D xaglobe Ampoules51t'rHe aqucou. injedabk sUspcn5ion

E IN NE NAT & INFANT

l!aI..h I ml conlalns :

Actlvs: lopnUcnls'Rdamcthasonc Dipropionatc 6."1 ma(tq 10 S mg 8Clamethuonc)Betamethasooe Sodium PhOiphat( 1 6) f11 (Eq to 1 mB 8etamcthuon'Mclin Inf:mficnts'Dlsodlum Phosphate :l H1Q Monosodium phosphate lbO. Sodium ( hlMIde.Dlsodlum edetate, Polyeorbate so. BC02yl Alcohol. Methyl pan hydrmyhl'f11oa e,I)ropyl pera-hydroxybenzoete, Sodium carboxymethyl cellule (w 1.1' ).M:U.fOKOI 4000, Waler for tnjection

• PharmacolO£ical ActiOQ .

Oexaglobe sterile aqueous suspension IltOvhJc. at 10.0mb n.alkNl of highly solubleand very sUghtly 50Iubie esters ofbetametheeene thllt produce antl·tnflammatory..ntl-~umatic and anti-allergic effecu (Irompl therapeutlc activit)' is achieved bythe aolublc ester ,bctamcllwooc lum pbosphate , which Is quickly absorbedafttr In}c:ction .50 tamed activity •• provided by betametbasone dlprcplcnetewhlchl 0fl1ysli8htlysolu~andb«om arrpo iloryor low iMnrllllClll,therebyrontrol1ingsymptomsovn'a~'r ••lnnfC dl fhllt II •• 111 II "t I Itto(betamethasone djproptceate permits tbe \,..- I" 1111.. \hl n II (u!' 1,1 1ft.) (orIntradermal and intralestonal adminlJfr Ik ••••

• Pharmaceutical Form'Sto'Ut aqurous 1.nl«labk susperv;ion

·lnd 1100;()elul~l(lb( 1.lndkl\ted for systemic and hh..II, 0I11t1t 111111 • \II !HI I hrunlcconk o 1(1'0111 responsive disorders, tll}(\I.lly 1IIIIu lul1c,wlnM,u.HUlluII':Mu.a<ulo kA:1 lill LU"IUA,an \iuJjuH\.!lVt" thtr.tpyofsbort term dUlln Ih(' ,ult .11011 U( _"~(',hAllon 'itfthe fullowfnA"dl eut$: O51eoarthritls, rht"urnllc-'J Ilhllll <_I"' 1.1 ~"t•.•may requirea low('r nMlllh I ACedose), bursitiJ. ankylc IIltc puudyhll cl'l,.,tlllyllil radlc 'tis,Cou.}'\Jynl., I 11t,;1.lumbago, stiff neck • '"flle)vl.1 ~y t "u lilt' .1. 1111.

WllliJ:mdlDunna tv t. fhoatlunor as mainren.a.nce therapy in 50fnCCaatl of, klllic lupuserythcltlAU",u.. J('rodenna. dermatomyositis. polyarteritis n<Mk6.11rei_ OIwlllunAJ adJun...llvt 11\('1 I'Y'" asthmadc condilions and h)'pC'rwnsilivity ructions to drugsorlruc:d\eIIlKIn SC'vcrcIIICI6I# '1ItkJitKHlJ unr pondlni to convcntional methods-In particularacute: lila ~ nd ""~rlh.llun u(lh •. fllllllwlntld"ascs: chronic bronchialastseasonalor(l«'ftllnl~1 11,.1 ,hi ~II', I 11f! II hmnc:hitls.,severeangioedn-ta,serum sicilne:S5.llopic derntatitla, n III, ••lrllll"lllI \01'11 t.1 d 'rmalilis, urticaria.severe solar rxanthema.permalQIo&ical DjSOrdCaAIOpic dermatitis, neurodcrmalil"', OC'croblt)6ls Ilpolt.!llll tll.ll~th 1'111111, 11'11f ~Qr "IM.tll.,old lupu~ c:rythematous. psoriasis, kelolds, pemphlgul. detllllAllll,ht11k'IIIUlIIII ,urtl arlal,Hyperltophic lichen planus. necrobiosis lipoidic.dlllilt tk,orum. alopecia areata. discoid lupu. erythematosus. psorla So kclclhJpemphlaua, dcrmatitis herpetiform1&. cystLe aent:.NcDplastic DISCa60For palliath-e trealmenl ofl k,.lasand lymphoma In aduh. and at.ule kulr.cof children.Olhcr,undltAdtC'u.. nll,,1 ),1 •• IIlll»e, ulcerative ..:(\Iltl r('Klo".1 ilMds. podiatric disorders(bunllh undn .lft-k~1 durum, hallux d lu 1)1 1IIIIuinii varus )disordersr(qUlrhl.1 ut)j,I"'Iundlval inj«tion.((ltll"ulfTuhl, I'ClII,1 I~,,,toddy r: I.n('ph"'ll .11"I.hnlll~ yndrome.prlmaryut IllIhl.,y .11 IU"'IIIII Iln'l,IIIIIC'nctmaybC"lr Itilwllhf)cx.agiobcsterileaqU( •• U_I " ••.,Ihlll hllul..thc:'luwlemmlc:d __Ith mlneralocortkoid.

'llil1uc un I00 Ins r(~I"lrmmIS arc-variable Ind muM M In,llvk.lul1lll 11m Ih •. h" I ut Ihespedfi dl, &c,the severity of the condilion I.ullh •• r POIIII(' ~ItIh(' Jl IltnlThe Inilial do e hould be mai.ntained or lu1Iu,lf\1 unili. NI,.,.lthUY rt 1)c1Il~ Isobsctvh.l If. atisfo.ctory clinical respon.t dl nul IH,;(ur ",ntr '" I .'41nuhlt 11(:rofliltlC'lt ",Immt with ~x:aglobe. su'pt'nrJou hcmkl hr dlMOIIllnufd 6I,1\(1 nlheaplwoprl.1 IhC'rapy InitiatedSf, em ~ "dJl11Jlb~ (or systemic Ihchll'Y .llulmuU I 11I11I••lul wllh I 101.in mo ondllj4wlC nd repeated as net I YAdmlnl II I un I hyd«p intramuscular (1M) IIIJ dhttlln Ihf lult: II IIIUUDo g( IkJ fr ItUrtl\,:yofadministralKUl will c"l 11.1,1" Ih \: rlly nj II ".IUcondltl ••fl nd Ih Il\crapeutk rapon'CIn. v tlJl" Ul.hllSlupuserythem.llt ,>I III! lulltnl ••" ""hl..h".hrc,ol~ t ht I'Pfl'I'tiate lire -saving prc NUl I I nil nil n t I '1"\ I IlIltllllyA wide ~ ,klY II' lItrmatoJogiccondllklll " l"IIn.1 If' 1M Inlf' 111,,\1C"

eoeucosterords An 1M Injection of t ml, Ilf' ted according 10 the respon of thecondition, hu been found to be effecuveIn ~'Plratory trKt dilOrders, onset of rdl , 1)(I)'mptoms hIS occur within a fewhoul'1llficr 1M injection of Dexaglobe eu rc:u.1onEffective control of symptoms with 1-1 mlill ,lbtalncd in bronchial asthma, hay fever,allergic bronchitIS and allergic rhinillIn the treatment of the acute or chronk. h~1I II i, excellent results are obtained with I10 1 ml or De:xaglobe suspension, re t 1.1 • n«eaary,Local admjnjgtratioo .Concomitant use oftocal anestheli It I I Iy ntcnsary. If cosdmmlstranon of 1\

kKaJ .ncsthetk is desved, Oexagloht II I II Ion may be mixed (in the syringe) withJ'" or 1'" proalne hydrochloride or 11I1.k.•llIt, using formulations which do notcentalne I'M l)ml. Similar local ane I"rll\ uuybe also used. Anesthetics containingmethyl pftr.btn , propyl rar.htn ,I,h nl,l rtc should be avoided. .The required doseofl)uagJobt ."_,,c·II,llttll.I"11 wlll__". nlnto the syrtnge , the local anesthetics isthen drawn In and the ,yrlngt _ .hllkell 1,,1 flyIn acute subdelrold .subacromla! , Olt'ftllli'il ntl jlr<,paltllar brutltfs , an tntrabursalinjection of t 101 ml or Dexaglobt II I II I"" III"" telleve pain and r lun'lullrange of movement within a rew hnur, ( IIIIUIII hllr ills maybe Irf.llrt! willi r de fd ge once ecute .ymjltoln. I.re COl111 II .1 III I, ute I(oOl)'nO\'III., lentUnll1 n.1rrrlkll(llnlll ,on III' ,tltm nllku '~Il "'f'cllwnn should alkvl.tc the conlJlUollIn ,h(c.nl~ 11'"11 .,1111 wll.lltlun, II,ullybt: necessery to repeat the inje:ctionsasthe •••111;111' UttldllUtn requue loll~I"'IO' I() 1 ml inlra ocular administration of(~u&Jobc I pen IonRelje( of pain. soreness and stiffn", t II wllh .tll"mll tUid ,lrth •.•ll andosteoarthtrtus may be apcrierk.:oJ Ihltl t t I., f,.uI huul IJuI.lhm (II rth f,which varies widely in both dlsca& tt ftlUl l" IIIlIlf wt'd.t; In the 1Il.lluruyof cases.An intra-articular injection ot De I.~. "I II "n I 'oWllloiel It'd In the joint andperiarticular tissue. Recommended II" f ,,1111, rtl~ular In,t<<tlon are large joints0'"«. hip. shoulder) 1-1 mi. mr.-lllIl!! J.,el.1 ( 11~lw. wrist. ankLe) 0.5-1 ml, smalljoints (foot. hand. chest I O_l~ o.t 1111Dc:rmatologic condlllof\J m.iy rC-'llItlM.iIII hll' II lun.-I administration ofOex:aglobrsuspension. Re 1H.)Il 1.1 lint· II \1111 ,,,,II. ".1 dlr(ctly may be due to s1lghlsystemIC effftl (II till lhlll(. 1"I"If I _1,111.•1111 CIIIIIII, 1111intradermal dosage of0.1 mil 1,;11I2nlll •• t(II'lo .11 I' "I,m III) IlIlr, led with a tuberculin syringeand 16 HuaKt lIr ,II, 1." "111111 11,1. ,I lit j"",I",muunt ofDcxaglobc suspensionIn'C·1 d 1\1.11'Iff I,,, W ~ 1".ul,1 It! I II I 11I1l"ltugluNo u I't''' l'IIIIU04yh. II tl" el Iyhltll~)rdtrsorthefoollhatarerespon ive IU (WI I c~1 u Itl 1\1" III ",I 'Irllttn~ durum may be controlled withtwo UCC($WVfInJ«tI('». o( O.lt 1111 j,In ~m conditions uch uHallu II •• III vi ," tocand acute gcuty arthrttls ,OO\oe:t o( rchef may be rapid. A lul I'U,) ,1111 wllh" l~ ltUi1Jgt' n("'((llt' II sultabkfor m<MllnJ«IIOfU rc ommendcd ~ I h.l. flu' 1~lll••~I", ••lcl,. IIUf \Nt' 11.:burlnl undO' heloma durum or mull I, ,"11 hill ill .11111I ~ killM"" 1 puro.~ml.hur&ltlloverhalluxrigiduao Uti b , III II flV ululll \1!1tof 11\ml.6YflOvlalq·10.lS o·Sml.fT\I.Mltlh r.'''l,il ("'I~I' Ifll In, 0. tnl,I(oo.ynovitllo.sml,periosititisof(ul I •• 1\.1 It ,ut 111111111 (l~ I

ml .After (avorable response is obtall .1 ,Ic ,'h'l In.niln hnHt.lI)fdd rmlned by d~aslng the initial dl 1111"1 II II '11\" 'I I I I IIulIntervals until the lowest dose which ""11I1I1.I11I1i,lo .-'IIA~I 'III II ,lIn I, I " IdeterminedExpo~urC'oflheJlIII JIlin .Ire: ful situ 114111unrdated to Ihe f.hlll'lllli1Il.'yn .r.~1t IrlwllIll dill. nr'lrXIIKlobcsuspcnsion.ifthechuKllhllu111- 1111111111.II UII Inu.. I 1111lilt I I'V, lhe do" should be decreased graduilll,.

• ('unlu lilt tllunAswlthtllh •.rlUlIi Ii" 111 •• I."with s)'5lcmlc lUll': 1111' II I 111 11

diproplonale, bctlmclh 'tl' Ithlluml'oo"'I'OC1(nl uf ,hi. pt\Xlul)cJt;:IJ(luhc au J'C'nainnI "'It In Ilot .11", nl.ttfCd intramuscularly to patients witht.J101 Ihl thf(},"bck.yll~nlc f>\lf)'"f"PU'&O'PC)i Ny ••• ", MQlhco £tdl.h·00 not .dmlnlster Injections prot'( wllh benzyl alcohol to prem~lure Infantneonatts, infants bel W 13 yelrs, prfltl HIwomen or nursing mother 8(07ylalcohol has been usoaated wilh KtlUljt adverse events &- death. particularly It\pediatric paUenu (It may cause Ga I'illf( 'yndrome~ Injections prescrvative freeshould lx uRd In Ihese popubtlom

• WanllO£fA< Pn:cautions .lhl. produd contains benzyl alcohol whl~ h Is potentially toxk when adlUlnlsleredkxlllly to lltural" ue.lhe ufl;p~n Ion it not for Intravenou 01 .lIlt\. ulancous useCOOlpli .illoll. of cortkosteroidthe:rnI'Y I \I"flablc according to dosage anddurftll'lIl uftrt'lIlm('nt The btndlu Inti II L. .hollid hf' evaluated ror ('tIch CI f11I4,lI~j~IIltllly

·,h lull Ilf,II"· ncss ofbetamethuon4 IIk(' aU glucocorticoids. is achleVCtI ailcrr I huUt CKI..Un, the preparation hlmltl not be administered In hfe- thrfillening

IUIAIII,n,j.. thmatk dlsorder.k If lIt'rglC ~actions) unless anOilwot Irt'atmentwllh 1II1IIIuh It' a(.l/on ls considfrtd.Up"",. 11 r "'e'fal Ule of oottkosteroid. ~ U' hy~sensilivity reacUoos. u h1~)fI.1 t " ••. bronchospasm and 1.1 llllyt (.lit: shock mayoccurin rare (

I ul",,1 fly In II li(ntJ With aJJergicdl !tw-I! ,rg:bronchiaJ althlN oralLeray (0

some medJ. 1,111)11W(' IOU t 'Iherefcre ensure the .v.~1 hllily of emfrgC'ncy treatment(epiufphrillt, 11I1t"~I"I1I1U nulda. resuscitation).In ca 11' Ih lilt ~11"h hiAI. Ihma , theadmloislAllfln lit Ilo:aglobc II onlymad/un II II 1IIIfili .,.,hl~h don not rcplacecOtwffll6Quai tMnpy.1t I notedvi t~ hi ,lnlllll.1 I .IU\lk(tI'ticoid, in case of re I"r lory diseases withoutcOIl1I'"~ Ilul\Cor1I u I ,11.lth. nil,. In ••y use psychic disturb.n..: manlfested as euphoria[nlOft II II ".1 1111"'11,11111I&(,severe dq>reuion IHid 10 pi)\:.hologica.J manifestationsm.y.~~111 ( 11111.I' Itllll.1 molYIncrease psychic lability or p ycboUc tendencies thatalr.I,ly"11

IlIlt"t adminbtratlon ofchollnesterase Inhibitors as'I • Inhibit IS reduced which increases the risk of

·1nJcr«loil wllh !llher JIIcdlc;i'w.alLiuildiw.uCOOCUH lit \I .,11'11.-111,1 Ihlt I. filampin • phenYhlln '" fJlhedrlnc mayenhtn~ •. t.11( III II 11"11'1,1111I hlill III , thus r ucin81hfl l'Cull( tffeels . ExcessivecorliLc"'trrul.1 fli I III Y,~q"r In patients rcct:ivinK hulh • (orlic(){teroid and",Nit 11C~lIhllll III" 1.t(urlll.O$lcroids\\<ithjX>t .••"um dcpleungdiureticsmay CI1 ••••••••. hyl''''~'' 1111 (fmc:urrcnt use of coru'f_lc:ruIJ and cardiac glycoskle:smay fnh III r III I'" 11'lllIy tll .rrhythmias or diSh II h;,l..lly .uaodated withhypuk.l1c1l1L1 C 'ttll " I"'MII m.y enhance e poc.a IU1I1 d('rkuon auSt:dbY'OIl'''t,1 tl 111JI t "'1\ 1111 nt u of cort trold with wumarin - type

"' koagulants may increase or decrease the anticoagulant effects , possibly requiring'~UJtment in dosage. Combined effects of non- icosteroidal anti.inRammatory

dr g. or alcohol with gJucocorticoids may result in an increased occurrence orIn reased SC"o'crilyof gastrointestinal ulcera lion. Cortiro erolds may decreaseblnod salicylarC' concentrations. When corticosterotds arc given to diabetes. dosageIJustmenl5 of the antidiabetic drug may be neatsary

Coocomltant glucocorticoids therapy may inhibit the response to scmatotrophin.

• ONe L laboratory tat interactions'OttUC051eroids may affect the nnroblue tetrazollem test for bacteria infection andproduce false -neganve results

• dver e ffTbe edverse t'ft~I' depend cn strengrh, mode of adtnintstranon and durati.on ofIrclllment,llge.!tCx of the pafknl and the disease be:lng treated.'·(lr short term treatment: the risk of adverse effecrs Is minimal .It should be howeverlU eldered that intestinal bleeding (often caused by stress) can be psychosomaticduring treatment with corncosteroids. -It. "Ii ofllrolongcd treatment with high doses Le, If the Cushing threshold dose (>1"' hflllnlflhu(Jne per day) Is exceeded. the known sidC':effect! of ccrttcosteeotdsoccurHOld and dcclrolytC Imbalance

ium and water retention. potassium and calcium depletion, hypoblemiclkalosi,. hypophosphatemia .hypertension, con esnve beast failure in susceptibleI' !lents.Mu.'" ulOlkcktal disordmMu"le weakness. myoatrophy. Ste:roidmyopathy. OIlcopomsis (especially inIII Imencpausal women). aseptic bone necrosis, ~atcbral compression fractures,1, .•lhvlog"al bone fractures.,ut olnlCluoal disorderst 1,,1••.,. nausea, gastric ulcer with possible: perforatlon and bleeding, perforation o(

III malllntesttne and colon, especially In patients wlth Inflammatory bowel disease,1~111I'llnal distension, pancreatitis, ukerative esophagitis.

1 h IUlJt.oJg,lcal djsgrdlTSI. I.yt'd wound healing. petechiae and ecchymoses, (Ace lve sweating. (ada!1111hlill and hot fl •• he, (flushing). hypo-or hype:rpI8melltlltion. ,kin atrophy with11M. hed marks,l"h"muKul ar administration repeatedly (and mira rtkular and sub-lesicnal)I •••methasone (or other gJucocorticold) can cause eve-e local tissue damage (up to"""I,h)" ilnlJ n«rosis).III lIunoloe'CI' d1wtts

I' •., II) oqati\'e effut on the number and function o( lymphocy1es, increased11,.1 rl.ubdlty to Infection. masking orinfcctioru, dtc:rt:ascd or lack of ruponseII' kill I ling. activation oflatcnt function suscfl"lbtlity 10 infection. maskingf,llnl lions. d«reued or abstnt response to skin tHOng. activation oflalcntIII Ihlnl. opportunistic inft:etions. hypersensitiVlIY reactions. in rare cases up toI l'hyl.I tic reactions with hypotension. circulatory collapse and lor bronchospasm.,Iv 1 ((ACtIOns when applied intralcsional and InlrasyncMal outbreak of Joint

Il1ft.mmiition charcot arthropathy. inrection at the Injection site after non sterile:11I~f1lionequipment.

ululoiIWDlao.n1w( IWIlI 11111'" ell"I1lt'. ,hc"d."h ,I'llr ated hltl'l\c""nlal pressure with papillarycdClIlJ

Psychiatric dlsorutuEuphoria. Insomnia, mtMHI ,h.nK • pcor50nality chanSf . worstning of affectivedl rders and psychotic temicf\\,:y ult tu lIIanlf(SI psychosis. KVtfe depression.l:.ndocrjn( di§QnkrsM nslrual irregularities. development of u hin id appearance; stunted growth inchildren, adrenocortical insufficiency and pituitary Iide. cspcdally in cases of strc5Sdut to trauma. reduced carbohydrate tolerance. manlfestltions or latent diabetesmtllllUs.OpblbalmoJops;a1 diwUtmp, IcriOt subcapsular cataracts.elevated intraocul., pressure. glaucoma.ell phthalmos, isolated. cases of blindness after lnlraleslona! application in the faceIJlIJ had.OJuod and yucylar dj$QrdmI.eukocytosis.lympbopenia. eosinopenia. thromboembolism.M lAboJi'djsordersN live nitrogen balance due to protein cataboli m, lipomatosis, wtight gain,In rcascd appelite.OthwMyocardial rupture ailer acute myocardialln(arction

• IIDi"-SI()f'( at lemperalure not exccutlng 30·CK P out of reach of Children.fKk.;(' lion box containing 1ampoule of 1ml & inscrtlc.Oct..

Manufactured By:Sunny PharmaceotkalPacked by: Marcyr! Phannaceutical Industries

!of: Marcyrl Phannaceutical Indosln••EI Obour CIty-Egypl