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SHINCLOP Film cuated tablet
Clupidũgt'el ?5 mg-
[as Clupỉdogrel bisulfate)
CÙMPDSI'I`IÙN
— Ácưưẹ ír1grạn'a'ent Ctupỉdngxel. [as C]ondugtl bisullảtejl ............ ĩỉmg
- Iừcĩỵưepư: Lmư suhslìrumd hyđmxypmpylccìlulosu, Ilnwlac,
cmspưv'cdunm mpwidonn. Lulc, mllaídat silicunc d1'mciủe, magneslum
smang Pin]: Gpaliư ma EDW4-um.
DUS.ILGE FÙRM: Film chnd 1:1th
HDW SUPPLTED: Bum ní'3 b]islem x ID labs.
[.N'DICATIDNS
— vamũun ol' a1llcmũưcrmhuũc events in: Palimu SullỀliJig fmcm
nạmdinl ỉnfarctiun {frum a few days until q; rlaysj, ìschaemic sưuk:
[fi-um ? đ:ựs until =-ủ muulhs] or establishud pcriplmraJ meria] d1'sm
- Pat'lenls suffm'ng fmm ncm-ST sr.gmenl e]evatinn acuu: mmmy
syndrmm [1mslu'bte angim. or nun-Q wave nưom-đủl inlủctinn) in
mmbinatiuu will: aspirin or ST segửlznt elqựulỉnn amie myocardial
mfarctiml. iu cnm'h'uuation wifh uspirỉn. in mcdicale mled. peticum
eligìhlc furthrumbulfflic Ihcmnf.
DfflAGE MHIJ ADIHIJFSTIIIÀTIỦN
F Aers mdeIdaủ-z
— Fmvnnt'mn ofa1llerơthrmnbuủ eumtsr 15 mg mm: nhììlf, ta.km vn'rh ucr
witlmul: fìlDd.
—- ảcule euronazy sỵndmme: single 300 mg lumlíng dnse and llưn cuufimfflì
at ?5 me. nnoc a dny [wilh aspỉn'n ĩã — 325 mg daily). For paxiunls mm ?5
years ủfagc. shoud sum will:mut aloud'mgdm
? C'Iaíửĩrm aưd'aưnl'zscznrs: Thc sal':ty uud e…Ilỉcaqr ufcIupúdugrel in Iilesa
suhjưr.s have nnL ỵnei hem establishnd.
DÙNTRAffl'IIIDI'IIÙN
— l-Iypcmcmiliúly tn Clnpidugrnl m'1ù any cnmpnncnt uí'llue dnJg
— Sưerc live: ỉmpainan
— ảcliv: pethulngìca] hlnmlủg such as pcplin ulcer or intracmin]
hamnunhạge_
PRECMĩTIỦN ~
— Du: tu the risk ùbeccd1'ng n.nd haemamluginul adưme rcactiuns, blund.
ccll cuu.nt detenm'naliun andl'or uthcr appmprỉale testing shuutđ he
pmmpdy cumĩdemd wtmncvu nI'uaical sạnnpsunu Euggfflth'ũ ot“ hlw:ang
an'su. Use with caurinn in ụu_Líents whn may be nt risk of [nmwcd
h1ọud'mg Frmn uauma. ãuĩgcry.
- Slnp usỉng clupỉdngm] ? dnỵr. prỉoftu surgcry.
— Clop[dngrel pm]ungs blebding Iimc arỵd shqud he used. wỉth mríun in
patlents who hn: [eainms with a ;ưupcnsliy tn blocd ẸJ1IJJ'tỉB-uliìx'ljl'
gustmỉnlest'ưul amd intmoquar}.
- .When la.kíng c!upìdagrel nlnne m- in numhinnt'um with ASA I`m.- lungưnn
ưcnlJnent. smỵ: thdrug ỉí' b]eeđing wmas and ma… la physiciun. Pn1.ients
should infon-n lùysEdans and dmrỉsE mm. d:le are taking dnkangrel
Izdưe any surgcry is schaduled and bẹfum .-my n-m medicinal prudu.ct is
1akm.
— Clup[dngrel is not muanmmded during ủn fi.rst ? days nEt:r HEIII.E
immni: strukt.
- Use with cauliun in pat'umlầ wi1h nm] impahmml, paliean with mud.crme
hcpulìc :Ilsemaahu mayhua hleeding dialhcsns.
— Pu1ỉEnL'ỉ with ran: hmulitaư pm'blm uf galmlme intoleramc. th: Lupp
lacluc: :Ieủcimny nt g1wmu-galastnse malahsnrp1iun should not lakc this
mduct. - '
_ USE ]]ƯRING FREGNÀNCY ảNIJI EREảST-FEEDING
- As nu clininal :lam on cxpu5urc … c]opidngrcl during pregnancy alt:
_ availablmữuus shoud nut usẹclopldug-nl dnring pregnamy,
- ]: is unknưwn whather clnpỉdugrul is exmatẸd in human breast milk.
Mimal studir.s have shnwn cmmủam …” clupidugrcil 1'n hreast milk.
'Ihmfurc. buml-íủidillg slmulcl natbc cnntủauer]. during m:an
. EFFECIE ON AEILIIY TỦ DRW'E âND UE'E- MACHINES
C]opidlugrcl l1as …: ocr neglỉgihle; 'mũumce nu 1.1m B.hiliự tn drive and use
mrtchinm.
DRUG INTEHACI'IĐN
- Walìưjn, fflycnprmnin ll'bũIla inhihitucs; mưj ỉncrease tha ỉmcna'ư nl'
hlnedings.
- Mpirin. hcpariu: increased risk ufb1mdìng.
—-'Ihmmbohrlics: There is nu suửty dam ủf'flĩủ cnrlmmltanl mhnh'lỉstratlưn
~.mn clepỉdngre].
- NSAII)GL increawi Hak'ofgasưuỉnteslỉnal hlnưling, _
— Nu :liniczalử siguỉí'lmnt phmnauođyrmnỉc intemctiơns … obsmed
when clnpỉdugre! … c…minĩslcrsd wirh menuha], nỉfedipins, m hum
:ltennlnt and. nifcdipim
- The activity uf elnpcidngrel was not signifimtty inllucncnd hy the cu-
admí.níslntinn ofphmn'harhllal. cỉmcn'di-n: m- ueattogen.
Tel.: [051²2190633
- Tile phannauukinrlìcs of diguxỉn ncrthnuphyilline wersnut mudii'ml. hy 1Jw
m-edrrứm'sfflUmi of cìopìdngrcỉ.
— Anumỉds did. nm; modltặr th: mdcnl. uf clopĩclngrcl. ahsm-pliun.
- The mlbuaquin uc'ul mambelitu ot” clơpidugml cnuld inhibit m: acliưiiy nt“
Gì'N5ũ 2C9, thus, il may innffls: anmna lavcls of pheuaioin,
tolhulaưnĩdn, NSAIIJs Ẹv.hich arcmmbulised tuy [.'YPũIJ 2C9}. Hù'iul'ffl'El,
phcrrytuin and tulbuủmidamn ủsufflỵ' cn-edminismui wilhchpỉdugrc].
- There ís no eviđcncc nt“ cliuim1Jy sigm'ũcant advme intemmimas whr.n
clupidoqựel. is ED-Eđminủ'lảffl with d'Lurnt'uzs, ben blockm, âCEl,
m1cium m'Jtugnnisìs, cholesfflol |.uwcxing ugmts, on uasudLlatnrs.
anliđỉahut'u: aguuls ['mcluding 1'nmliu}, anliepllepiìu: agcms. …! ỦPIINfflG.
anưagunisis.
SIDE EFFECI'S
— Cummnm Hacmammn; uplsiaxis-ạ gastroỉnmstủul hnemmdmgc, dimhueag
:1'bdcnminal pnin, dyspepsia'. bruising.
- Uncanmmu: Thrombongtopcnỉu, 1:ucnpenia. wsủuphi1iư, IJ:tmczfanủl
b]eedỉng [mme cam were rqpou-tnd with ram umm), headachc.
pmesthnsiu, đizziness; eye b]coding {mnjunctỉvaL oculn. mtimú); gasuir.
u1ccr and dumienal 1.1Iu:ncr` gaslrltia, vumìting, nausnu, mmtỉpaliun,
flnmlcnoc; nlsh, pmitua, skin hlr.ad'mg l[purpwaj; hzmưuaturia; 'lJleeđing
tim pmlm:lgud, neumphii www l_iccreused, ptmeIe: umm: dmrcasení.
— Eare: Nm1mpem'a: miao; rcuopm'tnnan1 E1aưmonủga
Jnj'arm ú:durs 1rííh sfđe ffl'ỉsđ: wImn using nwdỉcĩne.
PHÀMHCÙDYNAfflC FIHJFERTIES
— ClupJ'dngcel ìa a prudmg. be meJaboliscsì by CĩF—iffl mzyma m pmdutt':
IỈ'LẸ active mB’lĩlbũliủ This active muahufli:e inhỉbìla ám b'ưulĩng ní
ađeuosìnc li1'phusphũle ẸủDI'J up in plzumlel receptor and lhc subsequenl
ADP-unbdintcd mtiva1.imu ùffhE g1fcumlciu ỦPIMlII. cumplcx, rherehy
ith1J'ItingpilabdnLagụtgfflùan.
- Due to thu: immỉbln binđing. plntctels axposad m at'I'nuied fìJr thua
remainũcr offlmi.r lifảspzm and ronuvnry uf'numml plntcict fuunt'mul occle
ut a me musi5tmt wirh plntelet Iumm-ur.
- P!alelm BBEECgẸIIỈDII iuduned by agonistu ulhư Ihan ADP is n1sủ inhihủxeđ
by blocking thu umplỉficatĩun ùfp1aẸclumúfution by relea.wi ADP.
FHAHMAfflKIIN'E-T'IC PRDPERTIES _
- Mssnrplium Mỏ: single and rcpuulnd cura! duses of 15 mgfday.
cJupỉdogm1 1's rapcidly absmhcd. Mcnn ụr.ủk plasma. ]evcls ul' unuhanged
clapidogrcl [qựmúmuieily 22 — 2.3 nẩml) uccun'ed appruximmly 45
mìnmes afbcr dnsing. Absorptim: ỉs al Leusl 50%, bam! un urhmy
excret'mn of mcmbulitcx.
- Dĩalrlhutinn: 'Clupidngrel and the main nlĩnulffling 1inuctỉuuì melabulitu
bim mvnrsiblỵ' m vHro to hLumn plasma prmcins [93% und 94%
respectivdy}
… Membulủrn: ClùpfflngreL is mctu1sia'eily membnliscd by the Liver into
J'Jmctiw ẹarbnxyli: acid de:ivalive {35% ùf circulutinp, mmmbnlitesj.
C]npidogrcl 'Ls first memanIscd In a 2-om-ctnpidnpvl inmr:md.iata
me1abalite. Subscqucnl melabulism results ĩn funnaliun ufthu act'm: 1h'ml
dcrìvalh'e. It bĩnds mpiđlỵ_nmì ỈIIIửTISỈÌJẸ' m platnle: recepmra. lhus
inhìbìủg platelel. aggmgstiun.
— Eliminatinn: appminmlcly 5D% was emmozl in Ll:e uriJm u.ud
approximaIB-ly' 4fflin … &… ìn lhe Lzũ-hmư ỉntmul uíter dnsỉng. The
eliminatinn hulF-Hĩề nt“ the mein cimúating metaimlib: was 11 hùưrs alìer
s'nga and rcpcu'bed udminisuafiw.
UVEHDDSE AND TIEIINI'MENT
- Efmpfm m-cq-dasc: nf clnpidngml may lrad … meungccl hLucding tim
nm! suhsequcnthlnuíủg. mnnpliffliuns.
- Trmímau: Appcrupưiale 1]luapy slmuld 'lze cunsíduui it“ blnulíngs are
ùbsen'ch. Nu anfidnte has been found. lỉ' pmmpt wmtiun ul' pmlunged
b]eeding I'ĩmc is muirmì, plateJct trm1slìuiun may reufcmc th: ufflacis of
ctnpìdogml.
HECDMMEN'JHT'ION
- Keep nut ní rcnch nỉchild ren1
- Thủ- drug Is used Ẹll'llJ" lự dutlnr’s prescrlptĩun.
- Rzull calruí'lally tTmeIrzailtl before use.
- Cunuaẹt yunrdnzfurỉur l'urlller lnfnrmulỉnu.
SIũMGE: Stofe ỉn a tìght wmaincr, pmlected i'rum Iighl, … »:1.ụl placu
mmpemxum below 30”C. ~
EXPLIư DATE: % months I`m… lhe manul'acturing dam
SPECIFICATIDN: USP 30.
SIIIINEPDUNG DảEWDD I'lleìRủì Cuu Ltd.
- Fmrỵ:Nu.1b Sưut9AEảuI-lmlndustdfflỉ'mh'n. ì.DunplalfrmĩmqìũclNam
umw. Roumùĩ. Flnm sP. Tm m_ Eựẹrlĩchlủĩủng. Nn. ues. mSư, Wnrd. li Did. II.… cm Minh Ciu-
Fu:anJ mu
F.rnaũ .':hinpoocửzọđảùl'ffllffl
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