ANEKS I

CHARAKTERYSTYKA PRODUKTU LECZNICZEGO

1

1. NAZWA PRODUKTU LECZNICZEGO

NovoMix 30 Penfill 100 jednostek/PO]DZLHVLQDGRZVWU]\NLZDĔZHZNáDG]LH NovoMix 30 FlexPen 100 jednostekPO]DZLHVLQDGRZVWU]\NLZDĔZIDEU\F]QLHQDSHáQLonym ZVWU]\NLZDF]X

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NovoMix 30 Penfill

1 ml zawiesiny zawiera 100 jednostek rR]SXV]F]DOQej LQVXOLQy DVSDUW

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NovoMix30FlexPen

1mlzawiesinyzawiera100jednostekUR]SXV]F]DOQHMLQVXOLQ\DVSDUW

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4.1 Wskazania do stosowania

NovoMix 30 jest wskazany w lHF]HQLX FXNU]\F\ XGRURVá\FKPáRG]LHĪ\LG]LHFLZZLHNX10 lat i SRZ\ĪHM.

4.2 Dawkowanie i sposób podawania

Dawkowanie

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1RYR0L[8SDFMHQWyZ]FXNU]\FąW\SXPRĪHE\üVWRVRZDQ\ZPRQRWHUDSLL.1RYR0L[PRĪHE\üWDNĪHVWRVRZDQ\ZVNRMDU]HQLX]GRXVWQ\PLlekamiSU]HFLZFXNU]\FRZ\PLjHĞOLVWĊĪHQLHJOXNR]\wekrwiXSDFMHQWyZMHVWQLHZ\VWDUF]DMąFRNRQWURORZDQHSRGF]DVVWRVRZDQLDVDP\FKGRXVWQ\FK]DOHFDQDGDZNDSRF]ąWNRZDSURGXNWyZSU]HFLZFXNU]\FRZ\FK8SDFMHQWyZ]FXNU]\FąW\SX 1RYR0L[WRMednostekZSRU]HĞQLDGDQLaLjednostekZSRU]HNRODFMi(SRVLáNXZLHF]RUQego)./HF]HQLHSURGXNWHP1RYR0L[PRĪHE\üWDNĪHUR]SRF]ĊWHodjednejGDZNLQDGREĊ– jednostek

ZSRU]HNRODFMLSRVLáNXZLHF]RUQHJR-HĪHOL1RYR0L[MHVWVWRVRZDQ\UD]QDGREĊGDZNLZLĊNV]Hod30jednostek]DOHFDVLĊSRG]LHOLüQDGZLHUyZQHF]ĊĞFLSRGDZDQHwSRU]HĞQLDGDQLDLNRODFML-HĞOL

2

GZDZVWU]\NQLĊFLDQDGREĊSURGXNWX1RYR0L[EĊGąSRZRGRZDá\QDZUDFDMąFeKLSRJOLNHPLewFLąJXGQLDGDZNĊSRUDQQąPRĪQDUR]G]LHOLüQDGZLHUyZQHF]ĊĞFLSRGDZDQHZSRU]HĞQLDGaniaiwSRU]HRELDGX

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NovoMix30

mmol/l<80mg/dl- jednostki– mmol/l 80–110 mg/dl 0– mmol/l 111–140 mg/dl

jednostki –10 mmol/l 141–180 mg/dl +4 jednostki >10 mmol/l >180 mg/dl

jednostek

3RGXZDJĊSRZLQQRE\üEUDQHQDMPQLHMV]HVWĊĪHQLHJOXNR]\we krwi SU]HGSRVLáNLHPPLHU]RQH w FLąJXRVWDWQLFK WU]HFKGQL'DZNDQLHSRZLQQDE\ü]ZLĊNV]DQDMHĞOLZ FLąJXt\FK GQLZ\VWąSLáD KLSRJOLNHPLD'DZNDPRĪHE\ü]PLHQLaQDUD]ZW\JRGQLXDĪGRRVLąJQLĊFLDRF]HNLZDQHJR +E$F.*OLNHPLDSU]HGSRVLáNLHPSRZLQQDE\üSRGVWDZąRFHQ\GRVWRVRZDQLDGDZNLSRSU]HG]DMąFHMSRVLáHN

8SDFMHQWyZ]FXNU]\FąW\SXLQG\ZLGXDOQH]DSRWU]HERZDQLHQDLQVXOLQĊZ\QRVL]Z\NOHRGdo1jednostkiNJGREĊ.NovoMix30PRĪHZSHáQLOXEF]ĊĞFLRZRSRNU\üWR]DSRWU]HERZDQLH.

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Szczególnegrupypacjentów

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USDFMHQWyZZSRGHV]á\PZLHNX]DOHFDVLĊzintensyfikowanePRQLWRURZDQLHVWĊĪHQLDJOXNR]\ZHNUZLRUD]GRVWRVRZDQLHGDZNLLQVXOLQ\DVSDUWGRLQG\ZLGXDOQ\FKSRWU]HE.

=DEXU]HQLDF]\QQRĞFLQHUHNLZąWURE\

=DEXU]HQLDF]\QQRĞFLQHUHNOXEZąWURE\PRJą]PQLHMV]Dü]DSRWU]HERZDQLHSDFMHQWDQDLQVXOLQĊUSDFMHQWyZ]]DEXU]HQLDPLF]\QQRĞFLQHUHNOXEZąWURE\]DOHFDVLĊzintensyfikowanemonitorowanieVWĊĪHQLDJOXNR]\ZHNUZLRUD]GRVWRVRZDQLHGDZNLLQVXOLQ\DVSDUWGRLQG\ZLGXDOQ\FKSRWU]HE.

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MHVWRJUDQLF]RQHSDWU]SXQNW

Nie ma GDQ\FK na temat stosowania NovoMix 30 XG]LHFLZZLHNXSRQLĪHM lat.

Zmiana stosowanych rodzajów insulinowych produktów leczniczych

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WF]DVLH]PLDQ\VWRVRZDQHJRURG]DMXLQVXOLQ\LkilkatygodniSR]PLDQLH]DOHFDVLĊGRNáDGQHPRQLWRURZDQLHVWĊĪHQLDJOXNR]\

SDWU]SXQNW.

Sposóbpodawania

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3

V]\ENRG]LDáDMąFHMLoSRĞUHGQLPF]DVLHG]LDáDQLDZVWRVXQNX

1RYR0L[SRGDMHVLĊtylkoSRGVNyUQLH.

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6]F]HJyáRZDLQVWUXNFMDXĪ\FLDSDWU]XORWNDGODXĪ\WNRZQLND

NovoMix30Penfill

3RGDZDQLH]DSRPRFąV\VWHPXSRGDZDQLDLQVXOLQ\

NovoMix30PenfillMHVWSU]H]QDF]RQ\GRVWRVRZDQLD]V\VWHPDPLSRGDZDQLDLQVXOLQ\ILUP\1RYR1RUGLVNLLJáDPL1RYR)LQHOXE1RYR7ZLVW.NovoMix30PenfillSU]H]QDF]RQ\MHVWZ\áąF]QLHGRSRGDZDQLDZHZVWU]\NQLĊFLDFKSRGVNyUQ\FK]DSRPRFąZVWU]\NLZDF]DZLHORNURWQHJRXĪ\WNX-HĞOLNRQLHF]QHMHVWSRGDQLH]DSRPRFąVWU]\NDZNLQDOHĪ\NRU]\VWDü]ILRONL

NovoMix30FlexPen

3RGDZDQLH]DSRPRFąZVWU]\NLZDF]D)OH[3HQ

1RYR0L[)OH[3HQMHVWIDEU\F]QLHQDSHáQLRQ\PZVWU]\NLZDF]HPR]QDF]RQ\PNRORUHPSU]H]QDF]RQ\PGRVWRVRZDQLD]LJáDPL1RYR)LQHOXE1RYR7ZLVW:VWU]\NLZDF]FlexPenXPRĪOLZianastawieniedawkiwzakresie1-MHGQRVWNĊMHGQRVWHNZRGVWĊSLHFR NovoMix 30 FlexPen SU]H]QDF]RQ\MHVWZ\áąF]QLHGRSRGDZDQLDZHZVWU]\NQLĊFLDFKSRGVNyUQ\FK-HĞOLNRQLHF]QHMHVW SRGDQLH]DSRPRFąVWU]\NDZNLQDOHĪ\NRU]\VWDü]ILRONL

4.3 Przeciwwskazania

1DGZUDĪOLZRĞüQDVXEVWDQFMĊF]\QQąOXEna NWyUąNROZLHNVXEVWDQFMĊSRPRFQLF]ą Z\PLHQLRQąw SXQNFLH .

4.4 6SHFMDOQHRVWU]HĪHQLDLĞURGNLRVWURĪQRĞFLGRW\F]ąFHVWRVRZDQLD

3URGXNWX1RYR0L[QLHZROQRSRGDZDüGRĪ\OQLHJG\ĪPRĪHWRVSRZRGRZDüFLĊĪNąKLSRJOLNHPLĊ.1DOHĪ\XQLNDüSRGDQLDGRPLĊĞQLRZHJRNovoMix30QLHPRĪHE\üVWRVRZDQ\ZSRPSDFKLQVXOLQRZ\FK

3DFMHQWSRZLQLHQVNRQVXOWRZDüVLĊ]OHNDU]HPSU]HGSRGUyĪąSRPLĊG]\UyĪQ\PLVWUHIDPLF]DVRZ\PL gd\ĪPRĪHE\üNRQLHF]QHSU]\MPRZDQLHLQVXOLQ\LSRVLáNyZRLQQ\FKSRUDFK

Hiperglikemia

1LHRGSRZLHGQLHGDZNRZDQLHOXESU]HUZDQLHOHF]HQLDV]F]HJyOQLHZSU]\SDGNXFXNU]\F\W\SX PRĪHSURZDG]LüGRKLSHUJOLNHPLLLFXNU]\FRZHMNZDVLF\NHWRQRZHM=Z\NOHSLHUZV]HREMDZ\ KLSHUJOLNHPLLSRMDZLDMąVLĊVWRSQLRZRZFLąJXNLONXJRG]LQOXEGQL i VąWRZ]PRĪRQHSUDJQLHQLH F]ĊVWV]HRGGDZDQLHPRF]XQXGQRĞFLZ\PLRW\VHQQRĞü]DF]HUZLHQLRQDVXFKDVNyUDVXFKRĞü w XVWDFKXWUDWDDSHW\WXRUD]]DSDFKDFHWRQXZZ\G\FKDQ\P SRZLHWU]X:FXNU]\F\W\SXQLHOHF]RQDKLSHUJOLNHPLDPRĪHSURZDG]LüGRFXNU]\FRZHMNZDVLF\NHWRQRZHMNWyUDVWDQRZL]DJURĪHQLHĪ\FLD

Hipoglikemia

4

PoPLQLĊFLHSRVLáNXOXEQLHSODQRZDQ\GXĪ\Z\VLáHNIL]\F]Q\PRĪHSURZDG]LüGRKLSRJOLNHPLL.

+LSRJOLNHPLDPRĪHZ\VWąSLüJG\GDZNDLQVXOLQ\MHVW]E\WGXĪDZVWRVXQNXGR]DSRWU]HERZDQLDQDLQVXOLQĊ. :SU]\SDGNXZ\VWąSLHQLDKLSRJOLNHPLLOXESRGHMU]HQLDZ\VWąSLHQLDKLSRJOLNHPLLQLHQDOHĪ\ SRGDZDüSURGXNWX1RYR0L[3RXVWDELOL]RZDQLXVWĊĪHQLDJOXNR]\ZHNUZLSDFMHQWDQDOHĪ\UR]ZDĪ\ü dostosowanie dawki SDWU]SXQNW\

L

:SRUyZQDQLXGRGZXID]RZHMLQVXOLQ\OXG]NLHMSURGXNW 1RYR0L[]GHF\GRZDQLHEDUG]LHM]PQLHMV]DVWĊĪHQLHJOXNR]\ZHNUZLZFLąJXJRG]LQSRZVWU]\NQLĊFLX']LDáDQLHWRPRĪHE\ü]áDJRG]RQHSRSU]H]LQG\ZLGXDOQHGRVWRVRZDQLHGDZNLL

OXEVSRĪ\FLHSRVLáNX

8SDFMHQWyZXNWyU\FKNRQWURODJOLNHPLL]QDF]QLHVLĊSRSUDZLáDQSZZ\QLNXintensywnejLQVXOLQRWHUDSLLPRJą]PLHQLüVLĊW\SRZHGODQLFKREMDZ\]DSRZLDGDMąFHKLSRJOLNHPLĊoF]\PSowinni]RVWDüSRLQIRUPRZDQL8SDFMHQWyZGáXJRFKRUXMąF\FKQDFXNU]\FĊREMDZ\]DSRZLDGDMąFHKLSRJOLNHPLĊPRJąQLHZ\VWĊSRZDü

ĝFLVáDNRQWURODglikemiiPRĪH]ZLĊNV]DüryzykoKLSRJOLNHPLLGODWHJRQDOHĪ\]DFKRZDüV]F]HJyOQą RVWURĪQRĞüZSU]\SDGNX]ZLĊNV]DQLDGDZNLWDNMDN]RVWDáRWRRSLVDQHZSXQNFLH

Z XZDJLQDSRGDZDQLHSURGXNWX 1RYR0L[ZEH]SRĞUHGQLP]ZLą]NX]SRVLáNLHPnDOHĪ\XZ]JOĊGQLüV]\ENLSRF]ąWHNG]LDáDQLDXSDFMHQWyZXNWyU\FKZVSyáLVWQLHMąFHFKRURE\OXEleF]HQLHmoJąVSRZDOQLDüZFKáDQLDQLHSRNDUPX

:VSyáLVWQLHMąFHFKRURE\]ZáDV]F]D]DNDĪHQLDiVWDQ\JRUąF]NRZH]Z\NOH]ZLĊNV]DMą]DSRWU]HERZDQLHSDFMHQWDQDLQVXOLQĊ:VSyáLVWQLHMąFHFKRURE\QHUHNZąWURE\OXEFKRURE\PDMąFHZSá\ZQDQDGQHUF]DSU]\VDGNĊOXEWDUF]\FĊPRJąZ\PDJDü]PLDQ\dawkiLQVXOLQ\

-HĞOLSDFMHQFLzmieniaMąOHF]HQLH]MHGQHJRW\SXLQVXOLQRZHJRSURGXNWXOHF]QLF]HJRQDLQQ\ZF]HVQHREMDZ\]DSRZLDGDMąFHKLSRJOLNHPLĊPRJąXOHF]PLDQLHOXEVWDüVLĊPQLHMQDVLORQHZSRUyZQDQLXGRREMDZyZZ\VWĊSXMąF\FKSRGF]DVVWRVRZDQLDSRSU]HGQLHJRW\SXLQVXOLQ\

Zmianastosowanychrodzajówinsulinowychproduktówleczniczych

=PLDQDW\SXOXEURG]DMXLQVXOLQ\SRZLQQDRGE\ZDüVLĊSRGĞFLVáąNRQWUROąOHNDU]D=PLDQ\VWĊĪHQLD

LQVXOLQ\URG]DMXZ\WZyUFDW\SXSRFKRG]HQLDLQVXOLQD]ZLHU]ĊFDOXG]NDOXEDQDORJLQVXOLQ\i

OXEPHWRG\Z\WZDU]DQLDUHNRPELQRZDQH'1$OXELQVXOLQD]ZLHU]ĊFDPRJąwymagDü]PLDQydawki3DFMHQFL]PLHQLDMąF\OHF]HQLH]LQQHMLQVXOLQ\na1RYR0L[PRJąZ\PDJDüZLĊNV]HMOLF]E\G]LHQQ\FKZVWU]\NQLĊüOXEzmianydawkiZSRUyZQDQLX]GRW\FKF]DVSU]\MPRZDQ\miLQVXOLQowymiSURGXNWDPLOHF]QLF]\PL.-HĞOLGostosowaniejestNRQLHF]QHPRĪHWRQDVWąSLüSRGF]DVSRGDQLDSLHUZV]ejdawkiOXEZFLąJXSLHUZV]\FKNLONXW\JRGQLOXEPLHVLĊF\

5HDNFMHZPLHMVFXZVWU]\NQLĊFLD

7DNjakZSU]\SDGNXOHF]HQLDNDĪGąLQVXOLQąPRJąZ\VWąSLüUHDNFMHZPLHMVFXZVWU]\NQLĊFLDEyO]DF]HUZLHQLHQLHSRNU]\ZNDstan]DSDOQ\]DVLQLHQLHREU]ĊNLVZĊG]HQLH.&LąJáH]PLDQ\PLHMVFZVWU]\NQLĊüZREUĊELHMHGQHJRREV]DUX]PQLHMV]DMąryzykowystąSLHniatakiFKUHDNFML5HDNFMH]Z\NOHXVWĊSXMąZFLąJXNLONXGQLOXEW\JRGQL:U]DGNLFKSU]\SDGNDFKUHDNFMHZPLHMVFXZVWU]\NQLĊFLDPRJąZ\PDJDüSU]HUZDQLDOHF]HQLDSURGXNWemNovoMix30.

Stosowanieinsuliny1RYR0L[wskojarzeniuzpioglitazonem

=JáDV]DQHSU]\SDGNLQLHZ\GROQRĞFLVHUFD]ZLą]DQH]OHF]HQLHPSLRJOLWD]RQHPZVNRMDU]HQLXzLQVXOLQąGRW\F]\á\ZV]F]HJyOQRĞFLSDFMHQWyZREFLąĪRQ\FKF]\QQLNDPLU\]\NDUR]ZRMXQLHZ\GROQRĞFLNUąĪHQLD]SU]\F]\QVHUFRZ\FK3RZLQQRWRE\üEUDQHSRGXZDJĊZSU]\SDGNXUR]ZDĪDQLDOHF]HQLDVNRMDU]RQHJRSLRJOLWD]RQHPLSURGXNWHP1RYR0L[-HĞOLVWRVXMHVLĊOHF]HQLHVNRMDU]RQHSDFMHQWyZQDOHĪ\REVHUZRZDüF]\QLHSRMDZLąVLĊXQLFKSU]HGPLRWRZHLSRGPLRWRZH

5

REMDZ\QLHZ\GROQRĞFLVHUFDSU]\URVWPDV\FLDáDLREU]ĊNL1DOHĪ\]DSU]HVWDüVWRVRZDQLDSLRJOLWD]RQXZSU]\SDGNXQDVLOHQLDVLĊREMDZyZVHUFRZ\FK

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3U]HFLZFLDáDSU]HFLZNRLQVXOLQLH

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4.5Interakcjezinnymiproduktamileczniczymiiinnerodzajeinterakcji

WieleSURGXNWyZOHF]QLF]\FKPDZSá\ZQDPHWDEROL]PJOXNR]\

=DSRWU]HERZDQLHSDFMHQWaQDLQVXOLQĊPRJą]PQLHMV]DüQDVWĊSXMąFHSURGXNW\GRXVWQHleki

SU]HFLZFXNU]\FRZHLQKLELWRU\PRQRDPLQRRNV\GD]\,0$2OHNLEORNXMąFHUHFHSWRU\EHWD-

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=DSRWU]HERZDQLHSDFMHQWaQDLQVXOLQĊPRJą]ZLĊNV]DüQDVWĊSXMąFHSURGXNW\GRXVWQHOHNLDQW\NRQFHSF\MQHOHNLWLD]\GRZHJOLNRNRUW\NRVWHURLG\KRUPRQ\WDUF]\F\V\PSDW\NRPLPHW\NLKRUPRQZ]URVWXLGDQD]RO

/HNLEORNXMąFHUHFHSWRU\EHWD-DGUHQHUJLF]QHPRJąPDVNRZDüREMDZ\KLSRJOLNHPLL

2NWUHRW\GLODQUHRW\GPRJą]ZLĊNV]DüOXE]PQLHMV]Dü]DSRWU]HERZDQLHQDLQVXOLQĊ

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4.6:Sá\ZQDSáRGQRĞüFLąĪĊilaktacjĊ

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