n NO J 460010 1- J 408 12

MI1HMCTEPCTBO 3,ll,P ABOOXP AHEHIDI 11 COWMJThHOrO P A3B11TIDI

POCCl'IliCKOi1 <pE~P ALU1I1

I1HCTPYKUIDI

rro rrpHMeHeHHlO JIeKapCTBeHHoro rrperrapaTa ,l\JIl! Me,l\Hl\HHCKOro rrpHMeHeHHl!

r JIlOKOll>AlK®

ToprOBoe Ha3BaHHC: fmoKOCPalK®

MHH: MenjJOpMHH

JIeKapcTBCHHan tjJopMa

Ta6JIeTKH I10KpbITble I1JIeHO'IHOH 060JIO'IKOH

COCTaB

O,UHa m6JIeTKa co,UeplIGfT:

fuillQ:

A'W1U611bIii w/zpeouellm: MeTcpopMHHa m,UpOXJIOPH,U - 500/850/1000 Mr;

BcnoMOeameJlbllble Ullepeouellmbl: I10BH,UOH 20/34/40 Mr, MarHHJI cTeapaT 5,0/8,5/1 0,0 Mr.

IIJIeHo'iHan 060JIO'IKa:

,lI,03HPOBI<a 500 Mr H 850 Mr: mnpOMeJIJI03a 4,016,8 Mr.

,lI,03HPOBI<a 1000 Mr: ona,UpaH 'IHCTbIH 21 Mr (mnpOMeJIJI03a 90,90 %, MaKpOrOJI 4004,550 %,

MaJ<porOJI 8000 4,550 %).

OnncaHlle

)J,03upOBKa 500 Me, 850 Ale:

neJIble, KpyrJIble, ,UBOl!KOBbIIlYKJIble Ta6JIen<ll, nOKpbITble I1JIeHO'IHOH 060JIO'lKOH.

Ha nOnepe'lHOM pmpe3e - O,UHopo,UHa5I 6eJIa5I Macca.

)J,03Up06KC/ 1000 MZ:

neJIble, OBaJIbHbIe, ,UBOJIKOBbIIlYKJIbIe Ta6JIeTKH, nOKpbITble nJIeHO'lHOH 060JIO'lI<OH, c PHCKOH c

06eHX CTOPOH H rpaBlIpoBl<OH <<1000» C O.l1HOH CTOPOHbI.

Ha rrOrrepeqHOM pa3pe3e - O.l1HOpO.l1HalI 6eJIalI Macca.

<l>apMaKoTeparreBTJI'leCKall rpynna

n NO 14600/0 1- 1408 12

frmorJIlmeMlIqeCKOe Cpe.l1CTBO rpymlbI 611ryaHll.l10B .l1JIlI rrepOpaJIbHOrO rrpllMeHeHlllI .

Ko.l1 ATX: AlOBA02

<l>apMaKoTeparreBTH'leCKlle CBOHCTBa

<l>apMaKO.l1I1HaMIIKa

fmoKo<p3)!(® CHlIlKaeT rllrreprJIllKeMHlO, He rrpHBO.l1lI K pa3BllTHlO rHrrorJIHKeMIIH. B OTJIHqHe 01'

rrpOH3B0.l1HbIX CYJIb<P0HHJIMOqeBllHbI, He CTHMYJIHpyeT CeKpel1HIO HHCYJIHHa II He OKa3bIBaeT

rHrrorJIHICeMHqeCKoro 3<j)(jleKTa y 3.l10POBblX JIHI1. IIOBblIIIaeT qyBCTBHTeJIbHOCTb

rrepmpepJl'IeCKHX pel1errTOpOB K HHCYJIHHY H YTHJIH3al1HlO rJIlOK03bI KJIeTKaMIl. CHI!)KaeT

Bblpa60TKY rJIlQK03bJ rreqeHblO 3a CqeT llHrH6HpOBaHHlI rJIlOKOHeOreHe3a H rJIHKOreHOJIH3a.

3a.l1epll(l!BaeT BcaCblBaHHe rJIlOK03bI B KHIIIe~HKe.

MeT<pOPMHH CTIIMYJIHpyeT CHHTe3 rmmoreHa, B03.l1eHCTBYli Ha rJIHI<oreHCHHTa3Y. YBeJIHqHBaeT

TpaHcrropTHYIO eMKOCTb Bcex TllIIOB MeM6paHHbIX rrepeHOCqHI<OB rJIlOK03bI.

KpOMe 1'01'0, OKa3bIBaeT 6JIarOrrpHliTHbIH 3<jJ<jJeKT Ha MeTa60JIH3M JIHrrll.l10B: CHI!)IcaeT

CO.l1epll(3HHe 06111ero XOJIeCTepHHa, JIHrrOrrpOTeHHOB HH3KOH rrJIOTHOCTH H TpHrJIHl1epH.l10B.

1-1a <jlOHe npHeMa MeT<popMHHa Macca TeJIa rral1HeHTa JIH60 OCTaeTCli cTa6HnbHOH, JIH60

YMepeHHO CHI!)KaeTC5I.

<l>apMaKoKIIHeTIiKa

IIocJIe npHeMa BHYTPb MeT<POPMllH a6cop6HpyeTcli H3 lKeJIY.l10qHO-I(I!IIIeqHoro TpaKTa

.l10CTaTOqHO nOJIHO. A6coJIIOTUali 6H0.l10CTyrrHOCTb COCTaBJIlieT 50-60%. MaICCIlMaJIbHali

KOHl1eHTpaI1H5I (Cmax ) (npHMepHo 2 MKr/MJI HJIH 15 MKMOJIb) B nJI33Me .l10CTHraeTCli qepe3 2,5 q.

IIpH O.l1HOBpeMeHHoM nplleMe nllll1H a6cop6111151 MeT<popMllHa CHHlI(3eTCli II 3a.l1epll(l!BaeTcli.

MeT(jlOpMHH 6bICTPO pacnpe.l1eJI5IeTCli B TKaHH, npaKTllqeCI(I! He CB1I3bIBaeTC5I C 6eJIKaMil

nJI33MbI. IIO.l1BepraeTCli MeTa60JIH3MY B OqeHb CJIa60H CTen eHIl II BbIB0.l111TCli rrOqKaMIl.

KJIllpeHC MeT<jlOpMHHa y 3.l10POBblX cy6beKToB COCTaBJIlieT 400 MJI/ MllH (B 4 pa3a 60JIbIIIe, qeM

KJIllpeHC KpeaTHHllHa), 'ITO CBH.l1eTeJIbCTByeT 0 HaJIllqnll aKTllBHOH KaHaJIbl1HeBOH CeKpel1llll.

IIepHo.l1 rrOJIYBbIBe.l1eHHlI COCTaBJIlieT rrpH6JIll3HTeJIbHO 6,5 qaCOB. I1PH rrOqeqHOH

He.l10CTaTOqHOCTH OH B03paCTaeT, rr05lBJIlIeTC5I PHCK KYMYJIlIl1llH rrperrapaTa.

2

f1 NO 14600/0 1 - 1408 12

IIOKa3aHlfH I, npUMeHeHIfIO

CaxapHbl ll ~lla6eT 2 Tllna, oc06eHHo Y lJal\UeHTOB C OlKHpeHHeM, rrpH He3<p<peKTuBHoCTH

~HeToTepaIllnl H <pll3wrecKux HarpY30Ic

• Y B3POCJIblX B Ka'IeCTBe MOHoTepaIllIll llJIll B CO'leTaHHU C ~pyrllMll rrepoparrbHbIMH

rllrrOrJIllKeMWreCKllMll cpe~cTBaMll, llJIll C HHCYJIHHOM;

• Y ~eTell C 10 JIeT B Ka'leCTBe MOHoTepanHH llJIll B CO'leTaHHll C ImCYJIHHOM.

IIpOTlfBonOKa3aUUII

• IToBblIlIeHHall '1YBcTBHTeJIbHOCTb K MeTqJOpMIIHY llJIll K JIl060MY BCl10MOraTeJIbHOMY

Bell\eCTBY;

• ~Ha6eTII'IeCI<Hll KeTOal\H~03, ~Ha6eTwlecI<a1l rrpeKOMa, KOMa;

• rrO'le'lHall He~OCTaTO'lHOCTb HJIH HapYIlIeHlle <PYHKl\llll rrO'leK (KJIllpeHC KpeaTllHllHa MeHee

60 MJI/MHH);

• oCTpble COCTOllHHll, rrpOTeKalOIl\He C PHCKOM p33BllTHII HapYIlIeHHII (PYHKl\HH rrOqeK:

~erH,1\paTal\Hll (rrpH ,1\Hapee, pBOTe), TmKeJIble llH<peKl\HOHHble 3a6oJIeBaHllll, IlIOK;

• KJIHHH'IeCKH BblpmKeHHble rrpOIIBJIeHHII OCTpblX HJIll XpOHHqeCKllX 3a6oJIeBaHHll, KOTopble

MorYT rrpHBO,1\HTb K pa3BHTlllO TKaHeBOll rHrrOKCllH (B TOM '1llCJle, Cep,1\eqHall llJIll

,1\b1XaTeJlbHall He,1\OCTaTO'lHOCTb, OCTPbIllllH<paPI<T MllOKap,1\a);

• 06IlIllpHbie xHpyprH'IeCKHe Orrepal\HH H TpaBMbI, KOr,1\a rrOKa3aHO rrpOBe,1\eHHe

HHCYJlHHOTeparlHH (CM. p33,1\eJI (OC06ble YK33aHlllI»);

• neqeHO'lHall He,1\OCTaTOqHOCTb, HapYIlIeHHe (PYHKl\HH rreqeHH;

• XpOIfHqeCKHll aJIKOrOJIH3M, OCTpoe OTpaBJIeHlle aJIKOrOJIeM;

• 6epeMelmOCTb;

• naKTOal\ll,1\03 (B T.q. II B aI-laMHe3e);

• npllMeHefIlle B TeqetIlle MeHee 48 'I ,1\0 II B TeqeHlle 48 'I rrocne npOBe,1\eI-lHII

pa,1\HOH30TorrHblX HJIH peliTreHOJlOrH'IeCI<HX HCCne,1\OBaI-lHll C BBe,1\eHHeM llO,1\CO,1\eplKaIl\ero

KOHTpaCTllOrO BeIl\eCTBa (CM. p33,1\eJI «B3aHMO,1\ellCTBlle C ,1\pyrHMH JIeKapCTBeHHbIMH

Cpe,1\CTBaMH»);

• C06J1IO,1\eHHe rHnOl<aJIOpHllHOll ,1\HeTbI (MeHee 1000 KKarr/cYT).

C OCTOPOlKI-IOCTbIO

ITpHMeHllTb npenapaT Y nlll\ CTapille 60 neT, BbIIlOJII-IIlIOIl\llX TlIlKeJlYIO <pH3H'IeCKYIO pa60TY, 'ITO

CBII3aI-lO C rrOBbIIlIeHHhIM PHCKOM p33BHTHll Y HHX JIaKTOal\H,1\03a; B nepHO,1\ rpY,1\HOrO

BCKapMJIHBaHlllI.

3

n NO J 4600/0 1- 1408 12

IIpnMcneHlle BO BpeMS! 6epeMennocTn n B ncpnOA rpYAnoro BClmpMJlUBanllS!

~eKoMrreHcllpoBaHHbIH caxapHhIH AHa6eT BO BpeMll 6epeMeHHocTll cml3au C rrOBbIllieHHbIM

PllCKOM B03HllICHOBeHll5! BpQ)KAeHUbIX nopOKOB II nepllUaTaJIhHOH CMepTHOCTll. OrpaHll'leHHOe

KOJIWleCTBO "aHHhIX CBll"eTeJIbCTByeT 0 TOM, 'ITO nplleM MeTcjlOpMllHa Y 6epeMeHUbIX )KeHlIJllH

He YBeJIll'!llBaeT PHCK p33BllTll5! BpQ)K"eHHbIX nopOJ<OB y "eTeH.

I1Pll nJIaHHpOBaHllll 6epeMeuHOCTH, a TaK)Ke B cJIy<rae HacTynJIeHllH 6epeMeHHOCTH Ha cpOHe

nplleMa MeTcpopMHHa, npenapaT "OJl)KeH 6bITb oTMeHeH, II H33Ha'!eHa llHCYJIllHOTeparrll5l.

He06xo"llMO rrOMep)KHBaTb CO"ep)KaHlle rJIIOK03bI B rrJI33Me KpOBll Ha ypoBHe, Hall60JIee

6JIll3KOM K HopMe "JIll CHl!)KeHllll pllcKa B03HllICHOBeHllll rropoKoB p33BHTllH rrJIo"a.

MeTcpopMllH BbIBO"llTCll C rpy"HbIM MOJIOKOM. I1060,!HbIe 3<pcpeKThI y HOBopQ)K"eHHblx rrpll

rpYNJOM BCKapMJIllBaHllll Ha qlOHe nplleMa MeT<popMllHa He Ha6mo"aJIHCb. O"HaKO B CBH3ll C

orpaHll'!eHHbIM I<OJIll'!eCTBOM "aHHbIX, npllMeHeHue npenapaTa B nepllO" KOpMJIeHllH rpy"blO

ue peKOMeH"OBauo. PellieUlle 0 npeKpalIJeUllll KOpMJIeUll51 rpy"bJO "OJl)KUO 6bITb npllHHTO C

y'!eTOM rrOJIh3bI 01' rpy"Horo BCKapMJIllBaUll51 II nOTeHl1llaJIbHOrO pllCKa B03UllICHOBeUllll

rr060'!HbIX 3cpcpeKTOB y pe6eUKa.

Cnoc06 npUMenenuS! II A03L1

I1pllMem!IOT BUYTpb.

B3pOCJlble:

MOlfomepaml5l 1I KOM6111f1lpOaaliliafl mepaml5l a co~emallllU c OPY211MlI nepopaJ/b/iblMli

2un02J/UKeMu~eCKUMU cpeocmaaMU:

• 06bl'lUall Ua'faJIbHa5I ,,03a COCTaBJUIeT 500 Mr llJIll 850 Mr 2-3 p33a B CYTKll nOCJIe llJIll BO

BpeMll rrplleMa rrlllIJll. B03MQ)[(UO "aJIbUeHlliee rrOCTerreuuoe YBeJIll'IeHHe ,,03bI B

3aBllCllMOCTll OT KOUl1elfTpal1llll rJIIOK03bI B KpOBll.

• I1oMep)KllBalOlIJa5I ,,03a rrperrapaTa 06bI'IHO COCTaBJI5IeT 1500-2000 Mr/cYT. ~JUI

YMeUbHIeUll5I lJ060'fHbIX HBJIeHllH co CTOPOUbI )[(eJIy"O'fUO-KllHIe'fIJOro TpaKTa CYTO'fUYJO

,,03Y CJIef\YeT pa3"eJIllTb ua 2-3 rrplleMa. MaKCllMaJIbUa5I ,,03a COCTaBJIHeT 3000 Mr/cYT,

p33"eJIeUUaH ua Tpll nplleMa.

• Me"JIeuuoe YBeJIWleHHe ,,03bI MQ)[(eT crroc06cTBoBaTb YJIyqHIeHlllO )Keny"o'!Ho-KllHIe'!HoH

rrepeuocllMoCTll.

• I1al1lleUTbI, rrpmIllMalOlIJlle MenjlOpMHu B ,,03ax 2000-3000 Mr/cYT, MoryT 6bITb rrepeBe"eubI

ua rrplleM rrperrapaTa fmoKocp3)[(@ 1000 Mr. MaKCHMaJIbHa5I peKOMeH"OBaHHal! ,,03a

COCTaBJIl!eT 3000 Mr/cYT, p33"eneHHall Ha 3 rrplleMa.

4

n N0 14600/0J -1408 12

B cny'lae nnaHHpOBaHHlI nepexoAa C npHeMa Apyroro rHnOrnHKeMH'leCKOrO CpeACTBa:

HeofixOAHMO npeKpaTHTb npHeM Apyroro CpeACTBa H Ha'laTb npHeM npenapaTa fmOKO(jJa)!(® B

A03e, YKmaHHOil BblIIJe.

J(oM6UHal/Ufl C UlICYJIUIIOM:

,I(n5I AOCTHlKeHHlI Jl)"IIIJerO KOHTpOnli rmOK03bI B KpOBlf MeT!jJOpMHH H HHcynHH MO)!(HO

npHMeHlITb B BHAe KOMfiHHHpOBaHHOil TepanHH. OfibI'IHali Ha'lanbHali A03a npenapaTa

fmOICO(jlalK® COCTaBnlleT 500 Mr HnH 850 Mr 2-3 pa3a B CyTKH, B TO BpeMli KaK A03Y IfHcynHHa

IIOAfiHparOT Ha OCHOBaHHH KOHl\eHTpal\HH rmOK03bI B KpOBH.

llemu U nOOpOCmKU: y AeTeil C 10-neTHero B03paCTa fnIOKotPalK@ MOlKeT npHMeHHbcli KaK B

MOHoTepanHH, TaK H B CO'leTaHHH C HHcynHHoM. OfibI'IHali Ha'lanbHa51 A03a COCTaBJIlleT 500 Mr

HnH 850 Mr 1 pm B CYTICH nocne HnH BO npeM5I IIpHeMa IIHIl\IL Lfepe3 10-15 AHeil A03Y

HeofixoAHMO cKoppeKTHpoBaTb Ha OCHOBaHHH KOHl\erITpal\HH rmOK03bI KpOBH. MaKCHMallbHa51

cYTo'lHaH A03a COCTaBnlleT 2000 Mr, pa3AeneHHali Ha 2-3 IIpHeMa.

llauueHmbl nOJlCUJlO20 603pacma: H3-3a B03MOlKHoro CHHllceHH5I (jJYHKl\HH IIO'leK A03Y

MeTtPopMHHa HeofixoAHMO rroAfiHpaTb rrOA perynnpHbIM KOIfTpOneM nOKmaTeneil tPYHKl\HH

rrO'leK (orrpeAenllTb KOHl\eHTpal\HIO ICpeaTHHHHa B CbIBopoTKe KpOBH He MeHee 2-4 pm B roA).

IT pOAOnJKlITeJlbHOCTb J1e'lellllSI

fmOKO(paJK@ cneAyeT rrpHHHMaTb e)!CeAHeBHO, fie3 rrepepbIBa. B cny'lae rrpeKpaIl\eHHlI ne'leHH5I

nal\HeHT AOlllKeH COOfiIl\HTb ofi 3TOM Bpaqy.

ITo6o'llloe AeilcTBue

LfacToTa rrOfiO'lHblX 3<j)(jleKToB rrperrapaTa paCl(eHHBaeTC5I cneAYIOIl\HM ofipmOM:

O'leHb 'IaCTble: ;:0: 1110

LfacTble: ;:0: 11100, < 1110

He'laCTble: ;:0: 111000, < 11100

PeAKHe:;:O: 1110000, < 111000

O'leHb peAKHe: < 1110000

TIofio'llloe AeilcTBHe rrpeAcTaBneHo B rropliAKe CHHllceHHlI 3Ha'lHMOCTH.

HapYIIJeHHlI co CTOPOHbI ofiMeHa BeIl\eCTB H rrHTaHHlI:

O'leHb peAKo: naKTOal(HA03 (CM. «OCOfible YKa3aHH5I»).

5

n NO 1460010 1- 1408 12

I1PH JVJHTerrbHOM npHeMe MeniJOpMHHa MOlI(eT Ha6mo):laTbcjJ CHHlI(elme BcaChmaHHlI BHTaMHHa

B 12. I1PH 06HapYlIWHHH Merarr06rracTHoJ.i aHeMHI1 He06xo):lHMO yYl1TbIBaTb B03MOlKHOCTb TaKoJ.i

3THOrrormi.

HapyweHl1l1 CO CTOPOHbI HepBHoJ.i CI1CTeMbI:

qacTO: HapyweHlIe BKyca.

HapyrneHl1l1 CO CTOPOHbl )Kerry.aO'lHO-KHIIIe'IHOrO TpaKTa :

OqeHh q aCTO: TOWHOTa, pBOTa, ):Illapell, 60rrl1 B )KI1BOTe H OTCYTcTBl1e anneTHTa.

HaH60rree '1aCTO OHH B03HI1KalOT B Ha'larrbHblH nepHO):l rre'leHl1l1 H B 60rrhIIIHHcTBe clIyYaeB

cnOHTaHHO npOXO):lllT. ,l(rrjJ npe):lOTBparueHl1l1 CHMnTOMOB peKOMeH):IyeTclI npHHI1MaTb

MeniJOpMI1H 2 Hrrl1 3 pa3a B ):IeHb BO BpeMjJ HrrH nocrre npHeMa nHruH. Me):lrreHHOe YBerrH'IeHHe

):103M MOlIWT yrry'lwHTb )KerrY):lO'lHO-KHllle'lHYIO nepeHOCHMOCTb.

HapyrneHHlI CO CTOPOHbI KO)KI1 11 nO):lKOlKHblX TKaHeH:

O'leHb pe):lKO: KO)KHble peaKL(lm, TaKHe KaK 3pHTeMa, 3Y):l, CbIllb.

HapYIIIeHl1l1 CO CTOPOHbI n e 'leHI1I1 )KeJI'IeBbIBO):lllWHX nyreH:

O'leHb pe):lKO: HapyweHHe nOKa3aTeJIeJ.i <PYHKL(HH ne'leHH H renaTHT; nOCJIe OTMeHbI

MenpOpMI1Ha 3TI1 lfe)KeJIaTeJIbHbJe lIBJIeHl1l1 nOJIHOCTbIO HCqe3a1OT.

Ony6JII1I(QBaHHble ):IaHHble, nOCTMapKeTI1HrDBble ):IaHHble, a TaK )Ke KOHTpOJIl1pyeMble

KJII1HI1'1eCKl1e I1CCJIe):lOBaHl1l1 B OrpaHH'leHHoJ.i ):IeTCKOH nonYJIlIIjl111 B B03pacTHoJ.i rpynne

10-16 JIeT nOI(a3bmaIOT, 'ITO n060'lHble 3<p<iJeI(Tbl y ):IeTeJ.i no xapm<Tepy 11 TlDKeCTI1 CXO)I(J1 C

TaKOBblMI1 y B3POCJIbIX naL(l1eHTOB.

IIepe):lo3Hpom,a

I1PH npl1MeHeHI1H MeT<popMHHa B ):I03e 85 r (B 42,5 pa3 npeBblwalOrueJ.i MaKCI1MaJIbHyIO

cyTD'lHyIO ):I03y) pa3BI1THlI mnOrJIHKeMHI1 He Ha6JIIO):IaJIOCb. O):lHaKO B 3TOM clIyYae

Ha6JJ1O):IaJIOCb pa3BHTHe JIaKTOaI1H):I03a. 3Ha'lI1TeJIbHali nepe):l0311pOBKa HJIH COnpll)KeHHble

<paKTopbI pHCKa MorYT npHBeCTH K pa3BHTHIO JIaI<TOaI1H):I03a (CM. «OC06ble YKa3aHHlIJJ) .

JJe'lellue: B CJIyYae nOllBrreHHlI npH3HaKOB JIaKTOaL(H):I03a JIe'lelme npenapaTOM He06xo):lHMO

r-reMe):lrreHHO npeKpan!Tb, 60JlbHOrO CPO'lHO rocmrraJII1311pOBaTb 11, onpe):leJlHB KOHI1eHTpaI1HIO

JlaKTaTa, YTO'lHI1Tb ):IHarH03. Hal160Jlee 3<iJ<peKTI1BHbIM MepOnpHlITl1eM no BblBe):leHI1IO H3

6

II NOI4600/0 1- 140812

Opraml3Ma naKTaTa H MenjlopMHHa lIBJllIeTClI reMOJ\HanH3. ilPOBOJ\llT TaK)Ke CHMnTOMaTHqeCKOe

Jle'leHHe.

B3aHMOACiicTBIlC C J\pynlMIl JlCIC3PCTBCHHblMH CPCJ\CTB3MH

flpOmUGOnOKa3allllble Ko,,,,6ullat/UU

HoocooepJ/cau/ue pelimceIlOf(OllmpaCl1l11bl.e cpeocl11ea: Ha IPOHe <PYHl(].\HOHanbHOM rrOqe'lliOM

HeJ\OCTaTO'lHOCTH y 60JlbHbIX CaXapHbTM J\Ha6eTOM paJ\HOnOrH'IeCKOe HCCneJ\OBaHHe C

npHMeHeHHeM MOJ\COJ\ep)Kall.(HX peHTreHOKOHTpaCTHbIX CpeJ\CTB MQ)KeT BbT3bIBaTb pa3BHTHe

JlaKTOaI.\HJ\03a. JIeqeHHe npenapaTOM rmOI<OIPalK@ He06xoJ\HMO OTMeHHTb B 3aBHCHMOCTH OT

<PYHKI.\HH rrOqeK 3a 48 'I AO HnH Ha BpeMli peHTreHOnOrHqeCKOrO HccneJ\OBaHIil! C npHMeHeHHeM

MOJ\coJ\ep)KaIl.\HX peJ-ITreHOKOHTpacTHblx cpeJ\cTB H He B0306HOBnllTb panee 48 'I nocne, npH

YCJlOBHH, 'ITO B xOJ\e 06cneJ\OBaHHll nO'leqHali <jlYHKI.\Hll 6bma npH3HaHa nopManbHoM.

HepeKoMelloyeMble KOM6Ullat/UU

Allf(02011b: rrpH OCTPOM anKoronbHOM HHTOKCHKal.\HH yaenwIHBaeTClI PHCK pa3BHTHlI

naI<TOaI.\HJ\03a, oc06eHHO B cJlyqae :

• HeJ\OCTaTO'IHOrO rrHTaHHll, c06nlOJ\eHHlI HH3KOKanopHHHOH J\HeTbI;

• rreqeHOqHOH HeJ\OCTaTOqHOCTH.

Bo BpeMlI npHeMa npenapaTa cneJ\yeT H36eraTb npHeMa am<oronlI H neKapCTBeHHbIX cpeJ\CTB,

COJ\ep)l(aIl.\HX 3TaHon.

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JIPOll3BOAIITeJJb

MepI< CaHT:') c.a.c., <fJpaHUMli

Merck Sante s.a.s., France

IOpuou~ecKuii oopec:

37, PIO CeH POMeH - 69379 TIMOH CeAeI<C 08, <fJpaHUMli

37, rue Saint Romain - 69379 Lyon Cedex 08, France

Aopec np0U3800C1neelfIl0l1 nJlOUlooKU:

CeHTp Ae rrpoA)'I(CbOH CeMya, 2 PIO AIO I1peccyap Bep - 45400 CeMya, <fJpaHUMll

Centre de production Semoy, 2 rue du Pressoir Vert - 45400 Semoy, France

JIpeTCH3I111 rroTpe6uTeJleii HanpaOJlHTb no a)J.pecy:

000 «lhllcoMeA )J,lIcTpn6blOwH CenT.»)

119048 MocI<Ba, yn. Y CaqeBa, A. 2, CTp. 1

Teneq)OH: (495) 9335511; cpaI<c: (495) 5021625

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