Danarti n2 izoket , aerozol

gamoyenebis instruqcia
izoketi®

savaWro saxelwodeba
izoketi®
saerTaSoriso aradapatentebuli saxelwodeba
izosorbidis dinitrati
wamlis forma
dozirebuli aerozoli 1.25 mg/doza, 15 ml
Semadgenloba
xsnaris 0.05 ml Seicavs
aqtiuri nivTiereba – izosorbidis dinitrati 1.25mg;
damxmare nivTierebebi: makrogoli 400, eTilis spirti 100% (uwylo).
aRwera
gamWvirvale ufero xsnari spirtis suniT.
farmakoTerapiuli jgufi
vazodilatatorebi gulis daavadebebis samkurnalod.
organuli nitratebi.
aTq kodi
C01DA08.
farmakologiuri Tvisebebi
farmakokinetika
absorbcia – maRali. bioSeRwevadoba lorwovani piris Rrus saSualebiT 60%.
sisxlis plazmebTan SekavSireba - 30%. naxevargamoyofis periodi (T1/2) Seadgens
60 wuTs. metabolizdeba RviZlSi or aqtiur metabolitad: izosorbidis 5-
aminonitrati, romlis doza Seadgens 75-85%-s, naxevargamoyofis periodi – 5 saaTi
da izosorbidis 2-mononitrati, romelic Seadgens 15-25%-s 2.5 saaTiani
naxevargamoyofis periodiT.
preparati gamoidevneba TirkmelebiT (TiTqmis srulad metabolitebis saxiT).
farmakodinamika
periferiuli vazodilatatori venozur sisxlZarRvebze upiratesi zemoqmedebiT.
astimulirebs azotis oqsidis warmoqmnas (endoTeliuri marelaqsirebeli
faqtoris)
guanilatciklazas aqtivacias, ris Sedegadac adgili aqvs cikluri guanozin monofosfatis (vazodilataciis mediatoris) momatebas. amcirebs miokardiumis moTxovnas Jangbadze predatvirTvis Semcirebis xarjze. gaaCnia koronarogamafarTovebeli moqmedeba. amcirebs marjvena winagulisken sisxlis nakads, xels uwyobs wnevis dawevas sisxlis mimoqcevis mcire wreSi da simptomebis regresias filtvebis SeSupebisas. aumjobesebs koronaruli sisxlis nakadis gadanawilebas Semcirebuli sisxlismimoqcevis ubnebSi. zrdis fizikuri datvirTvebisadmi tolerantobas gulis iSemiuri daavadebis, stenokardiis mqone pacientebSi. rogorc sxva nitratebis SemTxvevaSi, preparatis moxsnisas (mkurnalobis dros Sesvenebisas) mgrZnobelobis swrafad aRdgena. piris Rrus lorwovan garsze Sesxurebis Semdeg efeqti vlindeba 30 wamis Semdeg da grZeldeba 15-120 wuTis ganmavlobaSi. gamoyenebis Cvenebebi - stenokardiis Setevebis kupireba da profilaqtika - miokardiumis mwvave infarqti - gulis mwvave da qronikuli ukmarisoba. gamoyenebis wesi da dozebi aerozoli izoketi gamoiyeneba piris Rrus lorwovan garsze Sesasxureblad. xsnaris SesunTqva ar SeiZleba. aerozoli miitaneT pirTan, xeli daaWireT gasasxurebels da SeisxureT xsnari piris RruSi: - SeisunTqeT Rrmad - SeikaveT sunTqva - SeisxureT xsnari pirSi (am dros SeiZleba aRiniSnos enaze msubuqi wva) - daxureT piri da daaxloebiT 30 wamis ganmavlobaSi isunTqeT cxviriT. zemoT warmodgenili informaciiT isargebleT maSin, Tu eqimma ar mogcaT sxva rekomendaciebi. daicaviT mocemuli pirobebi gamoyenebis Sesaxeb, vinaidan, winaaRmdeg SemTxvevaSi, izoketis aerozolma SeiZleba ar moaxdinos sasurveli moqmedeba. stenokardiis Setevis kupirebisaTvis an fizikuri an emociuri datvirTvis win, ramac SeiZleba gamoiwvios Seteva, aerozoli unda SeisxuroT pirSi 1-3-jer Sesxurebebs Soris 30-wamiani intervalebiT sunTqvis Sekavebis fonze. 3 Sesxurebidan erTjeradi doza Setevis kupirebisaTvis SeiZleba gaizardos mxolod eqimis mkacri rekomendaciiT. miokardiumis mwvave infarqtisa da gulis mwvave ukmarisobisas preparatis gamoyeneba iwyeba 1-3 SesxurebiT arteriuli wnevisa da gulis SekumSvebis sixSiris mkacri kontrolis qveS. efeqtis ararsebobisas 5 wuTis ganmavlobaSi Sesxureba SeiZleba ganmeordes eqimis kontroliT. Tu 10 wuTis ganmavlobaSi ar aRiniSneba gaumjobeseba, arteriuli wnevis kontroliT SeiZleba izoketis aerozolis ganmeorebiTi gamoyeneba. Sesasxurebelze yoveli daWerisas xsnaris Tanabari raodenoba gamoifrqveva umciresi wveTebis saxiT. advilad aRwevs piris lorwovani garsiT da wamebSi xvdeba sisxlis nakadSi. erTi doza (erTi gafrqveva, rac udris 0.05 ml xsnars) Seicavs 1.25 mg izosorbidis dinitrats. izoketis aerozoli ar Seicavs freons, ar aris mavnebeli garemosaTvis. kidev erT upiratesobas warmoadgens flakonis gamWvirvaleoba, rac saSualebas iZleva droulad moxdes flakonis Secvlis aucileblobis SemCneva. gverdiTi moqmedebebi xSirad
- Zlieri Tavis tkivili (“nitratuli”), romelic xSirad gadis ramdenime dReSi preparatis xangrZlivi gamoyenebisas - orTostaturi hipotenzia (zogjer bradikardiasTan erTad) zogjer (1:1000)
- gulisreva, Rebineba, saxis kanis hiperemia da kanis alergiuli reaqciebi - arteriuli wnevis mkveTri daweva gulis areSi tkivilebis gaZlierebiT - kolafsis mdgomareoba, zogjer bradikardiiT, sinkope iSviaTad (1: 10 000)

- kanis mZime anTebiTi daavadebebi (eqsfoliaturi dermatiti/stivens-jonsonis hipoventilirebul alveolarul zonebSi sisxlis nakadis gadanawilebasTan dakavSirebiT) - miokardiumis tranzitoruli iSemia (gulis iSemiuri daavadebis mqone pacientebSi sisxlis nakadis gadanawilebis gamo) ukuCvenebebi
- momatebuli mgrZnobeloba nitratuli naerTebis an preparatis sxva - mwvave sisxlZarRvovani ukmarisoba (sisxlZarRvebis kolafsi) - gamoxatuli arteriuli hipotenzia (sistoluri arteriuli wneva 90 mm ver. st-ze dabla, diastoluri – 60 mm verc. st-ze dabla) - glukoza-6-fosfatdehidrogenazas deficiti - bavSvebi da mozardebi 18 wlamde (efeqturoba da usafrTxoeba dadgenili ar - fosfodiesterza-5-is inhibitorebis erTdroulad gamoyeneba (magaliTad, gamoiyeneba sifrTxiliT Semdeg SemTxvevebSi:
- miokardiumis mwvave infarqti parkuWebis avsebis daqveiTebuli wneviT - hipertrofuli obstruqciuli kardiomiopaTia (gulis kunTis daavadeba - konstriqciuli perikarditi da gulis tamponada - midrekileba orTostaturi reaqciebis mimarT (arteriuli wnevis mkveTri - daavadebebi, romlebsac Tan axlavs qalasSida wnevis momateba, hemoragiuli - Tirkmelebis mwvave ukmarisoba, RviZlis ukmarisoba (methemoglobinemiis
urTierTqmedeba sxva samkurnalo saSualebebTan

SesaZlebelia hipotenziuri moqmedebebis gaZliereba imavdroulad Semdegi
saSualebebis gamoyenebisas:
- sisxlZarRvebis gamafarTovebeli saSualebebi (vazodilatatorebi) - eTanoli da eTanolis Semcveli saSualebebi - ereqciuli disfunqciis samkurnalo saSualebebi, romlebic Seicaven preparat izoketis imavdroulma gamoyenebam dihidroergotaminTan erTad SeiZleba
gamoiwvios sisxlis plazmaSi dihidroergotaminis koncentraciebis momateba da
amgvarad, gaaZlieros misi hipotenziuri moqmedeba.
im pacientebma, romlebic adre gadiodnen Terapias sxva organuli nitratebiT,
sasurveli hemodinamikuri moqmedebebis misaRwevad aucileblad unda miiRon
izoketis ufro maRali doza.
gansakuTrebuli miTiTebebi
pirveli gamoyenebisas da im SemTxvevaSi, rodesac izoketis aerozolis bolo
gamoyenebis Semdeg gasulia 24 saaTze meti, pirvelad xsnari unda gaafrqvioT
haerSi, vinaidan SeiZleba ar moxdes sruli dozis miwodeba. sasurveli moqmedebis
uzrunvelyofisaTvis aucilebelia uwyvetad da bolomde daaWiroT Sesasxurebels
da isev auSvaT. gamoyenebisas aerozolis flakoni unda geWiroT vertikalurad,
SesasxurebliT zemoT. moerideT xsnaris TvalebSi moxvedras.
Terapiis periodSi aucilebelia arteriuli wnevisa da gulis SekumSvebis
sixSiris kontroli. xSirad daniSvnam da maRalma dozebma SeiZleba gamoiwvios
tolerantobis ganviTareba, aseT SemTxvevaSi, rekomendebulia preparatis moxsna
24-48 saaTiT an 3-6 kviris ganmavlobaSi regularuli miRebis Semdeg aucilebelia
Sesveneba 3-5 dRe da am dros izoketis aerozolis Secvla unda moxdes sxva
antianginaluri preparatebiT.
gTxovT, aerozoli SeinaxoT oTaxis temperaturaze da drodadro SeamowmeT, Tu
rogor muSaobs Sesasxurebeli. es gansakuTrebiT mniSvnelovania gamoyenebisas
xangrZlivi Sesvenebis dros. aerozolis flakonis etiketze qvemoT mocemulia
isari. rodesac siTxis done flakonSi aRwevs isris zeda zRvars, unda SeiZinoT
Semdegi aerozoli. aseTi flakonis SemdgomSi gamoyeneba kidev SeiZleba im
dromde, sanam Semwovi milis Tavi msubuqi daxrisas jer kidev siTxeSia.
xsnari Seicavs daaxloebiT 85% alkohols. izoketiT mkurnalobis periodSi unda
gamoiricxos eTanolis moxmareba. preparatis uecrad moxsna ar SeiZleba, doza
TandaTan unda Semcirdes.
orsuloba da laqtacia
orsulobisa da ZuZuTi kvebis periodSi izoketis aerozolis gamoyeneba unda
moxdes Zalian frTxilad, mxolod im SemTxvevebSi, rodesac mosalodneli
sargebeli dedisaTvis mniSvnelovnad aRemateba nayofisaTvis an bavSvisaTvis
SesaZlo risks.
satransporto saSualebebis da sxva meqanizmebis marTvis unarze samkurnalo
saSualebis zemoqmedebis Taviseburebani
preparatze individualuri reaqciebis Taviseburebebma SeiZleba gamoiwvios
zemoqmedeba satransporto saSualebebis da sxva meqanizmebis marTvis unarze. es
efeqti mniSvnelovnad Zlierdeba mkurnalobis dasawyisSi, dozis momatebisas da
preparatis Secvlisas, agreTve alkoholTan erTad gamoyenebisas.
Warbi dozireba
simptomebi: kolafsi, gonebis dakargva, Tavis tkivili, Tavbrusxveva, guliscema,
mxedvelobis darRvevebi, hiperTermia, krunCxvebi, kanis hiperemia, momatebuli
oflianoba, gulisreva, Rebineba, diarea, methemoglobinemia (cianozi, dispnoe),
bradikardiebi, qalasSida wnevis momateba, dambla, koma.
mkurnaloba: preparatis Semdgomi gamoyeneba unda Sewydes. sawolis Tavi unda
CamoeSvas da avadmyofma fexebi maRla unda aswios. methemoglobinemiis dros –
venebSi Seiyvaneba 1% meTilenis cisferi, 1-2 mg/kg. oqsigenoTerapia.
epinefrinis (adrenalinis) da masTan monaTesave naerTebis Seyvana ukunaCvenebia!
gamoSvebis forma
15 ml preparati yavisfer gamWvirvale SuSus flakonSi Camosacmeli Tavsaxuris
fiqsaciisaTvis, dozatoruli saqaCiT, TeTri feris, plastmasis, mtkiced
mimagrebuli gamafrqveveliT (aerozolis Tavi) da wiTeli feris damcavi xufiT.
erTi flakoni saxelmwifo da rusul enebze preparatis samedicino gamoyenebis
instruqciaTan erTad moTavsebulia muyaos kolofSi.
Senaxvis pirobebi
inaxeba ara umetes 250C-ze.
inaxeba bavSvebisaTvis miuwvdomel adgilas.
Senaxvis vada
5 weli
preparati ar gamoiyeneba SefuTvaze miTiTebuli vargisianobis vadis gasvlis
Semdeg.
afTiaqidan gacemis wesi
farmacevtuli produqtis II jgufi - gaicema eqimis daniSnulebiT.
mwarmoebeli
“kolep si si el laiphaim gmbh da ko kg”, germania
fokerStrase 11 da 12
88471 lauphaimi, germania
saregistracio mowmobis mflobeli
“usb farma gmbh”, germania.
im organizaciis misamarTi, romelic yazaxeTis respublikis teritoriaze iRebs
momxmarebelTa pretenziebs produqciis (saqonlis) xarisxTan dakavSirebiT
“usb farma gmbh”-s warmomadgenloba yazaxeTis respublikaSi
050000, q. almaata, tole bis q. 69, ofisi 21
tel: +7 (727) 2727839, faqsi: +7(727) 2507096

Source: http://moh.itdc.ge/files/Administraciuli_Aqtebi/01_REGISTRACIA/2012/04/02-537/2.pdf