » XemopeuerrTopuara TpHrep 50H. Kaynuuna eduxacnocr u Gesonacoct Meroxaonpamn| o6i1ek4asa CHMITOMMTe, NpHAKHEHH OT CMYIIEHHH B CTOMALIHO-HPeBHHA TPA: allen, NOBPBINAHE, YYBCTBOTO Ha MuAHOTA H TEKECT B CrOMaXa M xnnuane. MeToxTONpaMi He [POABABA napachMATHKOTHTHHA, ANTHXHCTAMMEA, ATHCepOTONeHHNHa AKTHBHOCT, opaLtH KoeTO He BATHAC BPAY aPTepHAMHOTO KPBBHO HATATAHE, AMUIAHETO Hin ApyrH. Hwa HesHawitresIen ‘expexr BEPXY ToHYca Ha eGen0TO HepBO H IKTBAHHA MEXYP, He TIOBAHMABA CTACNAHETO Ha ACTEM, CTOMAUIHH H MaHKpeaTHUHtH cOKoRe. 5.2 @apmaxoxuuerwuna cnoiicraa Pasmpenencnne Tlaoutra nox KpuBara KOHMeHTpaulHs-BpeMe pacte JMHeTHO c 103a oT 20 70 100 mg. 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Myrareauoet ‘Ames TecTa 3a myTareMocT, HaNIpaseH! c MeTORIONpaMHA, © OTpHMATEneH. ‘Teparorennoer Meroxsonpamng Hsia Teparoreno HelicTBHe. 6 ®APMANEBTHYHH JAHAE 6.1 Cnaew na nomommure wemectsa X.oposonopoana kuceauna (3a Kopurupane na pH crotimocrra) Bona 3a wmxexut 6.2 _Hecbpmecramocra He ca vawectun, 6.3 Cpox na roanocr 5 ronmnn Jlexapetuensr npoxyxr He tps6sa na ce ynorpeGana csiem cpoxa Ha romHocr. 6.4 Cnenwasuu yesonusra sa cexpanenne Za ce cuxpaniasa Ha macto, HeAOCTBMHO 3a nua. a ce coxpanssa npu Temeparypa rion 25° C Ha SamHTeHO OF MpsKa CBETIHNA MACTO. 2 [oe 6.5 Buy mexmepaanne ua onaxonkara Amnyan or GesuneTHo crbkio (BBrpemtara HORbpXHOCT HMA XHAPOMMTHYEH Ka 4802), » xaprosiena ontaxonKa nl 10, 25 wx 50 6pos anny or 2 ml winxeKHO) ceumppacamm 10 mg/2 ml NerowonpaMiiios xWIpOXTOpHs MOHOXHApaT.6.6 — Ceqmannn mpernasnn mepke npa woxenpats Hawa 7, TIPHTEXKATEJI HA PA3PEDIEHMETO 3A YIOTPEBA Lek Pharmaceuticals d.d. ‘Veroyskova 57, Ljubljana, Cnosenna 8 HOMEP HA PA3PEIEHHETO 3A YIOTPEBA Per-No: 20050259 9. __ JATA HA ITPBO PA3PEWIABAHE/MOHOBABAHE HA PA3PELIEHHETO 3A. ‘YIOTPEBA Thepao PY: 04.05.2005 Tlontonasatie wa PY: 27.09.2010 10. ATA HA AKTYAJIM3MPAHE HA TEKCTA 12019