midllictepctbo 3ap abooxp ahei-iidi pocci1hckoh eaep … · 2014-05-28 · midllictepctbo 3ap...
TRANSCRIPT
MIDlliCTEPCTBO 3AP ABOOXP AHEI-IIDI POCCI1HCKOH <l>EAEP AlU1I1
PemcrpaU;110HHoe Y,LIOCTOBepeHHe N2 Jill-000509 AaTa pemCTpaL\1111 «01}) MapTa 2011 r.
MepK CaHT3 c.a.c., 37 pm CeH POMeH, 69379 JIlfOH Ce,LIeKC 08, <l>paHL\I1S1
(HaHMeHOBaflHe JOpHI\l1'leCKOro JlHL\a, Ha 11M>! KOTOPOro Bhll\aHO pemCTpaL\110HHOe YI\OCTOBepeH>le,
al\pec)
HA Jill 000509-010311
HaHMeHOBaHl1e JleKapCTBeHHoro rrpenapaTa
Ta6neTKIT npOJJOHrlfpOBaHHOrO ,LIeHCTBl1S1, 750 Mr JleKapCTBeHHM <\lopMa, I\0311pOBKa
MepK CaHT3 c.a.c., <l>paHL\IUl
MepK KTaA, repMaHlfSl HaHMeHOBaHHe npOH3BOI\HTeJl" (ShTnyCKaJOlL\MM KOHTPOJlb Ka'leCTBa), CTpaHa
UB0413 AaTa BHeCeHl111 H3MeHeHl1SI « » _ _____ _ 20
HOBaH pe.LIaKI..\HH
r.
HA3BAHlIE IIPEllAP ATA MHHHCTEPCTB03)J.PABOOXPAHEHllR POCCIDfCKOH <DE.D.EPAl.\HJ1
JIEKAPCTBEHHAH <l>OPMA
Ta6JIeTKFI rrpOJIOHrHpOBaHHOro l\ei1cTBfIj[ 750
Mf
ME)I(~APO~HOE
HEllATEHTOBAHHOEHA3BAHHE
HJIH rpYllllHPOBO~OE HA3BAHHE
PerHCTpaU;110HHoe YI\OCTOBepeHl1e N2 nTI-000509
.D.aTa pemcTpaU;1111 «01» MapTa 2011 r.
MepK CaHT3 c.a.c., 37 PIO CeH POMel!, 69379
nl10H Cel\eKC 08, <DpaHUI1j[
HOPMATMBHAH~OKYMEHTA~HH
H.D. nn 000509-010311
MeT<\lopMI1H
MHH3llPAB POCCHH
d/ n 00050g- 0 8 0 4 1 3 COfJlACOBAHO
M3MeHeHMe N~ 2 K H,U JIII 000509-010311
3AHBHTEnLPErHCTPAQHH
(BJIA)1,EJlElJ: PY)
MepK CaHT3 c.a.c., <l>paHUHfl
fJIlOKocj>alK® JIOHr
ToprOBOC IIaHMeliOBaHHe JleKapC'I'OCllllo r o n p en apaTa
MeTcj>opMIIH
MC)I(llYllapOJ\lIoe Hc n aTeH'l'OaaUIiOC II1lU XIIM ~lyeCKOe
IJa~IM eHOBa H~le
C.2
IlP0I13BO)),HTEJIb Ta6J1eTKH npOJlOHrHpOeaHHoro l\eHCTBIDI, 750
MepK KfaA, fepMaHl1fl MepK CaHT3 c.a.c., <l>paHl1lIl!
<I> ACOBlWIK (IlEPBM1ffiAJI.
YllAKOBKA)
MepK KraA, fepMamul MepK CaHT3 c.a.c., <l>panUHfl
YIIAKOBll.(HK
(BTOPHlJ.HAWTPETI1lJ.HMJ
YnAKOBKA)
MepK CaHTJ c.a.c., <l>PaHUHlI
BbllIYCKAIO~IDi KOHTPOJlb
KA'lECTBA
MepK CaHT3 c.a.c., <l>pa1mHlI
3AJ1.BHTEnL (B <l>ry «HlJ: 3CMlI»)
000 «HHKOMel\ ,[(HCTPH6blOllJH Cel:IT3»,
POCClliI
n CKap CTBeHHa s. CjIOPM8. }l.03UPOOI(8
IlPOM3BO,[(I1TEJIb
MepK KraA, fepMaHHlI
MepK CaHTJ c.a.c., <l>paHUHlI
<l>ACOBlUI1K (TIEPBI1lJ.HA5I
YITAKOBKA)
MepK KraA, fepMaHFll!
MepK CaHTJ c.a.c., <l>paRl.\HlI
YllAKOBI1.{I1K (BTOPWlHA5I
(ITOTPEEI1TEJIbCKA5I)YITAKOBKA)
MepK KraA, fepMaHlul
MepK CaHT3 c.a.c., <l>paHI\Flll
BbIITYCKAIOllJ,IDI KOI-ITPOJIb
KATffiCTBA
MepK KfaA, fepMaHHl!
MepK CmIT3 c.a.c., <l>paHUlllI
MAPKIIPOBKA MAPKlIPOBKA
Ha 6/lucmepe liG PYCCKOM Jl3blKe Yl<a3bUJGlOm: Ha 6/lucmepe I/a PYCCI<OM Jl3bll<e Yl<a3b16010m:
ToprOBoe H83BaHHe npenapaTa C ToproBoe H83BaIDIe upenapaTa C
rrpel\yrrpel\HTeJIbHOH MapKHpoBKOii ®, MHH, npel\YIIpel\HTeJIbHOH MapKllpoBKOii ®, MI-IH,
JIeKapCTBcHHYIO c!>0PMY, l\03I1POBl(Y, JIOrOTlIll JIeKapCTBeHIlYlo c!>0PMY, l\03HPOBKY, JIorOTlrn
c!>lIpMbI-np0I13BOl\HTeJlJl (Ra JIaTmml1e), (ImpMbl-rrpOH3BOAHTeJlll (Ha JlaTl1IlI·II.\e),
lliMeHemre NQ 2 K H.D: Jill 000509-010311 C.3
BOBaH peAaKlI.HH
JTorOTIITl «J-1F1KOMe,l(» (Ra JTaTIlliI1l.\e), CI1MBOJT JTOroTIlli <PI1PMbl-t(lICTPll6bIOTOpa
«M» t(JHI 3all\I1TbI OT <jJaJTbClflPllIcal.\l1l1, HOMep naTmrnl.\e), CHMBOn « M» t(nS! 3alI(HTbl OT
cepHH, t(aTY rrpOII3Bot(CTBa, t(aTY OKOWIaHllSl qHUU,CH(PllK~I1I1 , HOMep cepHH,
cpOKa rot(HOCTH, rrpOH3Bot(CTBeHHble KOt(b1. npOH3BOt(CTBa, t(aTY OKOH'IaHliSl
!fa KapmOl-ll-lOlI na~Ke lIa PYCCIWM 5l3blKe rot(HOCTII, TeXHOJTOHI'IeCKl1e/npoH3Bot(cTBeI-I-
y'W3blBalOm: ToprOBoe Ha3BaHHe npenapaTa C HMe OTMeTKH ynaKoBKH (rrpii
npet(yrrpet(HTeJTbHOH MapKHpoBKOH ®; MHH; He06xot(IfMOCTH)_
neKapCTBellHYIQ <jJOPMY; t(03HPOBl(Y; COCTaB; !fa KapmoHilOll na~/w fla PYCCKOM 5l3blKe
I<OJTlfqeCTBO Ta6neTOK B ynal<OBKe; Ha3BaHHe YKa3bl6alOm: ToprOBoe Ha3BaHlfe rrpenapaTa C
<»HpMbI-npOII3BOt(llTeJTSI H CTpaHY; Ha3BaHlre II npet\YIIPe,ll.IITeJTbHOH MapICHpoBKOii ®; MHH;
CTpaHY pernCTpal.\HOIIIiOro neI<apCTBeHHYIO <jJOPMY; t(03lfpOBKY; COCTaB;
yt(OCTOBepeHHSI/BbmycKaJOlI(ero KOHTPOJTSI KOJTWleCTBO Ta6neTOI< B ynaKoBKe; Ha3BaHlie II
KaqeCTBa; JTorOTllII <lllfpMbI-rrpoH3Bot(I1TenS! cTpany perIICYpal.\HOHHOrO
(na naTHHHl-\e); norOTHa «HIIKOMet(» (Ha yt(OCTOBepellIDI, Ha3BaFme II
naTliHIIl.\e); npe.ll.Yrrpet(HTeJTbHble Flat(rrHCH: npoII3Bot(IfTeJUJ!BbIIIycKalOll\ero KOUTPOJTSI
npenapaTa KaqeCTBa; norOTllrr <»lfpMbI-npmi3BO,ll.HTeJTSI
rrpoKoHcynbTHpyiiTeCb C Bpa'IOM», «XpaHHTb (lla naTHHH1\e);
B He,ll.OcTyaHoM t(nll t(eTeii MeCTe» ; crroc06 ,ll.I1CYpIf6bIOTopa
norOTllII qllfPMbI
naTillill1\e) ;
nplfeMa BnYYpb»); apet(ynpe,ll.HTeJTbHble
ycnoBlfe OTaYCKa 1f3 anTeK; ycnoBMW npHMeHeHlleM npenapaTa
HOMep perIIcTpaqrfOHuoro np0I<OHcynbTHpYHTecb C Bpa'IOM», «XpaHIITb
yt(OCTOBepeHHJJ ; cl1MBon «M » t(JTSI 3all\lITbI OT B net(OCTYJIHOM t(JTSI t(eTeH MeCTe»; cnoc06
HOMep cepHH;
npOll3BOt(CTBa; t(0:»; YCJTOBIIe OTnYCKa 113 aaTeK; ycnOBIfS!
rrpOIf3BOt(CTBeHHble KOt(bl ; IDYpIfX-KOt(.
CrrelUlarmCT no jJerI1CTpaL\I1I1 000 <<liHKoMe.n: .D:I1CTPIi6"bJOIllH CeRTI»
XpaHeHllJJ; HOMep perIICYpal.\HOHHOrO
yt(OCTOBepeHlUI; CHMBon «M» t(JTSI 3alI(HTbI OT
llOMep cepl·m ;
rrpOH3BOt(CTBa;
TeXHOnOmqeCKHe/rrpOII3BOt(CTBeHHble
OTMeTKll YlllIKOBKH (rrpH ne06XOt(HMOCTlr);
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llil AKO B.ll.
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MI1HI1CTEPCTBO 3m' ABOOXP AHEHl15I POCCIlliCKOH <DE)J,EP AI.Ulli
I-IaHMeHOB3HHe neKapCTseHIIOro npenapaTa
Ta6JIeTKU npOJIOHrUpOBaHHoro lleitcTBllll, 750 Mr nelmpCTBem-ta51 (llOpMa, l103HPOBlW
MepK CaRTJ c.a.c., <lJpaHUllll lIaHMeHOSaHHe npomBO,UHTeJBI (BbIIlYCKaIOlUHH KOHTPOllb Kal.feCTBa), CTpaHa
MaKeT nepBU'llIoit ynaKoBKll (6JIllCTep)
HOMep cepllll, llaTY npOll3BOllCTBa, llaTY OI<OHqaHllll cpOKa rOllHOCTll HaHOCliT no KpaliM 6JIllCTepa.
IJ:llljJpoBble naHTOHHble KOllbI (PMS): black, pantone rouge 186 C, securalic.
CneUUaJIUCT no pemCTpaUUll 000 «HllKoMell ,n:UCTPll6"blOIIIH CeHT3»
MHH3nPAB POCCHH
J n 000509 - 0 B 04 1 3
COfJlA(OBAHO
IlbIJIeHKo B.I1.
77722
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C. 2
Ml1HMCTEPCTBO 3)J,P ABOOXP AHEHIDI POCCIlliCKOM <DE)J,EP AIU1I1
H8H1vleHOS8HHe !IeKapCTBeHIIOro npenapaTa
Ta6JIeTKII rrpOJIOHrlIpOBaHHoro ,!leil:cTBIIH, 750 Mr JleKapCTBeHHa~ (~Opl ... Hl, ,U03HpOBim
MepK KfaA, fepMaHIIH
MaKeT rrepBf!QHoil: yrraKoBKII (6JIIICTep)
HOMep ceplIlI, ,!laTY rrpOII3BO,!lCTBa, ,!laTY OKOWJaHIIH CpOica rO,!lHOCTl! HaHOCHT rro KpaHM 6JIIICTepa.
l\mjlpoBI,Ie rraHTOHHble KO,!lbI (PMS): black (+ vignetted halftone), pantone 186 C, securalic CP007.
Crrel\lIanlICT rro perlICTpal\lIn 000 «HIII<OMe,!l ,[(lIcTpn6'bIOIIIH CeHT3» 11bIJIeHKo B.l1.
)
C. 3
MI1H11CTEPCTBO 3.ll:P ABOOXP AHEHl15I POCCrrtICKOM ct>E.ll:EPAI.lJ1l1
HaHMCllOlJaHHe ]lCKapCTBe~IHoro npenapant
Ta6neTI<H rrponOIirnpomuIHoro nei1cTBllll, 750 Mr JlCKapCTueHHaR lilopMa, )103HpORKa
MepK CaHT3 c.a.c., <1>panUlfll HaHMCllOBaHHe np0I13130,lJ,l1'renSl (IlI,IfIYCI\al01UHJ1I\oHTP0J1h Ka'JeCna), CTpaHa
MaKeT BTOPIf"IHOH (nOTpe6llTenbcKoii) ynaKoBKH (rra4Ka KapTOHHalJ N~30)
HI
l~i
Per. YA. No: I BnA/lEnEU PYIflPO~3BOn~TEnbi BblnYCKAiOLl1~~ KOHTPDilb KAYECTBA: MepK CaHT3 c.a.c., $paHlIl1f1
I WTP~X-KOA I AnR npM&Ma 8HyrPb. n!peA npllMe"'H"8~ npenapaTI !1poK011CYIlbTMpyRTe<:b c epa-. }(paHM", I He.QOCTyfl1IOMAfllI.A8f1ll M8CTe. XpaHMn."pM teM\tp8fYp8 He awwe 2S'C. Om)icK IU amam no pet\6flTy 8pa~a.
, , ' ,MERCK , ,
mlOKDct\A.>Kj(Q1j1 750 Mr
Ta6neTKM nponOHfMpOB3HHoro AeHCTBMA
MeT¢opM~H
30 Ta6neTOK 0
COCTAB: 1 ,,!Snau. eOA'pllMT AKTMIHGe .1114"'.0: MeT¢IopMHH8 rHAJ)OxnoplUl
BCnOMOflT.n ...... l. "WICTIJ: KapMlIIIOI»a HaTPMA ..•..•••.••..••..•... __ •.••••.••.• 37,5 Mf rMnpoMenncna 2208" ...................... _ ...... 294.2~ Mr
.... 750 !.If Manntfl cTeapaT .......... _ •••• .. .•••.... _ .........•. .•.•• 5,3 ~f
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TIbIJIeHKO B.I1.
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I
C. 4
MHHI1CTEPCTBO 3W ABOOXPAHEHIDI POCCllliCKOti <l>E~PAIJ,illI
nal1MCHOBaHHe nCKapCTBeHHoro npenapaTa
Ta6rreTKII nporroHrllpoBaHHoro neilcTBllS!, 750 Mr JICKapCTDCIlIIa}l qJOPMa, .u03HpODKa
MepK CaHT3 c.a.c., <fJpaHUlls! Hal1MeHOBmll1e npOmBO.llHTeJHI (BI.mycKaJOJUHH KOHTpOJlh Ka4eCTBa), npaHa
MaKeT BTOPll'IHOil (noTpe611TerrbcKoil) ynaKoBKll (naqKa KapTOHHal! N~60)
, "I c " . '. , c
I! \)
~ ~ § 0 ~
Per. YA. f>B:!
B11.AJ1E~pYlnpOl>13BOA~TEnbi BblnyC U.V-1~ KOHTPonb KA4ECTBA: Mep!{ CaHT3 c.a.c., ¢lP9H4HR
I WTP"X·KOA I .1
1'J"I()I<DC:nA~ 750 Mr Ta5Jlemnp<lnOHrMpoaaHHOro,Q:
60 Ta6l1eTOK a ' ,MERCK "
mlOKOcnA>K}(QH..J' 750 Mr
Ta6J1eTK~ np0J10HrHpOBaHHoro Ae~cTBHR
MeTcjJopM""
60 ra6neTOK 0
COCTAB:
Amool"'" IILIIICTIIO: Ml1<j>op.wo1a 1ltJ\POI<I'l>jlI\fI .............•.•..•... 150 LU
Bcna~ora ... n""~10 .. oLll"en. : I(QpueMO:lllIdl'll"~,.. . . .. ....... 37.5 ",r rlVlpoMennoJ8 2208 ... . ... . 2114.24 I,U MlOIIIft CltIilpaT ..... .. .. ............ " ...•..••. ~ ... 5,J r,u
-
/lt1~ "PI!eM;!BIl)'TIlb. n . pell IlpMMOl\eHII&M r¥>ellllpllli npoI(QHCI'l\I,l"pyKT"~ C' PlI'lIll,l. Xpamm. • ~.D.OCTynHOIo!Af\lI "",re i; .... ~TII. XpaHKI"Opit TeMoepal)'p4l HI IWUlO 25'C, OmyCl( Hl MT.", no pe~fIIIT)' Ipa-.a.
ETC 8 QmjlpOBble naHTOHHble KOnbI (PMS): black, pantone ro~~ 286 C, pantonejaune 1235 C, pantone 540 C + trame 151!.~lecuralic.
II [ 'HHKoMeA CneUllarrllcT no perllCTpal111H '1 3 ~ C " '" 000 «Hll](OMen ,lJ;IlCTPIl6b1011IH CeHT3}) \\'-:. JlH H em ~
~'0 r {}' ~.p 'ilia .... ",
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IIbmeHKo B.I1.
C. 5
Ml1Hl1CTEPCTBO 3,upABOOXPAHEHIDl. POCCIill:CKOH <l>E,lJ,EPAlJ,ill1
HaHMCITOOal-THe neKapCTDCH HOI"O npenapaTa
Ta6J1eTKH rrpOJlOI-lrHpOBlUlHOro llei1cTBHlI. 750 Mr JlCKapt."TReHHaJI CI)OpMa, ,U03HpOBKa
MepK KfaA, fepMaHHlI H3HMCIIORal-me np0I13Bo.nI-ITeJ1~ (SbmYCKaJOlI.{I1H [COHTpOJlb l{(llICcrna), CTpa HR
MaKeT BTOPH'lHOH (rrOTpe6HTeJlbCKoil:) yrraKoBKH (rra'lKa KapTOHHalI N~30)
it It. ~ ! ~
, , >I:JM3W' , , , 'ltO>4-x llld.J.m
~I4HeVoldaJ '\feJ)I )ldaV\l :V6D3h'1>l9lJOdlHO)!
l1~hlOl\f)!)AUI98 /9lJ31~1106E~OdU
~III'nHedCl> '7 eo, aHe) )ldaV\l ;\d m u311vU6
AM npVlE'MCI 8l-fYTpb. nepeA npl1MeHeHl'IeM npenapala npoKOHcynbTVlpy~ecb c Spa"'lOM. XpaHI1Tb a HE!.o.OCTynHOM AmI AeTeH MeaE'. XpaHHTb nplll T"Mnepiny~ He Bblwe 25 .c. OmycK .13 am(I!cVI no pellemy spa .. a.
Ta611eTKIo1 np0110HrHpOBaHHoro Ael1cT. B. "II" ••
MeTCjJopMI1H
30 Ta6neTOK Q
,-_ J I {OCTAD: BcnOMoraT~n~HloIe .~utKT1la: , TOI iSneTU (OJl~p)l(MT
AKrnlHoe IfLltfcrl O: M~T¢opMIIHa rll,tJ,poxnopliA ..... .... ... .. . 750 Mr
KipJoleMOJa HaTPIIII ...........•................ 31.5 I.Ir IWtpoMeruo3a 2208 , .......... .... .. .. ...... 294,24Mr Mall-ll>lSl CTeapar ..................... . ..... 5,3 Mr
Jill i I
ll.11<jJpoBbIe naHTOIDIble KOllbI (PMS) : Black (+vignetted halftone), Pantone 186 C (+70% halftone value and vignetted halftone), Pantone 286 C (+vignetted halftone), Pantone 1235 C (+vignetted halftone), Pantone 540 C (+15% halftone value), . 007.
I Btlt/1r "c,
~t. \ Cnel.\I1aJlHCT no pemCTpal.\l1H 000 «HIIKOM e.ll .I\HcTp!l6bIOIIIH CeHT3» IIblJleHKo B.I1.
C. 6
MI1HI1CTEPCTBO 3,D:P ABOOXP AHEHIDI POCCMMCKOM <l>E,D:EPAIJ,I1I1
HaHMCHOBaIme llelWpCTBCHHoro n penapaTa
Ta6JIeTI<H ITpOJIOHrllpOBaHHoro llenCTBIIS!, 750 Mr JIeKapCTBClIIIa 1l. Q)OPM8, )J.0 3 I1pOB lm
MepK KfaA, fepMaHIIS! Hal1M:CHOBa HHe n pOMJDO.IHHCJUI ( BI:,m YClm IOJI(HH KOHTPOJIh Ka ' lccTBa) , CTp aHa
MaKeT BTOPllqHOli (ITOTpe6I1TeJIbCKoli) yrraKOBKII (rraqKa KapToHHaS! N260)
!f! i ~ II ~
tJ'o>l-xl-'ldl.m
II I ... n?l~daJ 'Vl'J)I :«:Iav-l :WD3h'V)l
qlIOdlHO~ l:1 l-1tn Ol'V::O i\UIQa/QU31Il1tbBHIOdU
IIl-1nHedcp ")' 1.") U He) :«:IaV'j
:.-\d 113LJ3ttvLJ8
,------, :oN 'tt,A;'Ji/d
~750Mr n~n. '1<M npon""rnpo.IHHoro ~I""
GO Ta611eTOK t;;) , ,MERCK " ,
mlOKo~)(Q':W 750 Mr
Ta6neTKH nponOHrillpoaaHHoro AelitCTBHSl
MenpOpMIi1H
60 Ta611eTOK ~
COCTA8: I Ta6nen:a C~ep)l(I-IT An~ npHeMIl BMJ'TPb_ AKl l1 lHOe ULilKlIO: n epeJ1 " p!.IMe.JeHl1eU "penap,lTa MeT¢opMI1H" Il1,1lPOXll(lPI1J1 ............... 750 Mr npoKOHC)'nbTl1P'1fiTeCbc l p':" tOM. 8cnoMoraTen~Il~le '''U{&Tlla : I(.}pMennolJ H4TpI'~ ..... . . . .. .... . 37,5 1.l r XP ~KI'!Tb .I!eAocryn fiOMJIIl~AeTell Mecre. r\mpoM~nno)a 2208 ...• .. .... 294.24 Mr XfI<lHmb npl-'l Tm.rleparyfH' He 'blwe 25·C. MMH~A creapaT ........... ... ... ... . .... ... ..• .. . 5,3 Mr Omy(1( 1-'1) /II1re,,1'1 no pellemy B~'1a .
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L(mppoBble rraHTOHHble I<OllbI (PMS): Black (+vignetted halftone), Pantone 186 C (+70% halftone value and vigrretted halftone), Pantone 286 C (+vignetted halftone ), Pantone 1235 C (+vignetted halftone), Pantone 540 C (+15% halftone value), , ralO ~' 07,
(10 "'0 -<-'" (" ::;..~ ~,
Crrel\lIaJI11CT ITO perllCTpal\1l1l ~ 't,'~ 000 «HIIKOMe,ll ,[(IICTPIl6'bJOiliH CeHT3» ~ HKoMe~, ,, ~ II IIbIneHKo BJL
blOUlH Cem _'7 ;i '0 .§./J
~~ "~' ~ n ~ _ ____ . ,,'.
~rJ 2 - .. - .-.....
'-' npOllHTO H npOHYMepOBaHO H CKpenneHO nellaTblO L RHCTa(OS),
CneWtanHCT no perHCTpaUH" 000 <<HI1KOMe.ll .qHCTPH6bIOWH CeHn» n. OHKO RH.
ll,nHCb)
« ~» ~2012 .., .. -,., .., -0 .., = :: 0
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0 .., ~ u ::
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