楽加・ コ` and` ー
Contents
1. Go 1 6 4 12. 1 1 I 2 17 111
3. 2 23 2 1 1mL 1mL 15 19 20 60 4 15
4. 17 10 8 17 1 7 8 3 NM RIO
5. 2 1 0 2
6. 7 5 1 2 1 0 2 2007 4 18 No 235
7. _ _ HL HH2 VKORCI H7 H8 H9 CYP2C9 nT 3 UGTIA1 oonate ss UGT1A1
8. 1 1 PP 112 23 2 17 11 24 1124002 1mL 20 60 2 3 17 11 24 1124001 1124003
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11. K K VKORC1 S P450 2C9 CYP2C9 VKORC1 CYP2C9 VKORC1 H1 H2 H7 H8 H9 2 CYP2C9 3
12. 3 2 1 3 20 10
13. 3 TEL 0120 189 706 TEL 03 5253 1111 2 7 4 9 No 235 19 2007 4 19 4 4 1 19 3 20 1 079 1 465 21 4 3 185
14. No 235 21 2007 4 1 No 219 ICH EU 2
15. No 222 2007 4 12 No 235 5 1 18 11 8
16. WG WG WG 18 WG 3 18 WG 4
17. 4 3 3 20 12 2 1 3 20 2 12 2 3 1 2
18. lt lt gt 1 ICH E15 2006 2 Rieder MJ Reiner AP Gage BF et al Effect of VKRORCI haplotypes on transeriptional regulation and warfarin dose N Engl J Med 352 22 2285 93 2005 3 Aithal GP Day CP Kesteven PT Daly AK Association of polymorphisms in the cytochrome P450 CYP2C9 with warfarin dose requirement and risk of bleeding complications Lancet 353 1 717 9 1999 12 2 111 8 2001 5 17 6 706 10 2006 No235 23 2007 4 2 SI wc lt i 1
19. 0 IT 3 1 2 3 18 3 WEB
20. 20 21 3 31 20 4 tmL 20 RN 19 a i a No235 5 2007 4 5
21. 18 2 1B 9 1 6 4 5 3 1 No 235 2007 4 http www ncchd go jp kusuri index html
22. 8 9 10 1 2 C I 1 1 I 1a H Gb HCV RNA No 235 15 2007 4 19 3 20 19 4 4
23. No 235 1 2007 4 3 1 4 1 16 4 18 1
24. 19 2007 4 03 3595 2435 rs 100 8916 1 2 2 03 5253 1111 2755 2753 2751 Fax 03 3508 4364 RR Pharmaceuticals edieal Devices Safety Information No 235 1mL ImL 17 10
25. 1 L S SS FAX S FAX 03 3508 4364 E FE
26. 19 3 PDF 4 18 1 19 3 1 100 19 3
27. 2007 4 16 No 235 19 3 20 75 A B 3 A B 860 17 2 1 A B 13 2 2
28. TU C 100 0013 3 3 2 10 gg 0120 149 931 TEL 03 3506 9411 http www pmda goJp uk E mail kyufu pmda go jp
29. 4 16 4 19 4 1
30. VKORC1 H1 H2 9 4 1 CYP2C9 5 1 20 CYP2C9 Y 2007 4 22 No 235 VKORCI CYP2C9
31. 17 3 25 112 ISO lmL 17 11 24 1124002 20 mL 60 mL No235 3 2007 4 1 lmL
32. I O FAX Ti FAX 03 3508 4364 1 J 1 1 Crk SS r
33. lt S em S cm LE kg
34. No 230 6 1 1 7 19 2 6300 178 7 I
35. 19 26 100 oC 19 1 26 1 19 1 26 0 5mg 1 mg 19 1 261 0 005 0 05 0 2 25mg 50meg 19 1 261 75mg 19 2 22 250 500 1000
36. NN iT http wwwinfo pmda go jpD info houkoku htm http hanyouemhlw gojp Shinseicrn html CRNMenuFrame html ID http www pmda go jp kenkouhigai html
37. 1 D E cm kg 1 2 2 I 2 _ L LL 1
38. 20 2 20 mL 20 7
39. 30mg 18 10 24 la 30gg 18 11 6 0 5 18 11 6 18 11 29 3 mg 18 12 1 1 18 12 6 0 25mg 1mg 2mg 18 12 6 30mg 18 12 7 18 12 8 0 5 2 mL 1 2 mL 3 2 mL 18 12
40. http www jmed jp http Zwww info pmda gojp 2007 4 6 No 235 2
41. oH 1 11 1 O OO mfKd ER 1 My 2
42. ea 19 3 16 50 75 10 2a EMMA 0 _ 19 3 16 90 4g 180 gr 1 19 3 16 200nng 19 3 28 100mg 1 ID 2 3 7 4 5 6 B 7
43. URL Lhttp wwwr info pmda go jp 16 4 6 11 5 1 13 9
44. 2 2 2007 4 20 No 235 3 1 2
45. 20 60 2 mL 15 19 21 4 1 21 3 31HH 20 gt 00 21 3 31 21 4 1 20 20 19 eo eo gt 2 2 2007 4 4 No 235
46. gt cv gr SG c KH ix 111 Ne tH 2 pet ppt i 00 MM
47. 18 3 19 3 18 3 2 17 6 19 3 4 000 3 18 6
48. 18 19 2 304 1 6 18 9 30 2007 4 8 No235 NR 5 lt gt 1 Schardein JL Chemically induced birth defects 3rd ED NY Marcel Dekker Inc 2000 2 Koren G Bologa M
49. 14 2007 4 14 No 235 IEEE 19 1 9 1 30mg 19 1 101 19 1 22 500mg 19 1 2211 2 mg 5 5mg
50. 16 5 3 2 2 2 No 235 17 2007 4 2 28
51. 1 0 amp A CM 4 E mail info master pmda gojp No 235 13 2007 4 4 19 4 1 0 1 18 10 5 60mg 18 10 10 18 10 20 60mg 18 10 20H 50 18 10 20H
52. Long D Feldman Y Shear NH Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimcster Am J Obstet Gynecol 1989 160 5 1 1190 4 a PPPI 4 No 235 09 2007 4 157 8535 2 10 1 TEL 03 5494 7845 FAX 03 3415 0914 1000 16 00 http www ncchd go jp 983 8520 2 8 8 TEL 022 293 117
53. 1 1000 16 00 305 8576 2 1 1 TEL 029 853 3630 FAX 029 853 7025 900 16 00 105 8470 2 2 2 TEL 03 3588 1111 3410 FAX 03 3505 1764 830 17 00 104 8560 9 1 TEL 03 5550 2412 FAX 03 3541 1156 900 16 00 594 1101 840 TEL 0725 56 1220 TEL 19 5 14 2007 4 10 No 235
54. a y Pharmaceuticals Medical Devices Safety Information No 235 4 1 http www info pmda go jp http www mhlw go jp
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