BERLII{-CHEMIE

MEI\ARIl\I

?EWPtrH W?R'FIirrA.I 3A "UtrKOT

Espumisan */ Ecnytrlrcau
40 mg
(simetikon/cnuernxou)

^l 2. KBAJMTATT4BHI{HII tI KBA}ITIIITAT?IBHI,I COCTAB IIA JTEKOT I

EgHa MeKa KalcyJra coAp)Kr{ 40 rurrcrrMerrzrKon.

3a ercqr{rrr4encr{
nugw6.1,.

3. @APMAIIEOTCKH OEJII{K

Kancynu, MeKrd.

4. KITUIHpITTKH
fr OAAT OUU

.^ 4.1 TepanucKrr unAlrKarlrru

- 3a repanlaja Ha N{aLiHuHI4 npeApI3BI4Kar{nog He$u3l{ororuKu racHn cpoprtrai{r4vBo

Ar,rrecrr4BHr,ror rpaKT ( uereopH3aM, pe+nyrceu e:o$arur)
- llpernpeMa sa gujarHocrntlKn npoqetrypu Bo
Ar,rrecrr.rBHnorrpaKr ( paguorpa$crx ,
conortl acf cri,r, en/{ocKOrlcxu)
- l4ttroxci.il(al{i.{i,I
co cpeAc'fBa clleAcrBzr3a ncllcrLe ( :la o;1c't,parryRaHse
na trcrr;}T.aoA
i{I{fccT'I4llIIIIol' cncTctr4 ).

4.2 frostrpalbeH rraqrrrrHa npr,rMeHa

Bo-cqrlajx a-rtriisHr{Hrrltpurparff r
flpeuopaqeHaAo3aI{3HecyB a \'-2 Ka[cynrr Ecnyvrucaw3-4[arr,r Ha Ae]r 3a Ae
cTapocT, aAorlecrleHTr{tr Bo3pa cH.vl.

Ecnyrvlucall@ ce 3eMa Bo reKor 'rrpe[

Lrrrkrnocre o6poror, racro raKa rd
noTpeoHo.
Tpaeire Ha repanujara 3aBr4cpr
oA npr,IcyTHocTa Ha Mar{HLrHnTe.
 Ecuyr'Msau@'i(oxe
Aa ce Kopr.rcrrifloAonrBpeMeqcrhtreptroA,AoKonKye roa Heorrxo[Ho.

ga/rfjl rnocrr,rqr<a cnsvaq.a:

fTfrr,lnfreva
3 narlr no 2 Ecnyuucan@ K:[rcyn[ aa AeHrrpeAaenfiryBalr'a n 2 E crrlwrncau@rancylu nayrpo
Ha AeHOTIIa I,ICrIIzTJrBaII>e.
flpn rpyerra co cpeAcrBa3a fleperbe Ao3ara3aBrrcnoA cretreHor rra rpyeH,ero.Iloverna 4osa
Moxe Aa 6ngar 2-4 Karrcyrn eAnoKparno.

Hanowena:HoBoHacraHarr{TevluJru rrcpgvctnpatlKlire a64ounualufi 6olru rpe6a rcrI Hrr1lgf

Aa ce IrcIII4TaaT.

4,3 KcinrpamAnKaqu
Xr.rnepcenaurranuocr
rra epa unnnonef<eKoMnoHeHTlr
na onoj :rer.

4'4 rroce6uanpe4yupeAyBar'au MepK na nper[a3JrrrBocrnplr ynorpe6a HarreKor.

llopagrznpficycrBoro na uervnnapa6eirno oroj JreKMo)Kega ce uojaru yprr.*apnja
(ocr-rn).
3axacaera peaxqnja ao.Bt4A
HaKoHTaKreE e nsro rari lroxna.
[epMarr4Tr4c
Yprlrxaplrjaaufi npoMeHr{N 6pouxocnaralrcejaaynaa,rno perKri cnfrau,

fTf elrJnf efiynarr-e:

I
Onoj ngK coAp)Kr,r )Korrra noproKarroBa 6oja (E 1.10)" roja MO)Ke Aa npeAr,r3BrrKaaJleprr4cKa
peaKrlr4ja,BKrrfryBaj*u n 6pouxocrra3aMKaj oeo6w Kor4 ce [peoceTJrrIBH Ha oBaa c)mcTaHrla.
oene HecaKanr4eSerrlr ce nor{ecrrr Kaj oco6n Kor4 ce anepFr,rrrHu Ha al{eTr{ncanl4l{r{nHa
I

Krrcerrr4Ha.[oroJrKy cr{MnroM}rre rpaar noAorlro BpeMe}I roKpaj ilpeKHHoT Ha repanr4jaTa co

rreKoTnoTpe6Hoe Aa no6apaTe noMour oA rreKapoT.

4.5 VftirepaKrlr{ja co Apyru JreKoBrrrr Apyru Bpcrr,rr{HrepaKrluu

VnrepaKIIHjaH'aEcnyuucaH Karrcynara co Apyrn JIeKoBr,r

Ao cera He e no3Hara

4.6 IIpuMeHaBo neptroAor Ha 6peMeHocrrr Aoelbe

He nocrou orlacHocr3a y[orp e6a uaEcnyr,,tracaFl

KarrcyfirrBoreKor Ha 6peueriocr r.rnepr]oAor
HanoelLe.

4"7 Xlxlr.ialxcfcx{i} }{el(x${,}I{gx{xrri-{,r'x'e

{:rc$cft6rli}c'r}dB$ T'e-{{{ii{.irri}/i{i}ai}vr}srr]o c{} ilI{}',}'{}p }fi { rJ$3}tn i}
I1 l):iiiyxlitlx.,{]co hiilxiiltill{ !
EcttyullcaH@ KancyJII,ITe He nnr4jaar Ha pecbneKCzrre, ue ja r{aManyBaar
y[paByBarLe co MoropHo Bo3r{Jro }r paKyBarbe co MaIur{Hr{.

4.8 HecaKarrugejcrna

Ocnes rojaBa Ha rpeocerrrr,rBocr( ypnKapHeJrHH

npoMenlrn 6ponxocrra3aM,),[F
gejcrna oA rlpl{Menara Ha Karcynu E,cilyMr{caHAocera He ce orrnruaHn. ,(nu[r4,(.4).
 wmo
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W
r
1!:
4.9flpeqoerpare

Co o6srp gexa craveraKorlor xeMr{cxzu e norrroJrno alrepren, r4HToxcuraqraja

Susuo.uolrrKr,r e
npaKTr'rrrHo
r'rcK.rryveua.
foleua Ao3rrHa crrMerlr*oHce roJreprlpaar 6eg noreurxoruu.

s. o APMAK OJIOIIIKI,IIIOAAT OI{pI

5.1 OapnraxogunaMcxnrroAaroqrr
Ecnyltucan coAp)KI4aKTIzBHacyncraHlla crrMerrrKoH ( grauerrrrno:rzcvJroKciur
- 14AenyBa Bps rroBprrrl4HcKr'IorHarroH Ha reqHocrl4Te. Cul,.tetarono:r ) xoja e c:|a6wrIla
ro cMajryBa noBprrrnHcKl4or
IrarroH Ha reqHocrl4Te fiopaAlr Irrro MeypI4TeoA TeqHocra
Bo KoH rupo6""t racoBl4TeBo
ArzrecrriBHr'rorcrisfeM npcKaar r4 racoBr'Te Ce ofioboAyBaar za enuunnaTuja
""
og qpenara. Taxa
ocno6oser*rreracoBuMoxar ga 6ngar ror *.op6rpu",
;p;;;;;;"-"ii"*"ro, sr4Ar.rrrr{
elnMnaupaHuco S:rarynenqxja( enrepoxzneslrja
3lcrBoro Ha Ll vrerr.rKoHor r{Ma
7.
$usuvra KapaKTep a xeNrucKrr u QaplraxoAauaMcKr4 e
riHePTHacyficTaHqa.

-
5.2@apuaKoKr.rHernrrrnfloAaroqu

Crzuetrzron ue ce ancop6zpa nocJrerrepopanua npltMene L ce

ernrnr\HtrpaKaKoHenpoMegerBo
Qeqecor.

-
5.3 Ilperxaur tqrrr $apmaro.noruro rorcr.rrorolfiNrr troAaroqrl
Bo npeArcrru 4rrKr{Te Lrc.rrnrwa:ft,a ,, in vitro
- ,, rcll}IryBax e e$eRror IIa cEMerrlKoH Bp3
p-acnafaBero Ha MeypI4TeOA neHecrr4TepacrBopr4a octo6ogynan
ero na sapo6eHlrre racoBi.r.
Kop'creHu ce rouepqujanHr'r reql r neHn, pacrBoptr co
Harpr4yM nawvn cyn$ar xa'e e
- AoAaBaHcI4MerIzKoH u e KoHcrarr{pa}ro AeKa3a KpaTKoBpeMereqgr,ITe MeF{yMr4KoMrrJrergo
ce
I'{acfipaar ( nenara Bo rerrHocrrrre KoMJrerHoce ry6ra ).

- llocrojar u foJIeM 6poj excnepuuenrrz ,, in vivo

,, Ha eKcrrepr4MeHTaJrrrr4)Kr4BorHr4KaAe
cr{Merr{Konor e AaBaHrrepopanuo. flenectrate coApxr,rHliugTparacrpr{qHo
ce npeAr43Br4KyBaHra
co JalJreHAIzoKcI4nrr carroEtrlJn' a racrpl'IqHara uzyattusaquja na
re.ruo"rute e rpare,Ila co
- /loAaBaHrc }ra paAr4OaKTr4BarT narpr{y},{ jonul-pacraop pa1r,r<_rrpa(rcrfi_
cl{A{c'i'llKoiri
f{oxax<alro c gexa
IIocJIo nepopzlJlira iIIIJII'IKzllii4ja cl{rllfi4rnKzl}I'i'Flo rr{ ocJIC6ogyra 3apo6ei-lr,rre fzr
RO A],IICCTI,I]]HI,IOT C?ICTCM 32I NOHE}TAMOIIIHA HI,IBI.IA
HCCMCT'AHA EJII4MI4HAI{Hi
aAr'IuHl'Icrpaquja Ha 2 Mrr AuMerllrrro Jrr4ctriloKcaH Kaj Kyqr4rba
He [pegr{38}rKyBa eee
KpBHI4or rplrrl4coK MepeH Bo
SeMopaJIHa aprepl4ja, BpeMero Ha roiryna\uj;, nrra3M
Bonyv{eH,xeMorrlo6nnor, eJIeKToeHIIecbanofpaMor I4 eJleKToKapAr4orpaMor.

EKcnepLIMeH arHI'{Te pe3ynrarH oA HanpaBeHaTa aKyTHa, cy|aKy.r1a

u
KaAe cI4MeTIIKOHOTe anJ{I4r{upaH nepopaJrHo, HHTpanep}rroHeaJrHo
- norBpAyBaar AeKa cr{Mer[KOHOT noceAyBa H3pa3I{ToHLrcKaroKcr,rqHocr.

Excnepralreirra.irnoe AoKzDKaHoAeKa cuMerrrKoHor He noceAyBailpgnpgAy{rruia,

- eu6pnororcurr'a 14flepr.r'araJrHa
roKcr4rl'ocr r,rHeMaMyrare' raKapq]r'or"rl n6n"*IrJ -.

fi
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6.1 Jlusra na eKcrllrrruencrt

Merr,rnnapa6en,erawrr, rlrxIlepon (85%), x<orta noproKzrJroBa

6oja (E 110),Kr.ruorr.rn,
xonra
6nie l'F 1 O4\

6.2 Vlnt<oMr arrr 6 unu o cr

[o cera He e rro3Hara.

6.3 Pox Hayrorpe6a

Por Ha yrrorpela e 3 roguHu.

Onoj rIeKHe rpe6a Aa ce Kopl{cr}r [ocJre r,rcreKorHa poKor Ha yflorpe6a.

6.4 floce6un MepKuHa rrperrra3JrrrBocrnpr{ rryBarf,e

[a He ce aryBaHa reMneparypa HaA30oC.

6.5 ffaxyBarLe

EcuyvrucaH(cI{MerrrKoH),MeKaKancyJra40 nar x25 ( 6nncr€p/xyrnja )R.P.ScS

EcnyuHcaH(curwerrrKon),MeKa KancyJra40 nr x 50 ( 6nucrep/xyruja )

Ecnyrvrucau(orueruxon), MeKa r{ancyJra40 narx 100 ( 6nlrcrep/r<yruja )

6.6 Ilpupoga I{ cocraB rra Korrrar{rsa arrr6aJraxa

eetpl,raxol'epafiLrjcrzr cpegcrBo,noJrtrcnrioxcah,
z]irfr4nerLJrprilo
ry]yrre]: cpeACT'Bo
rrporl,rBneHrrr,rBocr
ATC KoA:A03AX13.

Erucrep raKyBalbeoArrpoBr{Ana
IIBI{lAn Sonnja.

6.7 \4tvteII afipeca Ha npOI,I3B0AI{TeJIOT

flpoasnoAr4ren : BERLIN-CHEMIE AG- EepntaH, fepua wuja I

Mecro Ha rrpor43BoAcrBo: R.P.Scherer GmbH- fepualr4ja

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 5.8 Ha.IrrHHa r{3AaBarLe

J-Ieror ce r{3gaBa6eg JieKapcKrrpeqenr.

6'9 froce6ua rvrepKaHa fiperrra3Jrl{Bocr ,,pu oAJIo]KyBe]*e

Ha Marepujarlrre Korr rpe6a,ga,,ce
orQplaT rrocJre[prrMeHara Ha JreKor

Heua noce6nn 6apawa

7.HOCUTBJIHA AO3BOJTA
Cenruua AooenCrconje,CasaKonaqee
nk 13 6p.9

oJIArAOnno

NTM HAilPBAAO3BOJIAI{
DUr{AoEHoBAffi

nANrS{vI rIA PEBITBI{IAIIA Tff(C.rOf

Anpun 20A9

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