Acnuprxo ra6,rerr 500 mg Summary of Product Characteristics

3EI,IPEH I,I3BEIIITAJ 3A OCOEIIHI{TE HA JIEKOT

I,IME HA JIEKOT

Acnnprx@ 500 mg ra6,reru

.,
KBAJII.TTATI,IBEH II KBAHTI'TATHBEH COCTAB
Elna ra6lera coapxn 500 mg aqerlqurrrll.tJrHa KrcennHa,

3a ue.nocsa ,rncra Ha eKcufinhencfi str.{ere ao aeror 6.1 .

3. OAPMAUEBTCKA AO3I,IPAHA OOPMA

Ta6nera

Fenr.r, orpyrarl ra6reru co Bayer-o8 Kpcr Ha eAHara crpaua n o:rarara Aspirin 0.5 Ha Apyrara.

4. K,'IIIHI,I T{KI{ TI OAATOUI,I

1.1 Tepanearcxx xHAIlKautln

Clrunrouarcxo ocro6olysa*e or uaao6o.nxa" :a6o6o.nra, 6olrll Bo rpnoro, 6o,lxa so rp6or,

MeHcrpyiurHfi rero6n, uycrynxa a :uo6ua 6onx4 yMepeHa aprpHTHqHa 6onKa t,t cfiMnroMarcKo
oJlecHyBabe oA 6onKa t,l HaMiuryBabe Ha 3roneMeHa rerecna reMneparypa lt TpecKa 3a BpeMe Ha
HacrriHKa { fprtn.

4.2 .{orxpa*e n uarux na ynorpe6a

Bozpacuu: EAnreqxa .{o3a e I ro 2 Ta6ner}r (500-1000 mg) uro Moxe aa ce 3eMar Bo

4.[o 8 qaca.
HHrepBiullr oa
Maxcruarsara anesHa .{ora e 8 ra6,'reu (4000 mg auerrlca.nnqrlua xxcernua).

,{e4a rnd l2 eoduwxa so3pacm: Ilpenopavauara ,[HeBHa ao3a Ha auerrrcanflu]rrHa Kt-tce;rtaHa

3aaeqae60mg/kgrerecxarexaHa,noaereHasa4,qo6o/uternnao3rl(I5mg/kgcercoa6raca
u,ra l0 mg/kg cexon 4 uaca).

Ta6rerrre rpe6a aa ce 3eMar nocle o6pox co roJreMo KoJrr{.recrBo Boaa.

4.3 Konrpann,quxaqtrx

Acnlp H 500 mg ra6,reru He rpe6a aa ce 3eMar Bo cneaHfiBe cnyqa[:

- flpevyscraurenHocr Ha auerucararrnJrHa Khcer[Hq apyrr ci]Jluurnarr xnt-t Ba.6H{p Koja oa
IpyrlrTe [oMolxHll cocToJI(x
- AKyreH qr{p Ha xenyAHfiKor r.r/rrnH ABaHaecernajreqHoTo qpeBo
- Xeuoparrcrca arjarera
- Hcropnja ua acrMarlqHl HanaAr{, npeAl.r3BltKaHr,t oa caJrtlltfinarfi tr{t,l cyncraHqln co crlqHa
AejcrBa,oco6eHo(HecrepoHAHl.rauruuxQ,ralraropHn,reroau) I
Acnrprao ra6neru 500 mg Summary of Product Characteristics

- Teurra 6y6peNua HHcyQnuueH11uja

- Teuxa xenararHa uucyrlrqllexqnja
- Teruxa cpuesa uHcyrfrureHuaja
- Hcroapeueua ynorpe6a Ha MerorpeKcar Bo aorN oa l5 mg/HeAenHo HrH fioBette (BHAH aen 4.5
I4Hreparuuja co.qpyrlr neroBr.t n apyrt $opr*lr.r ua nnrepaxqtja)
- Ilocre4uoro rpruecevje aa 6peuexocr.

4.4 lloce6sn MepK[ Ha nperrra3nlBocr H noce6ux npe4ynpeayBarta

Bo cle4naee c,ryvar, Acnnpnx 500 ra6,rerr Moxe !a ce ynorpe6yBaar caMo aKo pll3ltKor lt
KopHcra oA rlrauara ynorpe6a BHr..rMarerHo ce trpoqeHerlt:
- Hcrorpeueno .neKyBalr,e co aHTnKoafynaHTHH JreKoBx
- facrpoturecrtHarHfi qr.rpeBx (xponuruu Hnu noBTopnxBlr ula ncroprja ua rpaape*e)
- HapyueHa Qyuxqrja xa qpuuor 1po6 u 6y6pe:tre
- flpevyacrarrelHocr Ha .{pyrfi agraat$lauaropxu/axtrpeavartvHn reKoBr r{nl-t .{pyfll
anepfeHcKli cyncTaHuHH

Jlexoetlre uro coapxar aqelrrcarnut.rJrHa KficeJluHa Moxe aa ce ,{aBa:lr Ha aeqa h aAonecueHTr..r

co rpecKa, caMo aoKonKy pu3uunre n 6eHeQrufiHTe ce lperxoaHo BHr.rMarerHo npoueuera. Oaa
Moxe !a Boal.r ao raxaHapeqeH Pejoa cuH4pou, MHory perKo, Ho onacxo no xnaor ta6olyaarue.

Auerurcarr.rqanHa K[cerHHa Moxe aa npeaH3Btxa 6poHxocna:au tt,{a npeax3BrKa Hana.4[ Ha

acrMa r{Jll.r ,{pyrH xl,|nepceH3}.trHBHfi peaKur.rH. Pu:rxor e noronerrr xaj nauHeHT}t KoH narar oA
6poxxnja.nra acrMa, xpoHlqHa oncrpyKTxBHa 6enogpo6na 6o.necr, a,repraja Ha noneHoB npaB
HJrH OTeqeHa Ha3aJlHa MyKO3a (Ha3anHH nO,rnnn). oga ucro raKa ce oaHecyBa 3a naqlreHTtr KoH
ce npeoceTnttBx Ha Apyrtt cyncTaHuHH (np. xoxHr.r peaKUHx. veuane, ypruxapuja).

flopaAu rrxt6rropulror e$exr ua arperaqnjara xa rpou6oqlrrure, [tro Moxe Aa rpae Ao

HeKonKy AeHoBl,t nocle anluxaqtjara. auerfincar HulrHara KxcerfiHa Moxe .qa AoBe,[e Ao
3foreMeHa reH.{eHqHJa Ha KpBaperue 3a BpeMe n nocae x}lpyprxKrr onepa(xH (ox.nyvysaj(u r,la.nn
onepaqut-r, np. AeHTanHn excrparqut).

Ma.nu Ao:rl Ha auerlicalHuxJlHara KacerrHa ro HaManyBaar r.t3raqyBarbero Ha yphqHa

KucerllHa, uro Moxe aa npeAH3BHKa Hanal Ha raxr xaj nauteura xon ae*e tuaat renAexutia
ua xaua.neuo 6y6pexHo r43naqy8a[be.

Auerurcarrqusa KncerrHa ue rpe6a qa ja :euaar aeua unu a/loJlecqeHTfi 3a neKyBalbe Ha

erpycua NaQerqnja (co finu 6el noraqexa revneparypa), 6et coser oA loKrop. Kaj olpe4eHr.r
eupycHu ruSerqru, oco6eHo rphn rtln A, rpun rnn E u osqlr crrtaHrqa, nocron pr.t3l.lr o,4
Pejoa cau,qponr, MHory perKo, Ho orracHo no xltBor :a6orysan e, uro 6apa fiTHo MerrurlHcKo
BHrMaHhe, Pn:nxor naoxe ,Aa ce 3roneMr rrpn xcrospeMeHa ynorpe6a Ha aqeruncanfiqxnna
KHceIHHa, Ho He nocToH.4oKa3 3a HeKaKBa npl,lqr.lHcKa IIoap3aHocr. flpoAo,rxeHo noapa(ane ao
cx,ton Ha oslre 6orecrr 6u ruoxelo.qa 6lt1e gxax xa Pejoa cnH4poru.

flocrojar aoKa3r.r aeKa neKoBHTe KoH Bpuar rlnxa6uqnja Ha qt,rKnooKcflreHa3aray'cuHTe3ara Ha

npocrarnaHAxHx. Moxar Aa Bnqaar Ha oey.lautjara n 1a ja Haualar Qeprtluocra raj xeHare.
Oaoj eQerr e peaep3x6nneH no 3aBpuyBalbero Ha rperMaHor.

.....'
-,':;
Acnrprro ra6,'rerr-r 500 mg Summary of Product Characteristics

4.5 llxrepaxunx co apyrn nexoBrr u apyrl 0opMlt Ha HHTeparq[ja

hcroapeueua ynorpe6a Ha aqerr{ncanu(utHa KrceJlHHa r.i Merorpetcar (Bo Ao3t, oA 15

mg/HeAenHo Hnfi no8er(e) e r(oHTpaHHAr.tufipaHa. XeMaronorxKara roKcHqHocr Ha MerorpeKcar
ce 3foneMyBa Bo cny.ral Ha rcroBpeMeHa ynorpe6a Ha aqerhncarhu[JrHa KnceJruHa
(Hecrepor.taH[Te anrutHQlauaroptt.i JreKoBH ro HaManyBaar 6y6pexruor KJrrpeHc Ha
MerorpeKcar, a cartlqrJrarfiTe fo orcrpaHyEaar MerorpeKcar Bp3aH 3a nporenHure) (sfi.qa Aer
4.3).

florpe6Ho e noce6uo sHr.L{axfie 3a BpeMe ua rov6uHnpaxa tepanuja co cle4xuBe reKoBr4:

MerorDercar go aorr noua.lu on l5 mq/He,4eluo

Xevaro,roruxara roKcr'rqHocr Ha Merorp€Kcar ce 3roneMysa ao c.nyraj Ha HcroapeMeHa
ynorpe6a co arrer[nc:urr.rufiJr]ra KHceJ'rrHa (He-crepouluure auru-rHQrauaropHr.r JIeKoBH fO
HaMaryBaar 6y6peNxllor Kn[peHc Ha MerorpeKcar, a caJrr.tqr4rarlTe ro orcrDaHVBaaT
MerorpeKcar ap3aa :a nporeuxlre).

xeMocTa3a
3roleuex pH3t K oA KpBapeH,e nopaAN uxxn6upaxara arperaqaja xa rpov6oqurrre
fi noBpeAa
Ha srror
Ha croMaKor H AyoAeHyMor. Aqeralca,rrqulaa KlrcerrHa rh enlMl.tHupa opaflHfiTe
KoafynaHTH Bp3aHH 3a npoTelHHTe npeKy cantlu]rnaTtlTe.

.Ilovru HecrepoaaHlr aHa.nreruuk oaelHo co caaaurrara go roren r.4o:r.l

3roreuex px3HK or racrpoHHTecrHHaJIHo KpBapelbe H qftpeBh nopa,{x c[Heprrcruvxa e$ercru.

QeaexrugHr r.{Hxt6uropu Ha oeancopnuuia Ha ceporoH}rx

3roaeuen pt-t3r.rK oA racrporrHTecrrH:rnHo KpBape$e noparn crrHeprncrnvxn eSerra.

Ypr.rxo:vprqHa,rerosu : 6euso6pouapoH, npo6exuquA

Hava,rysan e Ha u3naqyBaH,ero Ha ypvs+a KHceJr[Ha (KoHKypeHrHo aejcrso ua ry6y,rare
ao
6y6pe:rre).

.Ilurorcnu
3roleuesa xosrleHrpaqaja Ha AnroKclrH Bo nJIa3Ma KoHueH.rpaqxHTe, nopaafi HaMa,leHa
ceKpellrja HH3 6y6pcrare.

np.rlHcynlH,cy.rrQouu,'rypea
4!r!a4g6
l oJreMH ro3r.r Ha arrerhJtcannultrHa KucenHHa
ro :ajaxuysaar xunorJrHKeMficxl,ror e$err ua
auru-laja6ernqare, nopaar.r lej:nHoro xrnorrrKeMHcKo gejcrao n ja e,ravlHnpaar
cy,rQorr.r.nypeara oA nporeliHcKara BpcKa np€Ky caJlfiuhrarfiTe.

.luvoeruut :aeaso co arrerxncar urlrHa Krrce;ruHa Bo Bl.lcoxr.l ao3r.t

Haualexa r,rouepy.rrapna Qtnrpaqtja 3apaAfi HaMaJleHa 6y6pexua cnure:a Ha npocrarnaHA{HH

Cacreucrt uyroroprlxoxal. co HcK,ryqoK Ha xlr,{poKoprx3oH KaKo 3aMecr}trerHa repanxJa 3a

A.{ncor{osa 6orecr
Kopraxocrepolrgure ja :rolelryeaar cerpeqtjara Ha cartaulrrarn, nopa,qu trlTo Hr.lBoro
Ha
Bo KpBra ce peAyrlHpa 3a BpeMe xa repantjara co KopTuKocrepofiAx; Kora
:anlllrtart4re
TepanxJaTa e npexfiHaTa, nocTor.i plr3HK 3a rrpe,{o3fipar|,e co canfluHIaTu.
Acnaparo ra6aerr 500 mg Summary of Product Characteristics

ACE-aHruoreHlnx roxeeDra3a xHx 6uroDa 3aeAHo co auerurcannurrHa KnceJluna Bo roJreMl

.|lo314
Hanaryaarse Ha rnoMepyrapHa Qr.r,rrpaunja nopaau nuxn6npaHara Ba3oAnrararltja ua
npocrarraHnrH Te nryc HaManeH aHTrlxH repreH3u Bet eSexr.

Ba.nnDoaqHa rnceltta
flouecryaarrero oA nporer.{HcKara BpcKa ao nJrar}Mara ja rrolelryaa roKcHqHocra Ha
Bannpol-tqHaTa KHceJItlHa.

AIKoXoI
Aqerrrcalu(n.nnara KrrceJruHa Ir aJrKoxoJror rMaar aalrrnBeH e$err, ruro ro 3roJleMyBa
HeTaTHBHOTO Bnr.{aHhe Ha racTpo-lrHTecTHHarHara MyKo3a h fo npoaonxyBa EpeMeTo Ha
KpBapelbe.

4.6 Ynorpe6a ta BpeMe Ha 6peuerocr u qoe*e

Haxu6aqajara Ha cnHTega Ha npocrarnaHA'rHr.r Moxe Herar'BHo ra arxjae aa 6peue uocra nlunu

pa:rojor ra ell6puonor/$erycor. lloaaroqnre oA en]raeM[onoruKnre cryAHn yKOKyBaar Ha
3foJreMeH pr.t3r.iK 3a cnoHTaH a6opryc r.r cpueau ua,r$opuau[r nocJte ynorpe6ara xa uuxt.t6nrop
Ha crHTe3a Ha npocrarnaHAxHr Bo paHara 6per.aexocr. AlconyrHxor pr{3HK 3a
Kaplfo8acKynapHa uar$oprvauaja ce 3roreMrjt oA noMarr(y ol l%o to oxo,ry l.5oZ. Ce aepyaa
.{eKa pu3HKor ce 3roneMyBa co Ao3ara H,lonxHHara Ha repanfijara.
Ynorpe6ara Ha nHxa6nropr Ha cHHTe3a Ha npocrarnaHr'Hr xaj xrsorrrte, orKpr 3roneMeHa
zary6a u Moprarltrer npea u no uun.rauraqaja na eru6pr.rotor/$erycor. l,lcrotpeueHo,
yrorpe6ara Ha nHxlr6tropu Ha cHHTe3a Ha npocrarnaHlHH Bo rrephoAor xa opratoreu*4 ja
3roneMyBa Qperaeauxjara Ha pa3nlrqHH HapyuyBalba, sx_nyvyaajttn Kap,{l.roBacKyJtapHx
uarQopuaurr.
3a opeue Ha npaoro H BToporo rpnuecevje oA 6peMeHocra, auerr.lJlquluuuJtHara KficerrHa He
rpe6a 4a ce AaBa ocBeH axo He e jacuo norpe6xo. ,{orolry auerfiJlciurnqfinHara rnce,rrua ja
ynorpe6yaa xeua roja cara ga ra6peuetA nrt 3a BpeMe Ha npEoro r.r rroporo rptuecevje o1
6peueuocra, rpe6a 4a xopucru HajMana.{o3a, a AonxuHara Ha rperuauor 4a 6t1e trrro e MoxHo
TIOKDATKA.

3a speue Ha rperoro rpr.ruecevje oA 6peMeHocra, ctre lrxxr,l6uroplr Ha c[HTe3a Ha

npocrarnaHrlHr.r Moxe aa ro a:,roxar $erycor Ha:
- xapAnonynMoH:rnHa roKcHqHocr (co pauo 3arBopalbe Ha ductus arteriosus I nynMoHaJrHa
xunepreH3fija);
- peHanHa 4rcQyxrqnja, lrro Moxe.{a nporpeafipa Bo peHiurHa rscyrDuunenuuja co onnro-
xr.rapoaMHao3a.
Majxara r aerero, Kor ce h3noxeH' xa ruxr6uropu Ha cr{HTe3a Ha npocra laHAHHu, ua rpajor
o4 6peuenocra, Moxe Aa ro.qoxllBear cneAHoBo:
- MoxHo npo.qonxyBalbe Ha BpeMero Ha KpBapelbe, aHTlrarperauuoHeH eQexr uro Moxe Aa ce
nojast.qypa t,t flocne MHory HHCKI, ao3n,
- uHxtt6nqaja Ha KoHTpaKqtlli Ha ]Tepyc, ltro AoBeAyBa Ao oAJroxeHo xr6 npoAonxeHo
nopo.qyBalLe.

r.aKo pe3ynrar Ha roa, aueTlncajrHuuJrHara KnceJrHHa Bo Ao3rj Haq 100 mg/aeu e

KoHTpaHHAHuxpaHa 3a BpeMe Ha rperoro rpHMece,rje oa 6peMeHocra.
Acnr-rpr-+r@ ra6aeru 500 mg Summary of Product Characteristics

Ca,raun:rarrre noMr..rHyBaar Bo Maj.rxHoro MJreKo Bo Marr KoJlnqllHh. EnAej(u Aocera ue ce

3a6enexaHr.r HecaKaHH lejcraa xa AeTeTo nocne noBpeMeHa ynorpe6a, o6x,{Ho e He[oTpe6Ho
npeKfiHyBase Ha aoe*ero, Cenax, npu peaoBna ynorpe6a Hnx npfl 3eMalr,e Ha sxcoKtr ao3u (>
300 mg ua aeu), 4oenero rpe6a nopaHo Aa ce npeKxHe.

4.7 B.nujauue np: cnoco6uocra 3a Bo3erte H paxyBarbe co Marrrlllru

He ce h:seaealr cryaux:a eQerrrre apr cnoco6xocra 3a Bo3elbe u paKyBalbe co MaurnHll.

4.8 HecarcaHH aejcrsa

C.neaHuse crarrKH Ha HHur{.qeHqa ce Kopxcrar 3a npoqeHyBarte Ha 3aqecrenocra Ha HecaKaHH

,4elcrBa:

Mnory qecro ( Z l/10) 9ecro (Z l/100 ao < l/10)

floBpeMeHo (Z l/1000 ao < PerKo (> l/10000 ao < l/1000)
I / 100)
Mrory perro (< l/10000), Heno3Harx (xe uoxe /la ce fipoueHar Bp3 ocHoBa Ha
pacnonoxnrrBuTe noaaroqr)

IacrponrrecrnxarHrr HapytuyBarsa
9ecrr ce mcrpoxHTecrrrHiulHHTe nopeMerysalla KaKo onlrrrr 3Haufi t-t cr.tMrrroMH ta lncnenctja
a 6orxa Bo croMaKor H noBp€MeH[ ce racrpor4HTecrxHillrHl{Te aocnaleHxja,
racTpouHTecTfiHarHr{Te qnpeBll, txTo MHofy peTKo Moxe aa .qoBeaaT Io KpBaperbe H
nepQopaurja, co la6oparoprcru xJll.lHHqKfi 3Haql ll ct.rMIToMH.

Hapyurynasa Ha KpBTa x .numSuuor cncreu

Aqerr.nca,ruuursara rcrcerrra ja cnpeqyBa arperauujara Ha rpov6oqtrnre, uro ro 3roneMyBa
plt3r.tKor 3a KpBapelbe. 3a6enexaHo e KpBapelbe 3a Bpeue Ha onepaqaja, xeMaroMl, KpBapelbe oa
Hocor, KpBapelbe oA reHr.rroypuHapuuor cficreM x KpBapebe o.q xenqara. flplrjaaexr{ ce fi perKx,
Ao MouHe perKn cepuo3Hr.r KpBapelr,4 KaKo [lro ce racrponHecruHaJlHra rpaaperra (xeuarevera,
ue,reHa), uo:ovro KpBapel$e (oco6euo raj naqnexrt co HeKoHTpoJll{pana xanepreu:uja u/anx
Ha HcroBpeMeHa repanrja co aHTuKoarynaHrxt lexorn), uro Bo noelrHetHn clyrat 6u
voNe,ro aa 6uae onacHo no xuBor.

Kpraperrero Moxe Aa AoBe.qe Ao aKyrHa h xpoHnqHa nocrxeMoparfiqHa aHeuxja/ aleutja

3apaAlr Heaocrarox Ha xeJre3o (:apaAu ua,ru cKpueHx xeMoparrn) co .na6oparopucKr H
K/'l I-l H lr 9 Kr{ 3Haufi }.t CHMnTOMI-1.

Hapyurynatr'o Hs HMyuonourKnor cxcr€M

Moxe Aa ce nojaBar peaKurli Ha npeocernuBocr Ha pecnr{paropHlor rpaKT co cooABerHfl
.na6oparopncru r.l KrriHnrrxfi cliMnroMlt, KaKo ulro ce cuHApoM Ha acrMa, 6lart Ao yMepeHn
KoxHr.r peaKurx, rrrro Moxe aa ja raQarar Koxara, pecnfiparopxnor rpaKT,
facTpoHHTecTfiHilJrHHoT TpaKT H KapaHoEacKynapHHoT cncTeM, co cHMnToMl, KaKo HcHn,
yprrxapnja, eaeM, qeuralbe! prHrrtc (socnaleHfie Ha HocHara cny3HHua), uocua roHrecrnja,
[opeMeTyBa6e Ha KapaHopecnr4paTopHl.toT cxcTeM n MHory peTKo TeuKu peaKuHr.t co
aua$r,raxrl-tvxu urox.

Hapyurynarua na xenaro-6x,rujapBnor cncreu

MHory perro 6nro npnjaaeuo HapyuyBalLe Ha xenapor co 3roneMeHn BpeAHocrx Ha
TpaHcaMxHa3fiTe.
Acnupauo ra6,rern 500 mg Summary of Product Characteristics

Hapyuryaaua Ha rrepBen cHcreM

Bpror,ranaua x 3yelbe Bo yrxxre uoxe 1a 6lgar lxaun Ha npeKyMepHa,{o3a.

4.9 IIpe4o:npa*e

huroxcrxaqrjara co caruuhrarn (> 100 mg/kg/Aeu noae(e oA ABa AeHa Moxe .Ia AoBeAe Ao
LlHToKcHKaUllja) Moxe Aa 6u1e peaynrar Ha xpoHuqHa repaneBTcKa ynorpe6a, rHroxclrxaqaja
I-ln]r xrr8or-3arpo3yBaqKa aK]"rHa xHToKcr{Karltija (npelo3xpa}be), KaKo pgynrar Ha HeHaMepHo
npero3[pa]be. np. Kaj,qeua xnl HeHaMepHa uHroxclxaquja.

Xpounvua uxroxctraqxja co cilJrrrlr{Jlarl He e JlecHo 4a ce ugexruQnryaa, 6taejicu 3Haurrre tl

clrMnroMhre ce uecneqaQn,rHt. YuepeHa xpoHHqHa uHToKcHKaunja co canl-lu]rnaru ]tJlH
caJllrur;rfi3aM, urro o6lr.ruo ce nojasyea caMo npn noBTopHa ynorpe6a Ha roreMH ,{o3r.r.
Cttunrouure ce 3aueMereHocr, BprorJlaBuua, 3yel$e Bo yrxuTe, nopeMeryBalbe Ha cnyxor,
norerbe, raAelse, noapaia*e, r,raao6o,rxa, rourly:r-rja H Moxe Aa ce cp€Aar co HaManyBaEe Ha
aorara. 3yerse Bo yrxr{Te Moxe Aa ce nojaBl Bo KoHqeHTpauufi Bo nJla3Mara norrreiy 150 u 300
mcg/ml. Terurr HecaKaHr.i AejcrBa ce nojaayeaar Bo KoHueHTpaunn ua n.natuara aa4 300
mcg/ml.

OcHogHara KapaKTep'tcrxKa Ha aKyrHa alroxcaraulja e reurKo nopeMeryBa$e Ha aull,4o-

6asuara pauHorexa, uro 3aBHcH oa Bo3pacra x creneHor Ha HHToxcliKaulja. Hajuecr:xax xaj
Aeuara e nera6o,q[qHa aquaoga. CreneHor Ha turorcuxaqaja He Moxe aa ce oapea]l caMo Bp3
ocxoaa Ha KoHueHTpaqfixre Bo rlra3Mara. EaaHara ancopnutja Ha aqerxlcal{u}lnHa KficeJluHa
uoxe.qa 6age pe3yrrar xa 6asHo npa3Helr,e Ha xenyant.tKor, nojasa ta raprr Qopuauurl so
xenyAHlKor l.rJrh KaKo p$ynrar Ha 3eMane Ha racrpo-pencrexrtt o6lrrqu. flocranxrre go
c,'ly,{aj Ha ulroxcuxaqnja co arlerunca:rllllunHa KuceJltiHa 3aBr,rcu oA o6euor, xuaoro u
KJIl..rHliqKrre c[MnroMr.r u Mopa ,{a 6uAe ao comacHocr co craHAapAHHTe MepKH Ha
urroxcrxauuja. I-,rasHrre nocranKr BKnyqyBaar ja6p3aHa cexpeur.rja Ha JreKor KaKo H
BocnocraByBal$e Ha auxAo-6a3Hara paMHorexa H Ha eJ'reKTponr4THHor 6araHc,
flopa.u xovnlercxu naroQt:tolonrn e$emn Ha uurorcarcaqtja co ciultutlnarlr, Moxe Aa ce
nojasar creAxrae 3Haufi u ct,tMnroMh:

jrauu u curlnmo,uu Pesynmamu od mecmoau lTDeete enu nocmqnxu

Jlecxa ao ymepeua Facrpllrna aasaxa a
qHToKcr|Kaur|ja aaMHH l-tcTpauIJa Ha axTrrBeH
jar"rex, ax.[yxu[ja Ha aJrKalHa
arype3a
TaxHnHea, ArKaneMsja, anxanypqja Mopa.qa ce xounextnpa ry6errero
xunepaeurt,l,rauaja, HA TEqHOCT T EJIEKTDOJIHTU
pecnHpaToDHa anKano3a
Jro.,reMeHo noTelhe
faaene. norDa*aree
Vmepera ao reurxa I acTpriqHa laBaxa n
nr|roKcr|Kaunja a.qMIlHxcTpauHJa Ha aKT[BeH
jar,nea, uaayrqaja xa arxilrHa
Aaype3a, xeMoAnjanr3a Bo c,\yqaj
xa reurxa urrrorcrxauria
PecnxparopHa ankano3a AuxaeMrija, auHAypnja Mopa aa ce FoMflen:rpa ry6envro
co KoMneH3l-|paHa Ha TeqHocT n erexTDoJl ltTll
Acnupuo ra6aerr 500 mg Summary of Product Characteristics

ucra6orrqna auuaoga
Tpecra Mopa ra ce rouner:upa ry6envro
HA TEqNOCT Ti ETEKII)OII{IN
Pecn uparopuo
nopeMeTyBarre:
Xtneprerrr.uraqnj a,
HexapAHoreH
6eroapo6ex eaeu,
HeHa.(eeH pecIrrjpaTopeH
nperas, cydorauria
KapanoBacxylapHo llp. upouera ra xpaen npmncor(,
nop€MgryBaBe: EKT
,ancpmMr.!4,
xr.rneprexruja, renaaeen
npernx na pa6orara ra
cpueTo
fy6e*e na revaocr I flp, xrnouaxeulja, Mopa aa ce |(oMneH3rlpa ry6€rbsro
eneKTponnTll: xnnepxarpeuaja, xnnorarpeuuja, HA T€qHOCT N EIEXTOOI]IT'I
aexraparaunj a, rapyuena 6y6pexaa rlyHxurja
onuf wula rtru aypu tr
6y6p€xHa
uacyduuxeruuia
Ilopeueryran e aa Xuneprrnxeurja, xanor.nuxeulja
uera6onr:uot aa (oco6eHo Kaj aeua), 3roreMeHh
rnyKo3a, KeTo3a BPCAHOCTH HA KETOH
3yerre ao yurre,
nop€MeTyBabe Ba
crvxm
facrponHTegrriHarHo
xDBaDer6e
Xenarolourxt IIp. npoao,rxero nporpou6rxcxo
nopeMgTyBarba: BpeMe, xunonporpou6uteuuja
uxxr6nqnja Ha
rpou6ouarr xoja oona
,aoxoarylonarria
Heapororuxo
nopeMgryBaEe:
TOXCtqHa
eaueQaronarnja r
aenpecnja ua I{HC uro
,qo8e,qyBa,[o nfiapnBJa,
xoHoy3rja, xoMa H
rDqeBt

5. OAPMAKOJIOUKI,I TIOAATOIII

5.1 Olpuaxoqunaucxrl cBojcrBa

OapuarorepanearcKa rpyna: MeAnunHcKl, npoH3BoAH rxro Bnnjaar Ha HepBHnor cllcreM,
aHaIreTuuH, apylH aHarlfgTrrrIH r.r aHTHnHpeTnrll,I, canrqrlJtHa kHceJr[Ha Il,(epHBaTH
ATC xoa: N02BA0l -_ '- : "r.-i

AqerncanxrrrrrHara KncenHHa npnnaia Ha rpynara HecrepoHAHr.l

aurnnHQlauaropHt JreKoBl,t co aHaJltercKrr, auTnnnpercrlt l cBoJcTBa.
Acrapnno ra6aera 500 mg Summary of Product Characteristics

Hej:nnoro,lejcrao e pe3ynrar Ha upeeep:a6nlxa tuxt6rquja Ha ufiKnooKcHreHa3ara, uro

YqCCTBYBA BO CHHTC3ATA HA TIPOCT ITAHIHHHTE.

Opa,rHu 4o:a o4 300 mg 1o I g aqertca,rnqu,rHa KflcentlHa ce ynorpe6yBaar:a oclo6o4yaarue

xa 6o,rrca u HaManyBalse Ha rpecxa, rlcro raKa 3a HacrltHKa fi rpln I :a oc.no6olyaa*e Ha 6onKa
eo lrro6osure fi MycKynnre.

Hcro raxa ce Koprlcrrl 3a neKyoa}le Ha aK}"THx r.t xpoHlqHr.t uxQlavaropan 6olecru, raxo nro
ce peBMaroHAHlror aprprrrllc, ocreoaprparacor H aHKllJto3HHor cnoH,[l.lJlltrnc. Kaj oBhe
cocroj6u BorraBHo ce Koprcrar roneMrl ro3r.r, oA 4 Ao 8 g au€ano, roaereHfi ao HeKoJrKy
eallHeqHI-t ao3H.

Auerucaruug,rHara Kfice;rr.rHa rcro raKa ja uxxt6rpa arperaqlrjara aa rpou6ounrure npery

6,roxuparse Ha chHTe3ara Ha rpor'l6orcat A2 Bo HnB, 3a raa ue.n, ce Kopxcrar !o3x oa 75 ao 300
mg AHeBHo 3a pa3nuqHr.r BacxyrapHll 6o.necru.

5.2 <Dapuaxoxnrercrcu cnojcraa

floc,re opa,rua agurrucrpaquja, auernca,nfiq[nHara Kficer]rHa 6p:o u ronnlerxo ce ancop6apa

o/l facTpoHHTecrnHaJrHfi oT TpaKT,

Auerrcaluuulrara KHceJrfiHa ce nperBopa Bo cBojor rJraBeH aKTuBeH Mera6on[T, caJrfirIHnHa

Kt|ceJIHHa, 3a BpeMell nocle ancopnqltjara. Hajatcorrre HfiBoa Ha aueTtlciutr.rr.lHrHaTa KrceJrHHa
t-l canflq[nHara K ceJ,trHa Bo nJta3Ma ce nocrxfHyBaar noc,re l0-20 utHyru, oluocxo 0,3
qaca. coo,[BeTHo.
-2

14aqerncarrqannara KrceJIHHa lr caJlllqltrHara KlcerhHa ce noBp3yBaar 3a nJla3Ma npore[HgTe

r 6pro ce gtcrplr6yupaar Bo cr{Te AenoBn oA Teroro. CaltunnHara KHceJItlHa ce noiagvsa so
uajvrxoro uaero u ja troMHHyBa nJraueHTara.

Bo uajroleu 6poj c,ryvan, canuqr.rnHara KFce,tHHa ce en[MHHHpa npery uera6olr:auuja Bo

upHnor .qpo6; uera6orlmn ce canHyplqHa Kncer'n.tHa, ca.nrqr,r Qeuo,r rnyKypoxxa, canxqHn
aqxn fnyKypoHlra, reHTr3l4HcKa KHcenHHa Il reHT]t3ypnqHa kflcejrHHa.
Knseruxara xa eltuuuaquja Ha calrl(l/'lHara KHcerHHa e 3aB[cHa oA Ao3ara,3aroa urro
ueta6orrrvor e orpaHltqeH oa KanaufiTeror Ha eH3HMr{Te Bo upnror apo6. floparu Toa
nonyxr.rBoror aa elluuHaqnjara Bapupa t-t ce .{BltxH norraeiy 2 I 3 vaca xaj M:rnH Ao3[, na Ao
oKony l5 qaca Kaj roJreMH ,[o31. Caatualsara KlcerHHa l,t sei:untte uera6oartrn ce
v,l.naeyBaar npHMapHo npexy 6y6pexex nar.

5.3 llperx.ruxuvxlt rroAaroux ra 6e:6eAsocr

l]perxlnrnvxaor npoQr.rn :a 6*6erHocra Ha arrerucarxuHJrHara K[ceJr[Ha e 4o6po

CryAttre co xr.tBorHr.t rroKarKare,{eKa ciutr.rqflJrarrre He trpelH3Br.rKyBaar
AoKyMeHTlrpaH.
oureryBana Ha apyrxre opraufiTe, ocBeH oureryoarbe ua 6y6p*ure.

Auerlca,ruullrtsara KHceJIxHa e,{eranHo npoyqeHa r.tH Br.rrpo l.r r.rH Bl.rBo Bo o,rlHoc Ha nejlrHuor
uyraren norexqtja.n. Her.ra peneBaHTHH ,qoKa3x 3a MyrareHHor noreuqnja:r, l4croro aaxa n la
KapqHHorcHfiTe cry4lll. CaluqalarHTe noKzDKa!'re reparoreHx eQerru xaj Hexojll(y xr.tBorr,rHcKl.l
BHAOBH Kaj CryAHH CO XI'rBOTHlr. HaMa,'leHa nun.naxraqrj4 eu6pnororccnuult x
$erotorccnvHu
e$erru, xaxo H HapyueHa c,loco6rocr:a yrerre ce onHruaHlr nocne npeHararHo H3noxyBarhe.
 t,
t- Acnnplcro n6nan 500 mg Summary of ProduC Characfcrisrics

I
6 OAPMAT{EBTCISTOAATOIE

I 6l Jlxcrr re erclltrf,escf,

I{elyaosen npae

I 6.2
Ilqesxapen cxpo6

lfrxornlrr6narosr
I He e nognara

6.3 Por ur rprere

I
4 roflHn
'1 64 Hrqrr nr syBare
il
.{a ce nna na reuneparypa,qo 30C,

I 65 llprpq4r r cogpxxr f,r trrryBaEero

IllValyxunnyn 6arcrep naryBane.

I upnryxarnoro na[yBar6€ coalrxfl 20 Ta6r€m,

7. HOCIITEJI HA OAOEPEETETO :tA CTABAEE I|A

I Bayer doo, Ilpercrarnnurno Cronjg
JIEXOT BO NPOMET

Va. Onran llpnqa 6, rcx.4tna.t:triu.2, 1000 Cronje

1
I
& BFOJ EA PEIIIErrnnTo 3A CTABAEE EA
JIEKOT BO IIP{OMET
''t r5-3780/08

g.AATYM HA trPBOTO
OAOBPEHITE 3A CTABAEE HA JIEKOT
AATYM HA trOCNEAIIOTO OEEOBEIIOOI BO IIPOMET II
I
3l.0E.2009

I rO. AATYMEANOC@AtrA PEBESIIJAHA

14.04.20t0

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