添付文書 - 大日本住友製薬 医療情報サイト
Contents
1. 541 0045 2 6 8 TEL 0120 034 389 651 0086 7 1 5 TEL 0120 360 605 www hllyanswers jp 107 18 3 6 28 8 1 14 5 0 75mg 6 6 6 8 7 1 5 PV0964JJAP2. 1 2 3 5 6 1 1 0 75
3. 3 g DPP 4 SGLT2
4. l MAO t 4 55 TINR
5. i AN i 0 75mg eA o 1 gt 9 NN a i AM a 10
6. HbA1c N 181 1 67 0 09 33 6 cg 65 1 650 11 6 2 61 1 57 0 11 3 3 66 1 69 0 13 6 1 71 1 65 0 13 9 9 1 52 2 52 52 0 10 0 24kg g 1 24 0 42kg 0 87 0 40kg 1 02 0 85kg 0 04 0 26kg 4 1 2 1 2 3 4 GLP 1 IgG4 Fc
7. 2 487 280 70 137 0 75mg 1 0 9mg 1 1 26 26 HbA1c 1 43 0 05 0 14 0 10 1 579 95 1 79 1 35 HbA1c 0 10 95 0 27 0 07 95 0 4 52 HbA1c 1 39 0 06 1 19 0 08 0 20 95 0 39 0 01
8. GLP 1 vo 2 1 5mg 1 10 2 10 180 AUC 2 0 75mg 1 26 AUC 0 3 2 1 5mg
9. 1 7 3 3 1 2 3 12 EE 4
10. 2 9 3 5 1 5 1 PR
11. 70mg dL 52 8280 2 9 47187 2 9 2 1 2 361 181 180 0 75mg 1 1 1 26 26 HbA1c 1 44 0 05 0 90 0 05 HbA1c 0 54 95 0 67 0 41 95 0 4 70mg dL
12. ny oy 7 2 GBDP 8 2 1 9 10 11 12 13 2 14 15 16 17 18 19 20
13. 65 gt 80mL min 16 50 80mL min 8 30 50mL min 8 30mL min 8 3 8 1 5mg AUC 90 1 20 1 06 1 35 1 28 1 13 1 44 1 14 1 00 1 29 1 12 0 995 1 26 C 90 1 13 0 963 1 31 1 23 1 05 1 43 1 20 1 02 1 40 1 0 950 1 30
14. lp 2 3 1 2 ADA 1 4 13 910 2 24 0 75mg 1 1 5 ts 4 5 108 5 AUCo es 1 45 N AUCoissn Cmax tm tre CLIF VgF ng hr mL ng mL hr hr hy 1 ga 5860 46 3 50 33 108 0 0764 11 9 21 22 45 87 94 67 71 8 145 22 24 5 24 8570W 67 7 48 00 108 0 0875W 18 6 21 24 22 67 96 48 71 7 167 31 35 CLF VZF
15. 21 22 Terauchi Y et al Endocrine Journal 61 10 949 2014 23 2 GBDY 24 2 GBDQ 25 Glaesner W et al Diabetes Metab Res Rev 26 287 2010 26 go LY2189265 27 2 1 28 29 SG 30 SGI 31 1 2 82 2
16. 0 085mg 0 75mg 1 0 75mg 4 1 1 2 145 0 25 0 5 0 75mg 1 12 12 HbA1c 0 75mg 1 35 0 09 0 18 0 09 0 75mg 0 001 0 75mg 1 2
17. DPP 4 GLP 1 cAMP 2 0 3 1 0 3 0 6 0mg 8 2 0 75mg 1 26 7 2 7 o
18. x 11 Child Pugh A 6 Chilq Pugh B 6 Chilq Pugh C 3 1 5mg AUC 90 0 774 0 649 0 922 0 669 0 556 0 805 0 791 0 632 0 989 C 90 0 791 0 654 0 957 0 703 0 582 0 849 0 761 0 597 0 971 0 75mg 3 6 2 29 65 76 0 5 0 75 1 5mg 1 6 2 0 75mg AUComw Ca tart to CLIF VzF ng hrmL ng mL hy hr Lhr 1 46
19. 8 4 0 75mg L971mg 5 0 07mg OB i 6 8 a By NE CN 7
20. 1 2 3 N 23 100 ng mL 1 N 24 2 5 N 24 0 st 0 24 48 72 96 1 20 144 1 68 h 2 0 75mg 1 1 5 gt 2 14 1 1 5mg 1 5 2 45 3 1 5mg AUC 90 0 978 0 941 1 01 0 989 0 956 1 02 0 75mg
21. 5 1 13 1 2 3 72 3 3 72 4 1 8 72 0964 0 75mg 2 14 15 DPP 4 GLP 1
22. 4 917 272 29 7 57 6 2 56 6 1 53 5 8 1 DPP 4 g
23. 47 181 26 0 86 180 47 8 26 0 48 0 17kg 0 94 0 17kg 2 2 0 75mg 1 52 HbA1c 52 70mg dL PD
24. 1 31 1 48 275 IgG4 Fc 2 16 30 57 63 64 Gly Glu Gly Pro Ala Ala 275 2 63 000 0 75mg70 5mL 2 0 75mg 5 1 2 3 4 5 6 rasH2
25. 40mg 27727 0 75 0 82 0 25 0 96 0 90 0 74 2 00 0 83 0 98 0 65 0 85 0 00 2 00 19714 0 4 0 90 1 09 0 79 0 97 0 00 2 00 1 01 0 89 0 50 2 100 A 0 86 1 17 0 73 1 08 0 00 1 02 siaisocee ongers a Ci 2 57 0 93 0 77 0 50 0 79 1 09 0 63 0 94 0 00 1 00 1 2 48 tmax 1 1 N AUC AUCozanr AUCors AUC Cmxx tas 1 1 4 2 48 ts 2 2 3 0 25mg
26. 9 2 3 4 10 1 28C es 14 30 C 1 0 75mg 12 rasH2
27. 1 2 Ia 0 3 s GLP 1 0 75mg 4
28. gg 0 88 0 64 1 00 el 0 85 0 92 0 59 0 70 0 73 1 73 59 1 05 0 94 0 02 1000mg 2 1 01 1 08 0 87 1 08 0 50 0 53 4 2291 1 00 1 04 0 02 2 0 96 1 03 0 96 1 14 0 50 0 09 3mg 1 ga 0 89 0 50 2 15 0 83 0 95 0 43 0 59 1 02 3 97 ge 1 13 0 96 0 97 1000mge 1 05 1 28 0 82 1 14 0 00 1 48 4 06 1 05 0 97 0 49 2 0 97 1 14 0 82 1 14 0 03 1 02 1 5mgW 1 1 agg 1 06 0 95 0 50 5S40 0 91 1 24 0 81 1 12 1 00 0 00 5 40m oe 4 gans 1 05 1 02 1 00 0 89 1 24 0 86 1 21 1 00 1 00 1 19 1 32 1 00 1 Y00ne 2009 1 11 1 98 1 20 1 45 0 00 3 00 10mg 8 28 25 0 98 0 0 96 1 01 0 74 0 88 3 00 5 00 R 28725 0 0 9 0 96 1 02 0 82 0 90 4 00 8 00 1 12 0 88 0 02 2 3912 1 02 1 22 0 80 0 98 0 05 1 03 4 ipm 1 15 0 99 0 02 1 05 1 26 0 89 1 10 1 03 1 02 0 96 0 78 0 50 2 1 2181 0 88 1 03 0 67 0 92 0 00 1 50 0 25m EE ke 2 so 0 96 0 83 0 50 0 89 1 04 0 71 0 98 0 00 0 50 0 79 0 30 2
29. 1 4 50 t 2 t 2 3 4 2 88 87 849 7 0 75mg 1 JAN Dulaglutide Genetical Recombination
30. 30 87 7 71 7 31 33 12 0 95 2 a 6 1 6730 51 6 48 0 181 0 111 19 2 32 30 24 0 72 5 107 189 32 19 CL F VZF 1 2 3 N 9 7 I 2 487 152 65 65 2 ve p 21 AUC Cmax tma hr 90 90 90 1mgW 1 1
31. ee 2015 7 1 GLP 1 J 7 0 75mg 22700AMX00701 TRULICITYs ATEOSe 2015 8 2 8C gt SS 2014 9 Geni ts _ 1 2
32. mg 71 21 1 0 75mg 27 1 0 75mg 149 2 7 8 1 2
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