新医薬品の「使用上の注意」の解説
Contents
1. 1 2 B TT 1 3 SR 1 0 US2. 2 24 0 75 mg 1 GBDP 1 5 4 5 108 5 AUC 1 45 3 2 II GBDP 7
3. 13 1 3 72 3 72 1 3 72
4. L eee GLP 1 1
5. 2 3 a 5 E A NE ET EO PR gt 1 1 3 3 a 1
6. GLP 1
7. 2 3 4 9 8 2 209 211 HMN17507 2 2
8. 1 L 10 1 2 1 26 2 L
9. 2 0 75 mg GBDP 52 280 8 2 9 SU GBDY 26 181 47 26 0 GBDQ 52 SU 131 44 33 6 61 2 3 3 c GYT 65 4 6 2 TZD 66 4 6 1 71 7 9 9 SU 2
10. DPP 4 GLP 1 Recommendation 3 14 4 1 18 10 GLP 1 DPP 4
11. 3 14 4 1 18 5 22 5 1 2 3 4 SI 1
12. 1 a 3 1 90 4 6 91 180 7 9 181 270 10 271 GBDP 2 0 21 5 gt 65 2 0 5 0 75 1 5 mg 1 6 GBCT 6
13. 3 Ne rr 3 PR 5 1 2 O 3 a lt gt 2
14. ag 9 1 2 10 11 1 2
15. L DPP 4 GLP 1 3 co DPP 4
16. 0 75 mg 1 2014 9 EU 2014 11 2 2015 7 2 2 24 0 75 mg 1 1 5 4 5 108 0 75 mg
17. gt gt a Rs 1 2 2 13 12 1 lt gt gt
18. 12 3 4 1 2 8 C 13 2 1 4 1 3 72 30 C ee
19. 1 Glaesner W et al Diabetes Metab Res Rev 26 287 296 2010 HMN30205 2 in vitrto LY2189265 3 2 GBDP RE 1 SL 0 2 0 4 gt ee 5 lik A AA AA AAA i kA 6 2 RR ak 6 G 5 8 EN Ni ANN 14 4 16 5 22 lt 23 24 24 5 ul ig0 9 9 25 Oc EKERKKRM Re 26 0 75 mg kk 2 gt 0709 1 22 7 9
20. 149 2 1 8
21. 8 o DPP 4 107 182 eb Te SGLT2 2015 7 1
22. 0 _ 5 3 5 mm GLP 1 6 NRN 4 3 1
23. 1 5 mg 3 19 0 75 mg 1 1 2 8 C
24. rasH2 0 3 1 3 mg kg 2 26 3 mg kg AUC 7 56 20 21 rasH2 2 2 gt 2 0 75 mg
25. 2 GLP 1 2 9 10 4 Keech A et al Lancet 366 9500 1849 1861 2005 HMN30393 5 Noel RA et al Diabetes Care 32 5 834 838 2009 HMN18830 6 Girman CJ et al Diabetes Obes Metab 12 9 766 771 2010 HMN19010 7 Urushihara H et al PLoS One 7 12 e53224 2012 3 ee GLP 1
26. 0 75 mg 1 2 4 1 18 24 9 1 ee II GBCN
27. 0 49 1 63 4 89 mg kg 3 1 1 63 mg kg AUC 22 5 4 89 mg kg AUC 71 1 0 04 0 12 0 41 mg kg 3 1 0 41 mg kg AUC 21 2 0 2 0 49 1 63 mg kg 3 1
28. AN i Gesn paa sag PD Answers 7 541 0045 2 6 8 651 0086 7 1 5 TEL0120 360 605 https ds pharrma jp 8 45 17 30 2 www lillyanswers jp 1 PHS TLC T001 R2 2015 9
29. lt t 4 5 5
30. 18 gt 23 7 8 1 5 mg 13 3
31. 4 1 0 75mg 71 1 P H 6 1 0 75mg 27 NE 75mg 7
32. 1 GLP 1 CHO 4 DPP 4 GLP 1 GLP 1 lgG4 Fc Fc IgG4 Fc B GLP 1 cAMP GLP 1
33. 3 MM tn 45 5 INR 0 75mg ee FE _ _ A 917 272 29 7 I 57 6 2 56 6 1 53 5 8 0 75mg 1
34. 2 GLP 1 C 0 5 ng mL 24 C 20 ug C 9
35. gt PB B B MAO MAO 2 4 1 18 11 9 2 176 179 1990 HMN04294 12 2 778 779 1998 HMN30395
36. 4 1 18 9 10 L BR
37. 13 53 7 505 508 2010 HMN19000 2 O 3 LU 0 _ 2 9 10 GBCZ GBDP GBDY GBDQ
38. INR gt GBCS t S 4 R 5 5 S R AUC R C S C 22 International normalized ratio INR INR INR AUC AUCj 2 INR 4
39. Company Core Data Sheet CCDS 2 II GBDP 0 75 mg 1 7 1 gt 3 72 3 72 1 1 77 3 72
40. a b c c d LOOCF 1 gt 2 1 gt 1 3
41. 1 gt 3 72 A B E 100 E 100 lt 5D S Lan 80 8 8 5 40 20 a Time week Time week 1 3 mmm 4 3 0 75 mg 1 5 A 6 B lt gt 5 DPP 4 GLP
42. 10 3 72 1 C 1 3 72 1 0 75mg 12 14 rasH2 15 DPP 4 GLP 1 2 2
43. 917 272 29 7 57 6 2 56 6 1 53 5 8 SONG 2 L GBDP GBDY GBDQ 0 75 mg 1 917 272 29 7 1 17 1 IIL GBDP GBDY GBDQ si Toml i Tota MedDRAver170 n 575 n 342 n 917 D0 n 575 n 342 n 917 5 0 5 cis 202 203 303 To 1002 2 0 2 1 0 1 1 0 2 1 0 1 1 0 1 7 1 2 8 0 9 1 0 1 4 0 7 4 0 4 57 6 2 1 0 2 1 0 1 9 1 0 1 0 2 1 0 1 7 0 8 1 02 2 02 33 3 6
44. wa 3 3 ADA 1 4 13 910 Pe 0 75mg 0 5mL 2
45. 2 I GBCZ GBDP 2 GBDQ 2 GBDY 2 0 75 mg 1 gt 2 I GBCB GBCL
46. 14 2 22 6 1 1 0 75 mg L O 71 21 1 0 75 mg L O 27 1 0 75 mg 149
47. GBDP 340 3 0 9 SU GBDY 176 1 0 6 GBDQ 394 9 2 3 a 26 lt GLP 1 872499 7 22700AMX00701 2015 9 0 75mg 2015 8 2014 9 TRULICITYe ATEOSe 2
48. 2 0 GBDP 52 0 75 mg i 7 9 2 10 2 N 280 N 269 N 265 n n n n 185661 1 43 21 12 09 0 0 o o 276271 4 HB 6 8 2 CE 7 1 6 o 5 6666 932 7 2 0O 0 64 G8 2 0 2 1 I 2 0 1 1 16 1646 4 4 15 0 0 4Q 4 0 0 oO 0 0 OO Eee 207 0 0 1 1 2 0 0 0 IT EE EE EE EE EE sqg 2 ss o i 6 14 0 1 0 oO 0O 9O 0O 52G865 17 19 10 6 KK an ll ss
49. 2 14 30 C _ 1 2 8 C 2 14 30 25 10 1 C 1 075 mg L O 12 rasH2 gt 0 05 0 5 1 5 5 mg kg 2 104 0 5 mg kg AUC 12 2 C C
50. II GBDP 0 75 mg 1 SU IIL GBDY 0 75 mg 1 0 75 mg SU TZD o GIE 9 GBDQ HbA1c 14 52 LOCF II GBDP GBDY GBDQ 0 75 mg 2 0 75 mg
51. 1 37mg 1 0 07mg 23 2mg 80 0 10mg DPP 4 pH 6 0 7 0 FT w 1 2
52. 1 0 2 1 0 1 3 0 3 1 1 1 0 2 1 0 1 2 0 2 1 0 2 1 0 1 90 1 0 2 1 0 1 1 02 2 0 2 2 02 1 02 1 0 1 1 0 1 140 24 3 193 21 0 1 0 1 40 7 0 57 6 2 1 0 1 43 7 5 56 6 1 1 0 1 40 7 0 53 5 8 1 0 1 13 2 3 22 2 4 1 0 1 16 2 8 20 2 2 1 0 1 3 0 5 6 0 7 1 0 1 4 0 7 4 04 2 0 2 0 00 1 0 1 2 02 17 3 0 20 2 2 1 0 1 0 i107 19 2 101 3 5 0 9 6 0 7 23 2 5 5 6 1 02 3 0 3 1 0 1 3 0 5 3 0 3 1 0 1 0 00 1 0 1 1 0 1 0 00 1 01 1 0 2 1 0 1 0 00 1 00 1 1 0 1
53. 1 0 2 1 0 1 1 0 1 2 0 00 1 0 1 1 0 1 1 0 2 1 0 1 1 0 1 Ed 8 1 4 12 3 3 03 12 1 3 3 03 2 0 3 6 0 7 2 0 2 1 0 2 2 02 1 0 1 0 00 2 0 2 1 0 1 1 0 2 2 0 2 1 0 1 2 03 2 0 2 1 0 1 1 0 2 2 02 3 03 3 0 5 4 0 4 2 0 2 1 0 2 2 0 2 1 0 1 2 03 2 0 2 1 0 1 1 0 2 1 0 1 1 0 1 2 0 3 2 0 2 1 0 1 0 00 1 0 1 1 0 1 1 0 2 1 0 1 10 1 0 2 1 0 1 9 1 0 1 0 2 1 0 1 4 0 4 1 0 2 1 0 1 1 0 1 1 0 2 1 0 1 1 0 1 1 0 2 10 1 0 1 i 3 2 03 4 0 4 5 05
54. rR FE EE 1 2 3 RR 4 5 1 2 0 3 4 2 1 _ RS 1 2
55. 2 2015 9 16 2016 3 15 2015 9 GLP 1 TRULICITYJATEOS 1 1
56. SGLT2 gt GLP 1 2 7 14 15 10 13 4 1 18 B MAO
57. II Company Core Data Sheet CCDS 1 S or NW 0 oN oo o 8S or oN 0 o fB S OS Av 2 26 Q ee w WW ENS NE NW 2 S SV OS PS ENN 7 7 7 10 10 9 9 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1 W 5 m ls S a PP RR VA SW 8 SW SA So WW 0 75 mg 8 GBDP 20 2 0 75 mg 0 75 mg
58. TZD o GI 2 394 0 75 mg 1 52 HbAlc 14 52 LOCF p lt 0 001 a b c c d LOCF ee
59. Biel F1 2 1 63 mg kg AUC 26 8 F1 1 F1 0 5 2 7 mg kg 7 3 1 Biel 7 mg kg AUC 149 15 16 17
60. 28 9 8 0 W adD 2 1 0 oO 2 7 EE EE 17 1 1 2 4 1 129 1 0 0 oO oe o o oo 26 3 3 7 8 8 30D 0 0 1 2 Ne EE EE EE EE EE EE EE EC EE EE EE 34Q21 8 13 8 5 0 0 0 1 16n 6 5 5 0 ao 1 o o i 2o7D 0 1 1 oO 1 6 1 0 1 0 oO ao 1 0 oO 129 0 0 1 oO 19 5 4 2 oO po 1 4 2 1 ij oo 1 oo ij o 160 9 3 3 3 3 4 3 0 0 1 om o o o o eol wa 0 3 lo EE LC EE EE EE EE I EE N n MedDRA J Version 17 0
61. II 0 75 mg GBDC 52 270 30 11 1 GBDB 78 272 154 56 6 GBDD 26 293 258 88 4 DPP 4 SU c GI 2 7 8 14 15 10 13 a b o c d
62. 11 12 2014 2015 HMN30394 4 34 HbA1c 3 lt 4 lt GBDP gt 2 280 0 75 mg 1 52 HbAt1c 4 52 p lt 0 001 lt GBDQ gt SU
63. 1 2 GLP 1 m 0 75 mg 1 6000 5000 4000 3000 2000 1000 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 II GBDP GBDY GBDQ 2 1 GBCB GBCL GBCZ 2 II GBDP GBDY GBDQ 0 75 mg
64. 8 1 4 9 1 0 24 2 6 1 0 2 1 0 1 1 0 1 7 2 03 3 0 3 1 0 1 1 0 2 2 0 2 1 0 1 1 0 2 1 0 1 1 0 1 17 D DPP 4 v
65. II GBCZ II GBDP GBDY GBDQ 1 II GBDP 2 20 0 75 mg 48 4 5 7 1 I 0 75 mg 1
66. GBCB GBCL GBCZ GBCD GBCJ GBCK 65 2 2 0 75 mg 1 GBDP SU GBDY 26 HbAlc 65 65 GBDY 65 65 a 0 75 mg 1
Download Pdf Manuals
Related Search