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MẨU NHÃN THUỐC
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Ngây 28111I2012
CTY TNHH DP SHINPOONG DAEWOO
/_M
h : Ioét dạ dây, tá trâng
11 uốngVAROGEL
\“!!! 1r› '! \ `
mAnnrnAmmõuono … ›… ế
- Hulchlt: o
( Nhộmhyđroidđ gel ................. 4. 03² ............................................ tương đương 0,4gNhõmoxid.
Mngneei hydroxiđ 30% pute …..UỒAJJ..ỆỔ ................................ tương đương o.soo4 g Magnesi hydroxid.
Simethicon 30% _ ' ' _ V tương đương 0,08 g Simethicon.
~ Tú m: Dung dceh D—Sorhntoi 70%. Xthan gum. xylítoL cm Giycylrhin. poviđon K30, Avicel S91, Stevion 1005, elorhexiđin aeeủt. mah thvnr.
peppemiint fluor. cthml, nước tinh khiết.
, , . .
' J.… 1’ tu… AJ.U…J a uĩWI . n. .. .4 nư1… ư_… '… ụn.flhh1hypớtzủrit, natri methylpuuheu.naùìpropyl
pưaben, nctđ benwm, hmnopol. polyethylen glyco sorbitzn In'stennt. methylceliulose, đimethyl silom, hyđnoxyl-tuminnteđ, polyethylcn glycol
stenrnt, siyca'idec. c14-18. mono- vi di-, nước tinh khiết.
n BÀOCHẺ:Hỗnđịchuồng
ouycAcunoNccónzoới 1o…1.. Hộp20gói.
c…nmn
- vtanioetdatiay—nunnzdọmontinh.
- Triệu chửng tingtiết ncid da đây (nỏng m, o chua ...), hội chửnsđc dửy kich thich,
- T1ionswcdadùy—thucqqiu-
utu LƯỢNG vA cAcn DUNG
I) Viêmloéldợdùji—tátrủưgdleơlthlừNgưừilớl:lOmL(igới)XZ—GWỵ
2) 7Hệnắlubngthigtiếtacn'ddadảưnónsrút.ợdma.J.hoiduhngdợdảyuchdnidtnùowdaday-rhưcquánmguờiiớn:10m1.(1g61)x2-4
n y.
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cuờuccnimnn
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- Bệnhnhtnsuythinnáng.
- Bệnhnhìngíim phosphatmủư
- Bộnhnhintlngmpmimiu. V'
._Trenhớ.dsebietờuehiniãtnuờchaynehisuythan. ị,
sưnụucmẠnnọnc /
- stitiung ' Iiếulượngvùdchdủng.
- Nếuuu2 eủcưiệuchứngkhõngcâiđtiếnthlphảibỏỉýkiếnbécsthoộcđượcsĩ.
- Khỏngđùngquáớgớilngùymùkhỏngcóchiđinhcùbtcsĩ.
- mnmsờnguờibímytimums mythtn.phù.xomohédounựivtivớinguờimớihidnymtuduờngtieuhớn.
- Nguờicaohtòi,dohenhtithoccớo `uniủuếc.oótbếbitáobónviphhrhdnthảnưongvếtưongtáethuỏc.
-_Kiếmtnđịnhkỳnđngđộphmphattmngquáninhđiếunílâuđii
sưnụncờmunơcónvacnocou nú
… Nhinchungcủcthuốcnntaciđửợccoilimtoimmiễnlâkhõngđủ 16nthiivờiièuuo.Đtoớủghnttcdusphunhuthtghougiimmngtesi
mhu,tingplúnxagânờbâotinivùưèwsủhkhinguờimeđùng maguỉantaciđliu 'ũchlếthvớiliếnem
- Chumii_iệunơoghinhenucdunspbucuathuóc,tuythuôcootiniưừqmsuuhtmgchunu glyũcùlHihlehnưếembủsữnme.
sừnụncơmtm
Chưaeỏtâiũèundìiếneừu
TÁC none LÊNKHẮNẮNG LẢIXEVÀ VẬNHÀNHMÁY MỎC
VưogelkhđngảnhhướnglênkhâninglảixevâVinhânhmáymóc
TƯỢNGTẢCtHUÔC _
Dùng chung với etc thuếc temeyclin. đigoxin. ìndomcthlcin, muối &. isoniniđ, alloptưinoi, benzodimepin, eotticoetetoiđ, penicilamin, phenothiazin.
nỉitiđinc. Im…l. iưnconuol, có thế lùn giiln hếp thu củc thuốc niy. Cẩn uống các thuốc nùy cách xathuóc Vlrogcl.
T cnụncmụ
VungelnỏichunngngeớtícùmuphutbbớnhlytiếuehIăìdiớlưphũhơphlihùnp'hnhùnvlmgưmihyđroxiđ.
- Msuọzrsobonchumiencdmzbtmephlnríuu nen.nỏmphhưinc
. cn… mủđlxiyrlkhiđùngthuồckếodiihoưiiếum.Ngộ®cnhđn.nhnybnmgcớthếxáynớnguờibệnheớhộichửngưếmineno.
~ Nhuy xương.bếnhnic.unitưituộvủthiếumiuhđngclunhỏđlxlynớWIlylủìmưltluhđủngnhômhyđmxidlùmũcnhângâyđinhkết
ph….
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nươcnựcnọc
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vị.giủphóugcủcnioneỏtđcđungưunghònưiđđađùy.hoơclimchkđùnchoniđùthy.nhmkhđngtteđộngđếnsưủủhndủùffl.
Th…u…giimuiưchứngưngnciớti;ay.giamaoncidmgthựcgùvưntmhémmnenntuiauumwdazmdmdytùgn
trongờngườibếnhloẻtdnđiy.Mnguelihyủoxiđeỏneótâcdungnhulnn-hgnếnlủngiinũcđuncủyttobđneuhnhđmhyùexii
- Simethiconllmộtdthkhửkhlkhớngcớhếthónznỏlhnthyđồinteehcbếnldldebđnshniưnuhếtihlhớtthhnngbđukhlủmdin
…houuthopwvnhinnyớuooiooihớaannqunuờhoihoumtien
oượcnoucnọc
- Nhớ…hyớnxidtmohAmtmngduayvùphnhnngvớitciuhyamionedmunhnuuctonavinuớc.m11-mnmtncuiduom
đượchđpthuvinhmhchỏngthiiưừqmđtlnờbếnhnhlncóchứcnlngđlhhhhtủờng
~ Mnmu'hyđmxiđnhmhchớngphlnửngvớioeiđhyửoeloricđếtoothhthgnúda-iđvùwớe.MIS-JOSSMMMMMW
htpthuvmnnhdtonguniuuqmmnớuhnnghenhuhhooohớcunnunhhhthuờu
- Sin…hioonitiohAtuovèmợtninhiýhoc.nókhcngbihApthuquomnuhouhuyummnớnunhoiddudiyhywhbthudcohhainh
đuờng.Slukhiuđng.thubeWthliưửớdonskhbnđếiưongphln
QUẢ utu vA xử TRI
Cỏcuiệuchửngqúliếubmgớmbuđnnớn,nôn.kichthlehtiếnhđqtiđueiiylttobùtDiếntn'trủeủngvihõw.
muvtucAo
- Đhntếnnyưèen.
- ĐỂ hướnụilnuuunntuớnhiớờng,
. N anthhgđl.lhhỏlýlđếibket
BÃOQUẢN:ngMbIWớMiRMutnhtnhung.nhiộtdôùrớiJO'C
HẠN DÙNG: 36 tiuin; kế từ nm … xuỉt.
ntucnuAmrccs.
CÓNG TY TNHH nv snnưPoom DAEWOO
Nhìnấy:SốlB.ĐườngĐAKCNBỏếnl-WLDMNẢVẺM ';
Vlnphòng:PhòngO5-07.Tấng9.TNplLĩhfflEvưicủnếfflMW,PJS.QJ . `
ĐT; (08) 22250683 Flat: (00) W Ennỉl: meu
JVfflWW
For peptic ulcer therapy
VAROGEL Suspension
COMPOSITION: Each pack of 10 mL conm'm:
- Acthe-c'agredlent:
Aiuminum hyđmxíde gel .. vu]
....... equl cnt to 0.40 8 ofAhuninum oxide
Mopmium hyđmxide 30% paste ...................................................... equivalent to 0 8004 1; of Mogaesíum hydroxide `
Simethicone 30% emulsion equivalent to 0.08 1; of Simethicone
- Eưlplmn: D-sorhitol solution 70%. Xnnlhan gum, xyiitol, glycyrrhiza extnet, povidone K30, Avicel 591. 5th 1005 chlorhexiđine neetzte, mall
thvot,I peppemint tlavor, ethanol, pun'ũed wetet
…: — ` . .. 'u: Sodium h hlori'le. sodium muh
sodium prđpyl paraben benzbic acid. bmnopol. polyelhylene glycol sorbllan lrislearate L ’ " ’ yPLDC' hydrm,I Iyỉl'patmben.
po/yelhylene glycol stearale. glycer1des. CI4-I8. mnno—anddi, purified woler I
DOSAGE FORM: On! suspension.
HOW SUPPLIED: Pack of lo mL. Box of 20 Pncks.
INDICA'I'IONS
… Acute and chronic gasưic und duodenal ulcer.
- Symptoms of guưic hypenciđity( bum, sour vomiting, ...), stimulateđ gastrointeitínnl syndrome.
~ Gastmcsophngeul refiux đisease.
DOSAGE AND ADMINISTRATION
l) Acute and dlromc gasln'c andduademl u/ccr: Ađults: l0 mL ([ pack) * 2— 4 n'malđay.
2) Symptoms ofgaslric hypemcidiiy( bum. sour ` ’ _, g…… '3yndmme; g...… , L g ' rejìux " Ađulu: lOmL ( !
pack) x 2— 4 timeslday.
Tnke đrug between male or afier meal lbout 30 minutes to 2 hours. at beđ time or whenevet symptoms oceur.
CONTRAINDICATION
- Hypcrsensitivity to any component of ihc drug.
- Patients with scvere ten:! dysfunction
- Putiems with hypophoeplntcmia.
- Patients with hypomagmsaemia
— Chíiđren, especially with dehyđnm'on or renzl faiiurc
PRECAUTlON
- Keep the recommended docage lnd administration.
- 11“ no impmvement ofsymptoms appears in 2 weeks, eonsuits with a physicians or a pharmacist.
- Do not administet more dum 60ml in a đay without physician’s prcsctiption.
- Use with cnution for patients with eongesn'vc henrt fnilum, tennl failure, edcma, cinhosis, mđ lơw sodimn dieu. and pntients recently sutfered from
gusưointestinal hemoưhege.
- Eidetly, đuc to đisense anđlov đrug thempy, mny be ptedispoecđ to constipotion and fecal ' ' ' Carefui . ' ' of, '“ đnlg '
must be done
Monitor phosphoms level: periodicnlly when pdíent is on ehmm'e tbcnpy
USB [N PREGNANCY AND BREAST FEEDING
- Antnciđs uc generally oonsidered safe as long n: clưonic doses are avoiđecL There have been repotts of antaciđs causing such ndverse effects as
hypomaguesemin, hypennagtemnia and increaseđ tendon retlexes in fenưes nnd ! or nconatcs whose mothefs were chnonic users of magiesium-
containing untaciđs (especially in high đoscs).
- Problem: in human have not been đoeumemeđ, although some nluminum and magnesitnn may be exereteđ in breast milk; the cơncenưation is not great
enougi to product an efi'ect in the ueonate.
USE IN INFANT
Tbe dosage ofVamgei in childten hns not ban emblished.
EFFECl'S ON ABILITY T0 DRIVE AND USE MACHINES: No cffect
DRUG INTERACI'ION
Concomitnm nđminislntion with tctmcyclinc nntibiotice. đigoxin, indomethacin, fenous uh. isoniaziđ, allopurinol. benzodiazepin. conicocteroiđ.
penicilarnin. phenothiazin, mnitiđinc. ketoconazol, itnconml, may reduce the hbsotption of these đrugs. These ahove drugs should be ỉư nđministeưed
with Vlrogd.
Sle EFFECIS
Vamgel shows less advem effects such as constipation md đianhen by pmpcv míxturc of Aluminium hyđroxiđc md Magnesỉum hyđroxide.
- Common: constipation, chalky taste, stomach cnmpc fecel impaetion, nnusen, vomiting, discoloralion of feces (white speckles).
- Hypophoplntemia may oecur with prolongeđ admùtisừation or large đosee; aiunu'nium iutoxication and osteomalacia may oociư in paticms with wemia.
~ Osteomalzcia and also eneephaiopathy, ^“ and ' , . have in patients with chronic rem] failure who received aluminiuin
hyđmxide ni : phosphnte—binđing agent.
hưann doctor: will: slde ẹơecB when using Mldna.
PHARMACODYNAMIC PROPERTIES
~ Vnrcgel Suspcnsion ư ui amaciđ medication that eontains A1uminium hyứoxiđe Mngnesium hyđroxide nnd Simethicom Aluminium hyLủxkle mđ
Mngnesium hydroxide đíssolvc' … acid gasưic sectetions, relensing nm'ons that ponially neutnlize gutric hyđrochion'đe ucid or bulĩer existing qunntities
of 310th ncid but have no đirect effect on its output This pmviđing reh'es or hypemeidity symptoms. reduce acid eoncentmion within the lumen of
the eosophngus nnd inhibit the proteolytic nction of pepsin, this ciĩect is pamuđưly importh in patient with peptie uiccr diseue. Mngnesỉum nnlaciđ
have : hxative action auđ reduce the mustipating cffects ofaluminium lntacid.
- Simethicone m | non—systemìc gasưic defonm'ng ngent thnt works by nltering the eiastỉcity of interfacee of mucus-embeđđed bubbks … the 61 tmct. Tbe
gas bubbies nre thư: broken down or coalesced and in this form, it is more ensin elimimteđ through emctatỉon Of pessing Mus.
PHARMACOKINETIC PROPERTIFS
- Alumim'um hyđrochloriđc is slowa solubilized … the stonuch md rems with hyđmchluic acid to form nlnminium chlonde and water Ahout 17— 30%
ot'nluminium chlon'đe formed' II absorbed and is npiđly excreted by the kidneys in putients with normal rem] function.
— Magnecium hydrochloriđe is npiđly reocts with hyđmchloric acid to form mngnuium chloride nnđ wnter. About 15— 30% of lluminium chlonde
fonneđ is absotbeđ and“ is rapidly excrcted by the kidneys' … puicnts with normal renal hmction.
- Simethicone is physiờlogienlly inert; it đoes not appeared to be absorbed írom the GI tnct to interfere with gastric sectetion ơr absorption of nuưients
Following oral administrltion, the đrug u excreted unchangeđ in the fcces.
OVERDOSAGE AND TREATM ENT
Symptoms of overdosage include nausen, vomiting, gnsưoinlestinul immion. dianhoea/eonstipation. Trentment should be symptmnatỉc and suppoưive.
RECOMMENDATION
-Kcep out of the mẹh oỤb children.
~ Rnđ cnnfully th luũdýd'ore un.
- For further ìnfornltion, place contnct your đoctor.
STORAGE: Storcfin a tight container, at đry place. protected from light, tcmpennưe below 30 °C.
EXPIRY DATE: 36 mooths from mmufactun'ng đate.
SPECIFICATIQN: Mnnufnctwer.
SHINPOONG DAEWOO PHARMA Co., Ltd.
Q ị Factoty: No. 13 - Sưeet 9A Bien Hoa lnđustriai Zone No. 2, Dongm' Province, Viet Nam
' Office: Room 05 — 07, Fioor 09, Tower Rl. Everrich Building, No. 968 30 Sư., Ward 15, Dist. 11, HCM City
Tel : (08) 22250683 Fax : (08) 2225068² Email : shinpoong@q›d.comyn
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