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Simvastatin 10m9 _ › ,
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Simvastatin 10m9
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…cuuuum' uicmyéuu wuaièum'uieu
KẾỂỄN CÁO:
- Trùhulhmylden.
- nủuycuumtheoqummuyade.
ỄẨ qudnsummmam
- mmumwýuh uu.
IÃOQUÀN:
Tmboobikh,ưhlliùủụùuơikbỏnhiũlđòùlúũữũ
moùnc:aemxèmwm…h
u£u cuukm USP 30.
còncưmuu or summnc nu:woo
MUy:SỒIJ.MOA.KCNĐhHùLDMMVÙM
thM;sk7.Lhì.ĩhbkl—TuúimmMnl IS.Q. II.Tp HCM
Fuz(Ol) 222506I1 W sz.m
"n.
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Anfihyperchnlcsterolemia and nntihyperlipidemỉa agents
SIMTEROL Film cnated tablet
' . Simvastatin lũ mg ~
CÙMFĐSITJỦN DRUG INTERA'ỮIIÙNS
- Ac.ffve ÍngứfÍffl'í: Simuslntin ..................................... 10 mg.
- Ẹm’prem: MinumystnUỉm; ceLlulus: PH 101, lactnse, Jưw substirutcd
]rydroqpropyl ' cclluttms, sndium staJc]l glywlam, pưvidom K30,
magncsỉmn smmte, sudíum lamyl sulfarc, usnorbic um'd.
huự!hyđmxfflnlucne, Op:drỵ 03862&59 Yellnw, Camzmbu wax.
DĐGÀGE FDHI\I: Film cũutaì Lable't
HDWSLJFPLIED: Bua ur] blisters x lũtahlem.
WDICJLTIGNS
— Treth 01” primaly liypcrchnleslumlacmia: hntcmzyguus i'amLHal
hypamhuicstemlazmiu. cư tuixcd dstlpldnmúa.
— Trealmmt nílmmmzygnus Eunitỉffl hypemhulestanlnccrn'm
— For cmdiuvasmlm risk reduzríun inhight-risk pnlimnẸ such us Umse wiứu
allLefùsclnmtic caudinvasquurdủease nr diabeles chiilus.
DDSAGE J\NIJ ADMINISTHATIDN
— .Fửprrcủdaưrơl'mnưea;
+ TlLe ma] slaming duse ís 10— 10 mgIdnỵ.
+ Patỉmm who require a large mduc1ìnm ĩn cholestm-uì. the usuu1 srani:ự
dns: in đũmgfrluy.
— Hnmoạgowfamflíaf Fụpuư-cùnl'eưeroỉa'enn'n: 40 mgfdạr nr EU mgf'day in
3 djw'dud duses of2tl mg. m mg, and an wcning dns: nl'4ử mg.
— Cm'dì'ưmscufnr rka ma’uch'm: 2ủ— nm mjđnỵ.
-'RennI f'fflpđữỉdefư.“ In palients with severe n:nal ilrlzi'uEEí'uciurmạI [:.-mutin'me
clearance c El] mb'nu'nJ, đm Jubuưe 10 nựday shqud be cumiùlìy
cụnsidered.
'Hư eĩderùa- Nu :[fflge udjưstmmt is ncoessmu
- Chửrừen am“ ưdufemanLr (Hỉ - H years nfage): hetanzyguus lìưm'lial
hyự:dmleammlaemím IUmgưday, ứu: mm'cimmn re:ũrumcndetl dusẸ is
an mgfday. -
*Mưe:
- Single :Insn in lhe :ưmỉng.
- Mjusm:ms ofdosngẹ. If'requimi. shqud tu: mađe at inmrvals uf'nnt [ess
than 4 Wuulm. lua ruaximum ul`Đù mgfday.
ỦONI'HÀIN'IẾIICÀ'I'IIJNS
— Iừperseusiriviư lù simvaslat'Ln nrtu :my ùnnpcmmts ot`thu drug.
- Aclive Hvư diseaa: ur lmuxplaineđ pmistent Elcvatĩuus uf sưum
transmninms. —
PRECÀUTIOHS
— Simvastatin mưionally cuust nưnpndự manifcstod as muscta puin,
weaknaa will]: iuaned m.ntinc b:Lnase {CK}; ur rhubdomwlỵsis with ur
willmuf. ecule mua] fflilun: sncmdary. Camíon shnqu he paid to patỉeuls
m'li1 hiẸ: rỉst ơi” myưpuĩiw {agcd } 65 Jurs, lfflủJ ;irnpailmmt.
unountmllud hypnfflymiđism, m, …} or unduguỉng uH-mr medimtiuns
which imrcasu [he simvastatin lwcls [la 111: p1asma. ClinicaJ muniiming
is recmnmcnded and simvastatin metapy shuu1d be diwominuul ifmere
is any sign of myupalùy nr 1hahdnmynlysfs.
— ]: is rucmnmendẹd that lĩwsr fimctinn tcm be pccntbrmed hcfure and
"TJbel’fflũur mẹ simwstalin ùmpy. esụ. nt a hígh dusc, :ests slwulđ be
perfunmd I'm- lhe filSt ạreaư uf'lmanneur. Use wiffl tauticm in patỉcnts whu
oom-umu subsìantinl quantitins ufalmhol. IflEle Lrunaaminas: tm]s rủ:
nhom 3 lỉm:s the uppư limit nf` normal, simvaslatin should h:
disnwlĩnued.
- Simvastatin. may cause 'mtmlirial luuỂ dfsease, mpccially with Iung mm
Ihcrapy. Symplmns can include dyspmca. non pruductivr. chh. Ifa
patĩcnt iltas dmlnped inlmtilial Il.uự disease, smu'n ũm-upy sthuld be
disuuntủiuecl.
- This pmđuct nmmỉns lamse. PaL'mms wirh gaJamose Intutcmnce, Lapp
Jactase defmimqr ur glucwe-gatmamsợ uuaLabsuqutĩunshuuld nm tai:: mỉa
mcdicínn
UGE DUHING I'REGNÀNCYAND NƯRSINI] MỪI'HERS
— Safety in pregnmmt aml:len hus nm baun estab]ishxd. Eecmnsn ui” Uue
poteutUal fqr seriaus adveme rcmions, du nut us: Ih1's dmg in xmmen
whn mpưgmantor u-y-iag m beuumc pregnunt.
- it is not knme aùdl1cr simvmutfn or irs mmbutỉta m em-md in
human milk. Because of me panũl I'm sen'ous udmme rnaqỉuns,
wurnen taking Sirnfustalin should nn: hmut-fced If.u:ir infaJus.
EFFECTS DN ABILI'I'Y TỦ DRIV'E AND USE MACIILN'ES
Simvaslalin has nu ur nngl'gĩbln ỉ-nflum nn the t:luilỉt_ụl tn :fJ'in: and us:
madl.ỉmss. Houever, when dn'w'ng vehichs ur operaling machỉnca, dízzĩ.nm
muy unmlr. -
“ ỂỆ
Tel :cu_s1 zzzsoas:
— Po.fưnl CI’F3AJ ủthfbifflrS f'ưs tĩfrachmufe, ữm'ơcmmíe. pumeWùL
ffl'l'ảf'Mgư'ửf, c!ưrfthromyứm Iefflhronựcin. HIV pmfmư inùĩửJ'ừm.
genự'xủroazíị tjr'CÍĐựửfflư. đumzn...Ẹr ÌI1EIEặSB Ihe simvastnliu lwu]s ín
plasma, n:null :in high r.isk ol' m)'ElpũlhỷhflẽlhđũĩllựllĩEiì ConLraindiuaTed
with simmlat'ua.
— Amfưỉmmm. vơrqmml'. đr'ửfazem: 1.he duse of Simvastatin should Im:
cxpwd lũ mge'day.
— Amỉqdịufne, Jú-nuủzín: the dm uf' Sĩmwstalin should nnt moed %
mgf'day.
— Ợmĩ mrímngm'antr ửtỉlrrmmữj: ]ng1dy incremd prơltưumhủ Iime.
mehmmlzn'n times shqud hc moniturcd during car]ự themer EI'
nuncum.iùmt ndmỉsLmtiun Mlh simvastatin
S]IIE EFFECTS
' Thu: comnmunm. side ect't'm of Ilmrquy wj1h simvastalln m1d ủther ml:ins
am ga.;tminhm'rinal disurdcra.
* Úthcrsidznf'fccts include:
- Hcadache, skin rashcs. dĩzzulness. bhưreui vủiun. imumnim dysgmsỉa.
— Rumsihl: incrensns in semm-mninotmnsủse mr:mtaĩimm mzu.r uccur
… ]iựer fuuntiun stumtd bu mĩmrcd.
- Hcpatitis and pancrfflù'u's have bum rcporte:L
- Hypnrsensiliw'ty reachnạ including anaphyìuis and angiocdema hm-u
:1lma uccurreủ.
- Myupallự. chazacteưisffl b} nưania cmm'ne phuữphùkinás:
comr.nrraIiuna has been repm1ed, upẹuialily in patienls also lakin
cEcJuspun'n. ũbn'n Ecỉd dm'mnủg or niuuliuic uzzid.
— Rm'ely, rhabdumyolỵsis wilh mm rena! fiu'iure maydưw]up.
JPỊfiJM đMM lv1'Iữịíđư ffl'ecừ wử'm using mdene.
I'HARMủCỦDYNÀMIC PRỦI'ER'HES
- Ưtcr uml Lngcsticrn, ' ' which is acn ỉnaũivc lulune. is
hdequ in liu: liver n: thu mmspundỉng ncliưc bela-hydruxpacíad fmm
which has a pntrznt activity in inhi'uiting ]]MG-CũA redudasc [3 hydmw
—-3 mcthyìgJutmyl CoA ruductnscj. This ertqrmccatnlym :ha conw.uĩnn
uf HMG—Coả to mưalunate, an carly and rale-limĩting step in the
biusynĩhffls cfflchffleslurol.
Simu1aalatin hus boen shuwn m ledum: but]: nnrmal and nlcvaìed LDLC
cnnumtm_tinns. T..DL is fimmd ửum wự-[uw-dcnsiijf III'DEẸÍ'Iì [W.DL}.
The mechanism ofĩhu LDL-lmveu-ing et'ìĩzct may involve huth reductiun
uf' mLchnicsteml {VLDL-C) unmentratỉnn and inducticm othc LDL
rweplof, lmdíngtù mduced productimu am] increased cauhulism uí' LDL-
C. ủpnlipupmteùu H afsu I'alE suhstmrLialty during ernưm. ln ỉ-lddĨĩ-"ỈDH,
simmtuĩin nmdm'atcư Encrmcs IIDL-E and mcluces plmnu. TG.
Theredỉurc, Ihemtĩus uf:uial- IED HDL-C and LDL- In HDI.-C arcrcduced.
PHAMIACOKINEI'IC PHDPERTIIÌS
- Abmrpfa'on: Simvastatin 1's mw.Jl uhaoưtle and madergucza extensEx-r;
hcpatỉẹ ĩưsL-puss exlrmtiun. Maxim… pLa5ma ommenlraliun ní' uch'ựo
inhibjlms is lcached approximưtely une: l-2 hum. Fnud đo nmafl'm lh.e
absorptimt.
- MemủaIisinr Simvastatin is 'u suhstmtc nf' CYP3A4. Th: major
mctabolĩlffl ot” simvastatin pmnt in human plasma are Ii1r; befLu-
hydmxyan'nd and fim: additionuI active mctuhnlitee.
- Didn'ủurímu 'I'lte pmin h'mdz'ng ul’sừm-astatin and iLa am'w. mntabutỉte
is 3 95 % Nu mcmnulaliml ufmr:dicinal pmdur.l ucnuned aíler multiple
dùsỉng.
- fflfmínaưmu Following an nmJ duse, IEEE: was exnrnted in ll1c urine and
64% in thu faacea wiưlùì 95 huurs. Fullưwing an 'ưmawmus injoctiml ul'
the ber.n-hydrmqncid meluhulile, iLs ItaIf-[Efè uưraged 1.9 huurs. An
averageuf CIan DJ % of dzr. IV dose Was w:ưmd 'm urine as inhĩhỉtors.
O'HJRDĐSE AND TREA'I'MENI' '
- Tu dam. a ũ:w cases nf wcrdnsagr. have bam rcpmlad; thu mmf.imum
dusc ml-nen mm 3.6 g. All mliems n:nm'elM withuut senquclc.
- Treapnenf: Thure Is m: spocl'fic chatmnì ìu thu event ofm'ửfdủffl In this
muc, mlphnmlic and anuportỉve mcasures Eil'.llĩlllld headuptcd.
REC'Oh—DtI'ENDATIÙH
- Kưp uul uf reach ufchild ren.
~ 'I'his drug is nm! oub~ hy ducmr's prestriplỉon.
— Hmđ mrci'uny th: lnallet beI'nre use.
- Cnn1actỵnurdocfurt'ur ruruưr lnl`ummlinn.
STDMGE: Smre ìn n tfgh: cnnta1'mal, pmtẹcted I'mm 1ỉgjư, n: dự place
lcmmmhưn: qudcr 3U°C.
EXPIRY DATE: 36 munffls i'mm lluJ mimufactun'llg :IaIn
SPECIFICATỈIJN: USP Ẻl-ũ.
summonr. nanwno PEARMA. c…, uu.
Fucam: Ne. I3 - Srreet % ElỉenHua Industriut Zune Nn. 2, Dongmu' FrmríJme, Wu Nnm '
Đfflce: Rmm s & 1 Floùt 9“, T… lu_ Ewn'uh Elul'ldùtg, … smum, Ward 15, DJ'sL 11, Ho Chi Minh cu;
Fax: (08) 22250632
Email :sl1.ùìpúung@gpd.ùamffl
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