伏立康唑说明书

™Vfend™VoriconazolePowderforSolutionforInfusionZhusheyongFulikangzuo2R,3S-2-2,4--3-5--4--1-1H-1,2,4--1--2-FFCH3NNFOHNNNC16H14F3N5O349.3P45014-1-22C.inconspicuaCladophialophoraspp.0.05-2g/ml2-22SBECDSBECDGMPTSBECDSBECDSBECD6B2771253%31%/84100%55241593/36/851281661072311177347313423-22561121366619152-123412-152057/61512-15271443/6170%()2200mg300mg14,2200mg2300mgAUC2.524261-296%34%24%pH4.6l/kg58%8P450CYP2C19CYP2C9CYP3A4CYP2C194-2215-20%3-5%AUC42N-72%2%80%83%94%96200mg6102425ng/ml(1193-4380ng/ml)3742ng/ml(2027-6302ng/ml)CmaxAUC18-4583%113%CmaxAUC6565CmaxAUC18-4561%85%65CmaxAUC18-453521224124mg/kg123mg/kg5-221186ng/ml1155ng/ml212124mg/kg2.5mg/dlSBECD200mgChild-pughABAUC233%Child-pughB2100mg2200mg,AUCChild-pughC10mg/ml2-5mg/ml3mg/kg12,96%1241216mg/kg(124)6-222424mg/kg40kg40kg124121400mg(124)121200mg(124)242200mg2100mg1216mg/kg(124)*4mg/kg121200mg121*40kg121200mg40kg121100mg624mg/kg23mg/kg25mg/kg,2300mg40kg2150mg50mg,2200mg(40kg2100mg)7-2250ml/minSBECD121ml/min4,SBECD55ml/minALT/GOTAST/GSTChild-PughABChild-PughC1212-18221214mg/kg1255121619ml10mg/ml2-5mg/mL10mg/ml10mg/mL10mg/mLkg3mg/kg4mg/kg5mg/kg309.0mL(1)12mL(1)18mL(1)3510.5mL(1)14mL(1)21mL(2)4012.0mL(1)16mL(1)24mL(2)4513.5mL(1)18mL(1)27mL(2)5015.0mL(1)20mL(1)30mL(2)8-225516.5mL(1)22mL(2)33mL(2)6018.0mL(1)24mL(2)36mL(2)6519.5mL(1)26mL(2)39mL(2)7021.0mL(2)28mL(2)42mL(3)7522.5mL(2)30mL(2)45mL(3)8024.0mL(2)32mL(2)48mL(3)8525.5mL(2)34mL(2)51mL(3)9027.0mL(2)36mL(2)54mL(3)9528.5mL(2)38mL(2)57mL(3)10030.0mL(2)40mL(2)60mL(3)28249mg/ml(0.9%)5%5%0.45%5%20mEq5%0.45%5%0.9%Aminofusin10%PlusAminofusin10%Plus4244.2%244.2%9-221493HIV6245.112-9012-184981956112136611%307/602381196B18530520019111%305307/602/B*N=1493N=200N=191N=196N=185N(%)N(%)N(%)N(%)N(%)30720.63115.584.25528.11(0.5)362.452.521.073.60201.321.002(1.0)030.20000936.20073.62513.5614.110.5003619.5483.2010.573.684.3251.70052.663.2130.90042.021.1372.50052.652.7291.90010.521.1261.710.5010.531.6231.50021.021.1885.921.031.6147.12915.7714.821.010.5115.6189.710-22412.763.021.094.642.2161.10031.563.2161.131.5042.00151.0010.531.5030.210.500070.5010.521.021.120.100052.740.30010.5010.10000543.6105.031.663.142.2281.931.5073.652.7SGOT281.984.021.010.50SGPT271.863.021.031.510.5241.60010.53619.5161.110.5073.694.9161.10021.0105.4120.810.5010.531.640.310.5005931.9372.500105.110.5201.3021.052.60865.83(1.5)1(0.5)13(6.6)7(3.8)161.1002(1.0)2(1.1)17(1.1)3(1.5)01(0.5)080.510.510.542.04021.670.5000115.9*B30%/11-22/28146%86/1493Stevens-JohnsonN20901%/QTGGT/LDH12-22Stevens-Johnson13.4%200/1493/305307/60213-22305*n/N(%)n/N(%)1.5×ULN8/185(4.3)7/186(3.8)AST3.0×ULN38/187(20.3)15/186(8.1)ALT3.0×ULN20/187(10.7)12/186(6.5)3.0×ULN19/187(10.2)14/186(7.5)*nNULN307/602*B**n/N(%)n/N(%)1.5×ULN35/18019.446/17326.6AST3.0×ULN21/18011.718/17410.3ALT3.0×ULN34/18018.940/17323.13.0×ULN29/18116.038/17322.01.3×ULN39/18221.4102/17757.60.9×LLN30/18116.670/17839.3***BnNULNLLNCYP3A4Q-TCYP3A414-22400mg121400mg121100mg12CYP3A282810mg/kg(mg/m20.3),/100mg/kg6/10mg/kg,Lapp15-22QT1Child-PughABChild-PughC50ml/minSBECD16-22121ml/min4,SBECD55ml/minStevens-Johnson261850mg/kgmg/m20.20.61.650mg/kg6mg/kg50mg/kg1030100mg/kgmg/m20.10.41.41.4AmesCHODNADNA50mg/kg,1.6/17-221212-18221214mg/kg1255≥659.2≥751.8AUCCmax1055280-90200mg,12/P450CYP2C19,CYP2C9CYP3A4CYP450600mgCmax18-22AUC9396()CYP450()CYP450PH2400mgCmaxAUC1823PH150mgCmaxAUCCYP3A41g500mgCmaxAUCP450CYP2C19,CYP2C9CYP3A4CYP45OCYP3A4Q-T()(CYP3A4)(2g)CmaxAUC5561014()CYP3A4()CYP3A4CmaxAUC1370(CYP3A4)0.1mg/kgCmaxAUCt1172211/3(CYP2C9)(2300mg)30mg,93CYP2C9CYP3A419-22(CYP2C9)(CYP3A4)CYP3A4CYP3A4CYP3A4CYP3A4CYP3A460mgCmaxAUC11%34%P-10.25mgCmaxAUCUDP-1gCmaxAUCCYP2C9CYP4501300mg,CmaxAUC49%69%;2400mg1300mgCmaxAUC67%81%2200mg2400mg;40kg,2100mg2200mg25mg/kgCYP4501300mg2200mgCmaxAUC69%78%2350mg,CmaxAUC2200mg96%68%2400mg,CmaxAUC20-222200mg104%87%CmaxAUC195%331%2200mg2350mg;40kg,2100mg2200mg25mg/kgCYP2C19CYP2C19CYP3A440mgCmaxAUC15%41%CmaxAUC116%280%CYP2C19CYP3A4(3,800mg)CmaxCmin()AUCCmaxAUCHIVCYP3A4HIV/NNRTICYP3A4CYP3A4CYP450delavirdNNRTI/35110121ml/min,SBECD55ml/minSBECD,200mg282421-2222-222824282430ml319ml10mg/mlPfizerIrelandPharmaceuticalsLimited,PotteryRoadDunLaoghaire,Co.Dublin,IrelandPFIZERPGMZoneindustrielle-29routedesindustries37530POCEsurCISSEFrance