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lamizili, 250 mg tabletebi terbinafini preparatis miRebamde ...

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<strong>lamizili</strong>, <strong>250</strong> <strong>mg</strong> <strong>tabletebi</strong><br />

<strong>terbinafini</strong><br />

<strong>preparatis</strong> <strong>miRebamde</strong> yuradRebiT, srulad gaecaniT instruqcias.<br />

- SeinaxeT instruqcia, vinaidan misi wakiTxva SeiZleba kidev dagWirdeT.<br />

- damatebiTi kiTxvebis SemTxvevaSi, mimarTeT eqims an farmacevts.<br />

- aRniSnuli preparati Tqven dageniSnaT. nu gadascemT mas sxvebs. preparats SeuZlia avnos, Tundac<br />

maTi simptomebi Tqvensas emTxveodes.<br />

- Tu romelime gverdiTi efeqti damZimda an SeniSneT am instruqciaSi aRniSnulTagan gansxvavebuli<br />

gverdiTi efeqti, mimarTeT eqims an farmacevts.<br />

instruqciis Sinaarsi:<br />

1. ras warmoadgens da risTvis gamoiyeneba <strong>lamizili</strong><br />

2. <strong>lamizili</strong>s <strong>miRebamde</strong><br />

3. <strong>lamizili</strong>s miRebis wesi<br />

4. SesaZlo gverdiTi efeqtebi<br />

5. <strong>lamizili</strong>s Senaxvis pirobebi<br />

6. damatebiTi informacia<br />

1. ras warmoadgens da risTvis gamoiyeneba <strong>lamizili</strong><br />

<strong>lamizili</strong>s <strong>tabletebi</strong> gamoiyeneba xelis da fexis frCxilis sokovani infeqciebis samkurnalod.<br />

<strong>lamizili</strong>s <strong>tabletebi</strong>, agreTve, gamoiyeneba Tavis kanis da Tmis, sazardulis da sxeulis sxva ubnebis,<br />

fexis terfebis (sportsmenis terfi) liqenis tipis infeqciebis (dermatofitozi) da lev skin infeqciebis<br />

samkurnalod.<br />

<strong>terbinafini</strong> Sedis sokos sawinaaRmdego preparatebis jgufSi da gamoiyeneba kanis, Tmis da frCxilebis<br />

sokovani infeqciebis samkurnalod. oraluri miRebis Semdeg, <strong>terbinafini</strong> infeqciis keras maRali<br />

koncentraciiT aRwevs, romelic sakmarisia sokos gasanadgureblad an misi zrdis SesaCereblad.<br />

2. <strong>lamizili</strong>s <strong>miRebamde</strong><br />

<strong>lamizili</strong>s <strong>tabletebi</strong> aucileblad eqimma unda daginiSnoT. zustad SeasruleT eqimis yvela miTiTeba,<br />

Tundac isini am instruqciaSi mocemuli zogadi informaciisgan gansxvavdebodes.<br />

ar miiRoT <strong>lamizili</strong>:<br />

- Tu alergiuli (hipersensitiuri) xarT <strong>terbinafini</strong>s an <strong>lamizili</strong>s romelime damxmare nivTierebis<br />

mimarT, romlebic instruqciis bolos aris CamoTvlili.<br />

- Tu gaqvT an axlo warsulSi gadaitaneT RviZlis nebismieri saxis darRveva.<br />

- Tu Tirkmlis nebismieri saxis darRveva gaqvT.<br />

Tu am mdgomareobaTagan romelime gexebaT, <strong>lamizili</strong>s gamoyenebamde acnobeT eqims.<br />

<strong>lamizili</strong> gansakuTrebuli sifrTxiliT gamoiyeneT:<br />

Tu sxva preparatebs iRebT (ix. sxva preparatebis gamoyeneba).<br />

- Tu iseTi simptomebi gaqvT, rogoricaa gulisreva, mudmivi da umizezo, Rebineba, darRvevebi kuWis<br />

mxriv, madis dakargva, daRlilobis uCveulo SegrZneba; Tu SeniSneT, rom kani an Tvalebi<br />

gagiyviTldaT, Sardi uCveulod muqi an ganavali uCveulod Ria ferisaa (RviZlis darRvevebis<br />

niSnebi).<br />

- Tu kanis raime daavadeba gaqvT, magaliTad, gamonayari, siwiTle, wylulebi tuCebze, Tvalebze an<br />

piris RruSi, kanis aqercvla (kanis mZime reaqciebis niSnebi).<br />

- Tu sisuste, uCveulo sisxldena, dalurjebebi an xSiri infeqciebi gawuxebT (sisxlis<br />

darRvevebis niSnebi).<br />

Tu am mdgomareobaTagan romelime gexebaT, <strong>lamizili</strong>s gamoyenebamde acnobeT eqims.<br />

gamoyeneba xandazmulebSi<br />

<strong>lamizili</strong>s <strong>tabletebi</strong>s gamoyeneba SeiZleba 65 welze ufrosi asakis pirebSi. Tu 65 welze ufrosi asakis<br />

xarT, dageniSnebaT igive doza, rasac danarCeni mozrdilebi iReben.<br />

gamoyeneba bavSvebSi<br />

<strong>lamizili</strong>s <strong>tabletebi</strong> ar aris rekomendebuli 2 wlamde asakis bavSvebSi.<br />

sxva preparatebis gamoyeneba<br />

SeatyobineT eqims an farmacevts Tqvens mier amJamad an axlo warsulSi miRebuli nebismieri sxva<br />

mcenareuli <strong>preparatis</strong>, oraluri kontraceptivis (Casaxvis sawinaaRmdego abebis) da ureceptod gacemuli<br />

<strong>preparatis</strong> Sesaxeb.<br />

zogierTi preparati urTierTqmedebs lamizilTan.<br />

esenia:<br />

- zogierTi antibiotiki (magaliTad, rifampicini);<br />

- kofeini;<br />

- zogierTi antidepresanti (magaliTad, dezipramini);<br />

- gulis darRvevebis samkurnalod gamoyenebuli zogierTi preparati (magaliTad, propafenoni);<br />

- sisxlis maRali wnevis samkurnalod gamoyenebuli zogierTi preparati (magaliTad,<br />

metoprololi);<br />

- kuWis wylulis samkurnalod gamoyenebuli zogierTi preparati (magaliTad, cimetidini);


- ciklosporini, preparati, romelic imunuri sistemis kontrolisTvis gamoiyeneba, raTa Tavidan<br />

iqnas aridebuli gadanergili organoebis mocileba.<br />

aucileblad uTxariT eqims an farmacevts am da Tqvens mier gamoyenebuli sxva nebismieri <strong>preparatis</strong><br />

Sesaxeb.<br />

orsuloba da laqtacia<br />

nebismieri <strong>preparatis</strong> <strong>miRebamde</strong> konsultaciisTvis mimarTeT eqims an farmacevts.<br />

orsuloba<br />

Tu orsulad xarT an fiqrobT, rom orsulad xarT, SeatyobineT eqims. <strong>lamizili</strong> ar unda gamoiyenoT<br />

orsulobis periodSi, Tu aucilebeli ar aris. orsulobis periodSi <strong>lamizili</strong>s gamoyenebis SesaZlo<br />

riskebs eqimi TqvenTan erTad ganixilavs.<br />

laqtacia<br />

<strong>lamizili</strong>s <strong>tabletebi</strong>s miRebis periodSi ZuZuTi kveba dauSvebelia, vinaidan SesaZlebelia bavSvze<br />

<strong>terbinafini</strong>s zemoqmedeba dedis rZis meSveobiT. aman SeiZleba bavSvs ziani miayenos.<br />

avtomanqanisa da meqanizmebis marTva<br />

Tu <strong>lamizili</strong>s <strong>tabletebi</strong>s miRebisas Tavbru gexvevaT, ar marToT avtomanqana an meqanizmebi.<br />

3. <strong>lamizili</strong>s miRebis wesi<br />

<strong>lamizili</strong> yovelTvis zustad eqimis daniSnulebisamebr miiReT. Tu rameSi darwmunebuli ar xarT,<br />

gaesaubreT eqims an farmacevts.<br />

ar gadaaWarboT rekomendebul dozas. Tu fiqrobT, rom <strong>lamizili</strong>s efeqtebi zedmetad Zlieri an sustia,<br />

uTxariT eqims an farmacevts.<br />

ra raodenobiT da ramdenad xSirad unda miiRoT <strong>lamizili</strong><br />

mozrdilebi<br />

Cveulebriv, rekomendebuli dozaa <strong>lamizili</strong>s erTi tableti (<strong>250</strong> <strong>mg</strong> <strong>terbinafini</strong>), dReSi erTxel.<br />

bavSvebi<br />

2 wlamde asakis (Cveulebriv, 12 kg-mde wonis) bavSvebis Sesaxeb monacemebi ar arsebobs.<br />

>40 kg wonis bavSvebi: rekomendebuli dozaa <strong>lamizili</strong>s erTi tableti (<strong>250</strong> <strong>mg</strong> <strong>terbinafini</strong>), dReSi erTxel.<br />

ramdeni xnis ganmavlobaSi unda miiRoT <strong>lamizili</strong><br />

es damokidebulia infeqciis tipze, mis simZimeze da sxeulis dazianebul ubanze. eqimi getyviT, Tu ramdeni<br />

xnis ganmavlobaSi unda miiRoT <strong>tabletebi</strong>. mkurnalobis miRebuli periodi Semdegia:<br />

terfis (“sportsmenis terfi”) liqenis tipis infeqciebisTvis (dermatofitozi), <strong>lamizili</strong>s <strong>tabletebi</strong> 2-6<br />

kviris manZilze unda miiRoT.<br />

sazardulis da sxeulis sxva ubnebis, liqenis tipis infeqciebisTvis (dermatofitozi) da lev<br />

infeqciebisTvis, <strong>lamizili</strong>s <strong>tabletebi</strong> 2-4 kviris manZilze unda miiRoT.<br />

mniSvnelovania, <strong>tabletebi</strong> yoveldRiurad miiRoT da maTi gamoyeneba ganagrZoT, ramden xansac eqimi<br />

girCevT. es saWiroa infeqciis sruli morCenisTvis da mkurnalobis dasrulebis Semdeg misi recidivis<br />

SesaZleblobis minimumamde dayvanisTvis. <strong>lamizili</strong>s <strong>tabletebi</strong>s miReba sakvebTan erTad an mis gareSe<br />

SegiZliaT.<br />

Tmis da Tavis kanis infeqciebi<br />

Tmis da Tavis kanis liqenis tipis infeqciebisTvis (dermatofitozi), mkurnalobis miRebuli periodia 4<br />

kvira.<br />

frCxilis infeqciebi<br />

Cveulebriv, frCxilis sokovan infeqciebs gankurnebisTvis ufro xangrZlivi periodi esaWiroeba, vidre<br />

kanis sokovan infeqciebs. frCxilis infeqciebis umravlesobisTvis, <strong>lamizili</strong>s <strong>tabletebi</strong> unda miiRoT 6-<br />

dan 12 kviramde.<br />

xelis frCxilis infeqciebi<br />

mkurnalobis periodi: umravles SemTxvevaSi, sakmarisia 6 kvira.<br />

fexis frCxilis infeqciebi<br />

mkurnalobis periodi: umravles SemTxvevaSi, sakmarisia 12 kvira.<br />

zogierT pacients, romelTac frCxilebi nela ezrdebaT, SesaZloa ufro xangrZlivi mkurnaloba<br />

dasWirdeT. amas eqimi TqvenTan erTad gaarkvevs.<br />

Tu dagaviwydaT <strong>lamizili</strong>s miReba<br />

miiReT tableti gaxsenebisTanave. Tu momdevno dozamde 4 saaTze naklebi darCa, moicadeT da momdevno<br />

doza Tavis droze miiReT. ar miiRoT ormagi doza gamotovebulis kompensaciis mizniT.<br />

Tu <strong>lamizili</strong> saWiroze didi raodenobiT miiReT<br />

Tu SemTxveviT eqimis daniSnulze meti tableti miiReT, dauyovnebliv SeatyobineT eqims an uaxloesi<br />

saavadmyofos gadaudebeli daxmarebis ganyofilebas miakiTxeT. <strong>lamizili</strong>s <strong>tabletebi</strong>s dozis<br />

gadaWarbebiT ganpirobebuli simptomebia: Tavis tkivili, gulisreva, muclis tkivili da Tavbrusxveva.<br />

sxva ra unda icodeT <strong>lamizili</strong>s gamoyenebisas


gankurnebisTvis da infeqciis recidivis Tavidan acilebisTvis sxva zomebic arsebobs. magaliTad,<br />

daicaviT inficirebuli ubnebis simSrale da haeris miwodeba, aseve, yoveldRiurad gamoicvaleT<br />

tansacmeli, romelic uSualod aRniSnul ubans exeba.<br />

4. SesaZlo gverdiTi efeqtebi<br />

yvela sxva <strong>preparatis</strong> msgavsad, lamizilmac SeiZleba gverdiTi efeqtebi gamoiwvios, Tumca ara yvela<br />

pacientSi.<br />

<strong>lamizili</strong>, Cveulebriv, advilad aitaneba.<br />

zogierTi gverdiTi efeqti, romelic SeiZleba mZime iyos:<br />

<strong>lamizili</strong>s tabletebma, iSviaTad, SeiZleba RviZlis darRvevebi gamoiwvios, romlebic Zalian iSviaT<br />

SemTxvevebSi, SesaZloa mZime aRmoCndes. mZime gverdiTi efeqtebi moicavs sisxlis ujredebis garkveuli<br />

tipebis Semcirebas (avtoimunuri darRveva), kanis mZime reaqciebs, mZime alergiul reaqciebs,<br />

sisxlZarRvebis anTebas, kuWqveSa jirkvlis anTebas an kunTebis nekrozs.<br />

dauyovnebliv acnobeT eqims Tu:<br />

- gawuxebT mudmivi da umizezo gulisreva, kuWTan dakavSirebuli problemebi, madis dakargva,<br />

uCveulo daRliloba an sisuste an Tu<br />

- SeniSneT kanis an Tvalebis gayviTleba, Sardis uCveulod muqi an ganavlis uCveulod Ria feri<br />

(RviZlis darRvevebis SesaZlo niSnebi);<br />

- gawuxebT yelis tkivili temperaturis momatebis da Semcivnebis TanxlebiT;<br />

- aRgeniSnebaT umizezo sisxldena an sisxlCaqcevebi (daavadebaTa SesaZlo niSnebi, romlebic<br />

sisxlis ujredebis garkveuli tipebis raodenobaze moqmedebs);<br />

- SeniSneT kanis, lorwovani garsebis an frCxilebis paTologiurad yviTeli feri, agreTve, sisuste<br />

an ZaldatanebiT sunTqvis siZnele (im daavadebaTa SesaZlo niSnebi, romlebic sisxlis wiTel<br />

ujredebs azianebs);<br />

- aRgeniSnebaT sunTqvis gaZneleba, Tavbrusxveva, saxis da yelis SeSupeba, siwiTle, muclis<br />

spazmuri tkivili da cnobierebis dakargva, agreTve, Tu gaqvT iseTi simptomebi, rogoricaa<br />

saxsrebis rigiduloba, kanze gardamavali gamonayari, cxeleba an Sesiebuli/gadidebuli limfuri<br />

kvanZebi (mZime alergiuli reaqciebis SesaZlo niSnebi);<br />

- gaqvT iseTi simptomebi, rogoricaa kanze gardamavali gamonayari, cxeleba, qavili, daRliloba an<br />

SeniSneT kanze mowiTalo-molurjo laqebi (sisxlZarRvebis anTebis SesaZlo niSnebi);<br />

- gawuxebT kanis nebismieri saxis mZime darRveva;<br />

- gawuxebT tkivili muclis zeda nawilSi, romelic zurgisken gadaecema (kuWqveSa jirkvlis anTebis<br />

SesaZlo niSnebi);<br />

- gawuxebT umizezo sisuste da kunTebis tkivili an Sardis muqi feri (moyavisfro-mowiTalo)<br />

(kunTebis nekrozis SesaZlo niSnebi).<br />

<strong>lamizili</strong>s miRebisas dafiqsirebulia Semdegi gverdiTi efeqtebi:<br />

Zalian xSiri (aReniSneba yoveli 10-dan 1 pacientze mets):<br />

gulisreva, muclis msubuqi tkivili, wvis SegrZneba muclis zeda nawilSi, diarea, muclis gadavsebis<br />

SegrZneba, madis dakargva, kanis reaqciebi, kunTebisa da saxsrebis tkivili.<br />

xSiri (aReniSneba yoveli 100-dan 1-10 pacients):<br />

Tavis tkivili.<br />

araxSiri (aReniSneba yoveli 1000-dan 1-10 pacients):<br />

gemos SegrZnebis dakargva an Secvla. es iSviaTia da Cveulebriv, <strong>lamizili</strong>s <strong>tabletebi</strong>T mkurnalobis<br />

Sewyvetidan ramdenime kviraSi qreba.<br />

zog pacientSi, aman SeiZleba madis dakargva da wonis mniSvnelovani dakleba ganapirobos. Tu gemos<br />

SegrZnebis cvlileba ramdenime dReze met xans gagrZelda, SeatyobineT eqims.<br />

iSviaTi (aReniSneba yoveli 10000-dan 1-10 pacients):<br />

RviZlis darRvevebi.<br />

Zalian iSviaTi (aReniSneba yoveli 10000-dan 1 pacientze naklebs):<br />

sisxlis gansazRvruli ujredebis raodenobis Semcireba, <strong>mg</strong>lura (avtoimunuri daavadeba), kanis mZime<br />

reaqciebi, alergiuli reaqciebi, Tmis cvena, Tavbrusxveva, fizikuri <strong>mg</strong>rZnobelobis daqveiTeba,<br />

<strong>mg</strong>rZnobelobis dakargva da qavilis SegrZneba.<br />

agreTve, dafiqsirebulia Semdegi gverdiTi efeqtebi:<br />

sisxlis wiTeli ujredebis raodenobis Semcireba, mZime alergiuli reaqciebi, sisxlZarRvebis anTeba,<br />

ynosvis darRvevebi, maT Soris, ynosvis samudamo dakargva, kuWqveSa jirkvlis anTeba, kunTebis nekrozi,<br />

gripismagvari simptomebi (magaliTad, sisuste, Semcivneba, saxsrebis an kunTebis tkivili), cxeleba,<br />

sisxlSi kunTebis fermentebis (kreatinfosfokinazas) donis momateba.<br />

5. <strong>lamizili</strong>s Senaxvis pirobebi<br />

ar gamoiyenoT muyaos kolofze, EXP niSnis Semdeg miTiTebuli vargisianobis vadis amowurvis Semdeg.<br />

vargisianobis vada gulisxmobs miTiTebuli Tvis bolo dRes.<br />

SeinaxeT 25°C-ze dabal temperaturaze, originalur SefuTvaSi.<br />

SeinaxeT bavSvebisTvis miuwvdomel adgilze.<br />

6. damatebiTi informacia<br />

<strong>lamizili</strong>s Semadgenloba<br />

- <strong>lamizili</strong>s aqtiuri nivTierebaa <strong>terbinafini</strong>s qloridi.<br />

- sxva komponentebia: magniumis stearati, uwylo koloiduri siliciumis stearati,<br />

hidroqsipropilmeTilceluloza, mikrokristaluri celuloza, natriumis glikolatis<br />

saxamebeli.


ogor gamoiyureba <strong>lamizili</strong> da ra Sedis SefuTvaSi<br />

kolofSi moTavsebulia blisteri 14 tabletiT.<br />

savaWro licenziis mflobeli da mwarmoebeli<br />

savaWro licenziis mflobeli<br />

novartis farma gmbh<br />

roonStrase 25<br />

D-90429 niurnbergi, germania<br />

mwarmoebeli<br />

novartis farma gmbh<br />

roonStrase 25<br />

D-90429 niurnbergi, germania<br />

preparatTan dakavSirebiT damatebiTi kiTxvebis SemTxvevaSi, mimarTeT eqims an farmacevts.<br />

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