Portuguese I Português
Irinotecan
BRUKSANVISNING
DC BeadM1
emboliserande läkemedelseluerande partikel
STERIL • ENDAST FÖR ENGÅNGSBRUK
• ICKE-PYROGEN
QDESCRIÇÃO:
%$#FBE.DPOTJTUFFNFTGFSBTFNCØMJDBTEFIJESPHÏJTDBMJCSBEBTDPNQSFDJTÍPQBSBFMVJÎÍPEFNFEJDBNFOUPT
"T%$#FBE.QSPEV[JEBTBQBSUJSEFÈMDPPMQPMJWJOÓMJDPTÍPCJPDPNQBUÓWFJTIJESPGÓMJDBTFOÍPSFBCTPSWÓWFJT
"T%$#FBE.TÍPDBQB[FTEFDBSSFHBSFFMVJSJSJOPUFDBOPFFTUÍPEJTQPOÓWFJTOPTTFHVJOUFTUBNBOIPT
Tamanho nominal das esferas
Cor do rótulo
70 - 150µm
Preto e amarelo
Ao carregar o irinotecano, as DC
#FBE.TPGSFNVNBEJNJOVJÎÍPEF
UBNBOIPBUÏRVBOEPDBSSFHBEBT
com 50mg/ml.
QAPRESENTAÇÃO:
t'SBTDPBNQPMBEFWJESPEFNM
t$BEBGSBTDPBNQPMBDPOUÏNBQSPYJNBEBNFOUFNMEF%$#FBEM1FNTPMVÎÍPTBMJOBåTJPMØHJDBUBNQPOBEB
FTUFSJMJ[BEBFOÍPQJSPHÏOJDB0WPMVNFUPUBMEFTPMVÎÍPTBMJOBF%$#FBEM1ÏEFBQSPYJNBEBNFOUFNM
t0GSBTDPBNQPMBÏWFEBEPDPNVNBUBNQBEFBMVNÓOJPFRVJQBEBDPNDBQBDPNDØEJHPEFDPS
t$BEBGSBTDPBNQPMBEFTUJOBTFBTFSVUJMJ[BEPOVNÞOJDPEPFOUF/ÍPSFFTUFSJMJ[BS&MJNJOBSUPEPTPTNBUFSJBJT
OÍPVUJMJ[BEPT
QINDICAÇÕES:
"T%$#FBE.GPSBNDPODFCJEBTFTQFDJBMNFOUFQBSBBDUVBSFNDPNPBHFOUFEFFNCPMJ[BÎÍPQBSBPUSBUBNFOUPEF
WBTPTRVFJSSJHBNVNDBODSPDPMPSFDUBMNBMJHOPNFUBTUJ[BEPQBSBPGÓHBEPN$3$
"T%$#FBE.TÍPDPNQBUÓWFJT
DPNJSJOPUFDBOPRVFQPEFNTFSDBSSFHBEBTQSFWJBNFOUFËFNCPMJ[BÎÍPFQPTUFSJPSNFOUFDPNPBDÎÍPTFDVOEÈSJB
FMVJSVNBEPTFDPOTUBOUFDPOUSPMBEBFMPDBMEFJSJOPUFDBOPOPN$3$EFQPJTEBFNCPMJ[BÎÍP
QCONTRA-INDICAÇÕES – DC BeadM1:
%PFOUFTDPNJOUPMFSÉODJBBQSPDFEJNFOUPTEFPDMVTÍPWBTDVMBS
"OBUPNJBWBTDVMBSRVFJNQFÎBBDPMPDBÎÍPEPDBUFUFSPVBJOKFDÎÍPEFÐNCPMPT
1SFTFOÎBPVQSPCBCJMJEBEFEFPDPSSÐODJBEFWBTPTQBTNPT
1SFTFOÎBPVQSPCBCJMJEBEFEFPDPSSÐODJBEFIFNPSSBHJBT
1SFTFOÎBEFEPFOÎBTBUFSPNBUPTBTHSBWFT
1SFTFOÎBEFBSUÏSJBTEFEJTUSJCVJÎÍPNBJTQFRVFOBTEPRVFBTSBNJåDBÎÜFTEJTUBJTEBTRVBJTFNFSHFN
1SFTFOÎBEFBOBTUPNPTFTFYUSBJOUSBDSBOJBOBTPVTIVOUTFWJEFOUFT
1SFTFOÎBEFSBNPTDPMBUFSBJTEPTWBTPT RVFDPOTUJUVBNVNQFSJHPQPUFODJBMQBSBBTÈSFBTOPSNBJTEVSBOUFB
FNCPMJ[BÎÍP
1SFTFOÎBEFBSUÏSJBTUFSNJOBJTRVFDPOEV[BNEJSFDUBNFOUFBPTOFSWPTDSBOJBOPT
1SFTFOÎBEFBSUÏSJBTRVFJSSJHBNBMFTÍPEFNBTJBEPQFRVFOBTQBSBSFDFCFSFNBT%$#FBEM1.
Biocompatibles
Excellence in Interventional Oncology
CN00496.1
Biocompatibles UK Ltd is a
BTG International group company
Portuguese I Português
Irinotecan
3FTJTUÐODJBWBTDVMBSQFSJGÏSJDBËTBSUÏSJBTEFEJTUSJCVJÎÍPRVFJNQFÎBBQBTTBHFNEBT%$#FBEM1BUÏËMFTÍP
/ÍPVUJMJ[BSBT%$#FBEM1OBTTFHVJOUFTBQMJDBÎÜFT
J &NCPMJ[BÎÍPEFUVNPSFTOÍPNBMJHOPT
JJ &NCPMJ[BÎÍPOBQSFTFOÎBEFTIVOUT"7EFHSBOEFEJÉNFUSP
JJJ &NCPMJ[BÎÍPEFTIVOUTBSUFSJPWFOPTPTPVTFKBPOEFPTBOHVFOÍPQBTTFQFMBUSBOTJÎÍPBSUFSJBMDBQJMBS
WFOPTBNBTEJSFDUBNFOUFEBBSUÏSJBQBSBBWFJB
JW &NUPEPTPTWBTPTTBOHVÓOFPTPOEFPBHFOUFFNCØMJDPEBT%$#FBEM1 possa passar directamente para a
BSUÏSJBDBSØUJEBJOUFSOBPVPVUSPTUFSSJUØSJPTOÍPQSFUFOEJEPT
QCONTRA-INDICAÇÕES – IRINOTECANO:
$POTVMUBSOPGPMIFUPEBFNCBMBHFNEPJSJOPUFDBOPBTDPOUSBJOEJDBÎÜFTSFMBUJWBTËVUJMJ[BÎÍP
AVISO: Alguns estudos têm demonstrado que as DC BeadM1 não formam agregados e, por
conseguinte, penetram nos vasos sanguíneos a um nível mais profundo do que partículas de PVA de
tamanho semelhante.
QCUIDADOS:
t/ÍPVUJMJ[BSDBTPPGSBTDPBNQPMBPVBFNCBMBHFNQBSFÎBNUFSTJEPEBOJåDBEPT
t"PTFBEJDJPOBSVNBNJTUVSBEFDPOUSBTUFOÍPJØOJDPÈHVBËTFTGFSBTDBSSFHBEBTQPEFIBWFSBMHVNBFMVJÎÍP
EFJSJOPUFDBOPBPMPOHPEPUFNQP4FBTFTGFSBTOÍPGPSFNJNFEJBUBNFOUFVUJMJ[BEBTQPEFIBWFSBUÏNH
EFJSJOPUFDBOPOBNJTUVSBEFDPOUSBTUFÈHVB4FUBMPDPSSFSQPEFSÈFYJTUJSVNBQFRVFOBEPTFEFJSJOPUFDBOP
EJTQPOÓWFMTJTUFNJDBNFOUFOPNPNFOUPEBBENJOJTUSBÎÍP
t/ÍPVUJMJ[BSBTFTGFSBTDBSSFHBEBTDPNJSJOPUFDBOPDPNBHFOUFTEFDPOUSBTUFRVFDPOUFOIBNTBJTQPSFYFNQMP
cloreto de cálcio)
t$FSUJåDBSTFEFRVFBT%$#FBEM1UÐNVNUBNBOIPBQSPQSJBEPQBSBPTWBTPTTBOHVÓOFPTQSFUFOEJEPT
t$POTJEFSBSBNVEBOÎBQBSB%$#FBEEFNBJPSUBNBOIPOBQSFTFOÎBEFTIVOUT"7PVTFBTQSPWBTBOHJPHSÈåDBT
EFFNCPMJ[BÎÍPOÍPBQBSFDFSFNSBQJEBNFOUFEVSBOUFBBENJOJTUSBÎÍP
t%FWFTFDPOTJEFSBSVNBUPNPHSBåBDPN5DN.""TFIPVWFSTVTQFJUBEBQSFTFOÎBEFVNTIVOU"7
t.POJUPSJ[BSPTEPFOUFTDVJEBEPTBNFOUFRVBOUPBTJOBJTEFFNCPMJ[BÎÍPFNÈSFBTOÍPQSFUFOEJEBTDPNPIJQØYJB
PVBMUFSBÎÜFTOPTJTUFNBOFSWPTPDFOUSBM
t"FNCPMJ[BÎÍPDPNBT%$#FBEM1TØEFWFTFSFYFDVUBEBQPSVNNÏEJDPDPNGPSNBÎÍPBEFRVBEBFNPDMVTÍP
JOUFSWFODJPOBMOBSFHJÍPBTFSFNCPMJ[BEB
t"RVBOUJEBEFNÈYJNBEFJSJOPUFDBOPRVFQPEFTFSDBSSFHBEBÏNHEFJSJOPUFDBOPQPSGSBTDPBNQPMBEFNM
de DC BeadM1. Exceder esta quantidade pode fazer com que algum irinotecano permaneça livre na
solução. Esta solução livre deve ser removida antes da utilização, para impedir que o doente receba a
dose excessiva como um bolus.
QCOMPLICAÇÕES POTENCIAIS:
t3FýVYPPVQBTTBHFNJOEFTFKÈWFMEBT%$#FBEM1QBSBBTBSUÏSJBTOPSNBJTBEKBDFOUFTËMFTÍPRVFFTUFKBBTFS
USBUBEBPVBUSBWÏTEBMFTÍPQBSBPVUSBTBSUÏSJBTPVMFJUPTBSUFSJBJT
t&NCPMJ[BÎÍPFNÈSFBTOÍPQSFUFOEJEBT
Biocompatibles
Excellence in Interventional Oncology
CN00496.1
Biocompatibles UK Ltd is a
BTG International group company
Portuguese I Português
Irinotecan
t&NCPMJ[BÎÍPQVMNPOBS
t*TRVFNJBFNMPDBMJOEFTFKÈWFM
t4BUVSBÎÍPEFMFJUPTDBQJMBSFTFEBOJåDBÎÍPEPTUFDJEPT
t5SPNCPTFJTRVÏNJDBPVFOGBSUFJTRVÏNJDP
t3VQUVSBPVMFTÍPEFWBTPTTBOHVÓOFPTFIFNPSSBHJB
t%ÏåDFTOFVSPMØHJDPTJODMVJOEPQBSBMJTJBTEPTOFSWPTDSBOJBOPT
t7BTPTQBTNPT
t.PSUF
t3FDBOBMJ[BÎÜFT
t3FBDÎÜFTBDPSQPTFTUSBOIPTRVFFYJKBNJOUFSWFOÎÜFTNÏEJDBT
t*OGFDÎÍPRVFFYJKBJOUFSWFOÎÍPNÏEJDB
t'PSNBÎÍPEFDPÈHVMPTOBQPOUBEPDBUFUFSFEFTMPDBÎÍPTVCTFRVFOUFEPTNFTNPTQSPWPDBOEPTFRVFMBTUSPNCPembólicas arteriais.
QINSTRUÇÕES PARA CARREGAR O MEDICAMENTO:
As DC BeadM1TÍPBEFRVBEBTBQFOBTQBSBBDBSHBDPNTPMVÎÍPEFJSJOPUFDBOP
3FDPNFOEBTFVNBTPMVÎÍPEFDBSHBEFNHNMEFJSJOPUFDBOP
Para obter uma carga final de 100mg de irinotecano por frasco-ampola de 2ml de DC BeadM1:
J 3FNPWFSPNÈYJNPEFTPMVÎÍPTBMJOBQPTTÓWFMEFVNGSBTDPBNQPMBEF%$#FBEM1 utilizando uma seringa
DPNVNBBHVMIBEFDBMJCSFQFRVFOP
JJ $PNVNBTFSJOHBFBHVMIBBEJDJPOBSNMEFTPMVÎÍPEFJSJOPUFDBOPNHNM
EJSFDUBNFOUFOPGSBTDP
ampola de DC BeadM1.
JJJ "HJUBSBTPMVÎÍPEF%$#FBEM1JSJOPUFDBOPTVBWFNFOUFQBSBBKVEBSBNJTUVSBSFFNTFHVJEBEFJYBS
SFQPVTBS"HJUBSBTPMVÎÍPFNJOUFSWBMPT®NFEJEBRVFBDBSHBQSPTTFHVFBTFTGFSBTBERVJSFNVNBDPS
UVSRVFTB
JW "DBSHBEFNPSBOPNÓOJNPIPSBT
v. Antes de utilizar, transferir as DC BeadM1 carregadas com irinotecano para uma seringa, remover e eliminar
RVBMRVFSFYDFTTPEFTPCSFOBEBOUF"EJDJPOBSNMEFÈHVBF/°0EFDMPSFUPEFTØEJP
QBSBJOKFDÎÍPFB
NMEFNFJPEFDPOUSBTUFOÍPJØOJDPQPSDBEBNMEF%$#FBEM1.JTUVSBSTVBWFNFOUFQBSBPCUFSVNBCPB
TVTQFOTÍP"ENJOJTUSBSBTVTQFOTÍPBVNSJUNPEFNMQPSNJOVUP
WJ ²QPTTÓWFMDBSSFHBSVNBEPTFEFBUÏNHEFJSJOPUFDBOPQPSDBEBGSBTDPBNQPMBEFNMEF%$#FBEM1.
WJJ &YJTUFNEPDVNFOUBÎÍPEFVUJMJ[BÎÍPDMÓOJDBEFVNBEPTFNÈYJNBEFNMEFFTGFSBTDBSSFHBEBTDPNJSJOPUFDBOP'JPSFOUJOJ*OWJWP
QARMAZENAMENTO DAS DC BeadM1:
1BSBNJOJNJ[BSPSJTDPEFDPOUBNJOBÎÍPNJDSPCJPMØHJDBBT%$#FBE.EFWFNTFSQSFQBSBEBTFNDPOEJÎÜFTBTTÏQUJDBTDPOUSPMBEBT%BEPRVFBTDPOEJÎÜFTEFQSFQBSBÎÍPFDBSHBEBT%$#FBE.FTUÍPGPSBEPDPOUSPMPEPGBCSJDBOUF
BTTJNRVFPGSBTDPBNQPMBEF%$#FBE.GPSQFSGVSBEPPBSNB[FOBNFOUPEVSBOUFNBJTEFIPSBTËUFNQFSBUVSB
BNCJFOUFPVEFIPSBTOVNGSJHPSÓåDPFOUSFF¡$ÏEBSFTQPOTBCJMJEBEFEPVUJMJ[BEPS
3
Biocompatibles
Excellence in Interventional Oncology
CN00496.1
Biocompatibles UK Ltd is a
BTG International group company
Portuguese I Português
Irinotecan
"T%$#FBE.DBSSFHBEBTDPNJSJOPUFDBOPTÍPGÓTJDBFRVJNJDBNFOUFFTUÈWFJTEVSBOUFEJBTTFGPSFNBSNB[FOBEBTOVNGSJHPSÓåDPFOUSFF¡$"TTJNRVFPNFJPEFDPOUSBTUFGPSNJTUVSBEPBT%$#FBE.DBSSFHBEBTDPN
JSJOPUFDBOPUÐNRVFTFSVUJMJ[BEBTJNFEJBUBNFOUF
QINSTRUÇÕES DE ADMINISTRAÇÃO:
t"WBMJBSDVJEBEPTBNFOUFBSFEFWBTDVMBSBTTPDJBEBËMFTÍPVUJMJ[BOEPQBSBUBMJNBHJPMPHJBEFBMUBSFTPMVÎÍPBOUFT
EPJOÓDJPEPQSPDFEJNFOUPEFFNCPMJ[BÎÍP
t$FSUJåDBSTFEFRVFBT%$#FBEM1TÍPBEFRVBEBTQBSBBQBUPMPHJBBTFSUSBUBEBPVTFKBBMWPWBTDVMBSUBNBOIP
do vaso).
t4FMFDDJPOBSVNDBUFUFSEFBENJOJTUSBÎÍPFNGVOÎÍPEPUBNBOIPEPWBTPBRVFTFEFTUJOB"T%$#FBEM1
UPMFSBNVNBDPNQSFTTÍPUFNQPSÈSJBEFBEFGPSNBBGBDJMJUBSBQBTTBHFNBUSBWÏTEPDBUFUFSEF
BENJOJTUSBÎÍP
t*OUSPEV[JSPDBUFUFSEFBENJOJTUSBÎÍPOPWBTPBRVFTFEFTUJOBFNDPOGPSNJEBEFDPNBTUÏDOJDBTDPOWFODJPOBJT
t"T%$#FBEM1OÍPTÍPSÈEJPPQBDBT3FDPNFOEBTFBNPOJUPSJ[BÎÍPEBFNCPMJ[BÎÍPTPCWJTVBMJ[BÎÍPýVPSPTDØQJDBBUSBWÏTEBBEJÎÍPEBRVBOUJEBEFEFTFKBEBEFVNNFJPEFDPOUSBTUFBPýVJEPFNTVTQFOTÍP
J (BSBOUJSDVJEBEPTBNFOUFVNBTVTQFOTÍPDPSSFDUBEBT%$#FBEM1 no meio de contraste para melhorar a
EJTUSJCVJÎÍPEVSBOUFBJOKFDÎÍP
JJ &YUSBJSBT%$#FBEM1DPNBBHVMIBEFVNBTFSJOHBDPNVNUBNBOIPTVQFSJPSPVJHVBMB(NN
iii. Injectar lentamente as DC BeadM1OPDBUFUFSEFBENJOJTUSBÎÍPTPCWJTVBMJ[BÎÍPýVPSPTDØQJDBPCTFSWBOEP
BPNFTNPUFNQPBWFMPDJEBEFEPýVYPEFDPOUSBTUF'B[FSVTPEFKVÓ[PDSÓUJDPFFYQFSJÐODJBBPEFUFSNJOBS
PQPOUPåOBMEBFNCPMJ[BÎÍP
t6NBWF[DPODMVÓEPPUSBUBNFOUPSFNPWFSPDBUFUFSNBOUFOEPBPNFTNPUFNQPVNBMJHFJSBTVDÎÍPBåNEFOÍP
desalojar as DC BeadM1RVFBJOEBTFFODPOUSBNEFOUSPEPMÞNFOEPDBUFUFS
t&MJNJOBSUPEBTBT%$#FBEM1DBSSFHBEBTDPNJSJOPUFDBOPRVFOÍPGPSFNVUJMJ[BEBT
QCONSERVAÇÃO E ARMAZENAMENTO:
(VBSEBSBT%$#FBE.QPSBCSJSOVNMPDBMGSFTDPTFDPFFTDVSPOBFNCBMBHFNPSJHJOBM
Utilizar dentro do prazo de validade indicado no rótulo do frasco-ampola.
/ÍPDPOHFMBS
QRÓTULO DA EMBALAGEM:
/ÞNFSPEFDBUÈMPHP
&TUFSJMJ[BEBBWBQPS
1SPUFHFSEFNJTUVSBT
/ÞNFSPEFMPUF
6UJMJ[BSBOUFTEF&YQJSBFN
"UFOÎÍPWFSJOTUSVÎÜFTEFVUJMJ[BÎÍP
/ÍPSFVUJMJ[BS
1SPUFHFSEBMV[
/ÍPDPOHFMBS
2
Biocompatibles
Excellence in Interventional Oncology
CN00496.1
Biocompatibles UK Ltd is a
BTG International group company