医薬品インタビューフォーム
Contents
1.2.
3.
4.
5. 33
6. 36
7. 37
8. 0 39
9. ACTH ACTH
10. 40 Co
11. 8 38
12. BS 1mL100 3 mL JIS T 3226 2 A A
13. 5 4 8 7 2 4 6 30
14. 2 2 3 4
15. 7
16. IF IF IF A4 9 IF IF 2 IF IF
17. 2 1 2 3
18. 4 IF IF IF
19. 2 1 2 3
20. 2 31 1 2 7 7 1 2
21. 2
22. 2 22 1 zo hIR A hIR B 1 htGF 1R 293HEK hIR A hIR B hIGF 1R 1 1 Ki nM hIR A 0 408 0 012 0 399 0 018 0 234 0 018 hIR B 0 453 0 028 0 450 0 037 0 293 0 030 hIGF 1R 16 0 0 4 15 5 0 6 78 5 6 2 K 3 125 A14
23. 2013 12 2014 12 2014 7 EU 1 2 10 3 7 4 1 1 24 10 22 24 5
24. w DPP 4 GLP 1 SGLT2 31 e y 32
25. 1 1 52 268 49 2 24 376 644 43 6
26. 1 BS HD 1mL100 3mL HD JIS T 3226 2 lt A A BD A
27. 2 3 4 3 1 2
28. MAO 0
29. 4 2 29 6 1
30. HbA1c HbA1c 10 2 HbA1c 2 HbA1c 6 3 10 15 mg dL HbA1c 0 4 0 5
31. GFR gt 40 mL min GFR 15 20 mL min 2
32. 2003 10 BS BS 1 21 3 4 0304007 PMDA Committee for Medicinal Products for Human Use CHMP FDA LANTUS
33. 19 10 9 HbA1c 49 2 4 1 51 4 7 8 3
34. 2 9
35. 32
36. 8 2 1 2 V V 5 1 1 2 2 1 2
37. 35
38. 2 1 2 3 4 0 5 kg 25 5 0 5 kg CL F 78 7 L hr 46 4 CV 6 0 5 kg V F 1120 L 57 4 CV 7 1
39. w 2 3
40. 3 4 3 1 2
41. 34
42. 11 12 13 1 2 1
43. 1 4 80 dl gt 1 1 mL 2 3 1 1 1 1 1
44. 3 4 3 4 53 1
45. 1 1 4 20 1 4 80 17 ABEC ELEMENT 2 gt 2 LANTUS 759 2 379 380 1 WHO 2 2 18
46. 4 2 2 HbA1c 1 1 4 20
47. 9 1 3 51 4 3 4 1
48. 2 7 6 1 ABEB 2 ABEC At1c HbA1c LANTUS 12 14 20 7 1 ABEB 52 268 49 2 ABEC 24 376 644 43 6 7 12 1 9 11 1 7
49. 1 1 1 3 24 LOCF HbA1c LOCF 6 12 24 36 52 HbA1c HbA1c 7 0 6 5 7 SMBG BMI
50. 24 2 BS 1 2
51. 3 1 ABEB 2 ABEC 65 65
52. 644 ABEB 49 268 ABEC 376 43 6 7 Em 644 647 644 647 MedDRA J ver 15 1 MedDRA J ver 15 1 1 43 6 7 37 5 7 6 0 9 4 0 6 18 28 13 20 5 0 8 4 0 6 12 1 9 11 1 7 QT 1 0 2 0 00 6 099 1 02 2 03 5 0 8 1 0 2 0 0 0 2 0 3 1 022 0 0 0 1 0 2 0 00 1 022 1 0 2 0 0 0 0 00 1 022 1 1 0 00 1 022 8 1 0 00 1 0 2
53. NN The Australian categorisation system for prescribing B3 2015 7 medicines in pregnancy Category B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed Studies in animals have shown evidence of an increased occurrence of fetal damage the significance of which is considered uncertain in humans SPC In general the safety profile for children and adolescents lt 18 years of age is similar to the safety profile for adults The adverse reaction reports received from post SPC marketing surveillance included relatively more frequent injection site reactions 2015 4 injection site pain inj
54. IF IF IF 2013 IF 2013 IF PDF IF IF 2013 25 10 IF 2013
55. 4 24 3 1 3 4 52 2
56. b c d JIS T 3226 2 A A BD e A f 1 2 2 3 cm 3
57. 1 1 300 300 2 pH pH BS BS pH 3 5 4 5 0 8 pH 3 2 1 1 3 mL 1 300 1 3 mL 1 300 2 BS BS gt 1 3
58. 1 10 24 LOCF HbA1c LOCF 4 8 12 16 20 24 HbA1c HbA1c 7 0 6 5 7 SMBG
59. IF 3 IF IF 2013 PDF IF IF IF MR IF IF IF
60. ayx a ES ABEA 1 80 ABEO I 91 oO ABEN I 40 O Ap ABEM I 24 O 2 1 a ABEE I 20 O Rs MS 1
61. 1 1 pH 1 pH 4 pH 1 24 1 1
62. 4 24 3 1 38 4 54 2
63. 4 lt gt a 2 8 C b c 30C d 28 lt gt a 2 lt 8 C b 30C c 28 4 IV 5 2 15 1 2
64. 1 ACE 2 16 47 1 1 VI 2 3 4 2 1 2 1 mg kg SD 10 1 1 4
65. ABEB 9 ELEMENT 1 2 ABEC 759 hn e 2 ELEMENT 2 1 1 2 1 1 ABEB ELEMENT 1 2 1 1 3 LANTUS 1 1 52 269 49 267 51 24 HbA1c 0 108 95 0 002 0 219
66. 1 1 ECgso nM SAOS 2 0 531 0 034 0 530 0 027 1 47 0 08 H4IIE 8 97 0 26 8 39 0 36 1 60 0 27 SAOS 2 H4IIE DNA 3H 50 EC 4 vitro 3T3 L1 de oo 1 1 A ECso nM Of 0 973 0 092 0 874 0 077 0 516 0 078 3
67. LANTUS 536 1 100 269 49 267 51 1 WHO 1 2 18 3 1 4 HbA1c 11 0 5 1 Visit 1 3 NPH 1 1 6 BMI 35 kg m2 NPH Neutral Protamine Hagedorn 1 8 2
68. ITSQ ALBSS lt gt 24 LOCF HbA1c p lt 0 001 24 LOCF HbA1c 95 0 4 HbA1c 95 0 4 PPS FAS 16 24 LOCF HbA1c FAS 24 LOCF HbA1c HbA1c N 267 1 7 755 0 066 7 419 0 053 0 352
69. 2 1 2 4 5 a 3 1
70. 24 5 6 7 3
71. 3 4 4 5 1 2 3
72. BS 1 2 24 3 2 8 C 4 1 2 14 www lillyanswers jp 3
73. 0 052 95 0 070 0 175 0 4 HbA1c SU 6 1 7 2 3 ABEA gt LANTUS 2 4 80
74. 1 4 80 1 ABEB 2 ABEC 6 1 7 2 20 6 3 4 1 2 21 VI 1 2 1
75. ATP KK
76. vw 2 3 8 2 1 45 14 46 1 lt gt a b c d 1 lt gt a
77. Lilly Answers TEL 0120 360 605 FAX 078 242 9849 www lillyanswersJjp IF 2015 3 http www pmda gojp safety info services drugs 0001 html Boehringer Ingelheim ae IF 1
78. 2 3 9 2 4 9 2 5 20 2 6 2 7 9 2 8 7 3
79. 3 4 4 5 1 2 3
80. 3 4 5 6 7 8 3 4 28 1 2 1
81. 0 1 lt 5 AST GOT ALT GPT 1 I ABEB 2 ABEC 0 15 42 4 1 ABEB 52 2 ABEC 24
82. 4 5 Lilly AnSWerS 0120 245 970 078 242 3499 www lillyanswers jp IT0280JJAI 2014 12 BS BS 0
83. 63 2 IF IF 10 9 3 IF 10 20 9 I F 2008 IF 2008 IF PDF e IF e IF
84. 9 44 10
85. 4 5 Lilly AnSWerS 0120 245 970 078 242 3499 www lillyanswers jp IT0290JJAI 2014 12 5 URL RMP Risk Management Plan http www pmda gojp safety info services drugs items information rmp 0002 html 6
86. 120 lux hr 200 W h m2 2 30 C BS 28 30C 1 32 Ge 7 V 14 1 8 1 2 10
87. 2014 12 26 BS 22600AMX01373000 BS 22600AMX01374000 11 2015 5 29 12 13 14 15 18 107 20 97 20 3 19 23 14 3 8 16 HOT RT BS
88. BS 50 BS HD BS BS
89. 1 1 5 kg 3 6 2 4 6 2 2 5 Visit 1 3 6 Visit 1 3 pramlintide 7 14 Visit 1 4 8 Visit 1 6 1 2 24 28 4 1 1
90. 2 3 4 5 26 5 1 2 CYP450 3 4 5 6 1 2 3 Oo 27 1 NS 1 2 1
91. 11 1 mL 1 100 1 1 36 38 ux g 12 13 14 V 1 gt 2 1 1 4 20
92. B A Sy le V OR Thr Ser Ser Leu Tyr Gin Leu Glu Asn Tr Cys Gly 3 21 B 0 LauCys Gly Val Glu Ala es Tvr_Leu lo Glu Am Gy Phe Phe Tr Thr Pro ys The Arg Arg 3 3 4 1 oo J CH4o4N72O07sS 6062 89 1 1 A 21 Asn Gily B C 2 Arg 1 21 A 32 B Insulin Glargine insulin Glargine Biosimilar 1 is an analogue of human insulin being substituted asparagine residue with glycine residue at 21st of A chain and added two arginine residues at C terminal of B chain It is a peptide composed with A chain consisting of 21 amino acid residues and B chain consisting of 32 amino acid residues LY2963016
93. ITSQ ALBSS gt 24 LOCF HbA1c p lt 0 001 24 LOCF HbA1c 95 0 4 HbA1c 95 0 4 PPS FAS 24 LOCF HbA1c FAS 24 LOCF HbA1c HbA1c N 369 1 8 350 0 06 7 044 0 06 1 286 0 06 N 375 1 8 310 0 06 6 9
94. 156 73 75 1991 2004 2006 259 262 2004 3 1 23 26 1987 49 653 658 1991 955 956 1995 84 9 1683 1686 1996 139 143 2000 451 458 1995 55 89 93 1997 2 208 210 2001 789 790 1995 69 1 85 89 1992 7 87 90 1995 100 114 1995 Diabetes Frontier 10 2 207 211 1999 197 213 2004 200 201 1997 15 6 613 617 1998 Ikenoue T et al Br JPharmacol 120 137 145 1997 Medicina 30 8
95. 2013 4 I ee 1 1 1 2 i 1 II 3 1 5 3 3 3 3 4 4 CPP 4 6 4 7 CAS 0 4 5 1 5 2 5 3 6 4 6 TV 7 A 7 2 krk Et 7 3 i 8 4 8 5 8 6 8 7 9 8 i 9 9 9 10 9 1 ER 9 12 9 13 9 4 RE 9 V
96. 200 e 100 C mol1 L 0 6 12 18 24 hr 0 5 kg C 4 0 5 kg C 4 4 24 N 1 AUCo 24 AUCo c Cmax tnax 2 t1 2 n pmol h L pmol h L pmol L hr hr 78 1820 3 2830 113 12 0 9 83 156 40 39 39 2 0 24 0 66 78 1980 5 2930 6 119 12 0 9 75 6 156 36 41 34 0 5 21 0 61 CV 1 N 4 n 2 3n 154 4 n 149 5 n 155 6 n 152 AUC C 90 0 80 1 25
97. 80 14 17 5 16 dl 1 1 4 20 1 4 80 8 4 5 1 2 ABEB ELEMENT 1 gt 1
98. 2 2 4 24 0 5 kg 7 0 24 AUCo 24 C_ C gt VI gt 95 0 80 lt 1 25 mg kg min 0 4 8 12 16 20 24
99. CAS 160337 95 1 1 1 2 99 5 3 4 5 6 7 6 8 2 1 10 C 30 5 C 6 30C 6 SD o n 30 C 60 RH Jp 6 8 ia
100. 0 4 52 HbA1c 0 020 95 0 099 0 140 24 HbA1c 2 ABEC ELEMENT 2 7 2 2 LANTUS 1 1 24 379 380 24 HbA1c
101. 4 0 6 4 0 6 41 43 IT 1 1 BS BS 2 Insulin Glargine BS Inj Lilly 3 0214 1 25 2 14 25 2 14 2 1 11 JAN 2 Insulin Glargine Genetical Recombination Insulin Glargine Biosimilar 1 JAN insulin glargine INN 3 3 21 A 32
102. BD A 24 2 BS 1
103. 1241099010101 2492420A1021 622410901 BS 1241105010101 2492420G1024 622411001 17 56 XI 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 Pieber TR et al Diabetes Care 23 2 157 162 2000 Ratner RE et al Diabetes Care 23 5 639 643 2000 Rosenstock J et al Diabetes Care 23 8 1137 1142 2000 Yki Jarvinen H et al Diabetes Care 23 8 1130 1136 2000 Schober E et al Diabetes Care 24 11 2005 2006 2001 1 2 zo 7 329 336 1995 212 216 1997 176 181 1997
104. gt 3 mL 100 mL 2 lt gt 3 mL 100 mL 2 J lt gt gt ABS PTFE 8 100 mL 9 2014 9 9 55 10
105. hr 0 5 kg 4 0 5 kg 4 4 1 a 2 i 95 3 78 156 2 87 Gad 78 0 93 1 05 mg kg min 2 89 Nr 156 GS EN 78 156 2590 64 095 78 0 90 1 01 mg kg 156 2723 18 NN 1 N 4 n 2 13 gt 80 11 13 8 16
106. 0 00 1 022 2 0 3 3 0 5 1 0 2 1 0 2 2 0 3 0 00 0 0 0 1 0 2 1 0 2 0 0 0 1 0 2 0 00 0 00 1 0 2 5 43 6 1 2 3 1 1 2 2
107. 125 IGF 1 2 vitro hIR A hIR B 293HEK 1 hiR A hiR B 3 1 PS ECso nM hIR A 3 70 0 20 4 50 0 20 1 86 0 23 hIR B 2 05 0 07 2 52 0 12 1 50 0 03 hIR A hiR B 50 3 7 Mo IGF 1 DNA 2 SAOS 2 H4IIE 2
108. 220 _ 200 ia0 160 PL 140 0 120 100 80 ll fi mg dl N Ns ut waa 2 2 3 24 7 SU gt FAS 24 376 26 6 9 380 23 6 1 4 1 1 4 1 1 6 1 6 1 0 3 3 0 8 3 0 8
109. 30 C 90 RH 2 vi 120 lux hr 200 W h m 2 3 4 MV 1 1 BS BS 0 1 3 mL 1 3 mL
110. 3 Visit 1 12 2 4 5 HbA1c 7 0 11 0 HbA1c 11 0 6 BMI 45 kg m2 1 90 LANTUS 2 1 1 5 kg 3 6 2 4 14 Visit 1 4 24 4 1 1
111. 4 0 6 3 055 2 033 1 02 2 0 3 3 0 5 1 022 0 00 1 022 2 03 1 022 0 00 1 0 2 1 0 2 0 00 1 022 1 02 1 02 1 02 1 0 2 0 0 0 1 0 2 1 022 1 022 0 00 1 02 0 00 1 022 1 0 2 0 00 0 00 1 022 1 02 0 00 0 00 1 0 2 1 0 2 0 0 0 0 00 1 022 SD 5 0 8 0 00 1 0 2 4 0 6 2 0 3 0 00 1 022 3 0 5 0 0 0 1 022 0 00 1 0 2 0 00 1 022 0 00 0 00 1 02 1 0 2 0 0 0 0 00 1 0 2 1 022 0 00 1 022 0 00 1 022 0 00 0 00 1 02 0 00 1 022 0 00 1 0 2 0 00 1 022 1 02 0 00 0 00 1 0 2 6 0 9 5 0 8
112. 0 053 N 267 1 7 788 0 066 7 311 0 054 0 460 0 054 95 0 108 0 002 0 219 1 N FAS 1 52 LOCF HbA1c p lt 0 001 HbAlc 95 0 3 FAS PPS 52 LOCF HbA1c FAS 52 LOCF HbA1c HbA1c N 267 1 7 755 0 066 7 515 0 057 0 256 0 057 N 267 1 7 788 0 066 7 495 0 058 0 276 0 058 95 0 020 0
113. 2 3 52 7 24 52 LOCF HbA1c 95 0 4 FAS PPS gt FAS 52 268 17 6 3 267 14 5 2 10 3 7 9 3 4 2 0 7 1 0 4
114. uc 10 1 10 2 naRRRad 10 11 VI 22 1 22 iP 22 24 1 24 2 25 4 26 EM RR 26 BEE 27 SS 27 7 uuu 27 8 27 WW 28 1 28 2 28 3 uuu uuu 28 4 ui 28 5 nN 28 6 30 7 31 3 41 9 44 10 45 11 45 12 45 9 2 45 MS 2 46 15 47 0100 7 LIN 47 ee 48 1a RE 48 A
115. 2015 8 4 87 2492 IF 2013 5 Insulin Glargine BS Inj Lilly 1 1 3 mL 1 300 1 3 mL 1 300 1 JAN Insulin Glargine Genetical Recombination insulin Glargine Biosimilar 1 JAN 2014 12 26 2015 5 29 2015 8 3
116. 0 0 3 1 3 2 NOAEL 0 3 mg kg gt 0 3 mg kg gt 1 mg kg 3 2 mg kg 1 mg kg 1 SD 10 1 1 4 0 0 3 1 2 NOAEL 0 3 mg kg gt 0 3 mg kg gt 1 mg kg 2 mg kg 1 mg kg 1 2 mg kg 1 3 mg kg 1 11 12 14 15 2 mg kg 3 48 4 49 X 1 BS
117. 0 5 kg 4 4 N n 2 90 AUCo 24 76 152 1821 86 0 91 pmol h L 76 152 2001 37 0 87 0 96 Cmax 78 156 112 85 0 95 pmol L 78 156 118 54 0 91 1 00 4 5 6 1 N 4 4 n 2 1 1 4 20 1 4 80
118. 33 o DPP 4 DPP 4 GLP 1 GIP GLP 1 GLP 1 GLP 1 SGLT2 SGLT2 w MAO
119. 099 0 140 1 N FAS 1 HbA1c 6 12 24 36 52 p lt 0 001 95 0 3 FAS 0 2 0 0 oj oz 8 S q FR 0 6 mm A4 0 8 T T T 1 T T T T 6 12 24 36 32 2 2 HbAlc 24 52 LOCF HbA1c FAS 24 52 LOCF 1 7 SMBG FAS 190 ll 180 170 160 mg dL 150 140 130 mm A 2
120. 1540 1542 1993 Diabetes Frontier 3 6 557 564 1992 10 2 113 121 2000 55 142 146 1997 Drug Interaction Facts Facts and Comparisons A Wolters Kluwer Co 564 1996 Bev L True et al Am Psychiatry 144 9 1220 1221 1987 R K Shrivastava et al Biol Psychiatry 18 12 1509 1510 1983 Drug Interaction Facts Facts and Comparisons A Wolters Kluwer Co 565 1996 Edward A Hartshorn Drug Intelligence 196 197 1969 V 75 77 1987 18 6 809 821 1987 L Korsgaard Christensen et al Lancet 1397 1399 1969 R Arem et al Arch Intern Med 143 827 829 1983 Seiji Hayashi et al Am J Physiol C337 C342 1993 Gyslaine Bertrand et al Eur J Pharmacol 214 159 163 1992 Jong I KIM et al Hypertens Res 26 4 307 313 2003 GLY30000 GLY30001 GLY30002 GLY30003 GLY30004 GLY30006 GLY30007 GLY30008 GLY30009 GLY30010 GLY30011 GLY30012 GLY30013 GLY30014 GLY30015 GLY30016 GLY30017 GLY30018 GLY30019 GLY30020 GLY30021 GLY30022 GLY30023 GLY30024 GLY30025 GLY30026 GLY30027 GLY30028 GLY30029 GLY30030 GLY30031 GLY30033 GLY30034 GLY30036 GLY30037 GLY30038 GLY30039 GLY30040 GLY30041 GLY30042 GLY30083 57 48 Diabetes Neutriti
121. 7 12 1 9 11 1 7 4 0 6 4 0 6 1 ABEB 2 ABEC 41 2 1 1 9 8
122. 91 0 06 1 338 0 06 95 0 052 0 070 0 175 1 N FAS 1 HbA1c 4 8 12 16 20 24 p lt 0 001 95 0 3 FAS MM 5 S 06 1 0 8 1 0 12 1 4 4 1 6 1 8 _ i 4 8 12 16 20 24 LOCP HbA1c 1 HbAlc 24 LOCF HbA1c FAS 24 LOCF 1 7 SMBG FAS 19 240
123. N 48 X ee 50 0 on 50 2 Ui 50 3 50 4 50 5 55 6 55 55 8 55 9 ll 55 10 56 11 56 12 56 13 56 56 15 56 NSRENSSRNSNESG2HU2G 56 17 i 56 XI 2 HH 57 1 SS 57 2 58 I 59 1 i 59 2 uri 59 1 1 IO Neutral Protamine Hagedorn NPH 1 2
124. T3 L1 14C 50 ECs 5 7 wo 1 1 IX 2 2 VIL 1 23 I 1 1 2 3 3 24 LANTUS 0 5 kg C
125. Y30049 GLY30050 GLY30051 GLY30052 GLY30053 GLY30054 GLY30055 GLY30084 GLY30057 GLY30058 GLY30059 GLY30060 GLY30061 GLY30062 GLY30063 I 1 2 1 FDA FDA 2015 6 30 FDA A B C D x
126. e IF http www info pmda gojp e IF e IF IF 2008 4 IF IF 2013 2 IF IF
127. ection site reaction and skin reactions rash urticaria in children and adolescents lt 18 years of age than in adults Clinical study safety data are not available for children under 2 years 59 XT www lilyanswersjp Q amp A 60 7 1 5 2 2 012518 GLY F001 R3 2015 8
128. mL 1 3 mL 51mg 51 mg m 8 1 mg m 8 1 mg 90g 90 ug pH pH oo 3 4 5 1 8 4 5C 24 g 7 5 C 24 a 8 0 30C 65 RI 6
129. on and Metabolism 2 1 81 1989 49 Edward Brogal et al Lancet 482 484 1969 50 49 659 664 1991 51 17 11 2436 2443 1989 52 MKoffler et al Diabetes Nutrition and Metabolism 83 84 1989 53 50 51 1996 54 1 3 268 274 1995 55 311 1995 56 Barrie J Hurwitz et al Lancet 369 1975 57 E Simon Sears Neurology 26 89 94 1976 58 H Kotzmann M et al Eur J Clin Invest 25 942 947 1995 59 K AL Rubeaan et al Diabetes Medicine 8 968 970 1991 60 2 594 597 1998 61 Brenda L Koop et al Eur J Endocrinol 130 581 586 1994 62 479 481 1995 63 102 106 1992 64 3 188 196 2001 65 Lois J Peterson et al J Am College of Nutrition 8 2 125 131 1989 66 Herings R M C et al Lancet 345 1195 1198 1995 67 30 8 889 891 1996 2 58 GLY30044 GLY30045 GLY30046 GLY30047 GLY30048 GL
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