Příbalový Leták

Orencia 125 Mg

Informace pro variantu: Injekční Roztok V Předplněné Injekční Stříkačce (3x1ml Ii,125mg), zobrazit další variantu

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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/388482/2015

EMEA/H/C/000701

Pe3WMe Ha EPAR 3a o6^ecTBeHO no^3BaHe

Orencia

abatacept

HacTOA^uAT goKyMeHT npegcTaBnABa pe3^Me Ha EBponeŇcKuA ny6nuneH o^HbneH goKnag (EPAR) 3a Orencia. B Hero ce pa3AcHABa KaK KoMuTeTbT no neKapcTBeHuTe npogyKTu 3a xyMaHHa ynoTpe6a (CHMP) e o^Hun neKapctboto, 3a ga gage nonowuTenHO cTaHOBu^e 3a pa3pemaBaHe 3a ynoTpe6a u npenopbKu 3a ycnoBuATa Ha ynoTpe6a Ha Orencia.

KaKBO npeflCTaB^ABa Orencia?

Orencia e neKapcTBO, KoeTO ctgtpxa aKTuBHOTO Be^ecTBO a6aTa^nT (abatacept). npegnara ce nog

^opMaTa Ha npax 3a npuroTBAHe Ha uH$y3uoHeH pa3TBop (BnuBaHe BbB BeHa) u pa3TBop 3a nogKO^HO

MHxeKTMpaHe b npegBapuTenHO HanbnHeHu cnpuH^BKu u npegBapuTenHO HanbnHeHu nucanKu.

3a KaKBO ce M3non3Ba Orencia?

Orencia ce u3non3Ba b KOM6uHa^A c meTOTpeKcaT (neKapcTBO, KoeTO getícTBa Bbpxy uMyHHaTa

cucTeMa) 3a neneHue Ha cnegHuTe 3a6OnABaHuA:

•    yMepeH go TextK aKTuBeH peBMaTOugeH apTpuT (3a6OnABaHe Ha uMyHHaTa cucTeMa, npunuHABa^o yBpexgaHe u Bb3naneHue Ha cTaBuTe) npu Bb3pacTHu (Ha 18 roguHu unu noBene), kouto He ca ce nOBnuAnu 3agoBonuTenHO ot gpyru neKapcTBa, BKnronuTenHO MeTOTpeKcaT unu „6noKep Ha TyMop-HeKpoTu3upa^uA $aKTop (TNF)";

•    yMepeH go TewbK aKTuBeH nonuapTuKynapeH WBeHuneH uguonaTuneH apTpuT (pAgKO 3a6onABaHe npu ge^, npunuHABa^o Bb3naneHue Ha MHoro cTaBu) npu WHomu u ge^ Ha Bb3pacT mecT roguHu u noBene, kouto He ca ce nOBnuAnu 3agoBonuTenHO ot gpyru neKapcTBa, BKnronuTenHO eguH TNF 6noKep.

^eKapcTBeHuAT npogyKT ce OTnycKa no neKapcKO npegnucaHue.

An agency of the European Union


30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

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flon^nHMTenHa MH$opMa^Mfl 3a Orencia:

Ha 21 MaM 2007 r. EBponeMcKaTa kommcma u3gaBa pa3peweHue 3a ynoTpe6a 3a Orencia, BaAugHo b EBponeMcKUA ctW3.

ntAHUAT TeKcT Ha EPAR 3a Orencia Moxe ga ce HaMepu Ha ye6caMTa Ha

AreH^ATa: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 3a noBene uH^opMa^A othocho AeneHueTo c Orencia - nponeTeTe AucToBKaTa (cb^o nacT ot EPAR) mam nonuTaMTe BawuA AeKap mam $apMa^BT.

flaTa Ha nocAegHo aKTyaAU3upaHe Ha TeKcTa 06-2015.

Orencia

CTpaHMua 4/4


EMA/388482/2015