ynATCTBo 3A HAL+MEHTOT

MEGASEF (MErACE®) 500 mg

®Mnivt-o6oxeH M Ta6neTM
(Cefuroxime axetil)
BHMlvtaTenHo npo"TajTe ro oBa ynaTCTBo npeA 4a 3anoiJHeTe co ynoTpe6a Ha oBoj neK,
3aToa LLITo co4PxM BaxHM MH¢opMaLiMi. 3a Bac.

• llyBajTe ro ynaTCTBOTo. Mo"e6M ke Tpe6a Aa ro npo"TaTe noBTopHo.

• AKo MMaTe AononHMTefl" npai]]aiba, o6paTeTe ce i{aj Bail"oT nei{ap MnM
¢apMaLLeBT.
• OBoj ner{ BM e npenMiilaH BaM M He Tpe6a Aa ro npenopallyBaTe Ha 4Py". Moxe
Aa MM HauTe" 4ypM M aKo cMMnTOMMTe ce Mc" i{ai{o BaLLiMTe.
• floKonl{y HeKoe oA HecaKaHMTe e¢eK" cTaHe cepMo3Ho MnM 4oKonl{y 3a6enexMTe
HeKoj HecaKaH e®eRT I{oj He e Ha6pojaH Bo oBa ynaTCTBo, Be MonMiv`e
MH¢opMMpajTe ro Baii]MOT neKap, ¢apMaLieBT MnM MeAMi+I"ci{a CecTpa
(noMe4HeTe Bo 4enoT 4.4).
'*

YnaTCTBOTo 3a naLiMeHTOT Co4PxM:

J
1. LIJTo npeTCTaByBa MErACE® M 3a il]To ce ynoTpe6yBa
2. LIJTo Tpe6a Aa 3HaeTe npeA Aa ro ynoTpe6MTe MErACE®
3. r{al{o 4a ro ynoTpe6yBaTe neKOT MErACE®
4. Mox" Hecai{a" 4ejcTBa
5. I(aKo 4a ce ilyBa MErACE®
6. CoAPxMHa Ha nal{yBalbeTo M 4Py" MH¢opMaL+MM

1. uTo npETCTAByBA MErACE® M 3A LliTo CE ynoTPE6yBA?

MErACE® e aH"6Mo"I{ Koj ce ynoTpe6yBa Kaj AeLia M Bo3pacHM. in y6MBa 6aKTepMMTe KOM
npeAM3BMI{yBaaT MH®eKLiMja. npMnafa Bo rpynaTa Ha aH"6Mo"LiM Hapeue"
I+ed)anocnopM".

MErACE® ce ynoTpe6yBa 3a TpeTMaH Ha MH¢eKi+MM I{oM ce jaByBaaT Ha:

• rpnoTO;
• C"Hyc"Te;
• CpeAHOToyBo;
• rpaAMTe M 6enMTeApo6oBM;

• ypMHapeH CMCTeM;

• KoxaMMeKMTKMBa.

MErACE® MCTO TaKa ce KOpMCTM:

1
J
• 3a nei{yBaibe Ha najMci{a 6onecT (MH¢el{L+Mi.a I{oja ce npeHecyBa nper{y napa3M"

HapeLie" KpnexM)

BaLUMOT 4oi{Top MOxe Aa BM HanpaBM TecT 3a 4a ro o4pe4ii BM4oT Ha 6ai{TepMjaTa i{oja ja

npe4M3BMr(yBa MH¢eKL+MjaTa M Moxe 3a BpeMe Ha Tepa"jaTa 4a npoBepM 4anM Taa
6aKTepMja e ilyBCTBMTenHa Ha MErACE®.

2. LLJTO TPEEA 4A 3HAETE npEA fLA ro ynoTPEBMTE MErACE®

He ro ynoTpe6yBajTe nei{oT ME[ACE® alto:
• CTe aneprm" (npeoceT"BM) Ha Lie®ypoi{cMM ai{CeTMn, ue¢anocnopMHCKM
aH"6Mo"HM MnM Ha 6Mno i{oja noMouHa cyncTaHUMja Ha MErACE® (nome4HeTe Bo

AenoT 6).
• CTe MMane cepMo3Ha anep"cl{a (npeoce"MBocT) peaKLiMja Ha 6Mno Koj TMn Ha 6eTa

nalFTaMci{M aH"6Mo"i{ (ne"L+MnM", MOHo6ar{Ta" M kap6aneHeMM).

He 3elviajme MErACE® alto HeKoja o6 oBue cocmoj6u ce oaHecyea Ha Bac. He 3eMajme eo

MErACE® ce 8ypu He pa3eoeapame co Bau)uom neKap.
'®

npe4ynpe4yBaiJ>a M Mepl{M Ha npeTna3nMBocT

MH¢opMMpajTe ro BauiioT flei{ap MnM ¢apMaueBT npeA Aa 3anouHeTe Co ynoTpe6a Ha
MErACE®.

AeLla
MErACE® He ce npenopaiiyBa 3a 4eua noManM o4 3 MeceL+M, 3aToa uTo 6e36e4HocTa M
e¢MKacHocTa Ha oBoj neK He ce no3Ha" 3a oBaa rpyna Ha hal+MeHTM.

MOpa 4a BHMMaBaTe Ha o4pe4eHM ci"nTOMM, i{ai{o LLITo ce anep"cl{M peai{L+MM, ra6mm

MH¢eKL+MM (KaKo LLiTo e: KaH4M4Mja3a) M TexoK BMA Ha TevHa cTonML+a

(ncevAOMeJvi6paHo3eH I(onM"c) 4o4el{a ynoTpe6yBaTe MErACE®. OBa ke ro HaManM

pM3MKOT o4 nojaBa Ha 6Mno KaKBM npo6neMM. noMe4HeTe Bo AenoT "CocToj6M Ha KOM LIJTo
Tpe6a 4a BHMMaBaTe" Bo 4enoT 4.

Mc"ryBaibe Ha I{pB
MErACE® MOHe Aa BnMjae Ha pe3ynTaTMTe oA TecTOT IIiTo ro oApeAyBa HMBOTo Ha uekep Bo
KPBTa, MnM I{pBHaTa cnMi{a, HapeLleH KOM6coB TecT. AKo Tpe6a 4a npaBMTe TecT Ha KPBTa:

KaFTeme My Ha nuuemo uJmo Bu 3eMa npuiviepoK oa KPBma aeKa ynompe6y8ame

MErACE®.

ynoTpe6a Ha 4py" nei{oBM

Be MonMMe MH¢OpMMpajTe ro cBojoT neKap MnM ¢apMaL+eBT AOKonKy

FIT cTe 3eMane 6Mno KaKOB neK.

2
nei{OBM LI]TO ja HaManyBaaT KonMiiMHaTa Ha "enyAOuHa KMcenMHa (aHTaLMAM KOM ce

I{opMCTaT 3a TpeTMaH Ha Bpakalbe Ha xeny4eilHa i{McenMHa Bo rpnoTo), Moxe Aa BnMjaaT

Bp3 4ejcTBOTo Ha MErACE®.
npo6eHeL+M4
opan" aH"KoarynaHCM

MH¢opiviupajme eo Bauuom neKap unu ¢apMaueem al(o ynompe6yeame 8aKBu neKo8u.

fleKo" 3a KOHTpaL+enLiMja
MErACE® Moxe 4a ro HaManM e¢eKTOT Ha neKOBM 3a rtoHTpaLienL+Mja. Tpe6a 4a

ynoTpe6yBaTe AononHMTen" cpeACTBa 3a KOHTpaLienLiMja Kal{o KOHAOMM, aKo

ynoTpe6yBaTe MErACE®. AKo BM Tpe6a coBeT, o6paTeTe ce Kaj BaliMOT nel{ap.

BpeMeHocT, AoeLbe M nnoAHocT

06paTeTe ce i{aj cBojoT neKap 3a coBeT npeA Aa noiiHeTe co ynoTpe6aTa Ha oBoj neK, aKo
MMcnMTe MnM cTe 6peMe", nnaHMpaTe 6peMeHocT MflM ako 4oMTe.

Bo3eibe M ynpaByBaibe co pa6oT" MauMHM ..

MErACE® Moxe 4a npe4M3BMKa BPTomaBML+a MnM 4py" HecaKa" 4ejcTBa KOM MOxe 4a
BM ja HaManaT KOHL[eHTpaLiMjaTa. He Tpe6a Aa Bo3MTe MnM Aa ynpaByBaTe Co Mail"" aKo
He ce vyBCTByBaTe 4o6po.

Bax" MH¢opivtaL+MM 3a HertoM on cocTaBHMTe KOMnoiieH" iia MErACE®

CeKoja MErACE® 500 mg ¢MnM-o6noxeHa Ta6neTa co4pxM 29 mg HaTPMyM. OBa Tpe6a Aa
ce 3eMe Bo npe4BMA 4or{OnKy CTe Ha AMeTa co t{oHTponMpaH BHec Ha HaTPMyM.

3. RAKO pr ro ynoTPEEyBATE nEKOT MErACE®?

Cei{orau 3eMajTe ro nei{oT MErACE® i{al{o LLITo BM Ka"an BaLLiMOT neKap MnM ¢apMaLieBT.

Alto He cTe cMrypHM, pa3roBapajTe cO BaLLiMOT nei{ap MnM ¢apMaL+eBT.

ynoTpe6yBajTe ro MErACE® nocne o6pol{. OBa ke noMorHe 3a 4a ce 3roneMM HeroBaTa

e¢eK"BHOcT.

ronTHeTe " Ta6ne"Te Liem co uau]a BOAa.

He rpMLii{ajTe rM, He Kpi]]eTe " M He pa3AenyBaTe " Ta6ne"Te, 3olJJTo oBa MOHKe Aa ja
HaManM e¢el{"BHocTa Ha OBoj nek.

llDenoDailaHa 4o3a
Bo3pacHu
npenopailaHa 4o3a Ha MErACE® e 250 4o 500 mg, 4Ba na" Ha 4e
cepMo3HoCTa M BM4oT Ha MH¢eKL+MjaTa.

3
 L]eLLa
npenopauaHa Ao3a Ha MErACE® e 10 mg/kg (Ao MaKCMMyM 125 mg) Ao 15 mg/kg (Ao
MaKCMMyM 250 mg), ABana" Ha AeH Bo 3aBMCHOT oA cepM03HOcTa M BMAOT Ha MH¢eKHM|.aTa.

MErACE® He ce npenopaiiyBa 3a AeLia nod 3 MeceuHa Bo3pacT, 3aToa lilTo 6e36eAHocTa M

e¢MKacHocTa Ha oBoi. neK He Ce no3Ha" 3a oBaa rpyna Ha naLiMeHTM.

Bo 3aBMCHocT oA 6onecTa MnM KaKo BMe MnM BalileTo AeTe pea"paTe Ha Tepa"jaTa,
noiieTHaTa Ao3a Moxe Aa ce npoMe" M" MOHKe Aa 6MAe noTpe6Ho noBeke oA eAeH I{ypc
Ha neKyBaibe.

npo6neMM co 6y6pe3i4
AKo MMaTe npo6neMM co 6y6pe3MTe, BauMOT nei{ap MOHe Aa BM ja cMe" Ao3aTa.
Pa3roBapajTe co BauMOT fleKap alto oBa ce oflHecyBa Ha Bac.

AI{o 3eMeTe noBeRe MErACE® oTi{onny LLiTo e norpe6Ho

AKo cTe 3eMane noroneMa Ao3a MErACE® oA npenopaiiaHaTa, Moke fla ce nojaBaT
HeBponolJ]i{M nopeMeryBafoa, Kai{o rpileBM (KOHByn3MM).

Pa3roBapajTe co BauMOT nei{ap i{onKy uTo e MOHHo no6p3o MnM i{oHTai{"pajTe co oAqenoT
3a MTHa noMolu oA Haj6nMCKaTa 6on"ua. 3eMeTe ro naKyBaibeTo oA neKOT 3a Aa My ro
noKa"eTe Ha Bai]]MOT neKap.

AKo cTe 3a6opaBme 4a 3eMeTe MErACE®

He 3elvlajTe HaeAHau ABojHa Ao3a 3a Aa ja HaAononHMTe nponyl].TeHaTa. CaMo 3eMeTe j.a
Hape4HaTa 4o3a Bo Boo6iiilaeHOTo BpeMe.

Alto ja npel{MHeTe Tepa"jaTa co MErACE®

He Tpe6a Aa ja npel{MHyBaTe Tepa"jaTa co MErACE® 6e3 Aa ce KOHcyn"paTe co BaLUMOT
nel{ap.
MHory e BaH{Ho Aa ja 3eMeTe Liena Tepa"ja Ha MErACE®. He ja npeKMHyBaj.Te Tepa"jaTa
ocBeH alto Tal{a He Be coBenyBa BauMOT neKap, AypM M alto ce ilyBCTByBaTe noAo6po. Alto He

ja 3aBpil"Te LienaTa Tepa"ja, MH¢ei{uMjaTa Moke noBTopHo Aa Ce noja".

Alto MMaTe Apy" npaLiJarba Bo BPcl{a co oBoj nei{, o6paTeTe ce I{aj. cBojoT neKap MnM

¢apMaueBT.

npujaeyealbe Ha HecaKaHu peaKuuu

HecaKaHMTe peal{L+MM oA neKOBMTe MOH{e Aa " npMjaBMTe Bo HaLiMOHan"oT I+eHTap 3a

¢apMaKOBM"flaHua npM AreHUMjaTa 3a neKOBM M MeAMUMHcl{M CpeACTBa (yn.CB.I{MPMn M

MeTOAMj 6p.54 KaT 1) MnM no eneKTpoHCKM naT npei{y Be6 cTpaHaT
http://malmed.gov.ink/.
 4. MOXHM HECAKAHM flEJCTBA
Kai{o cMTe neKOBM M MErACE® MOHe Aa npeAM3BMKa Hecai{a" peai{LiMM, I{oM He ce

jaByBaaT I{aj CMTe nauMeHTM.

ycnoBM Ha i{oM Tpe6a 4a BHMiviaBaTe

Mafl 6poj nyfe KOM 3eMaaT MErACE® Ao6MBaaT anep"cl{M peaKLiMM MnM noTeHLiMjanHo
cepi4o3" Kox" peai{LiMM. CMMnTOMMTe Ha oBMe peal{LiMM BMyHyBaaT:
• anep"Ci{M Peai{LiMM, CMMnTOMMTe BMyuyBaaT: jaAeH Ha KoxaTa MnM ocMn,

noHei{oraii. ce jaByBa OTOK Ha nMLieTo MflM ycTaTa, Li]To npeAM3BMKyBa oTeH{HaTo

4MLLJeibe.
• ocMn Koj Moxe Aa npeMMHe 80 nnycttaBLiM KOM i"aaT LieHTpanHO TeMHO MecTO Hoe e

onl{py"eHo co no6neAa o6nacT, co TeMeH npcTeH ol{ony pa6oT.

• npoli"peH ocMn co nniiKOBM M nyneibe Ha KOH{aTa. (oBa Moke Aa 6MAe 3Hai{ Ha

C"BeHC-LIOHcoHOB CMHAPOM MnM Toi{cMiiHa eniiAepManHa HeKponM3a).

Apy" cocToj6M KOM Mo"aT Aa ce jaBaT npii ynoTpe6aTa Ha MErACE®:

• ra6mHa MH®el{uMja. neKOBM I{ai{o MErACE® Moke Aa npeAM3BMi{aaT nperoneM

pacT Ha ra6i"i{M (Condt.do) Bo TenoTo i]]To Moke Aa AOBeAe Ao nojaBa Ha ra6MUHa

MH¢eKLiMja (KaKo ulTo e BocnaneHMe Ha ycHa cny3oi{oHa). oBa Hecal{aHo AejcTBo Ce

jaByBa npM Aonra ynoTpe6a Ha MErACE®.

• CepMo3eH BMA Ha TeuHa cToflMLia (nceyAOMeM6paHo3eH i{oflM"c). neKOBM i{ai{o

MErACE® Moke Aa npeAM3BMKaaT BocnaneHMe Ha Ae6enoTo LipeBo,

npeAM3BMKyBajkM cepM03eH BMA Ha TeiiHa cTonML+a, o6MUHo nponpaTeHo co nojaBa

Ha i{pB M cny3 Bo cTonMLiaTa, cTOMailHa 6onKa M TpecKa.

• JapMu-XepxeMMepoBa PeaKUMja. I{aj HeKOM naLiMeH" Mox{e Aa Ce jaBM BMCol{a

TeMnepanypa, TpecKa, maBo6oni{a, Myci{ynHa 6oni{a M ocMn Ha Ko"aTa AOAeKa

ynoTpe6yBaaT MErACE® 3a TpeTMaH Ha flajMCKa 6onecT. OBaa nojaBa e no3HaTa

I{al{o JapMu-XepxeMMepoBa peaKLiMja. CMMnTOMMTe o6mHo TpaaT OA HeKonKy llaca

AO eAeH AeH.

Be6Haur mpe6a 6a eo uH¢opMupame 8aouuom neKap aKo Bu ce jaBu HeKoj oa o8ue

cuiv\nmoMu.

Llec" HecaKa" 4ejcTBa

MOHe Aa ce jaBaT Kaj 1 oA 10 nauMeH":
• ra6MiiHa MH¢eKLiMja (KaKo ccrndt.dai);
• rnaBo6onKa;
• BPTomaBMLia;
• TevHa cTonML+a;
• Mau"Ha (raAeibe);
• 6onl{a BocTOMaKOT.
J

llec" Hecal{a" AejcTBa I{oM Mo"aT Aa ce jaBaT Bo i{pBHMTe TecTOBM:

• 3roneMyBalbe Ha 6PojoT Ha oApeAe" 6enMTe KPB" Me" (eo3MHo¢MnMja);

• 3roneMyBaibe Bo 6pojoTHa oApeAe" eH3MMM.

noManny Llec" HecaKa" AejcTBa

Moxe Aa ce jaBaT Kaj 1 oA 100 naLiMeHTM:
• l{oH{eHocMn;

• raAeLt>e.

llec" Hecai{a" AejcTBa i{oM Mo"aT Aa ce i.aBaT Bo KPBHMTe TecTOBM:

• HaManyBalbe Ha 6pojoT Ha TpoM6oLiM", (Me" KOM noMaraaT Bo KoaryflaLiMja Ha

{pBTa);

• HaMaflyBaibe Ha 6pojoTHa 6enM KPB" MeTI{M;

• flaH{Ho no3M"BeH KOM6coB TecT.

4Py" HecaKaHM AejcTBa

i*

Apy" Hecai{a" AejcTBa KOM ce nojaBme Kaj MHory Man 6poj Ha nyfe, "ja ¢pel{BeHUMja Ha
nojaByBaibe e Heno3HaTa:
• CepMo3eH BMA Ha TeuHa cTonMua (ncevIOMeM6PaHo3eH Ko""C);
• Anep"cr{M peaKL+MM;

• Ko"" PeaKUMM (BMvyyBajRM TeuKM KOM{" peaKi+MM);

• BMcoi{a TeMneparypa (Tpeci{a);

I • no"OnryBaibe Ha 6enl{MTe Ha o"Te MnM KOxaTa;
• Bocnane"e Ha L[p"oTApo6 (xena""c).

I Hecatta" e¢eRTM KOM MOHe Aa ce jaBaT Bo i{pBHMTe TecTOBM:

• Bp3O y"uTyBaHbe Ha L[pBe"Te KPB" Me"M (xeMonM"uKa aHeMMja).

Hecal{aHMTe Peal{L|MM oA nel{oBMTe MOH{e Aa " npMjaBMTe Bo HauMOHan"OT L|eHTap 3a

¢apMal{oBM"naHua npM AreHUMjaTa 3a nei{oBM M MeAMLiMHCKM cpeACTBa (yn.CB.KMPMn M

MeTOA14j 6p.54 KaT 1) MnM no eneRTpoHCKM naT npeKy Be6 cTpaHaTa Ha AreHLiMjaTa
http://malmed.gov.ink/.

5. KAKo Al cE LlyBA MErACE®.

flei{oT Tpe6a Aa ce uyBa Ha MecTa HeAocTan" 3a AeLia!

flei{oT He cMee Aa ce KopMc" no MCTei{oT Ha poi{oT Ha ynoTpe6a o3HaiieH Ha naKyBaibeTo.

Poi{oT Ha ynoTpe6a ce oAHecyBa Ha nocneAHMOT AeH oA Toj MeceL|.

Aa ce iiyBa Ha TeMnepaTypa Ao 25 °C, Bo opM"HanHOTo naKyBaibe.

6
He ynoTpe6yBajTe " MErACE® Ta6ne"Te aKo ce oLLiTeTe" MnM alto MMaaT Apy" BMAnMBM
3HaLLM Ha npoMeHa.

neKOBMTe He Tpe6a Aa ce Mc¢pnaaT iipeKy oTiiaAHiiTe BOAM M floMalJJHMOT oTnaA.

KOHcyn"pajTe ce co Bal]]MOT ¢apMaueBT KaKo " oTCTpaHMTe neKOBiiTe I{oM noBeke He BM ce
noTpe6". Ha Toj HauMH Re ja 3aiilTMTMTe xMBOTHaTa cpeAMHa.

6. c04pxMHA HA nAKyBALbETO M Apy" MH®OpMAL+MM

UJTO cOApxM MErACE®:
• CeKoja Ta6neTa coApxM 500 mg ue¢ypokcMM (Bo ¢oPMa Ha HeoypoKCMM aKce").
• noMou" cyncTaHLiMM: npexena"HM3MpaH cKpo6, i{pocnoBMAOH, i{poci{apMeno3a
HaTPMyM, HaTPMyM naypm Cyn¢aT, MarHe3MyM CTeapaT, KonoMAHa aHXMAPMpaHa
cMnMI{a (AepocMn 200), MaTepMjan 3a ¢mM o6noHKyBaHbe 6p.1 (Sepifilm LP 770):

(Me"nxMApoKCMnpo"n uenyno3a (E464), MMKpoKPMCTanHa Lienyno3a (E460),

cTeapMHcl{a KMceniiHa (E570), TMTaHMyM AMOKCMA (E171)).

KaKo M3meAa MErACE® M coApxMHa Ha naKyBaLbeTo:

MErACE® 500 mg Ta6ne"Te ce 6enM, ¢mM-o6noHKe", oA eAHaTa cTpaHa 3aceiieHM,
AonrHaBec", co BpeHaHo Nobel Ha ApyraTa cTpaHa. CnaKyBa" ce Bo 6en, HenpoBMAeH
PVC-TE-PVDC/Al 6flMCTep, Bo naKyBaibe oA 10 Ta6ne"/Ky"ja.

Hai"i+ Ha ii3AaBaibe Ha nei{oT

``neKOT ce ii3AaBa caMo Co PeuenT"

npoM3804MTen
NOBEL ILAC SANAYII VE TICARET A.S, AyLuue, TypLiMja.

HocMTen Ha peLLleHMeTo 3a npoMeT

HOBEn MnAil cAHAjMM BE TMLiAPET A.Lil.,

npeTCTaB"i].TBo Ckonje, C. P. MaKeAo"ja

4aTylvi Ha nocneAHa peBM3Mja Ha TeKCTOT

04.2019

BPoj M AaryM Ha oAo6pe"eTo 3a cTaBaibe Ha nel{oT Bo npoMeT