Pfizer

medroli®

meTilprednizoloni

gamoyenebis instruqcia

medroli®

MEDROL®

savaWro dasaxeleba: medroli

saerTaSoriso arapatentebuli dasaxeleba: meTilprednizoloni

Semadgenloba:

TiToeuli tableti Seicavs:

aqtiuri nivTiereba – meTilprednizoloni 4 mg, 16 mg an 32 mg;

damxmare nivTierebebi: kalciumis stearati, simindis saxamebeli, laqtoza,

Txevadi parafini (mxolod 16 da 32 mg-ian tabletebSi), saqaroza.

samkurnalwamlo forma: tabletebi

aRweriloba

elifsis formis, TeTri feris tabletebi, erT mxares jvaredinad 2 Rari,

meore mxares – amotvifrulia “UPJOHN” (4 mg tabletebi), “UPJOHN 73” (16

mg tabletebi), “UPJOHN 176” (32 mg tabletebi).

farmakoTerapiuli jgufi: glukokortikosteroiduli saSualeba

aTq kodi: H02AB04

farmakologuiri Tvisebebi

farmakodinamika

glukokortikosteroidebi (gks) ujreduli membranis gavliT warmoqmnis

kompleqsebs specifikur citoplazmur receptorebTan. amis Semdeg, es

kompleqsebi aRwevs ujredis birTvSi, ukavSirdeba dnm-s (qromatiniT) da

astimulirebs m-rnm-is transkripcias da sxvadasxva fermentebis Semdgom

sinTezs, riTac aixsneba gks-is efeqti sistemuri gamoyenebisas. gks ara

mxolod arsebiT gavlenas axdens anTebiT processa da imunur pasuxze,

aramed gavlenas axdens naxSirwylebis, cilebis da cximebis cvlaze. aseve

zemoqmedebs gul-sisxlZarRvTa sistemaze, ConCxis kunTebze da centralur

nervul sistemaze.

gavlena anTebiT processa da imunur pasuxze

gks-is miRebis umetesi Cvenebebi ganpirobebulia maTi anTebis sawinaaRmdego,

imunodepresiuli da antialergiuli TvisebebiT. am Tvisebebis saSualebiT

miiRweva Semdegi Terapiuli efeqtebi:

imunoaqtiuri ujredebis raodenobis Semcireba anTebis kerasTan

axlos;

vazodilataciis Semcireba;

lizosomuri membranebis stabilizacia;

fagocitozis inhibireba;

prostaglandinebis da maTi monaTesave naerTebis produqciis

Semcireba;

4,4 mg meTilprednizolonis acetatis doza (4 mg meTilprednizoloni)

axdens imave xarisxis anTebis sawinaaRmdego moqmedebas, rogorsac 20 mg

hidrokortizoni.

meTilprednizolons gaaCnia mxolod umniSvnelo mineralokortikoiduli

aqtivoba (200 mg meTilprednizoloni eqvivalenturia 1 mg

dezoqsikortikosteronisa).

gavlena naxSirwylebis da cilebis cvlaze

cilebTan mimarTebaSi gks axdens katabolur moqmedebas.

gamoTavisuflebuli aminomJavebi gardaiqmneba glukoneogenezis procesiT

RviZlSi glukozad da glikogenad. periferiul qsovilebSi glukozis

moxmareba mcirdeba, ramac SeiZleba gamoiwvios hiperglikemia da

glukozuria, gansakuTrebiT Saqriani diabetis ganviTarebis riskis dros.

gavlena cximebis cvlaze

gks-s gaaCnia lipolizuri moqmedeba, rac pirvel rigSi vlindeba

kidurebze. gks aseve axdens lipogenezur moqmedebasac, rac ufro

gamoxatulia gul-mkerdis, kisrisa da Tavis areSi. es yvelaferi

ganapirobebs cximovani CanarTebis ganlagebis gadanawilebas.

gks-is maqsimaluri farmakologiuri aqtivoba vlindeba ara plazmuri

koncentraciis pikze, aramed mis Semdeg, aqedan gamomdinare preparatis

moqmedeba, ZiriTadad, ganpirobebulia misi gavleniT fermentebis

aqtivobaze.

farmakokinetika

meTilprednizolonis Sewova xdeba ZiriTadad wvrili nawlavis

proqsimalur nawilSi, sadac is daaxloebiT 2 jer metia, vidre

distalurSi.

meTilprednizolonis kavSiri cilebTan (albumini da transkortini) –

daaxloebiT 40-90%.

ZiriTadi metabolitebi – 20β-hidroqsimeTilprednizoloni da 20β-

hidroqsi-6α-meTilprednizoloni.

gamoyofa. metabolitebi ZiriTadad gamoiyofa SardiT SeukavSirebeli

formiT, aseve glukuronidebis da sulfatebis formiT, romlebic

ZiriTadad warmoiqmneba RviZlSi da nawilobriv - TirkmlebSi.

meTilprednizoloni – esaa gks moqmedebis gardamavali xangrZlivobiT.

ujredSida aqtivobis xarjze vlindeba gamoxatuli gansxvaveba

metilprednizolonis sisxlis plazmidan naxevargamoyofis periodsa

(daaxloebiT 3,3 sT) da organizmidan mTlian naxevargamoyofis periods

Soris (daaxloebiT 12-36 sT). farmakoTerapiuli efeqti SenarCunebulia

maSinac, roca sisxlSi preparatis done ar isazRvreba.

Cvenebebi

garTulebebis Tavidan acilebis mizniT, preparati miiReba mkacrad eqimis

daniSnulebis mixedviT.

1) endokrinuli daavadebebi

Tirkmelzeda jirkvlis pirveladi da meoradi ukmarisoba (arCevis

preparatebia – hidrokortizoni an kortizoni; saWiroebisas

iniSneba sinTezuri analogebi mineralokortikoidebTan erTad.

mineralokortikoidebis damatebas gansakuTrebuli mniSvneloba

aqvs pediatriul praqtikaSi).

Tirkmelzeda jirkvlis Tandayolili hiperplazia;

qronikuli da qvemwvave Tireoiditi;

hiperkalcemia avTvisebiani warmonaqmnebis dros;

2) sayrden-mamoZravebeli aparatis daavadebebi (maT Soris revmatuli)

(damatebiTi Terapiis saxiT xanmokle droiT, mwvave mdgomareobis an

gamwvavebis dros)

fsoriazuli arTriti;

revmatoiduli arTriti, iuveniluri revmatoiduli arTritis

CaTvliT (calkeul SeTxvevebSi SeiZleba saWiro iyos

SemanarCunebeli Terapia dabali dozebiT);

maankilozebeli spondiliti;

mwvave da qvemwvave bursiti;

mwvave araspecifikuri tendosinoviti;

mwvave podagruli arTriti;

posttravmuli osteoarTriti;

sinoviti osteoarTritis dros;

epikondiliti;

3) SemaerTebeli qsovilis sistemuri daavadebebi

(gamwvavebis periodSi an calkeul SeTxvevebSi SemanarCunebeli Terapiis

saxiT)

mwvave revmokarditi;

sistemuri wiTeli mglura;

sistemuri dermatomioziti (polimioziti);

revmatuli polimialgia;

giganturujredovani arteriiti;

4) kanis daavadebebi

pemfigusi;

bulozuri herpesiformuli dermatiti;

mZime multiformuli eriTema (stivens-jonsonis sindromi);

eqsfoliatiuri dermatiti

sokosmagvari mikozi;

mZime fsoriazi;

mZime seboreuli dermatiti;

5) alergiuli reaqciebi (mZime an damainvalidebeli mdgomareobebi, romlis

drosac araefeqturia tradiciuli Terapia)

sezonuri an wliuri alergiuli riniti;

Sratismieri daavadeba;

bronquli asTma;

preparatebis mimarT momatebuli mgrZnobelobis reaqciebi;

kontaqturi dermatiti;

atopiuri dermatiti;

6) Tvalis daavadebebi (mZime mwvave da qronikuli alergiuli da anTebiTi

procesebi Tvalis dazianebiT)

rqovanas alergiuli wylulebi;

Tvalis wina segmentis anTeba;

difuzuri ukana uveiti da qorioiditi;

simpaTikuri ofTalmia;

alergiuli koniunqtiviti;

keratiti;

qorioretiniti;

mxedvelobis nervis nevriti;

iriti da iridocikliti;

7) sasunTqi organoebis daavadebebi

simptomuri sarkoidozi;

lefleris sindromi, romelic ar eqvemdebareba mkurnalobas sxva

saSualebebiT;

beriliozi;

filtvis elviseburi an diseminirebuli tuberkulozi Sesabamis

antituberkulozur qimioTerapiasTan erTad;

aspiraciuli pnevmoniti;

8) hematologiuri daavadebebi

idiopaTiuri Trombocitopeniuri purpura mozrdilebSi;

meoradi Trombocitopenia mozrdilebSi;

SeZenili (autoimunuri) hemolizuri anemia;

eriTroblastopenia (eriTrocituli anemia);

Tandayolili (eriTroiduli) hipoplaziuri anemia;

9) onkologiuri daavadebebi (paliatiuri Terapiis farglebSi)

leikozebi da limfomebi mozrdilebSi;

mwvave leikozi bavSvebSi;

10) SeSupebiTi sindromi

diurezis stimulaciisTvis da proteinuriis remisiis misaRwevad

pacientebSi uremiis gareSe nefrozuli sindromiT, romelic an

idiopaTiuri tipisaa, an sistemuri wiTeli mgluraTi gamowveuli.

11) kuW-nawlavis daavadebebi (avadmyofis kritikuli mdgomareobidan

gamoyvanis mizniT)

wylulovani koliti;

regionaluri enteriti;

12) nervuli sistema

gafantuli sklerozis gamwvaveba;

Tavis tvinis SeSupeba, ganpirobebuli Tavis tvinis simsivniT;

13) sxva Cvenebebi

tuberkulozuri meningiti subaraqnoiduli blokiT an misi

saSiSroebis dros (Sesabamis antituberkulozur qimioTerapiasTan

erTad);

triqinelozi nervuli sistemis an miokardiumis dazianebiT;

organoTa transplantacia.

ukuCveneba

anamnezSi momatebuli mgrZnobeloba preparatis nebismieri komponentis

mimarT;

preparati sifrTxiliT gamoiyeneba Semdeg SemTxvevebSi:

kuWisa da Tormetgoja nawlavis wylulovani daavadeba, ezofagiti,

gastriti, mwvave an latenturi peptikuri wyluli, nawlavuri anastomozi

(bolo periodSi anamneziT), araspecifikuri wylulovani koliti

perforaciis an abscesis saSiSroebiT, divertikuliti; Saqriani diabeti an

misdami winaswarganwyoba, hiperlipidemia; miasTenia gravis, osteoporozi,

hipoTireozi, hiperTireozi, mwvave fsiqozi, miokardiumis mwvave da qvemwvave

infarqti, gulis SegubebiTi ukmarisoba, arteriuli hipertenzia, RviZlis

funqciis mZime darRveva (gansakuTrebiT, hipoalbuminemiiT mimdinare) an

Tirkmlis funqciis mZime darRveva, RiakuTxovani glaukoma, martivi herpesi

(Tvalis forma), Cutyvavila, wiTela, strongiloidozi, Sidsi, aiv-infeqcia;

aqtiuri da latenturi tuberkulozi, mZime baqteriuli an virusuli

infeqciebi (zrdis superinfeqciis ganviTarebis risks, niRbavs daavadebis

simptomebs), preparatis miReba dasaSvebia mxolod specifikuri Terapiis

fonze.

sistemuri sokovani infeqciebis dros ar aris rekomendebuli preparatis

miReba.

miRebis gzebi da dozireba

preparatis sawyisi doza SeiZleba Seadgendes 4–dan 48 mg-mde

meTilprednizolons dReSi, daavadebis xasiaTis mixedviT. nakleb mZime

daavadebebis dros sakmarisia ufro dabali dozebi, Tumca calkeul

pacientebSi SeiZleba saWiro gaxdes ufro maRali dozebic. maRali dozebi

SeiZleba saWiro gaxdes iseTi daavadebebisa da mdgomareobebis dros,

rogoricaa gafantuli sklerozi (200 mg/dReSi), Tavis tvinis SeSupeba (200-

1000 mg/dReSi), da organoTa transplantacia (7 mg/kg/dReSi). Tu drois

garkveuli periodis Semdeg ar iqna miRweuli damakmayofilebeli

klinikuri efeqti, saWiroa preparatis miRebis Sewyveta da sxva tipis

Terapiis daniSvna.

bavSvebSi dozas eqimi adgens sxeulis masaze an zedapirze gaangariSebiT.

Tirkmelzeda jirkvlis ukmarisobis dros – peroralurad 0,18 mg/kg an 3,33

mg/kv.m. dReSi 3 miRebaze, sxva CvenebiT – 0,42-1,67 mg/kg an 12,5-50 mg/kv.m. dReSi

3 miRebaze.

aRsaniSnavia, rom saWiro doza SeiZleba varirebdes da unda SeirCes

individualurad daavadebis xasiaTis da pacientis Terapiaze pasuxis

mixedviT.

xangrZlivi mkurnalobis Semdeg preparatis Sewyveta unda moxdes

TandaTanobiT. Tu mkurnalobis procesSi miRebulia kargi efeqti,

pacientisTvis unda SeirCes individualuri SemanarCunebeli doza, sawyisi

dozis TandaTanobiTi Semcirebis gziT drois garkveuli SualedebiT, sanam

ar aRmoaCenen umcires dozas, romelic miRweuli klinikuri efeqtis

SenarCunebis SesaZleblobas iZleva. saWiroa preparatis dozirebis reJimis

mudmivi kontroli.

zog situaciaSi SeiZleba saWiro gaxdes dozis koreqcia, magaliTad,

klinikuri mdgomareobis cvlilebisas, rac ganpirobebulia remisiiT an

daavadebis gamwvavebiT, preparatze pacientis individualuri reaqciis

gaTvaliswinebiT, aseve pacientze stresuli mdgomareobebis zemoqmedebis

dros, rac ar aris pirdapir dakavSirebuli ZiriTad daavadebasTan, razec

mimarTulia Terapia; bolo SemTxvevaSi SeiZleba saWiro gaxdes preparatis

dozis gazrda garkveuli droiT, rac avadmyofis mdgomareobazea

damokidebuli.

alternatiuli Terapia

alternatiuli Terapia - esaa dozirebis iseTi reJimi, romlis drosac gks-

is gaormagebuli dRiuri doza miiReba dRegamoSvebiT diliT. aseTi

Terapiis mizania maqsimaluri klinikuri efeqtis miRweva pacientebSi,

romlebic preparats iReben xangrZlivi drois ganmavlobaSi, da amave dros

arasasurveli efeqtebis minimumamde dayvana, rogoricaa hipofizur-

Tirkmelzedas sistemis daTrgunva, kuSingis sindromi, gks-is moxsnis

sindromi da zrdis Seferxeba bavSvebSi.

gverdiTi efeqtebi

wyal-eleqtrolituri balansis darRveva: natriumis Sekaveba, gulis

qronikuli ukmarisoba winaswarganwyobil pirebSi, arteriuli wnevis

mateba, organizmSi siTxis Sekaveba, kaliumis dakargva da hipokalemiuri

alkalozi.

Zval-kunTovani: steroiduli miopaTia, kunTovani sisuste, osteoporozi,

paTologiuri motexilobebi, malebis kompresiuli motexilobebi,

lulovani Zvlebis epifizebis aseptikuri nekrozi, myesebis gaglejva,

gansakuTrebiT aqilevsis myesis.

kuW-nawlavis: peptikuri wyluli SesaZlo perforaciiT da sisxldeniT,

kuWidan sisxldenebi, pankreatiti, ezofagiti, nawlavis perforacia.

gks-iT mkurnalobis Semdeg aRiniSna sisxlis SratSi alanintransaminazas

(alt), aspartattransaminazas (ast) da tute fosfatazas donis mateba.

Cveulebriv, es cvlilebebi umniSvneloa, ar aris dakavSirebuli klinikur

sindromebTan da Seqcevadia mkurnalobis Sewyvetis Semdeg.

dermatologiuri: Wrilobebis gviani Sexorceba, peteqiebi da eqkimozebi,

kanis simkvrivis daqveiTeba da gaTxeleba.

metaboluri: uaryofiTi azotis balansi, ganpirobebuli cilis

katabolizmiT.

nevrologiuri: qalasSida wnevis momateba, Tavis tvinis fsevdosimsivne,

fsiqikuri darRvevebi, krunCxva.

endokrinuli: menstrualuri ciklis darRveva, hirsutizmi, kuSingis

sindromis ganviTareba, hipofizur-Tirkmelzeda sistemis daTrgunva,

naxSirwylebisadmi tolerantobis daqveiTeba, latenturi Saqriani diabetis

gamovlena, insulinis an Saqris donis damaqveiTebeli peroraluri

preparatebis momatebuli moxmareba diabetis mqone pirebSi, bavSvebSi

zrdis darRveva.

ofTalmologiuri: ukana subkafsuluri kataraqta, TvalSida wnevis

momateba mxedvelobis nervis dazianebis riskiT, egzofTalmi.

imunologiuri: infeqciuri daavadebebis dros waSlili klinikuri suraTi,

latenturi infeqciebis aqtivacia, pirobiT paTogenuri gamomwvevebiT

gamowveuli infeqciebis ganviTareba, momatebuli mgrZnobelobis reaqciebi,

maT Soris alergiuli sistemuri reaqciebi, SesaZlebelia reaqciebis

daqveiTeba kanis sinjebis warmoebis dros.

sxva: gks-is moxsnis sindromi.

Warbi dozireba

preparatis Warbi dozirebis klinikuri sindromi ar aris aRwerili. gks-is

dozis gadaWarbebisas mwvave toqsikurobis ganviTareba aRiniSneba

ukiduresad iSviaTad. ar arsebobs specifikuri antidoti. xangrZlivi

periodis ganmavlobaSi preparatis xSirma ganmeorebiTma gamoyenebam

(yoveldRe an kviraSi ramdenjerme) SeiZleba gamoiwvios kuSingis sindromi

da sxva garTulebebi, damaxasiaTebeli gks-is xangrZlivi gamoyenebisTvis.

mkunaloba simptomuria. meTilprednizoloni gamoidevneba dializiT.

urTierTqmedeba sxva samkurnalo saSualebebTan

samkurnalwamlo urTierTqmedebis qvemoT moyvanil magaliTebs SeiZleba

hqondes arsebiTi klinikuri mniSvneloba.

meTilprednizolonis da ciklosporinis erTdroulad gamoyeneba iwvevs

metabolizmis urTierTSekavebas, amitom dasaSvebia, rom yoveli am

preparatTaganiT monoTerapiisas gamovlenili gverdiTi movlenebi maTi

erTdrouli gamoyenebisas ufro xSirad ganviTardes. (aRwerilia krunCxvis

SemTxvevebi am preparatebis erTdrouli miRebisas).

meTilprednizolonis Terapiuli efeqti qveiTdeba RviZlis mikrosomuli

fermentebis induqtorebis gavleniT (efedrini, Teofilini, fenobarbitali,

fenitoini, rifampicini), rac saWiroebs preparatis dozis momatebas

sasurveli efeqtis misaRebad.

oleandomicins, ketokonazols, peroralur estrogenis Semcvel

kontraceptivebs SeuZliaT gks-is metabolizmis inhibireba da misi

klirensis Semcireba, naxevargamoyofis periodis, Terapiuli da toqsiuri

efeqtebis gazrda. aseT SemTxvevaSi, aucilebelia meTilprednizolonis

dozis Semcireba Warbi dozirebis prevenciis mizniT.

meTilprednizolons SeuZlia xangrZlivi periodis ganmavlobaSi da didi

dozebiT miRebuli acetilsalicilis mJavis klirensis gazrda, ramac

SeiZleba gamoiwvios SratSi salicilatebis donis daqveiTeba an

meTilprednizolonis moxsnis SemTxvevaSi salicilatebis toqsiurobis

riskis gazrdas. salicilatebTan erTad miRebisas izrdeba gastropaTiis

ganviTarebis riski. hipoproTrombinemiiT daavadebulebisaTvis

acetilsalicilis mJava gks-sTan erTad iniSneba sifrTxiliT.

meTilprednizoloni gavlenas axdens peroraluri antikoagulantebis

moqmedebaze, monacemebis mixedviT, aZlierebs an asustebs

antikoagulantebis efeqts, romlebic erTdroulad miiReba

meTilprednizolonTan. antikoagulantis saWiro efeqturobis

SesanarCuneblad aucilebelia koagulaciis maCveneblebis mudmivi

gansazRvra.

hipokalemiuri moqmedebis gamo zrdis sagule glikozidebis toqsiurobas

(ariTmiebis ganviTareba).

Tiaziduri diurezulebi, karboanhidrazas inhibitorebi, sxva gks da

amfotericin B zrdis hipokalemiis ganviTarebis risks, natriumis Semcveli

preparatebi – SeSupebis da arteriuli wnevis risks.

alkoholi da arasteroiduli anTebis sawinaaRmdego saSualebebi zrdis

kuW-nawlavis ulceraciis da sisxldenebis safrTxes. arTritis

samkurnalod arasteroiduli anTebis sawinaaRmdego saSualebebTan

kombinaciaSi meTilprednizolonis dozas amcireben Terapiuli efeqtis

sumaciis gamo.

paracetamolTan kombinaciaSi izrdeba hepatotoqsiurobis riski (RviZlis

fermentebis induqcia da paracetamolis toqsiuri metabolitis warmoqmna).

amcirebs hipoglikemiuri saSualebebis moqmedebas.

antacidebTan erTad miReba amcirebs meTilprednizolonis Sewovas.

meTilprednizolonis maRali dozebi Trgunavs somatotropinis efeqts.

androgenebi zrdis SeSupebis ganviTarebis risks.

amcirebs vaqcinebis efeqturobas (cocxalma vaqcinam meTilprednizolonis

miRebis fonze SeiZleba gamoiwvios daavadeba).

mitotanma da Tirkmelzeda jirkvlis qerqis funqciis sxva inhibitorebma

SeiZleba ganapirobos dozis gazrdis saWiroeba.

antiTireoiduli preparatebi da Tireoiduli hormonebi:

meTilprednizolonis klirensi mcirdeba hipoTireozis dros da izrdeba

hiperTireozis dros, amitom, meTilprednizolonis dozis SerCeva xdeba

funqciuri testebis monacemebis safuZvelze.

aCqarebs izoniazidis, meqselitinis metabolizms, rac aqveiTebs

preparatebis plazmur koncentracias, gansakuTrebiT “swraf”

acetilatorebSi.

gansakuTrebuli miTiTebebi

radgan gks-iT Terapiis garTulebebi damokidebulia dozis sidideze da

mkurnalobis xangrZlivobaze, TiToeul konkretul SemTxvevaSi

mkurnalobis saWiroebis Sesaxeb gadawyvetileba miiReba

riski/sargebelis Tanafardobis gaanalizebis safuZvelze, aseve

sazRvraven mkurnalobis xangrZlivobas da miRebis sixSires.

saWiroa preparatis im umciresi dozis miReba, rac uzrunvelyofs

sakmaris Terapiuli efeqts, saWiroebisas dozis daqveiTeba xdeba

TandaTan.

gks-iT Terapiis fonze SeiZleba ganviTardes sxvadasxva fsiqikuri

darRvevebi: eiforia, uZiloba, ganwyobis cvalebadoba, pirovnebis

cvlileba da mZime depresia, mwvave fsiqozuri gamovlinebebi. Ggarda

amisa, SeiZleba gaZlierdes ukve arsebuli emociuri arastabiluroba an

fsiqozuri reaqciebisken midrekileba.

avadmyofebisTvis, romlebic eqvemdebarebian stresul situaciebs gks

Terapiis fonze, naCvenebia preparatis dozis gazrda stresamde,

stresuli situaciis dros da mis Semdeg.

avadmyofebSi, romlebic Rebuloben gks-is imunodepresiuli efeqtis

gamomwvev dozebs, ukunaCvenebia cocxali an cocxali Sesustebuli

vaqcina, magram SeiZleba mkvdari an inaqtivirebuli vaqcinis miReba,

Tumca aseT vaqcinaze reaqcia SeiZleba daqveiTebuli iyos. avadmyofebSi,

romlebic Rebuloben gks-is im dozebs, romlebic ar iwvevs

imunodepresiul efeqts, Sesabamisi CvenebiT xorcieldeba imunizacia.

gks Terapiis fonze zogierTi infeqcia SeiZleba mimdinareobdes

waSlili formiT, garda amisa, SeiZleba ganviTardes axali infeqciuri

daavadeba. gks-is miRebis dros SeiZleba daqveiTdes organizmis

mdgradoba infeqciis mimarT, aseve SeiZleba dairRves organizmis mier

infeqciuri procesis lokalizebis unari. sxvadasxva paTogenuri

organizmebiT, iseTebiT, rogorebicaa virusebi, baqteriebi, sokoebi,

umartivesebi an helminTebi, romlebic lokalizdebian adamianis

organizmis sxvadasxva sistemaSi, gamowveuli infeqciebis ganviTareba

SeiZleba dakavSirebuli iyos gks rogorc monoTerapiasTan, aseve sxva

imunodepresantebTan erTad gamoyenebasTan, romlebic moqmedeben

ujredul imunitetze, humorul imunitetze an neitrofilebis funqciaze.

SeiZleba es infeqciebi ar mimdinareobdes mZimed, magram rig

SemTxvevebSi SesaZlebelia mZime mimdinareoba da letaluri gamosavalic

ki. amasTan, rac metia gks-s gamoyenebuli dozebi, miT metia infeqciuri

garTulebebis warmoSobis riski.

preparat medrolis gamoyeneba aqtiuri tuberkulozis dros naCvenebia

elvisebri an diseminirebuli tuberkulozis mxolod im SemTxvevebSi,

rodesac gks gamoiyeneba Sesabamis antituberkulozur qimioTerapiasTan

erTad. Tu preparati iniSneba latenturi tuberkulozis an dadebiTi

tuberkulozuri sinjebis dros, mkurnaloba unda Catardes mkacri

saeqimo dakvirvebiT, ramdenadac SeiZleba moxdes daavadebis reaqtivacia.

gks xangrZlivi Terapiis dros aseT avadmyofebs unda CautardeT

saTanado profilaqtikuri mkurnaloba.

preparati sifrTxiliT gamoiyeneba Tvalis dazianebis dros, romelic

gamowveulia martivi herpes virusiT, radgan SeiZleba moxdes rqovanas

perforacia.

gks xangrZlivi gamoyenebis SemTxvevaSi SeiZleba ganviTardes ukana

subkafsularuli kataraqta, glaukoma mxedvelobis nervis SesaZlo

dazianebiT da izrdeba sokoebiT an virusebiT gamowveuli meoradi

infeqciebis ganviTarebis SesaZlebloba. SesaZloa ganviTardes

alergiuli reaqciebi (magaliTad, angionevrozuli SeSupeba).

hidrokortizonis an kortizonis saSualo da maRalma dozebma SeiZleba

gamoiwvios arteriuli wnevis mateba, natriumis ionebis da wylis

Sekaveba, da kaliumis eqskreciis gazrda. es movlenebi naklebad

viTardeba sinTezuri gks-is gamoyenebis dros (magaliTad,

meTilprednizoloni), im SemTxvevebis garda, rodesac isini maRali

doziT gamoiyeneba. saWiroa saWmeli marilis miRebis SezRudva da

kaliumis preparatebis miReba. yvela gks zrdis kalciumis gamoyofas.

osteoporozi warmoadgens xSir, da amave dros, iSviaTad

diagnostirebul gverdiT efeqts, romelic viTardeba gks-is xangrZlivi

gamoyenebisas.

bavSvebs, romlebic preparats Rebuloben yoveldRe, ramdenjerme dRe-

RameSi, SeiZleba aReniSnos zrdis Seferxeba, amitom dozirebis aseTi

reJimis gamoyeneba SeiZleba mxolod absoluturi CvenebiT.

alternatiuli Terapia saSualebas iZleva gamoiricxos an minimumamde

iqnas dayvanili aseTi arasasurveli efeqtebi.

Tirkmelzedas qerqis meoradi ukmarisobis gamovlinebebi, rac axlavs

gks-iT mkurnalobas, minimumde SeiZleba dayvanil iqnas dozis

TandaTanobiTi daqveiTebiT. SedarebiTi ukmarisobis es tipi SeiZleba

aRiniSnos ramdenime Tvis ganmavlobaSi mkurnalobis dasrulebidan,

amitom, am periodSi nebismier stresul situaciaSi isev iniSneba gks.

amasTan erTad, SeiZleba darRveuli iyos mineralokortikoidebis

sekreciac, ris gamoc aucilebelia eleqtrolitebis da/an

mineralokortikoidebis daniSvna.

gks-is ufro gamoxatuli efeqti aRiniSneba hipoTireozis da RviZlis

cirozis dros.

ar arsebobs erTiani azri peptikuri wylulis ganviTarebis Sesaxeb gks

mkurnalobis fonze. preparatis miRebam SeiZleba SeniRbos peptikuri

wylulis simptomebi, ris gamoc SeiZleba ganviTardes perforacia an

sisxldena gamoxatuli tkivilis sindromis gareSe.

gks sifrTxiliT gamoiyeneba araspecifikuri wylulovani kolitis dros,

Tu arsebobs kuW-nawlavis traqtis kedlis perforaciis, abscesis

ganviTarebis an sxva Cirqovani infeqciis riski; aseve, divertikulitis

dros, axali nawlavuri anastomozebis arsebobisas, aqtiuri an

latenturi peptikuri wylulis, Tirkmlis ukmarisobis, arteriuli

hipertenziis, osteoporozis, miasTenia gravis dros.

aRwerilia, rom avadmyofebs, romlebic iRebdnen gks Terapias,

ganuviTardaT kapoSis sarkoma (gks-s moxsnis Semdeg SeiZleba dadges

klinikuri remisia).

preparatis kancerogenuli da mutagenuri moqmedeba, agreTve misi

arasasurveli gavlena reproduqciul funqciaze ar aris dadgenili.

orsuloba da laqtacia

cxovelebze Catarebulma kvlevebma aCvena, rom gks-is maRali dozebis

gamoyenebam mdedrebSi SeiZleba gamoiwvios nayofis simaxinjeebi. radgan

saTanado kvlevebi adamianis reproduqciul funqciaze gks-is gavlenis

Sesaswavlad am momentisTvis ar aris Catarebuli, preparatis gamoyeneba

orsulobis, laqtaciis periodSi da reproduqciuli asakis qalebSi xdeba

mxolod qalisTvis, embrionisa da nayofisTvis sargebelisa da potenciuri

riskis Tanafardobis Sefasebis safuZvelze. orsulobis dros gks iniSneba

mxolod absoluturi CvenebiT.

gks advilad gadis placentaSi. bavSvebi, romelTa dedebi orsulobis dros

Rebulobdnen gks-is maRal dozebs, saWiroeben yuradRebian gamokvlevas

Tirkmelzeda jirkvlis hipofunqciis SesaZlo simptomebis gamovlenis

mxriv. gks-is gavlena mSobiarobis mimdinareobasa da gamosavalze ucnobia.

gks gamoiyofa dedis rZeSi. amitom, laqtaciis periodSi preparat medrolis

miRebis aucileblobis dros, bavSvebis ZuZuTi kvebas wyveten.

gamoSvebis forma

tabletebi 4 mg:

1, 3 da 10 polivinilqloridis/aluminis folgis blisteri, TiToeuli 10

tabletiT, muyaos yuTSi;

30 tabletis Semcveli 1 muqi SuSis flakoni muyaos yuTSi.

tabletebi 16 mg:

14 tabletis Semcveli 1 polivinilqloridis/aluminis folgis

blisteri, 5 blisteri, TiToeuli 10 tabletiT, muyaos yuTSi;

50 tabletis Semcveli 1 muqi SuSis flakoni muyaos yuTSi.

tabletebi 32 mg:

20 an 50 tabletis Semcveli 1 muqi SuSis flakoni muyaos yuTSi.

Senaxvis vada: 5 weli.

vargisianobis vadis gasvlis Semdeg ar gamoiyeneba!

Senaxvis pirobebi:

inaxeba 20-25°C temperaturaze. sia b.

SeinaxeT bavSvebisaTvis miuwvdomel adgilas!

afTiaqidan gacemis pirobebi: farmacevtuli produqtis jufi II, gaicema

forma #3 receptiT.

mwarmoebeli-sawarmo:

faizer italia s.r.l., askoli piCeno, italia.

Pfizer Italia S.r.L, 63046 Marino Del Tronto, Ascoli Piceno, Italy.

CPS12/12/94

mTargmneli: elmira aruTiniani