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This insertconta¡nsbasicprescribing infomationonly For more mmprehens¡ve infomaüon,a PRoFESSIONAL BRoCHUREis available to phys¡cians onrequest.
Schering-Plough
DESCRIPTION: Eachgramof ELOMET* Cream0.1%mntains1 mg mometasone fuffite, whitepetrolatum, glyml whitewax,propylene glyml,t¡tanium stearate, stearylalcoholandeteareth-2o, hexylene dioxide, purified aluminum starchoctenylsuÉinate, waterand phosphoric ac¡dto adjustthe pH. Eachgramof ELOlrEf Ointment 0.1%conta¡ns 1 mg mometasone glycol,whitewd, prcpylene furoate,hexylene glym¡shaÉte,white petrolatum, purífied waterandphosphor¡c acidto adjustthe pH, ACTION:Mometasone furcate,a synthetic mrtimstercid, exh¡b¡ts anti-infammatory properlies. antiprur¡t¡c andvasomnstrictive INDICATIONS AND USAGE:ELOMEr Creamand Ointment0.1% are ind¡Étedfor the relief of the inflammatory and prurit¡c manifestations ofmrtimstero¡d responsive dermatoses, suchaspsoriasis andatopicdermatil¡s. DOSAGE ANDADiTINISTRATION: A thinfilmof ELOilEf Creamor Ointment 0.'l%shouldbe applied to theafiected skinareasonedaity. ADVERSE REACTIONS: Lml adveree reactions reported verymrelywithELOMFr Cream0.1%includeparesthesia, pruritus andsignsóf skinatrophy. ; Lo€l adversereactions rarelyreported wilhELOlrEf O¡ntment 0.1%includebuming,pruritus, tjngling/stinging andsignsof sk¡natlphy. - fh+-f€fi€sin€.|€st€dvffi r€a€tiffi+3w bes r€porbd infrequenüy > w¡th thsFsof other topieElcorticostsoids:iribÍen, hypemlcñosis, ' perionldematit¡s, hypopigmentation, allergicmntactdematitis,maceration of the skin,semndary infuction, striaeandmiliaria. CONTRAINDICATIONS:ELOMEPCreamand O¡ntment 0.1%aremntmindi€tedin patients whoare sensitive to mometasone furcate,to other mrt¡mstercidsor to anycomponent of thesepreparations. PRECAUTIONS: lf ¡ritationor sensitiation develops withthe useof ELOMEPProducts, treatment shouldbe dismntinued and approp¡iate therapyinstituted. In the preseneof an ¡nfection, useof an appropriate antifungal or antibacterial agentshouldbe insütuted. lf a favorable response d@snot occurpromptly he mrti@steroid shouldbe dis@ntinued untilthe infection is @ntrolled adequately. Any of the sideeffectsthathavebeenreported following systemic useof mrtimstercids, including adrenalsuppression, mayalsooccurw¡th topimlcortimsteroids, espec¡ally in infantsandchildren. System¡c absorption of topi€l mrtimsteroidswill be increasedif extensivebodysurfa@areasare feated or if the @dusivetechniqueis usd. pre@utions Suitable shouldbe takenunderthesemnditions particularly or whenlong-temuseis anticipated, ¡n infantsandchildren. Pediatric patientsmay demonstmte greatersusceptibility to topical@rtimstercid-¡nduced hypothalamiGpituitary axis suppression and Cushing's patients syndrcme thanmature be€useof a largerskinsurfae areato bodyweightmtio.Useof top¡€lmrt¡msteroids in children shouldbe l¡mitedto the ieastamountcompatible with an effect¡ve theEpeuüc regimen. Chron¡c mrtimsteroid therapymay interfere withgrowthand development of child¡en. ELOMEr products are notfor ophthalmic use. USAGEDURINGPREGNANCY AND lN NURSING WOilEN:Sine sfe use of ELOIúET.Productsin pregnant womenhas not been established, topi€l @rtimsteroids just¡fies shouldbe usedduringpregnancy potential onlyif thepotential benefit riskto thefetus.Drugsof this classshouldnotbe usedon pregnant pat¡ents periodsof time. in largeamounts or for prclonged It is notknownwhether topi€l administEtion of mrtimstemids couldresultin sufficient quantities systemic absorptior to produce detectable in breastmilk.Systemi€lly administered @rticosteroids are secreted intobreastmilkin quantities not likelyto havea deleterious effecton the infant.Nevertheless, a decision shouldbe madewhether to discontinue nuEingor to dismntinue he drug,ták¡ngintoacmuntthe ¡mportance of the drugto the mother DRUG INTERACTION: No knowndata @ircreÉlo adrenal¡nsufiic¡ency. Treatment: Appropriate symptomat¡c treatment ¡s indi€ted.Acutehypermrtimid symptoms are virtually reveFible. Treatelectrolyte imbalan€, if necessaryIn €ses of chronictoxjc¡tyslowwithdmwalof @rtimtercids ¡s advised. HOWSUPPLIED: C¡eam :Tubesof59,10 9,15g and50 g. Ointment: Tubesof 5 o and 15o. STORAGE: Storebelow30"C. SHELFLIFE: 36 months. Keepoutof reachof children. Furtherinfomation en be obtained fromthe doctoror he phamacist. Manufactured by: PT schering-Plough lndonesia Tbk,Jl. RayaPandaan Km.48, Pandaan, Pasuruan, EastJava,Indonesia underauthority of Schering-Plough Corporation. 01987,1988, 2002Scher¡ng-Plough Corporation, Kenilworh, NewJeFey,U.S.A. All RightsReserued 'Trademark
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ELOMET" Kem,lvlóO,f7o g¡etduoc cüamometasone furoate Schering-Plough
Td huúng dán slr dung náy chi cung cáp nhúng thóng tin ké toa ñ **un khoa sé cuns cápthém thóns tin cho bác si iÍi;iíllíSín
bnf oür.¡cóFoonuEu MÓ TA: Mé¡gram Elomet*Kem O,l% chúa 1 mg mometasonefurcate,dáu parafintráng, sáp tráng, propylenglycol stearat, stearylalcoholvá @teareth-2o,hexyleneglycol,t¡tan¡umd¡ox¡d,alum¡n¡umstarch octenylsuccinate,nuóc tinh khiét vá acid phosphor¡cdé d¡éuchinhpH. Mé¡gram Elomet. Mú 0,1o/ochva'l mg mo-metasone furoate,hexyleneglycol.sáp tráng, propylenglycol stearat,dáu parafin tráng,nuóc t¡nhkhiétv¿ ac¡dphosphorictlé cliéuchinhpH. TAC DUNG:_Mometasonefuroate lá m6t cort¡costero¡dténg hqp, có tác dung chéng viém, chéng ngúa vá co mach. CHI DINH VA SU DUNg: Elomet* Kem, Mó 0,1% tfuoc chi dinh dé g¡ám v¡ém vá ngúa ó ec bénh dá có dáp úng vó¡ corticosteroidnhuváy nénvá viém dadi úng. LlEu LtfgNG.vA cAcH DÜNG: Bói móJ tóp móng Etomet*Kem hoác Mó O,t% lén vüns da bi bénh, ng¿y mot tán. TÁc DUNG BAT Lgl: Rát hiém có báo €o phán úng uát lEi tai ché vói Etbmett Kem 0, f%, baó góm mái cám giáó, ngúa vá cácdáuh¡éuteo da. H¡émcó báo cáo phán úng bát lq¡ ta¡ ché vó¡ Elomet. Mó 0,1%, bao góm nóng rát, ngúa, alaunhói/kimchám vá các dáu hieu teo da. Cácphán úng bát lq¡ sau dáy dugcbáo €o kh6ngthuong xuyén khi súdung cáccort¡costero¡d ta¡ché khác:kích úng, chúng ram lóng,g¡ámsác tó, v¡émda quanhmiéng,viém da tiépxúc di úng, totda, nh¡émkhuánthú phát,néi ván vá bCnhké. Thóng báo cho bác ú nh(tng phán úng bát loi gáp phá¡ kh¡ súdung thuéc. CHÓNGCHIOINH:Chéngchid¡nhdüngElomet*Kem,Mó 0,170cho nhúngbCnhnhánmán iám vó¡ mometasonefuroate, vó¡ các corticosteroidkhác hoácvói bát ki, thánh phán náo cúa ché phám. THdN TRQNG: Néu xuáthién kích úng hoácmán cám kh¡düng cácché phám Elomet*thinén ngüng thuécvá có d¡éutri thích hq' rD-7rs3oA
Khi có biéuhiQnnhiémkhuánnén düngthuécchéngnám hoic khángsinhthich hqp. Néu khóngdáp úng tét. nén ngüng corticosteroidcho dén khi kiémsoát hoántoán nhiémkhuán. Bát ki, tác dung phu náo duqc báo cáo khi düng corticosteroidtoán thán, ké cá suy thAn, cúng có thé xáy ra vói các düngta¡ché,déc bictÓ nhúnhivá tré em. corticosteroid hén d¡Cnronghoáckhi bángkín.Nénthántronghong,nhqngtruonghop Hápthu to¿nthánsé tánglén khi bóicort¡costeoid náy hoáckhi dU doánsé düngthuóckéo dá¡,nhátlá ó tré em vá nhú nhi.So vó¡ ngud¡lón bénhnhicó thé mán cám hon vói cort¡costeroid taichégáysuytructuyényén-duo¡dóivá hóichúngCushinghon do ti lé diéntíchb¿ mátda/cánnánglón hon. Néndüngcorticosteroid ta¡ch6chotré em vói só luqng giói han nhátnhungvánduytr¡hiéuquádiéutri.Diéutricorticosteroid dái ngáy có thé ánh huóng dén su táng truóng vá pháttriénó tré em. KhóngdüngcácchéphámElomet.trongnhánkhoa. THAI KY VA CHO CON BÚ: Do chua dánh g¡ású dungan toán cúa các chó phámElomet*trén phu nú mangthai nén chi I di¡¡g 6¿¿66¡¡¡costero¡d ta¡ ché khi lqi íchvuqt troi nguy co tiém táng cho thai. Khóngdüng các thuéc thu0c nhóm náy cho phu I núcóthaivó¡luong lón hoácdüngkéodá¡. : Khóngbiét viCcdüng các corticosteroidtqi ché có dán dén háp thu toán thán dú dé tao ra mot luong xác d¡nhduoc trong súa I me hay khóng.Các corticosteroiddüng toán thán duEc b¿it¡étqua súa.me vói mQtluqng dudng nhu l¿ khóng @ hai cho tré nhó.Tuynhién.pháiquyétdinhngüngchoconbú hoácngüngdüngthuóc,tínhdénsu quantrgngcúathuóctfóivó¡ ngud¡me. TUONGTAC: Khóngcó dú lié-. QUÁ LlÉU: Ttiéuchung: Dúngnhiéuvá kéodá¡các corticostero¡dtai ché có thé úc ché chúc nángthuong thán-tuyényén dán dénsuythuqngthánthú phát. Dftju trli Diéu tr! trieu chúng thích hgp. Các trieu chúng táng corticosteroidcáp có thé h¿i phuc hoán toán. Diéu ki mát cen tü tü trongtrudng hgp ngódócmantính. bángdiéngiáinéucán.NCnngúngcorticosteroid Kem i-Tu-úp5 s, 10 s, I 5 s vr 5_og-. ,----OÓ!|c.GtjtL '. y ó : T u y p s v ái s g . HAN DÜNG:36 thángtü ngáysánxuát. BÁo ouÁN: Duói 3o'c. Dé ngoáitám tay tré em. Xin hói bác sí ho{c duqc sÍ néu cán thém thóngtin. SAN XUAT BÓl: PT Schering-Plough IndonesiaTbk,Jl, RayaPandaanKm 48, Pandaan,Pasuruan,EastJava,Indonesia duó¡ bánquyéncúatáp doánScheriñg-Plough. @1987,1988,2002Schering-Plough Corporation, Ken¡lworth, NewJersey,U.S.A. Tátcá bánquyénduqcbáoluu. .Nhánhiéuhánghóa.
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