医薬品インタビューフォーム
Contents
1. 25 7 1 2 1 22. 29 11 12 13 14
3. 523 34 6 5 3 0 6 3 0 6 511 ALT GPT 6 1 2 400 g
4. 24 400 gu g 1 2
5. 3 g kg 0 6 g kg 0 6 g kg 4 20 100g kg 20 g kg 100 g kg 33 4 zo zo vivo wo DNA UDS vtro
6. Draize 1 2 400g 1 1 400 g 1 1 g gt 1 2 1
7. 4 6 2 3 4 5
8. 400 g 400 g 1998 1 1 2009 10 400 g 9 200 g 28 2012 1 2 1 1 1 2 400 x g 3
9. 9 10 1
10. 3 400g N 54 1 28 1 24 0 18 1 20 1 10 4 0 1 3 1 10 2 1 1 5 95 1 62 0 94 0 87 0 52 N 184 110 1 79 1 73 0 93 1 52 1 91 1 69 1 75 6 7 4 1 0 90 4 0 3 5 1 75 6 8 2 8 95 2 04 1 54 1 22 0 64 2 26 1 57 N 113 57 55 3 10 1 95 1 29 1 85 2 37 1 85 3 30 7 8 1 7 1 10 5 9 2 0 2 10 6 1 1 6 95 3 46 2 73 1 78 0 80 2 87 1 87 N 16 4 10 2 86 2 29 0 98 1 16 2 44 2 01 2 20 7 4 0 1 1 05 2 1 0 3 2 45 6 3 0 2 95 4 08 1 64 2 82 0 87 3 88 1 00 FP 6 1
11. 2 200 g 28 1 1 1 1 200 g gt 3 1 400 g 1 I 14 716
12. 400 g 523 511 ALT GPT AST GOT 27 4 96 523 9 12 2 3 523 34 6 5 48 9 13
13. IF IF IF A4 9 IF IF 2 IF IF IF IF
14. 2008 9 TI BRINN ETN TI IN ETRE 1 VERRIER RETESTED EIRENE ER CD 2 es ES POT ee es COAS NN Jo nA o N 1 ee 2 3 RE RS 4 es NV 1 2 3 4 5 6 TFT PPHTT TTPPTYTFPFPHTYTFFHTP IT 7 8 9 V OE 1 es 2 3 OE VI 18 1
15. 2 gt 300g kg 15 g kg 1
16. w 16 31 1 1 TVI 2 3 i i 1 5 0 10 30 100 drwin a b c 10 d 10 e Haffner 10 10
17. 3 400 g 1 FP 200g 2 FP FP 400 g 1 FP200 x g 2 3 FAS e n 162 FP n 161 O n 83 T
18. IF 4 IF IF IF
19. 400 ug lt 26 3 1 5 1 ALT GPT AST GOT
20. 1mg 0 05mL 34 X 1 2 3 3 4 1 2 400 g 1 2 3 200 g 28 1 2 3
21. 3 4 20 100g kg 4 g kg 20 g kg 100 gg g kg 30 100 300 ux g kg 100 g kg 300p g kg 100 g kg 0 6 3 15 g kg
22. 24 FP 1 1 4 2 FP 35 30 lt 25 20 2 15 1 3 10 Ss 5 lt 0 L200 400 200 400 gxZsites FP n 8 wm Median p lt 0 01 vs Wilcoxon 1 1 4 24
23. 4 5 6 400xg PTP 70 7 x 10 200 g 28 2 10 7 400gg PTP 200 rg 28 00 2 35 9 2009 10 16 10 400g 2009 10 16 22100AMX02248000 200 g 28 2012 1 18 22400AMX00048000 11 400 g 2009 12 11 200 g 2
24. 400 g 1 12 3 FAS p 0 002 vs 2 4 6 8 10 12 n 133 133 132 130 129 126 124 n 38 32 32 32 32 38 31 mean S E p 0 05 Vs p lt 0 01 vs t 15 QOL FAS n 0 0 0 10 0 12 0 2 4 8 12 58 28 57 28 57 22 56 22 mean S E O lt 0 05 lt 0 01 vs 1 p 0 001 vs 16 4
25. 4 1 2 3 4 5 6 7 8 9 10 11 400 g 1
26. io 6 OH DX 1 7 CPC 21 oic acid DX CES 22 2 CYP450 CYP3A4 CYP1A2 3 4 VI 2 2 5 VI 1 3 6 1 400 g 6 800 g 1 1 14 1 DX 17 CPC 5 72 0 023 0 020 1 400 g gt 9
27. 0 1mg kg 15 24 DX 17 CPC 6 12 BA 2 7 63 3 1 4 DX 17 CPC 4 gt 9 3H 0 1mg kg 30 27 3 0 1 2 C 0 7 1 2 gt 9 H 0 1mg k
28. 2 1 400g
29. mm mm mg oO 15 8 5 8 60 7 3 200 g 28 1 5 6mg 1 200 rg 3 4 400 g 129 200 g 28 5 pH pH 6 2 1 400 g 1 400 g 200g 28 1 5 6mg 1 200 g 2 3 3
30. 5 1 S9 vtro CES DX 17 CPC CYP3A4 CYP1A2 CES ls CYP3A4 CYP1A2 UK 1 DX 1 7 CPC CYP3A4 CYP3A4 CYP1A2 CYP1A2 68 OH DX 17 CPC 68 OH DX
31. 1 32 28 ME 16 L 4 285 406
32. 1 2 3 4 5 6 7 8 9 10 11 400g 1 1 FP 200 g 2 2 lt
33. 2 17 MI 1 2 1 2
34. S9 S9mix wo DNA 0 05 0 1 0 2mg kg 6 p53 03 1 3mg kg 6
35. 400g 95 FP FP
36. 2 400 gu g 165 12 406 400 g 1 FP 200 g 2 1 2 3 FP A 0 6 t P lt 0 001 3
37. IF 2008 IF 2008 IF PDF IF iF 2008 21 4 IF 2008 IF
38. a 5 b 5 c 5 3 0 1 3 10 1 a 0 10 30 100 0 10 30 100 0 3 10 30 107 10 10 mol L b 10 0 3 10 30 1mg kg Na K C pH 0 1 3 10 3mg kg Na 10 0 10 30 100 K CF 0 3 10 30 pH 0 10 30 100 10 0 3 10 30 _
39. 1 zo 79 DX 17 CPC FP DX 3 9 100 80 4 60 1 8 40 amp 20 0 1070 109 108 107 mol L e DX 17 CPC FP DX mean n 3 Ki mol L 2 51 x 10 DX 17 CPC 7 20 x 10 FP 18 5 33 x 10 8 27 x 10 Ki mean n 3 2
40. mean S E D lt 0 001 vs t 3 FAS 95 0 i vs FP 1 41 1 95 640 10 0 07 0 32 0 46 1 51 1 77 6 41 0 93 1 67 1 39 162 FP 161 vs 83 1 11 1 58 0 64 12 n 162 32 19 8 77 47 5 3 1 9 42 25 9 8 4 9 0 0 0 109 67 3 FP n 161 26 16 1 82 50 9 5 3 1 45 28 0 1 0 6 2 1 2 108 67 1 n 83 2 2 4 42 50 6 2 2 4 32 38 6 4 4 8 1 1 2 44 53 0 FP 0 2 95 10 4 10 41 13 3 400 g
41. gt ns 3 4 V 5 1 2 1 2
42. met h asone 3 4 C H4FO 570 69 5 9 Fluoro 11 17 21 trihydroxy 16 methylpregna 1 4 diene 3 20 dione 21 cyclohexanecarboxylate 17 cyclopropanecarboxylate 6 NS 126 NS 126C NS 126M 7 CAS 132245 57 9 1 1 2 WW 99 5 3 4 269 C 5 6 pH 2 0 9 0 1 7 2
43. 4 5 400 g PTP 60 RH 36 PTP 75 RH 6 NN 3 XI 1 1 75 RH 4 1 1 1000 x 1 2 120 Ilx hr 200W h m 200 g 28
44. 200uug 28 14 4 3 5 523 34 6 5 3 0 6 3 0 6 511 ALT GPT 6 1 2 400 g IT 1 1 400g 200 g 28 2 Erizas Capsule for Nasal spray 400 Mg Erizas Nasal Powder 200 g 28 metered spray 3 2 1 JAN 2 Dexamethasone cipecilate JAN 3
45. 60 RH P 75 RH P D 3 RE a 9 75 RH 1 120 lx hr 200W h mz 2 3 1 2 4 IV 1 1 2 400 g 1 400 g
46. 200g 28 http www pmda gojp 1 63 2
47. FP cmHsO0XmL mL sec Xh 35 J EE 30 T 25 AUCs 20 1 15 10 5 0 4 40 400 4 40 400 g XPsites FP mean S E n 8 0 01 vs Aspin Welch D 0 05 Dp 0 01 vs Dunnett s 3 2 19 WI 1 1 2 1 3 3 2 400 g 6 400 g 1 1 14
48. DX 17 CPC 16pg mL 6 800g 1 1 14 3 DX 17 CPC C 35 9pg mL 28 0pg mL 4 5 6 2 1 2 3 3 4 5 6 20 7 gt H vtro 95 9 gw 3
49. 95 200 rg 0 263 71 5 61 1 29 173 019 0 275 0 800 ug _ 0 6 31 1 69 1 99 019 p 0 336 10 2 400 g 400 g 1 FP 200 g 2 2 FP FP 16 406 1 3 2 1 IgE CAP RAST
50. 3 5 1
51. 1 1 400 g 1 1 800 g 14 1 400 ux g 4 5 1 400 g 200g 1 200 g 2 400g 1 2 L 16 285 lt 3 2
52. 7 36 7 6 3 Ds 6 000 lx 1 2 120 lx hr 200W h m 6 7
53. 2 3 2 4 0 1 0 2 0 16 65 1 2 3 4 5
54. 1 1 400 g 1 H 3 0 0 0 0 4 0 6 0 8 0 87 1 0 0 94 0 001 0 001 400ug 1 n 72 200 g 1 mn 71 mean p lt 0 001 n 70 t 3 P 70 5 94 1 31 60 45 2 1 1 p 0001 200 gy _ 1 0 1 p 0001 0 1 0 8 0 t 5 400 rg i P vs H p lt 0 001 GDR ss 253 020 P vs L1 p 0017 3 1
55. 12 3 QOL JRQLQ 12 QOL
56. lgE CAP RAST 200 g 1 L1 200 p g 2 L2 400 g 1 H 2 T NNN PEO N a 200 g 400 g 200 gg g 1 L1 200 g 2 L2
57. 400 g 1 2 4 3 1 2 4 3 200 g 28 1
58. 35 2 NRE NETS ERE dt 35 3 FT 35 4 wm 35 5 CR RR CR I 35 6 te 35 7 35 8 35 9 36 10 36 11 mie 36 12 err as 36 13 1 PP 36 14 WRN 36 15 36 16 FFP PF 36 17 aaareestedeerzsee 36 XI 8 37 1 NE EERE NRE SATERA 37 2 DN TS 37 XI EE 38 1 RG ES GI 38 2 38 XL FFP 39 se 39 I 1
59. 95 400 g 1 6 45 2 03 1 41 1 95 FP200 g 2 6 40 2 10 1 51 1 77 1 3 2 400 g 6 41 0 93 1 67 1 39 vs FP 0 07 0 32 0 46 vs 1 11 1 58 0 64 50 g 100 g 200 g 400 g 200 g 400 g 14 100gu g O1 DX 17 CPC lt 16pg mL
60. 12 16 165 1 lt 3 2 1 lgE CAP RAST 2 3 2 3 16 4 5 1 1 2 3
61. 4 6 3 31 143 g kg 26 1 1 5 6 28 g kg 4 4 0 18 106 g kg 13 0 79 3 7 19g kg 39 0 49 1 66 5 30 g kg 4 4 6 3g kg 26 5 6 WA g kg 4 4 0 g kg 13 3 7 g kg 39 5 30 g kg 4 DX 17 CPC
62. IF IF 10 9 3 IF 10 20 9 IF 2 IF IF
63. zo Inoue N et al J Pharmacol Sci 112 1 73 82 2010 97 X TI 1 38 XL 39
64. 18 2 eo 18 20 1 20 2 ir 20 3 ee 21 4 eee 21 5 ananaeeesoresesettsseteo 22 6 23 7 eee 23 W 24 1 io 24 2 24 3 FFP 24 4 oonoonononnnmm 24 5 rr 24 6 A RRA SRR 25 7 A OANA RN RNR A RNR 26 8 ee 26 9 ee 29 10 eee 29 11 30 12 so 30 13 oo 30 14 30 15 31 16 31 32 1 ieee 32 2 AR 33 XX RE RNR 35 1
65. 9 2 0 4 0 2 ALT GPT 6 1 2 3 0 6 3 0 6 3 0 6 GTP AST GOT 1 0 2 1 0 2 3 0 6 1 0 2 1 0 8 1 0 2 2 1 0 2 2 0 4 1 0 2 1 0 2 1 0 2 1 0 8 126 400 g 28 5 6
66. 2 3 30 1 2 3 15 w
67. H 2 6 1 JO gt 9 168 97 2 64 5 92 6 3 7 23 1 2 1
68. 2015 9 7 871329 IF 2008 400ug Erizas Capsule for Nasal spray 400ug 00ug88 R FErIZaS Nasal Powder 200ug 28 metered spray 400 g 200 g 28 400 g 1 400 g 200 g 28 1 5 6mg JAN Dexamethasone cipecilate JAN TEL 0120 321 372 FAX 075 321 9061 http www nippon shinyaku cojp medicine product product_index html IF 2009 10 400 g 2012 1
69. 3 IF IF 2008 MR PDF IT MR IF IF IF MR IF IF
70. 8 2012 5 31 12 13 14 8 2009 10 16 2017 10 15 15 16 HOT 400g 1195422010201 1329712A1028 621954201 200 rg 28 1215168010101 1329712R1021 622151601 17 36 1 1 2 3 4 5 6 7 8 9 10 11 I 127 1 16 2010 103 1 85 98 2010 103 3 277 286 2010 125 1 17 2010 103 5 489 502 2010 Barnes PJ Immunol Allergy Clin N Am 25 451 468 2005
71. H wo YE90 9 93 0 85 3 92 7 3 gt 9 0 1mg kg 3 C 3 AUC 15 0 16 7 38 8 0 1mg kg 5 C 2 5 AUC BA 14 0 12 6 26 9 14 6 DX 17 CPC
72. a 0 003 03 3 3mg kg 1 1 3 b 10 0 0 03 0 3 3 1 1 7 c 10 3mg kg A os 5 10mg kg 1 2 32 2 1 gt 61 7mg kg gt 2 000mg kg gt 2 000mg kg 2000mg kg gt 2 000mg kg gt 14 2mg kg gt 125mg kg 125mg kg DX 17 CPO 2
73. g gt 9 VH 0 1mg kg 2 4 1 7 3 lt 4 21 5 gt 9 H 0 1mg kg 2 24 168 2 24 168
Download Pdf Manuals
Related Search