医薬品インタビューフォーム
Contents
1. 25 3 1 5 Te ALT GPT AST GOT2. 2 6 1
3. gt ii a ER bE gt 1
4. 28
5. 1
6. 1mg 0 05mL 32 1 400g 2 3 3 4 1 2 I 14
7. 7 1 2 8 1 523 34 6 5 3 0 6 3 0 6 511 ALT GPT 6 1 2 2
8. FP FP 3 400g FP N 54 14 1 28 1 24 0 18 1 20 1 10 4 0 1 3 1 10 2 1 1 5 95
9. T UNDE o ll a T 200 g 400 g 200 rg 1 L1 200xg 2 L2 1 1 400 g 1 H 3 0 0 0 8 0 4 LNA METN 0 6 0 8 _1o0 0 94 O 001 400 g
10. w 29 1 1 TVI 2 3 1 5 win 0 10 30 100 2 _ a
11. 523 511 ALT GPT AST GOT 26 4 523 9 34 6 5 48 523 511 9 12 2 3 9 22 4 3 1
12. 3 4 5 6
13. 5 6
14. 9 8 CYP3A4 CYP1A2 CHs UK 1 DX 17 CPC CYP3A4 CYP3A4 CYP1Ag CYP1A 6g 0H DX 1 7 CPC 6 0H DX y 5 F Ho NH 68 OH DX 17 CPC 21 oic acid DX CES 21 2 CYP450 CYP3A4 CYP1A2 3 4
15. 2 a 1 2 3 24 4
16. 34 5 es HOT 400g 1195422010201 1329712A1028 621954201 XI 1 1 127 1 16 2010 2 103 1 85 98 2010 3 103 3 277 286 2010 4 125 1 17 2010 5 103 5 489 502 2010 6 Barnes PJ Immunol Allergy Clin N Am 25 451 468 2005 7 vitro 8 Inoue N et al J Pharmacol Sci 112 1 73 82 2010 9 10 11 2
17. 2 6 1 JO gt 9 168 97 2 64 5 92 6 3 7 22 1 Il 1 2 1
18. 4 IF IF IF 2008 9 ER eR OE Pf TE 1 ee EEE REES Db o NN oohonn 0 NO MA 0 NM m ea 1
19. FP 16 406 1 3 2 1 IgE CAP RAST 2 3 2 4 0 1 0 2 0 3 16 65 4 5 1 1
20. 2 1 2 1 vitro 3 DX 17 CPC FP
21. 2 1 2 3 3 4 5 6 19 7 1 2 3 4 lt gt 9 3H vitro 95 9 w 7 3 H vivo 90 9 93 0 85 3 92 7 lt gt 9 3H 0 1 mg kg L 3 C 3
22. 10 10 400g 1 1 FP 200 g 2 2 3 400 g 1 FP 200 g 2 FP
23. 2 gt 300 g kg 15g kg 1
24. 1 7 20 5 lt gt 3H 0 1mg kg 2 24 168 2 24 168 5 1 S9 Vo CES DX 17 CPC CYP3A4 CYP1A2 CES
25. 7 8 9 10 11 400g 1 12 UL 13 3
26. 2 i 1 2 23 5 1 2 1
27. 2008 IF 2008 IF PDF IF IF IF 2008 21 4 IF 2008 IF 3 IF IF 2008 MR PDF IT
28. FP 400g 1 FP200 g 2 3 FAS e n 162 FP n 161 O n 83 3 FAS 5 1 mean S E xD lt O 001 vs 1 J 95 162 a os vs FP 640 10 0 07 0 32 0 46 RMORS 151 177 vs 83 167 99 1 11 1 58 0 64
29. 25C 60 RH 36 40 C 75 RH 6 60C Too Ee 60 C 75 RH SL 32 2 7 120 lx hr 200W h m 2 3 1 2 4 IV 1 1 2
30. gt 61 7mg kg gt 2 000mg kg gt 2 000mg kg 2 000mg kg gt 2 000mg kg gt 14 2mg kg DX 17 CPC gt 125mg kg 125mg kg 2 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 19 g kg 39 0 49 1 66 5 30 g kg 4 4 6 3g kg 26
31. mean S E n 8 0 01 vs Aspin Welch D 0 05 Dp 0 01 vs Dunnett s 3 1 2 18 1 1 2 1 3 3 6 400 g 1 1 14 L 0 DX 17 CPC 16pg mL 6 800ug 1 1 14 3 DX 17 CPC Cs 35 9pg mL 28 0pg mL 4 5 6
32. 1 2 4 3 1 2 4 3 w
33. met h asone 3 4 C H FO 570 69 5 9 Fluoro 11 8 17 21 trihydroxy 16 amp methylpregna 1 4 diene 3 20 dione 21 cyclohexanecarboxylate 17 cyclopropanecarboxylate 6 NS 126 NS 126C 7 CAS 132245 57 9 1 1 2 99 5 3 4 269C 5 Me 6 Me pH 2 0 9 0 1 7 2
34. 28 775 16 ar a gt fa 2 406 5
35. 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 0 1 mg kg 15 24 DX 17 CPC 6 12 BA 2 7
36. 24 FP lt 35 30 2 lt 25 20 2 2 15 3 10 Ss 8 5 8 0 L200 400 200 400 ugx2sites FP n 8 w Median p lt 0 01 vs Wilcoxon 1 1 4 24 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 x2sites FP
37. MK 058 a 1 Dg opoppop 2 1 120 lx hr 200W h m 2 6 7 8 9 1 0 12 13 14 15 Draize
38. 2 3 4 5 1 2 3 4 5 6 7 8 9
39. MR OF IF IF MR IF IF IF
40. 16 V 1 2 1 1 400 g 1 1 39 gt 1 2 3 1 1 32 1 14 16 1
41. VI 2 2 5 V 1 3 6 1 6 800 gg 1 1 14 1 DX 17 CPC 5 72 0 023 0 020 1 1 400 Ng gt 9 5H
42. 2009 10 2 1 1 1 2 3 3 lt 4 523 34 6 5 3 0 6 3 0 6 511 ALT GPT 6 1 2 II 1 1 400g 2 Erizas Capsule for Nasal spray 400 g 3 2 1 JAN 2 Dexamethasone cipecilate JAN 3
43. DX 3 9 100 8 80 a 60 e DX 17 CPC FP RR 40 DX 20 0 10 9 109 108 107 mol L mean n 3 Ki mol L 2 51 x 10 DX 17 CPC 7 20 x 10 FP 5 33 x 10 10 DX 8 27 x 10 Ki mean n 3 17 2 24 FP 1 1 4
44. 100 p g kg 31 4 jn wo zo vivo i wo DNA UDS zo S9 S9mix vivo DNA 0 05 0 1 0 2mg kg 6 p53 03 1 3mg kg 6
45. 35 NN 36 XL 37
46. 1 2 3 5 6 PTP 70 7 x 10 7 PTP 9 2009 10 16 10 2009 10 16 22100AMX02248000 11 2009 12 11 33 8 2009 10 16 2017 10 15
47. 2 4 6 8 10 12 n 133 133 138 130 129 126 124 n 38 38 38 38 32 32 31 mean S E p lt 0 05 vs 0 01 vs 1 14 QOL FAS nN 0 0 0 10 0 12 0 2 4 8 12 58 22 57 22 57 22 56 22 mean S E D lt 0 05 D lt 0 01 vs 1 p 0 001 vs 15 4 95
48. 23 3 TTF PT 23 4 23 5 ER RI I 24 6 Se SR 24 7 A ed dd P17 25 8 25 9 eee 28 10 ww 28 11 io 29 12 ee 29 13 29 14 SR A EN 29 15 29 16 29 EE 30 1 ee 30 2 ee 31 XX rh i i ESR RS 33 1 33 2 Wa 33 3 OR 33 4 wm 33 5 er ERED 33 6 a 33 7 a 33 8 a 33 9 33 10 33 11 ee 33 12 TT 34 13
49. 1 62 0 94 0 87 0 52 N 184 110 96 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 2 16 VI 1
50. 11 32 77 3 42 8 0 109 n 162 19 8 47 5 1 9 25 9 4 9 0 0 67 3 FP 26 82 5 45 1 2 108 n 161 16 1 50 9 3 1 28 0 0 6 1 2 67 1 2 42 2 32 4 1 44 n 83 2 4 50 6 2 4 38 6 4 8 1 2 53 0 FP 0 2 95 10 4 10 4 12 3 12 es gt 16 165 1 lt 3 2 1
51. 10 b 10 c 10 pe d 10 e Haffner 10 10 3 a 5 b 5 10 10 10 mol L c 5 4 3 0 1 3 10 5 a 10 0 10 30 100 b 10 0 3 10 30 Na K CT pH 10 0 1 3 10 0 10 30 100 0 3 10 30 1ng kg 3mg kg Na K
52. 50wg 100g 200g 400g 200 ug 400uug 14 100 g 1 DX 17 CPC lt 16 pg mL 1 1 400g 1 1 800g 14 L 1 400 g 4 5 1 200g 1 200g 2 400 g
53. pr er 34 14 Eee 34 15 34 16 en en 34 17 34 XI lt EP pr TERETE TRI ER 35 1 EE RN PE FEI NAO RN 35 2 DS ed 35 x PC 36 1 da hr 36 2 36 XH a 37 ea ES 37 I 1 400 x g 1998 1 1
54. 100 g kg 300W g kg 100 gu g kg 0 6 3 15 NM g kg 3 g kg 0 6 g kg 0 6 g kg 4 20 100g kg 20 g kg
55. QOL JRQLQ 12 QOL 400g 1 12 3 FAS 0 0 TT Z 1 0 FF 1 15 p 0 002 vs g 0 FF 5
56. 12 165 2 406 400g 1 FP 200 g 2 1 2 3 lt FP A 0 6 t P lt 0 001 3 mm 95 400 Lg 09 6 45 2 03 vaFP 1 1 41 1 95 620 FP200Zg 1 4 6 40 2 10 SYS 2 1 51 1 77 6 41 093 I 1 1 67 1 39 ee 3
57. 1 2 L 16 285 3 2 IgE CAP RAST 200g 1 L1 200 g 2 L2 400 ug 1 H 2
58. 5 6 g kg OD 4 0g kg 13 3 7 g kg 39 5 30 g kg 4 DX 17 CPC 3 4 20 100g kg 4g kg 20 g kg 100g kg 30 100 300 g kg
59. IF 10 20 9 IF 2 IF IF IF
60. 1 n 72 GO0 g 1 n 71 mean p 0 001 n 70 t 3 mu gt A P L1 H 2 5 P 70 5 94 1 31 1 05 020 2 1 1 p 0001 1 0 1 p 0 001 Th 59 200g 71 561 129 _175 020 t 5 1 L1 P vs H p lt 0 001 P vs L1 p 0 017 400 g 1 H 72 6 38 1 61 2 53 0 20 3 Tn 95 _ i a RS i a 71 5 61 1 29 1 73 0 19 0 263 0 275 0 800 lt 6 31 1 69 1 99 0 19 p 0 336 2 L2 2 400 g 1 FP 200 g 2 2 FP
61. IF IF A4 9 IF IF 2 IF IF IF IF IF
62. YT TIT TT LTT EN ARE ECAC EERE 29 inonieyieteinteionep aa Sa CAS SO EC A i a ee et i ei 3 ea 2 VI So RE ESE 17 1 17 2 17 eee 19 1 19 2 ir 19 3 RA 20 4 a 20 5 21 6 DD uD ua dedi 22 7 A 22 23 1 SS 23 2
63. C pH 00 a b c 10 10 10 0 10 30 100 0 3 10 30 0 0 03 0 3 3 1 1 3 0 0 03 0 3 3 1 1 7 0 0 03 0 3 3 1 1 9 3mg kg 3mg kg 3mg kg 5 10mg kg 1 2 30 2 1
64. lgE CAP RAST 2 3 2 3 16 4 5 gt 1 2 3 4 gt 1 2 3 4 5 6
65. 2011 2 3 J 871329 IF 2008 L J pi 400ue Erizas Capsule for Nasal spray 400ug I 3 1 400 g JAN Dexamethasone cipecilate JAN 2009 10 16 2009 12 11 2009 12 11 i TEL 0120 321 372 FAX 075 321 9061 http www_nippon shinyaku cojp medicine medicine_conts IF 2009 10 http www inf
66. 3 35 9 9 2 0 4 1 0 2 mm 3 0 6 1 0 2 0 3 0 6 ob 1 0 2 7 GTP 1 0 2 3 0 6 AST GOT 2 0 4 3 0 6 1 0 2 1 0 2 1 0 2 3 f 1 0 2 1 0 2 Te a 09 1 08 1 02 1 02 1 02 2 0 4 5 1 0 2 1 0 2 1 0 2 1 0 2 1 0 8 126 27 5 6 10
67. 63 3 1 4 DX 17 CPC gt 9 H 0 1mg kg 30 27 3 0 1 2 C 0 7 gt 9 0 1mg kg gt 9 0 1mg kg 2 24
68. mm mm mg O 15 8 5 8 60 7 3 3 4 129 5 pH pH 6 2 1 1 400 g 2 3 3 4 5 25C 6o RH a 36 et 8 5 PTP NM NG 40 C 75 RH 6 ny 1 60 C 3 5
69. o pmda gojp IF 1 63 2 IF IF 10 9 3
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