PemCTPaUHOHHblH HOMep: JICP

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JICP-006455/09-270 11 0
HHCTPYKUIDI
no Me~Hl.\HHcKOMY npHMeHeHHIO
rn>EIlAPATA
I>OI>OTHKВ®, KaIlJIH ~JUI npHeMa BH)'TPh 66,66 Mr/MJI,
MEMHA <1>APMA AKQMOHEPHOE OEI.QECTBO, IlOJlbllIa
PemCTPaUHOHHblH HOMep: JICP-006455/09
CpOK BBe~eHHlI H3MeHeHHH C ''rJ)p' _ _.::..
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CTaPIlll pe.!laKQlIlI
HOBIllI pe.!laKQlIlI
UpeACTIlBIITeJILCTBO B POCCHHI
OpraHII3aQHH, npHIIHM8101Q811 npeTeH311H
Opr8HH3aQHH, npHHHMalOlQall npeTeH3HH
nOTPe6HTeJIeif
nOTpe611TeJIeif
OAO В«XIIMIIKo-lj>apMaueBTH'IeCKIIH
KOM6HHaT В«AKPHXHHВ»
142450, MOCKOBCKIllI o6J1acTb, HOrHHCKllli
paifOH, r . CTapllll KYllaBHa, YJI. KllpoBa, 29
TeJl. (495) 702 95 06;
Ij>8KC (495) 702 95 03
000 В«nOJlbCKHe JleKapcTBaВ»
109029, r. MOCKBa, CH6HPCKHH npoe3.!l, JI.. 2,
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TeJl.: (495) 721 36 97 (98)
lj>aKc: (495) 723 72 82
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JICP-006455/09-130809
HHCTPYKUWI
no Me.1lHUHHCKOMY npHMeHeHHIO npenapaTa
I>060THKВ®
Pezucmpll/(UOHHWa HOMep:
Topzo(loe HIl3BaHUe npenapllma: Eo60THKВ®
Me3ICOYHapOOHoe HenameHm061lHHOe H1l361lHue: CHMeTHKOH
JleKIlpcm6eHHIlR tjJOPAfIl: KanJIH ,l\nJl npHeMa BHYTpb
Cocmll6:
AKmUOlioe oeUjecm60: CHMeTHKOH - 66,66 Mr/Mll (B cpopMe 30% 3MYllbCHH - 222,2 Mr/MJI)
BcnoMOZameJlblible
oeUjecm8a:
HaTpHlI
caxapHHaT,
MetHlInaparn.1lpOKCHfieH30aT,
npOnHJInaparH.1IpoKcHfieH30aT,
KapMeJJlI03a
HaTpHJI,
JIHMOHHOli
KHClIOTbl
MOHOrH.1IpaT,
apoMaTH3aTop MaJlHHOBblli, BO.1la O'lH[JleHHaJI.
OnucllHue:
o
ryCTaJI, Henpo3pa'lHaJI lKH.1IKOCTb OT fielloro .110 6eJloro C
KpeMOBblM OTTeHKOM
UBeTa C <!JPYKTOBblM 3anaxOM .
,[(onycKaeTCJI paJ.lleJleHHe Ha lKH.D.KHH CJJoli H OC3.1\OK, KOTopble nOCJJe B3fiaJJTblBaHHlI 06PaJYlOT
O.llHOPO.1lH)'IO 3MYJIbCHIO.
4lapIll8KOTepaneBTH'IeCII:aH rpynna: BeTporoHHoe Cpe.1lCTBO
Ko.D.
A TX: A03AX
4lapMaKOJlOrH'IecKHe cBoiicTBa
(/)IlPMIlKOOUHIlMU/(1l
CHMeTHKoH
(aKTHBHpoBaHHblll
MeTHlIHpoBaHHblX
.1IHMeTHKoH)
JlHHeliHblx
TPHMeTHlICHJIOKCHlJOBblMH
npe.1lCTaBJIlieT
CHlIOKcaHOBblX
rpynnaMH
C
KpeMHHJI
co60li
nOllHMepoB,
.D.HOKCH.1\OM.
KOM6HHaUHIO
cTa6HJIH30BaHHbIX
CHHlKaJI
nOBepXHOCTHOe
HaTJllKenHe Ha rpaHHue paJ.1Iella CPaJ, 3aTpY.D.HlIeT 06paJoBaHHe H cnoc06cTBYeT pa3pyweHHIO
ra:.!OBblX
nY3blpbKOB B CO.1lePlKHMOM
OKKT). BbICB060lK.1IaeMbI~
KHWe'lHIlKa
H CJlH3H
lKellY.1lo'lHo-KHwe'lHoro TPaKTa
"PH 3TOM ra3bl MOrYT nOrJIOll\aThCJI CTeHKaMH KHWe'lHHKa HJIH
DLl60.1llll b~>l GJldl U).ldJ.l>l Ih:VH~ IdJlb 1HKe.
:J lU
1IJ.l~).ly 11 veJll).lael o(jpa:.!OllaHH~ UOJlbWHX ra:lOBO-
ClIH311CTblX KOHrllOMcpaTOB, BbI3bIBalOll\HX 60JIe3HeHHoe B3.11YTHe lKIlBOTa.
npH
COHO-
H peHTrenorpacpHH
npe.D.ynpelK.1\3eT
B03HHKHOBeHHe .1Ie<!JeKTOB
1130fipalKeHHlI;
cnocoficTByeT JIY'lweMY opoweHHIO ClIH3HCTOli OfiOIlO'lKH TOIICTOli KIIWKH KOHTP3CTHblMII
npenapaTaMH, npenllTCTBYJI paJPblBy KOHTPaCTHOli nlleHKH.
BClIe.uCTBHe
XHMH'!eCKoli
npIICYTCTBYIOll\He B
)lCKT.
HHepYliOCTH
He
BIIHlIeT
H3
MIIKpoopraHH3MbI
H
cjJepMeHTbl,
He YMeHblll3er BcaCblBaHHe nHll\H, He 113MeHlUIT peaKUHIO H Ofi'beM
lKeIlY.1IO'lHOro COKa.
(/)llpMa/(O/(UHemUKIl
CIlMeTHKOH noclle nepOpaJIbHOrO BBe.1leHHlI He scaCblBaeTCli H3
)lCKT
H BblBO.1lHTCli '1epe3
KIiWe'lHHK B HeH3MeHeHHOM BH.1Ie.
nOKR3RHHH II: npHMeHeHHlO
вЂў
Y CHJleHHOe
ra30ofipa30BaHHe
II
HaKonneHHe
raJOB
B
)lCKT
(KOIIIIKH,
Oll\Yll\eHHe
HanOIlHeHHR B 6PlOWHOli 1I01lOCTH, MeTeOpH3M B T.'!. B nOClIeonepaUHOHHOM nepHO.D.e,
CHH.1IPOM PeMrellb.1la, a3po<!tarHlI);
вЂў
nO.1lrOTOBKa K .1IHarnOCTH'!eCKIlM HCCJIe.1l0BaHilliM opraHOB fiPlOlIlHOIl nOIlOCTll H MaJlOrO
Ta3a (peHTreHorpa4JHlI. COHorpacpHlI, raCTpoCKonHlI II .uY0.1leHOCKOnllll - npocpHIIaKTHKa
ofipaJOBaHHlI neHbl) .
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46609
JICP-006455/09-130809
npOTHBOnOK818HHII
вЂў
nOBblWeHH811
... YBCTBHTenbHOCTb
K
CHMeTHKOHY
H
'HnH
,lIPYrHM
KOMnOHeHTBM
npenapaTa;
вЂў
KHWe'lH8lI HenpOXO.l1HMOCTb;
вЂў
OficrpYKTHBHble 3afioneBaHHlI
вЂў
HOSOpolK.,lleHHble .l1eTH .l10
28
)f(KT;
llHlIlICH3HH.
npHMeHeHHe npH 6epeMeHHoCTH H B nepHo)t Jl8KTSUHH
Bo BpeMli fiepeMeHHocTH npHMeHeHHe npenapaTa B03MOllCHO TonbKO B Tex cny'laJIx, KOr.l1a
npe.l1nOnaraeM8lI nonb3a .l1nll MaTepH npeBblWaeT nOTeHUHaJlbHbIt\ pHCK ,llnlI nnO.l1a вЂў
.()rCYTCTBYIOT ll8BHble 0
nepHO,ll KopMnCHHlI
fie30naCHOCTH npHMeHeHHlI npenap8T8 Y
rpY.l1blO
pefieHKa npenapaT llomKeH
KopMlImHX lKeHmnH. B
npHMeHlITbClI
TonbKO
B cnY'Iae
6e3ycnoBHoi! Heofixo.llHMOCTH.
Cnoeo6 npHMeHeHHII H ilO]bJ
o
BHYTPb, nocne e.l1bI.
nepe,ll npHMeHeHHeM B360nTaTb .l10 nonyqeHHlI O.l1HOPO.llHOH 3MynbCHH.
,[(JIll TO'lHOil .l103HPOBKH
npenapaTa, BO BpeMlI 3aKanbIB8BHlI, t\lnaKoH cne.l1YeT ,lIeplKaTb
BepTHKMbHO.
YCHneHHoe f830ofipaJOBaHHe H HaKonneHHe raJOB B ofinaCTH
28 .l1HlI lICH3HH ,lI0 2 neT no 8 Kanenb (20 Mf CHMe:rHKoHa) 4 p838 B cYTKHi
2 ,lI0 6 neT no 14 Kanenb (35 Mr CHMeTHKoHa) 4 paJa B CYTKH;
,lIeTH CTapwe 6 neT H B3pocnbIe no 16 Kanenb (40 Mr cHMeTHKoHa) 4 p838 B CYTKH.
вЂў
,lIeTH OT
вЂў
,lIeTH OT
вЂў
)KKT:
,[(JIll fionee Y.l10fiHOfO BBe,lleHHlI npenapaTa,
B '1aCTHOCTH ManeHbKHM .l1eTlIM, ero MOlKHO
npe,llB8pHTenbHo CMewaTb C He60nLwHM KOnH'IeCTBOM xono.l1Hoil KHnll'leHot\ BO,lIbI, .l1eTCKOfO
nHTaHHlI HflH HeraJHpoBaHHoii lKH,llKOCTH .
nocne HC'Ie3HOBeHHlI CHMnTOMOB npHeM npenapaTa cne,llyeT npeKpaTHTb.
nOilroToBKa K ilHarnOCTH'IeCKHM npouenypaM:
PeHmZeHOi'parjJU'IeCKOe uccJIeooВ«Qllue )f(KT
3a OJlHH neH" .l10 HCCne.l10BaHHlI npenapaT npHHHMalOT
f)
вЂў
,lIeTH OT L.~ .l1HlIlICH3HH .l10
вЂў
.aeTH OT
вЂў
.aeTH CTapwe
2
.l10
2 paJa D CYTKH
(YTPOM H Be'lepoM):
2 neT - 10 KanenL (25 Mr)
6 neT - 16 Kanenb (40 Mr)
6 neT H B3pocflLle - 20 Kanenb (50 Mr)
COHozparjJU'IeCKOe uccJleooВ«o/JUe )f(KT
3a O.l1HH ,lIeHb .l10 HCCne,llOBaHHlI npenapaT npHHHMalOT
2
paJa B CYTKH (YTPOM H Be'lepoM) B
.l103HPOBKax, peKoMeH.l10BaHHbIX npH nO.l1rOTOBKe K peHTreHorpat\lH'IeCKoMY HccnellOBaHHIO. 3a
YpH '1aca.l10 Ha'lMa HCCne.l10BaHHlI .l103Y Cne.l1yeT nOBTopHTb.
n060'lHble l{eHCTBHH
B03MOllCHO p83BHTHe MnepI'H'IecKHX peaKuHH.
nepel{03HpOBKa
CoofimeHHlI 0 nepe.aOJHpoBKe OTCYTCTBYIOT.
CHMeTHKOH He BcaCbIBaeTClI H3
)KKT
H nepe.l103HpoBKa He npe.l1CTaBfllleT yrp03b1 .l1nll lKH3HH "
3.l10 POBbll.
83811MOileiicTBHe e ilPYfllMII neKspCTBeHllbIMII epeilCTBaMH
CHMeTHKOH MOlKeT Bbl3bIBaTb HapyweHHe BcaCbIBaHHlI nepopaJlbHbIX aHTHKoarynKHTOB.
fill _
--
46609
2
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JICP-006455/09-130809
Oco6Lle YK838HHH
npenapaT He COJleplKHT caxapa, B03MOlKHO npHMeHeHHe 60nbHblMH caxapHLlM .ZlHa6eTOM H C
HapyweHHJlMH nHmeBapeHHJI.
Bo BpeMJI ne'leHHJ! He peKOMeH.ZlYeTCJI npHeM ra3HpOBRHHLlX HamITKOB.
npHeM
npenapaTa
MOlKeT
HCKa3HTb
pe3ynbTBTbl
HeKOTopblX
.ZlHBrnOCTH'IeCKHX
TeCTOB,
HanpHMep TeCT C HcnOnb30BaHHeM rBaJlKOBOIi CMOJlbl.
BO)J()l.eHHe
TpSHcnOJITHLIX
Cpe.llCTB
II
06CJ1YlKHBSHHC
PS60TSJO/UHX
MeXallll'leCKHX
YCTpoiiCTB
npenapaT He OK83blaaeT BJlHJlHHJI Ha BOlK.lleHHe TpaHcnOpTHblX Cpe.ZlCTB H 06cJlYlKHBaHHe
MeXaHH'IeCKHX YCTPOHCTB.
CIlOPMS BLmYCKa
KanJlH.llnJI npHeMa BHYTpb, 66,66 Mr/Mn.
no 30 Mn BO IjJJlBKOHbl TeMHoro CTeKJla C nOJlH3THJleHOBOR np06Koii-KaneJlbHHueR
H
3aBHH'IHBaJomeRCJI nOJlH3THJleHOBOii KPblillKOii.
o
I IjJnaKOH BMeCTe C HHCTPYKUHeR no npHMeHeHHIO B KapTOHHoii na'lKe.
YCJlOBHH xpaHeHHH
B 3amHmeHHOM 01' CBeTa MeCTe, npH TeMnepaTYpe OT 15 В· C .ZlO 25 В°C.
XpaHHTb B He.ZlOcTynHoM )lJJR .ZleTeil MeCTe.
CPOK rOIlHOCTH
2 ro.Zla.
He HCnOJlb30BaTb nocne HCTe'leHHJI cpoKa rO.llHOCTH, YK83aHHoro Ha ynaKoBKe.
YCJlOBHH oTnycKa H3 anTeK
Ee3 peuenTB.
npOll3BO.llHTeJlL
MJ<:,LJ,AHA CIlAPMA AKUIIOHepHoe 06meCTBo
98 - 200 Cep3.ll3, YJI. JloKeTKa lU, 1I0JlbWA
npe.llCTaBHTeJJbCTBO B POccllwOpraHII3aJ.(IIa, np""HMaJO/Uaa npeTeH31111 norpe6HTeJleii
000 В«nOJlbCKHe neKapCTBaВ»
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lj>aKc: (495)
723 72 82
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MellHUHHCKHH COBel'HIIK
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