医薬品・医療機器等安全性情報 No.301
Contents
1. 35m s 10 G 3 6 102. 7 No 301 2013 5 3 PMDA
3. 3 Q 2 HD EE No 301 2013 5 4 25 5 1 RNR RS _ NG
4. 18 DSM IV DSM IV American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 4th edition DSM IV 2013 5 26 No 301 25 3 19
5. No301 2 1 MRI 2 3 MRI 2 2 2 1 4 16 mg dL 29 31 58 52 x10 mm 7 4 x10 mm 4 42 a x10 mm 197 Na mEq L 142 K mEq L 3 9 Cl mEq L 106 Ca mg dL 9 4 CRP mg dL 0 05 mg dL 79 ss IgG mg dL 1102 IgA mg dL 84 IgM mg dL 106 AST GOT IU L 16 ALT GPT IU L 12
6. 13 gt 0 25g 05g 025g gt 14 1b 960
7. 1 1 1 1 2 1 2 7 2 3 2 6 MRI
8. 1 1 2 lt gt PMDA No 38
9. X X X lt g
10. 1 9 G G 17 5g 5 G G 65 gt 1 9
11. 2 4 29 1 1 100 2 16 31 20 100 2 3 Ecoii 8 gt 1 2 400mg kg 5
12. gt d HD EG S S S UGT2B7 UGT2B4 CYP3A4 CYP2D6
13. 14 15 1 50 mg dL 2b 16 17 1 56 mg qdL 18 1 3 1 29 mg dL 1 25 1 08 mg dL 15 1I 7 1 i Mi g dL 11 8 11 8 106 93 93 mm 6 800 2800 3800 4700 5600 10 mm 146 10 7 16 6 14 2 16 4 mg dL 0 79 118 15 1 54 1 29 104 mg dL 65
14. PMDA No 38 http www info pmda gojp anzen_pmda file iryo_anzen38 pdf PMDA http www info pmda go jp anzen_pmda iryo_anzen html 1 25 3 26 0326 2 http wwwhoureimhlw go jp hourei doc tsuchi T13032710030 pdf 2013 5 4 No 301 2 25 3 26 2
15. 1 gt 15 10mg 6 17 ee 6 11 12 a 6 17 DSM W
16. 24 11 21 50 100 2 1 a 5mg 25mg 2mg 24 11 21 3mg A sh OO RR RE 24 11 21 40mg i crite 24 9 28 200mg No 301 29 2013 5 1 2 3 4 5 6
17. 245 25 5 1 W e PMDA PMDA http www info pmda go jp info idx push html
18. 1 No x N 0 4 C 1500mg 60 18 AU 1 1 500mg 400mg a 2b 15gg kg 3 i NM 4 1 1 50 5 7 1 18 mg dL 9 No301 15 2013 5 12
19. SS MC Ultra rapid Metabolizer CYP2D6 Ultra rapid Metabolizer No 301 21 2013 5 gt 6 dl N
20. 125 mg dL 15 1 02 mg dL 17 1mg 20 102 mg dL 29 Hb 9 6 g dL 32 40mg 34 400mg 47 GIF S1 stage 50 200mg 91 300mg No 301 17 2013 5 98 400mg 112 600mg 189 2
21. UGT2B7 UGT2B4 CYP3A4 CYP2D6 CYP2D6 Ultra rapid Metabolizer CYP2D6 Ultra rapid Metabolizer 22 No 301 g gt L 1 10 UGT2B7 UGT2B4
22. gt 100mg 200mg 50 Toxic Epidermal Necrolysis TEN Stevens Johnson 3 lt gt 300mg
23. 2b 2013 5 14 No 301 1 No ER 3 C 2250mg 50 27 2250mg 2b 15 g kg 800mg 3 1 500mg 16 28 1500mg 43 2b 7 CT KL 6 1444 U mL 2
24. HPV 16 18 CIN 2 3 ADEM ADEM 2 MRI SE 3 25 1 31 3 0 5 0
25. No 301 2013 5 250mg 1 TI la II 1b C 1 HCV RNA 2 2013 5 12 4 1 CRP
26. UGT2B7 UGT2B4 CYP3A4 CYP2D6 CYP2D6 Ultra rapid Metabolizer CYP2D6 Ultra rapid Metabolizer gt 2013 5 1 20mg 10
27. 25 4 12 250mg B OR EI 25 3 27 2500 a AA Nt 2 25 3 25 OD 60 z g 25 3 25 40mg a a se 25 3 25 5mg 10mg 6 a EE 25 3 15 4 mg 8 mg 200mg 25 3 8
28. CRP X 1 25 2 13 1 0 6 0 1 25 1 31 5 0 8000
29. 273 21 12 24 12 21 12 HD EG No 301 5 2013 5 No 7 2 1 O 5mL M 10 1 LF 05mL lt gt 1 1 1 1 1 1 2 2 14 2
30. mmHg 125 mmHgs 79 min a 55 36 7 10 mm 353 386 371 361 331 336 354 399 10 mm 18 5 32 9 35 5 337 33 1 306 31 5 32 8 37 8 g dL 109 11 9 114 111 104 105 11 1 127 mm 6400 3900 2400 3000 2 100 2000 2300 3500 92 3 36 0 418 570 54 7 10 mm 63 77 94 12 0 14 8 15 4 15 8 12 3 mg dL 23 20 19 24 46 44 50 43 CRP mg dL 5 69 205 205 040 0 16 007 005 003 001 mL min 77 1 849 117 9 1036 988 106 2 101 2 1012 ng mL 16 78 782 7 82 204 057 004 lt 0 02 PT PT PT INR 83 108 109 99 098 098 101 097 097 104 098 098 APTT sec 34 7 32 9 30 1 28 5 I 70 1 a ug mL 84 26 22 27 D g mL 36 11 1 1 12 30 2 69 0 3 g dL 56 70 g dL 32 4 2 A G 1 3 15 mg dL 07 05 AST GOT U L 70 19 ALT GPT UL 47 13 LDH U L 222 222 185 172 148 14
31. 6 11 DSM IV American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 4th edition DSM IV 2013 5 24 No 301 16 gt 25mg 50mg 6 17 i 18 6 17 DSM W 1 1 2 189 1 1 2 184
32. 1500mg 10mg 26 2mg 36 30 Hb 81 g dL 1 52 mg dL 400mg 3500 mm 2500 4000 mm 36 1 SSRI 1 44 mg dL Hb 5 0 g dL 5 10mg 1 2mg 10 400mg 11 20mg 12 Hb 11 1 g dL
33. 22 9 UNE 3 2250mg 800mg 2b 15 g kg 3 _ 4 2 94 mg dL 1477 mg dL 100mg 200mg 5mg 15mg 6 50mg 100mg 28 8 1 1 50 6 g 27 0 05 12 14 244 mg dL 90 mg dL 15 23
34. Pharmaceuticals Medical Devices Safety Information 2 EE No 301 245 1 19 2 27 http Wwww infO pmda go jp http www mhlw go jp 25 2013 5
35. 2 18 7 17 DSM V DSM IV American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 4th edition DSM IV gt 20 12 5mg 15mg 25mg 50mg 18 es 18
36. CK CPK 2013 5 20 No 301 lt gt 4 12 5mg 25mg LD HD AP BP MD EX MSD
37. E Coli 1 2b 16 99 12 6g dL 162 178 No 301 13 2013 5 4 6 8 11 18 22 29 36 43 50 10 mm 403 388 399 390 367 349 345 351 336 g dL 129 124 120 123 121 114 109 107 110 105 36 7 316 322 299 mm 3500 3200 3100 2800
38. UGT2B7 UGT2B4 CYP3A4 CYP2D6 CYP2D6 Ultra rapid Metabolizer CYP2D6 Ultra rapid Metabolizer gt
39. CYP3A4 CYP2D6 CYP2D6 Ultra rapid Metabolizer CYP2D6 Ultra rapid Metabolizer gt 10 120mg
40. 3 2 2b 3 20 21 750mg 200mg 2b 1 5 g kg 85 2b 2013 5 18 No 301 No 1 7 C 2250mg 60 45 2250mg 600mg 1 2b 15 g kg
41. 15 2 17 2 19 MLEF 2 20 MRI 2 21 3 2 3 2 96 MRI gt 2 14 RBC MRI CT ENG EMG 2 2 2 2 21 23
42. 9 03 3595 2435 100 8916 1 2 2 03 5253 1111 2755 2753 2751 Fax 03 3508 4364 6 Pharmaceuticals and Medical Devices Safety Information NE 0 2 1 25 3 26 1 19 2
43. 60 77 5 5 2 1500mg 400mg 2b 15g kg 3 11 1 50 2T 77 77 22 97g dL 300mg 66 200meg 71 2b 72 38 77 39C
44. 7 8 2013 5 30 No 301
45. 24 2 25 1 23 1 10 No 301 No N 1 C 1500mg NN 8 1500mg 400mg 2b 1 5g kg 3 6 1 50 8 120mg 1 1 576 mm 10 3g 6 G 5 g
46. 2 3 1 30 ng mL 39 5C 2 15 ng mL CRP 5 mg dL 0 0 30 1008 pH 7 5 mg dL 0 1 2 1 400 1 7 00 30 1 005 pH 5 5 mg dL 0 1 1 1 400 lt 1 12
47. 1000mg 400mg 29 1250mg 64 79 g dL 3 13 20mg 42 10 7 g dL 3 22 750mg 200mg DD 2b 1 5g kg 8 1000mg 42H 3 24 1 5 2 mg dL 8 15 22 29 36 43 5 g dL 13 3 13 5 11 8 10 3 96 98 10 6 10 0 mg dL 6 1 9 7 90 9 9 11 3 9 9 9 8 19
48. 12 H 8 15 22 50 12 1 g dL 10 3 10 4 10 4 11 0 10 7 10 9 10 9 96 mg dL 5 4 7 4 7 0 8 2 8 8 7 5 5 2 2b No 301 19 2013 5 J 245 1 25 3 26 3 29 2 gt 1 200mg 300mg 400mg 5 CK CPK
49. IR MR RE ERECT RE i 24 12 19 LD HD 10mg 24 12 3 1 24 11 30 100mg 250mg Meiji Seika 24 11 27 500mg 250mg i 24 11 27 40mg mL ena 24 11 22 504g NL OO 24 11 2 24 gg ea 24 11 22 50mg A
50. 1 69 3 189 DSM IV American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 4th edition DSML IV gt 1 20mg 30mg 7 17 18 7 17 DSM IV TR DSM IV TR American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 4th edition Text Revision DSM IV
51. 25 3 7 25 3 4 En RR 25 2 28 OR 25 2 28 75mg 5 RS 25 2 28 75mg 225mg 4 5mg 9mg 25 2 26 13 5mg 25 PIE5YCRTKOR2E 25 2 26 FF 10 1000mg 2013 5 28 No 301 i a 25 2 26 2 5mg
52. 98 7 3 27 48 69 97 127 155 g dL 93 98 96 91 112 121 mm 6400 8000 6 300 4900 9300 4200 10 mm 161 162 157 135 179 146 mg dL 108 105 092 1 07 1 14 100 BUN mg dL 22 15 mg dL 63 65 62 59 67 72 2b 2013 5 16 No 301 1 No 0 7 5 C 2250mg 60
53. 24 26 cels mm 242 151 99 lt 1 a 2 1 014 IlgG 044 Cl 126 a a Na 147 a a IgG 35 IgA 0 5 IgM lt 0 6 164 mg dL 38 59 CRP 0 1 lt 0 1 0 1 0 1 2013 5 6 No301 No 1 10 1 0 5mL 1 No 301 gt
54. 3 8 97 mg dL 750mg 12 21 2 50 1000mg 120mg 42 7 15 118 g dL 1250mg 600mg 200mg 36 28 30mg 16 42 45 750mg 7 19 750mg 1 L000mg 8 35 16 22 10 7 g dL 7 8 mg dL
55. 5mg 25 2 22 se 25 2 22 12 5mg HP 25 2 21 250mg 500mg 94 25 1 17 60mg 90mg 120mg 25 1 17 3 2g 25 1 10 7 7mg 25 1 9 300mg 25 1 9 ER a 24 12 21 OD 1207g OD 240 g
56. 4400 54 5 50 2 528 535 648 mm 1900 1 580 1610 1510 2830 BUN mg dL 15 15 17 17 mg dL 05 07 07 06 mg qdL 37 74 60 Na mEq L K mEq a Cl mEq L Ca mg qdL 64H rm 99 162 57 BD 71 1 8 36 71 Hb H 10 mm 347 308 298 302 283 g dL 110 97 95 96 89 94 126 31 2 28 1 28 4 28 3 26 7 mm 6700 2900 4000 22700 20200 6500 6500 5000 4800 82 3 64 2 656 95 8 954 54 4 54 4 56 mm 5500 1880 2620 21 690 19240 3550 3550 2780 PT 130 14 7 PT 750 61 9 PT INR 1 16 1 31 mg dL 494 g dL 114 BUN mg dL 16 14 12 72 82 45 mg dL 09 07 07 39 45 09 09 1 CRP mg qdL 2646 26 70 mg dL 69 5 7 5 1 13 3 14 5 59 59 59 Na mEq L 133 7 1371 1408 K mEq L 39 34 18 Cl mEq L 102 98 101 Ca mg dL 99 82 78
57. 2b 14 77 NUDE SN 1 1 3 196 X 7 301 X 196 14 7 KL 6 U mL 1 444 1 501 1 228 2b
58. 4 3 3 9 5 2 6 3 5 1 6 6 2b 1 No EO 6 C 1500mg 60 8 7 iL L500mg 400mg 2b 15 g kg 3 750mg 85 7 1 Bil 6 8mg dL 25mg 3 40mg
59. TR gt 19 25 50 75 Meii Seika 25 50 75 18 i 18 18 DSM W HD EG No 301 9 2013 5 gt 19 15mg Meiji Seika 15mg MSD 7 17 i
60. 1 132 175 ALP UL 183 186 197 220 211 210 211 256 12 No 301 2013 5 y GTP IU L 33 20 LAP IU L 55 51 JUL 278 259 CK CPK U L 998 50 CK MB IU L 9 8 UL 118 103 IU L 34 8 g dL 54 nmolmL 7 0 BNP pg mL 52 8 pg mL 1 9 mg mL 9 3 IU L 94 77 67 mg dL 8 6 6 8 11 12 13 17 mg dL 127 156 125 97 119 89 88 96 2b 1 No j ya 0 2 C 1 500mg
61. 30 1 914 mm No 301 1 1 2013 5 3 3 5 8 Fm 1 mmHsg 107 87 mmHg 57 54 min 68 120 365 40 3 EE g dL 138 12 7 mm 3 800 1700 535 339 10 mm 135 97 mg qL 46 7 1 5 7 47 41 CRP mg dL 0 01 0 02 3 09 mg dL 052 0 77 064 061 059 ng mL 30 56 i 0 3 5 7 10 14
62. 91 1 700 mm 357 4500 mm 4 6 8 14 15 23 5 g dL 12 9 10 5 94 10 3 8 1 5 0 8 4 11 7 mm 5 000 4000 4500 4 500 3 500 3 800 64 9 48 61 2 66 8 68 5 70 2 10 mm 288 182 159 243 21 1 245 ll mg dL 0 89 2 94 2 45 2 22 2 44 2 46 1 63 1 52 1 44 1 16 BUN mg dL 27 2 525 26 9 23 1 16 7 18 3 mg dL 8 8 14 7 13 3 11 5 9 0 8 9 5 1 5 8 5 1 4 3 E 8 15 22 29 36 43 50 77 105 168 g dL 11 1 10 2 9 5 96 92 6 9 8 2 9 0 10 6 11 3 10 5 mm 3400 4400 2900 3400 2900 3100 3400 2600 2500 2600 4 500 53 1 58 9 556 588 550 57 3 623 10 mm 15 4 168 18 0 17 7 15 9 16 0 16 9 16 8 19 1 222 27 2 mg dL 1 25 102 096 1 00 0 92 100 094 093 097 0 78 0 82 mg dL 3 9 3 5 3 3 3 7 4 0
63. GMI GQ1b 12 MCV 35 3m s 37 9m s 10 13 16 19 20 30 31 35 41 7 2013 5 19 48 44m s 50 0m s No 1 10 2013 5 0 5mL 1 0 5mL 1 DL SuralN SNAP lt gt
64. t HD EG 200mg No 301 23 2013 5 lt gt 1 100mg 400mg QT
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