エディロールカプセルインタビューフォーム
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1 () 1 0.5g 0.5g 0.75g 0.75g JAN EldecalcitolJAN TEL :3017:
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6 0.5g 0.75g D3 1) 腿 ADL QOL D3 D3 D3 2 D3 D33 腿 D3VI2 VI2 V3(5) V3(5) % % % % % 1) 10.4mg/dL 11.0mg/dL 2) 11.0mg/dL 1
7 0.5g 0.75g EDIROL Capsule 0.5g EDIROL Capsule 0.75g Effective Vitamin DInnovative D3ROL D3 JAN EldecalcitolJANeldecalcitolr-INN D /-calci- H H 3 C CH 3 H H 3 C OH CH 3 H CH 2 HO H O H OH H HO C30H50O (1R,2R,3R,5Z,7E)-2-(3-Hydroxypropyloxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triolIUPAC ED
8 N,N C 20 D mg ml100 mm 20 C 36 5 C 6 60 C70 C80 C ) C80 C 50 C 75%RH () lx hr 437 W h/m 2 3
9 0.5g 0.75g 6.6mm 164mg 0.5g 0.75g 0.5g 0.75g PTP 0.5g 0.75g 1 0.5g 0.5g 0.75g 0.75g 0.5g D- 0.75g D- 4
10 25 C 60%RH PTP/ C 65%RH PTP/ C 75%RH PTP/ 6 60 C 2 50 C 75%RH () lx hr 499 W h/m 2 (1R,2R,3R,6E)-2-(3-Hydroxypropyloxy)-9,10-secocholesta-5(10),6,8(9)-triene-1,3,25-triol (1R,2R,3R,5E,7E)-2-(3-Hydroxypropyloxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol 5
11 6
12 g g g g g D VIII.-8.(2) (6LI2) (ED-110JP) (ED-112JP) (ED-113JP) (ED005JP) (ED006JP) 2 7
13 (6CI2) (ED-71T-103) (ED-301JP) (ED-111JP) CYP3A4 (ED008JP) (ED-71T-201) (ED007JP) (ED-209JP) 1, g 13.4% g 17.5% 26% log-rank P= % 3.6% 71% log-rank P= g 3.4% g 0.1% Student t P< 腿 0.4%2.3% Student t P< % 17.5% 1.1% 3.6% 1Kaplan-Meier 2 log-rank P 26% P= % P= ) g 8
14 1.0g 3) g g 4) g 110.5g g0.5g0.75g1.0g2411 D 0.25g280.5g g261.0g 26 L2-4BMD sca uca sp1,25(oh)2d24,25(oh)2d25(oh)dintact-pth 2 4L2-4BMD 0.75g 0.25g %50.5g %7 0.75g %71.0g % g 0.5g 0.75g 13.8%21.0g 623.1%7 1.0g 1.0g g g 5) g 110.5g 2000 DXA L2-4BMDHologic QDR L2-4BMD 0.708g/cm 2 9
15 2-4 L2-4BMD 0.809g/cm g0.75g1.0g4811 D 25(OH)D 20ng/mL D 400IU20ng/mL 200IU 0.5g550.75g55 1.0g5653 L2-4BMD Total hip BMD sca uca sp1,25(oh)2d24,25(oh)2d25(oh)dintact-pth 48 L2-4BMD MeanSD %0.5g %0.75g %1.0g %0.5g 48 腿 Total hip BMD MeanSD %0.5g %0.75 g %1.0g % 0.75g %90.5g % g %281.0g % g g 6) g 110.5g ALF ALF YAM 60% g ALF 1.0g g ALF 0.5g25(OH)D 20ng/mL D 400IU 0.75g528ALF 1.0g526 L2-4BMDTotal hip BMD sca uca 1,25(OH)2D24,25(OH)2D25(OH)Dintact-PTHCT QOL g13.4%ALF 111.0g17.5% 26% log-rank P= %ALF 3.6%71% 10
16 V.-3.(5)2) log-rank P= L2-4BMD g3.4%ALF 111.0g0.1% ALF Student t P< Total hip BMD 0.4%ALF 2.3%Student t P< %320ALF %208 2) ED-71T-201ED007JPED-209JP g L2-4BMD Total hip BMD % % % % 7) 11
17 D D3 1,25(OH)2D3 D3 Ca 1,25(OH) 2 D 3 Ca VDR VDR D3 1in vitro 8) rhm-csf33ng/ml Receptor activator of nuclear factor kappa B srankl100ng/ml nmol/L nmol/L (mol/l) 12 mean + SE (n = 6) # P < 0.05 vs rhm-csf unpaired t-test * P < 0.05 vs rhm-csfsrankl Dunnett s multiple range test
18 2 Ca 9) g/kg 1,25(OH)2D31g/kg 6 Ca Ca 1g/kg 1,25(OH)2D3 Ca meansd (n = 4) * P < 0.05 vs Vehicle Dunnett s multiple range test 3 Ca Ca 10) g/kg/ 12 Ca Ca 0.1g/kg 2 Ca Cavehicle g/kg 12 Ca Ca 0.01g/kg 12 Ca Ca g/kg 2 12 Ca Ca 12 Ca Ca Vehiclen=80.005μg/kgn=80.01μg/kgn= μg/kgn= μg/kgn=78 0.1μg/kgn=8 meanse * P < vehicle 0 Dunnett-Hsu 13
19 4 11) g/kg/ 1,25(OH)2D g/kg/ 2 腿 腿 0.4g/kg 1,25(OH)2D g/kg/ 12 12) ) 12,13) 1 12 腿 DXA pqctperipheral Quantitative Computed TomographyStiffnessPeak Load AUC 腿 g/kg/ 腿 腿 腿 meanse (n=1215)sham OVX μg/kg 0.015μg/kg 0.03μg/kg * P 0.05** P 0.01*** P vs OVX Dunnett s test 14
20 腿 腿 OVX(ng/kg/day) OVX(ng/kg/day) meanse (n=910)* P 0.05** P 0.01*** P vs OVX Dunnett s test g/kg/ 腿 3 12,13) g/kg/ 12 L g/kg/ 16 腿 14) g/kg/ 4 15
21 16 ED008JP 15) Ca (ALF) 12 Ca 1 uca untxbap Ca 1 uca 1.0g 20 ALF 1.0g 20 untx BAP ALF Ca ALF 10 0 untx 10 0 BAP ED g μ ALF 1.0 g μ % -20 p0.003 (Student s t-test) % uCa(mg/day) uCa(mg/day) 16
22 VII.-1(3) 1 16) 0.75g Cmax (pg/ml) (n=10) kel AUC24h (pgh/ml) 1, (n=9) AUClast Tmax(h) Cmax AUCinf t1/2(h) (pg/ml) (h -1 ) (pgh/ml) (pgh/ml) , ,5611,245 MeanSD, n= g ) CL/F Tmax(h) t1/2(h) (L/h) (n=10) (n=10) (n=10) (n=9) (n=10) 4, (n=10) AUCinf (pgh/ml) 4,9551,489 (n=9) 17,8022,051 (n=10) (n=9) CLss/F(L/h) (n=10) CL/FCLss/F MeanSD g CmaxCminAUC24h t1/ g 4) 17
23 2 6) g pg/ml * 0.5g (n=49) (n=48) (n=44) (N=141) 0.75g (n=54) (n=52) (n=47) (N=153) 1.0g (n=53) (n=51) (n=45) (N=149) nn* (MeanSD) 3 18) 10 Child-Pugh ClassA8 ClassB2 0.75g 18 Cmax pg/ml AUClast pgh/ml (Child-Pugh ClassA) , ,936 (Child-Pugh ClassB) (63.1, 84.6) (2,622, 3,250) 16) , Child-Pugh ClassAn=8n=31 (Mean±SD) Child-Pugh ClassBn=2Mean(Min,Max) 4 CLcr 2) 2) 4,15, 19) CLcr (pg/ml) n=n= CLcr(mL/min)* (N=17) 0.75g (N=331) (N=19) (N=15) 0.75g (N=232) (N=150) 1.0g **(n=6) 1.0g ***(n=22) 1.0g ****(N=80) (Mean±SD) * Cockcroft-Gault ** *** ****24812
24 110.75g 110.5g 1 16) 0.75g Cmax (pg/ml) AUClast (pgh/ml) , , (Mean±SD, n=15) 2 17) 0.75g CYP3A4 90% 90% AUClast Cmax % 20)
25 ka1.62 h -1 20) 21) g/kg F g/kg F 75.3 VII.-1(3) CL/F0.101 L/h 20) Vc/F10.5 L 20) 1100ng/mL % in vitro 22) VII.-1(3) 75% VII.-4(5) 23) 15 3 H g/kg 6 24) 0.05g/kg 3 H pg eq./ml 2 AUCinf AUCinf 6% 20
26 VII.-4(5) 25) 3 H- 0.05g/kg H pg eq. of / g or ml (OH)ED hydroxypropyloxy ED hydroxypropyloxy 3-(1,25-(OH)2D3-2 -yloxy)propionic acid 3 26) 2 3-hydroxypropyloxy 24 27) in vitro 28) 21
27 H H 3C CH 3 CH 3 H H 3C OH H CH 2 HO OH H H O H HO ED-71 H H 3C CH 3 H H 3C OH CH3 H H 3C CH 3 H OH H 3C OH CH3 H H CH 2 CH 2 HO H HO H OH H HO OH H H O H 3-(1,25-(OH) 2 D 3-2βyloxy)propionic acid ED-138 HO 24(OH)ED CYP CYP1A11A22A62B62C82C92C182C192D6 2E13A4 4A11 in vitro CYP NADPH NADHNADP+ NAD+ CYP CYP CYP 29) 0.75g ) 3 H % 55.89% 30) 22
28 VII.-6(1) VII.-6(1) 23
29 VIII.-6.(1)VIII.-10. IX.-2.(3)VII.-4.(3) (1) (2) (3) (1) VIII.-8.(2) CLcr 30mL/min 11.0mg/dL PTHrP PTH PTH D (2) (3)VIII.-8.(2) 24
30 (1) (2) 36 1 (3) (4) 倦 (1)VIII.-2.VIII.-10.IX.-2.(3) (2)(3)(4)VIII.-8.(2) D PTH 25 D D3 D PTH
31 D % % % % % 1) 10.4mg/dL 11.0mg/dL 2) 11.0mg/dL 11.5% 倦 % 2) 11.0mg/dL 1) D3 11.0mg/dL % mg/dL % g V.-2 VIII.-5.VIII.-6. 2) D3 3) % D % % 26
32 2% 2% -GTP ASTGOTALTGPTLDH BUN 20.3% Al-P 15.0% 1) 10.4mg/dL 11.0mg/dL % 163 (20.3%) 132 (16.5%) 13 (1.6%) 9 (1.1%) 9 (1.1%) 7 (0.9%) 5 (0.6%) 5 (0.6%) 6 (0.7%) 4 (0.5%) 3 (0.4%) 3 (0.4%) 3 (0.4%) 3 (0.4%) 2 (0.2%) 2 (0.2%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 27
33 5 (0.6%) 5 (0.6%) 3 (0.4%) 2 (0.2%) 2 (0.2%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 扁 1 (0.1%) 1 (0.1%) 5 (0.6%) 3 (0.4%) 2 (0.2%) 1 (0.1%) 4 (0.5%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 4 (0.5%) 3 (0.4%) 1 (0.1%) 2 (0.2%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 4 (0.5%) 1 (0.1%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 2 (0.2%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%) MedDRA/J version
34 (1) g/kg/ g/kg/ g/kg/ (2) (3) VIII.-2.IX.-2.(3)VII.-4.(3) g g g (1) PTP PTP PTP 穿 (2) 29
35 SD 2 C Crl:CDSD C IX.-2.(4) 2) 30
36 g/kg ddy 疼 SD herg herg IC20 in vitro K CHO mol/l 2.84mol/L / ph SD BaSO4 ddy acetylcholine, histamine,bacl2 in vitro g/ml 6 SD g g g/kg g/kg g/kg 10g/kg 15g/kg 腿 kg kg g/kg g/kg g/kg g/kgCa 31
37 6 SD g/kg/ g/kg/ g/kg/ g/kg/ /0.045*g/kg/ Ca Ca D3VD g/kg/ g/kg/ g/kg/ g/kg/ g/kg/ 9 * g/kg/ 0.045g/kg/ 67 SD g 89 SD g g/kg/ g/kg/0.1g/kg/ SD g 娩 g/kg/ g/kg/0.125g/kg/0.5g/kg/ 餌 F g/kg/ 0.5g/kg/ 娩 F1 0.5g/kg/ 0.125g/kg/ 0.125g/kg/F1 SD g g/kg 0.16g/kg 15 5 Japanese White kg g/kg/
38 0.06g/kg/ 餌 0.3 g/kg/ 0.06g/kg/0.3g/kg/ 1 20 SD g/kg/ 7 20 Ca 0.125g/kg/0.032 g/kg/f g/kg/ 35) 3 in vitro Ames CHL ICR 50g/kg 24 36) 6 B6C3F1:Crlj g g g/kg/ ) 6 Crl:CDSD g g /0.03*g/kg/ C 0.02g/kg/ 0.02g/kg/ 0.02g/kg/ 0.02g/kg/ 0.05/0.03g/kg/ 0.02g/kg/ C 0.05/0.03g/kg/ 1 * g/kg/ 0.03g/kg/ 38) ASA PCA PCA 33
39 0.5g0.75g 3 VIII14 0.5g100 PTP140 PTP 0.75g100 PTP140 PTP500 PTP 700 PTP PTP PTP
40 g 22300AMX g22300AMX HOT(9 ) 0.5g M g M
41 1) NIH Consensus Statement 2000, March 27-29, 17(1), ) 3) 4) 15 5) 6) 7) 8) in vitro 9) 10) 11) 12) OVX 13) OVX 14) 15) 12 16) 17) 18) 19) 14 20) 21) 22) in vitro 23) 24) 25) 26) 27) 28) in vitro 29) in vitro 30) 31) 32) 33) 34) 35) 36) 37) 38) 36
42 37
43 38
44
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... -1... -1... -2... -6.... -1 (1)... -1 1)... -1 2)... -14 (2)... -19 (3)... -52 (4)... -18 (5)... -136.... -196 (1)... -196 (2) b... -224 (3)... -233.... -251.... -286.... -289 (1)... -289 (2)... -32
IMUSERA 3 3 4 4 5 5 5 5 6 1 1 12 18 25 25 31 31 31 31 32 32 37 43 43 45 48 48 48 48 49 5 1 2 3 4 3 4 1.56mg.5mg D- 3 15.9mm 5.8mm.96g FTY.5mg FTY.5mg OH NH2 OH H3C HCI 5 6 7 BCG Torsades de pointes a 2
50mg 75mg (1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH
3240 14 8 8 50mg 75mg 13 6 25 1-(1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH O N O C 56 H 70 N 9 NaO 23 S 1292.26 5-[(1S,2S)-2-
125 2 P 1st washout 2 PB P mg/dL nd washout 2 P 5.5mg/dL< mg/dL <2.5mg/dL P P 2 D D 3 Ca 10
. (1) 125 1 125 Renagel PB-94 P intact-pth P 1 b c a b 1 18 2 3 3 3 1 P 4 D 1 5 6 7 2 1HIV 2 3 4 5Hb 8.0g/dL ALT 48IU/L 6 7 PB-94 440mg 403mg 1-196 125 2 P 1st washout 2 PB-94 1 2 4 4 P 2.5 5.5mg/dL 1
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2.7.6 MJR a MRI CT b 2 Beecham r-afs mg/ mg/ Gn-RH 742
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グリセオール注インタビューフォーム
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エディロールインタビューフォーム2014年10月改訂
2014 年 10 月改訂 ( 第 8 版 ) 日本標準商品分類番号 873112 医薬品インタビューフォーム日本病院薬剤師会の IF 記載要領 2013 に準拠して作成 剤 形 軟カプセル 製 剤 の 規 制 区 分 劇薬処方箋医薬品 ( 注意 - 医師等の処方箋により使用すること ) 1 カプセル中 規 格 含 量 エディロールカプセル 0.5μg: エルデカルシトール 0.5μg 含有エディロールカプセル
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IF 1 MR 63 2 IF 10 3 IF 2IF IF IF 3IF A4 9 IF IF IF 11 1 IF IF 4IF IF MR IF IF MR Drug Safety Update IF
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Microsoft Word - 14_LCMS_アクリルアミド
3--2-3-Iodo-2-propynyl butylcarbamate (IPBC) Carbamic acid, butyl-, 3-iodo-2-propynyl ester Iodocarb CAS 55406-53-6 C 8 H 12 NO 2 I C (g/cm 3 ) (mmhg) log P ow 281.09 (280.9910) 64 68 1.51 1.57 (20 C)
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1.4 特 許 状 況 - 1 - - 2 - 1.5 起 原 又 は 発 見 の 経 緯 及 び 開 発 の 経 緯 FCT CT RH ... 1.5-1... 1.5-1... 1.5-1... 1.5-1... 1.5-2... 1.5-2... 1.5-2... 1.5-3...1.5-4... 1.5-5 i 10mg FCT 1 1 6 15 5mg CT 1 1 2 6 4mg CT
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