新医薬品の「使用上の注意」の解説
Contents
1. 1 1 1 22. 7 GWCK 2 2 0 mg 2 0 mg 84 145 188 U L 148 CT 1 10 0 6
3. 2012 11 2 mg EE 1 gt 1 1 3 5 1 kk 5 2 kk 9 3 23 29 47 6 kk 47 7 kk 49 8a oa 49 9 51 Um 0 0 0 ANCN 53 2
4. 11 12 gt SU SU SU SU
5. 4 1 3 gt 4 1 3 20 2 13 e 4
6. 15 8 1 14 22 2001 16 Weber G et al SOUTH AFRICAN MEDICAL JOURNAL 474 475 1967 17 DIABETES NUTRITION AND METABOLISM 2 1 75 93 1989 18 659 1991 26 3 2 1t 2 2 INR gt 1 2 GWAC
7. gt 2 mg 1 gt 2
8. 2 GWBX GWCK eR gt GWBW GWBX GWCK 2 2 mg 1 10 3 4 SO pg mL
9. GWCK 1 1 2 2 1 4mg 1 25 Calara F et al Chn Ther 27 2 210 215 2005 0 9 1 1 2
10. g 4 MAO 23 gt
11. C 0 5 ng mL 24 C 20 ng C 1 2 2 2 2 19
12. gt PR A NS 2 653 1991 3 955 956 1995 gt mk Pt 4 84 9 1683 1686 1996 139 143 2000 gt 7
13. i 6 by DONNA 43 gt GWBX GWCK CCDS Company Core Data Sheet CCDS GWBX 11 2 24
14. 19 Soon D et al J Clin Pharmacol 46 10 1179 1187 2006 26 3 HMG CoA AUC 40 C 28 tx 4 4 A PP 818 556 426 2 1 161 19 7 104 Q2 7 62 7 6 55 6 7 49 6 0 43 5 3 29 gt 1 2
15. MM 5 Ph 7 gt 2 gt GWBX 26 213 143 27 2 7 118 35 4 213 68 31 9 CWCK 26 336 206 45
16. 6G gt gt gt 1 2
17. Se 6 451 438 1995 7 89 93 1997 gt 4 8 2 208 211 2001 o 2
18. 33 gt MR Si GWBX 215 21 9 8 CWCK 340 63 18 5 SU 5 AC ET 5 SU
19. 15 ee no 6 17 1 2 3 PA gt cz 4 DPP 4
20. pg mL 0 8mg n 8 952 2 0mg n 6 am soo NN 0 2 4 6 8 12 14 16 18 3 0 8 mg 2 0 mg 1 10 GWBW 2 mg gt 1 2 2 2 2 1 30 1 2 30 30
21. gt HbAi 3 4 GWCK 2 2 2 0 mg 1 1 2 10 pg 1 2 340 338 HbAi 4 12 1 10 0 1 9 5 o
22. GWBW 2 mg _ 2 2 gt 2 0 8 mg 2 0 mg 1 10 3
23. 3 1 36 mg dL 2 1 68 mg dL 88 mg dL 10 12 9 13 1 3
24. 3 3 4 Hb HCT TINR 1 1 Hb 12 9 gdL 3 4 INR 49
25. Fine needle aspiration 40 4 1 4 Sma WE ore Tos wae Te one EE TGZ 41 gt GWBX GWCK CCDS Company Core Data Sheet
26. SU SU BG SU BG ZD SU TZD SU BG SU TZD BG TZD 2 11 gt 1 2
27. gt 4 1 1 lt gt 10 2 gt 26 WBX 4 46 9 76 bpm
28. 1 2 3 1 2 8C 2 4 30 N 1 gt 1 1 2 2 1
29. 2 ms 1 GLP 1 glucagon like peptide 1 GLP 1 7 36 amide 53 GLP 1 2 2 200 4 1 2 2010 10 2012 3 90 1
30. 10ugx2 30 1 10 ugx2 32 44 130 140 2 INR 6 7 Hb 7 1 g dL K 1 3 INR 3 1 9 3 gdL 2 137 199 66 mmHg
31. 2 INR INR 3 2 3 Sugx2 3 ugx2 60 1 22
32. 4 DPP 4 1 GLP 1 SU Recommendation 13 4 1 1 10 GLP 1 DPP 4 http www ds or 1D uploads photos 797 pdf gt 2 1 2
33. 2 ATL 368mg dL 387mg dL 311 mg dL 2 272 mg dL 304 mg dL 3 20 mg dL 4 C 0 2ngmL 5 126 mg dL 1 9 11 2012 2 5 3 4
34. 1 2 1 3 Nn E gt gt 1
35. PLG 1 1 2 PLG 1 2 2001 EU 2011 6 2012 1 2012 3 1 2 2012 3 2
36. SE EA CE FDA Pregnancy Category C 2012 1 2 An Australian categorisation of risk of drug use in presnancy C 2012 11 FDA Pregnancy Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans but potential benefits may warrant use of the drug in pregnant women despite potential risks An Australian categorisation of risk of drug use in pregnancy C Drugs which owing to their pharmacological effects have caused or may be suspected of causing harmftul effects on the human fetus or neonate without causing malformations These effects may be reversible Accompanying texts should be consulted for further details 48 6
37. 4 13 5 mg dL 38 9 mmolL K 5 2 mmol L pH7 3 150 mg dL 5 12 Na 140 mmolL Na 84 mmol L 21 mmolL EFNA 4 2 ATN L 24 10 9 mg dL 44 6 mmolL K 5 5 mmolL 0 4 mg dL HbA 5 5 2 3 0 mg dL 3 2 6 mg dL 7 1 mg dL
38. 48 1 2 3 CT Grade2 CT CT Grade 1 2 3 023 2 1 2 1 Grade 1 2 Grade 2 3 Grade 3 10 2010 2009 ERCP ES
39. 7 _ _ _ 10 2 49 gt MG gt gt 118 1 100 ug 10 2 3
40. 3 2 9 2008 BE 3 mEq Pa02 60 mmHg room air BUN 40 mg dL Crz 2 0 mg dL LDH 2 10 mm3 Ca 7 5 mg dL CRP 15 mg dL SIRS 3 70 80 mmHg 400 mL SIRS 1 gt 38 C 36 2 gt 90 3 gt 20 PaCO2 32 torr 4 gt 12 000 mms 4 000 mm3 10
41. gt 8 a i MAO MAO 11 9 2 176 179 1990 12 68 81 1994 13 1 6 11 1996 14
42. 1
43. 96 141 182 184 315 Ins 7 Ins 8 Ins Papillary Carcinoma 7 95 4 14 3 Ins 4 15
44. 29 gt 1 2 2 6 6 Pa 2 Suugx27 5S ugx2 HbA 9 20 1 10 ugx2 BMI 40 1 3 HbA 7 2 0 80 10uugx2 mg dL
45. 2 9 6 7 22 7 1 2 3 6 30 8 2 1 1 230 ng kg C C C C 0 3 1 0 3 0 mg kg 2 2 1 C 1 0 mg 3 0 mg kg C 6 GWBX GWCK 3
46. gt PLG 2 2 0 mg 1 10 8 8 2 0 8 mg 2 0 mg 1 10 1 3 2 2 0mg n 9 0 8mgn 10 F n 10 0 30 G 2 H3 T T T T T T T T T T i T T T T T T T T T T 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2 0 8 mg 2 0 mg 1 10
47. GWCK 7 1 24 1 2 9 8 33 1 nh 215 n 212 96 10 a ME a om 4 gt d 8 B 12 gt 12 16 gt 16 20 gt 20 24 gt 24 215 213 207 205 203 199 195 212 212 210 208 205 205 203 6 GWBX Full Analysis Set _ 1 2 1 10 4 gt d 8 gt 8 12 gt 12 16 gt 16 20 gt 20 24 gt 24
48. 30 32 2 1 Dt 110 72mgidL 1 1 Dtn 121fD 0 166mg dL wk 30 34 CPW L H 0 3 6 10 14 18 22 2B 303336 40 4 52 4 LAR 105 16 e eS ee 10
49. 2 778 779 1998 24 3 a 25 gt 07
50. SI gt 4 DPP 4 1 GLP 1 42 4 2 em
51. GWCK 3 35 10 02 bpm gt 1 2 3 3
52. 22 Lopez Ruiz A et al Pharm Worid Sci 32 5 559 561 2010 36 4 1 37 gt 0 2 GWCK 1 7 GWBX 26 2 0mg 1 26 1 CSD BCB108 1 BX 1 2
53. gt gt 1 2 GWAB CRE CLcr gt 80 mL min 8 CLcr 50 80 mL min 8 CLcs 30 30 mL min 6 CLck lt 30 mL mn 8 5 10 ug tt 1 45 2 12 3 16 5 95 tu 2 CLcr gt 50 mL m
54. 2013 2 6 2 ram BYUUREOUN 1
55. GWAG AUC 40 Cmax 28 4 HMG CoA 2 HMG CoA 20 Kothare P A et al Int J Clin Pharmacol Ther 45 2 114 120 2007 gt GWBX GWCK 2 mg 1 818 55
56. 1 2 HbA1c NGSP 0 4 8 12 20 26 1 HbA1c GWCK 2 6 7 3 gt
57. 11 a ON GWCK N 340 n n n n GWBX _ 1 2 1 U H 0 4 gt d 8 8 12 12 16 16 20 20 24 24 8 GWCK Intent To Treat 23 Yamaguchi K et al J Control Release 24 81 93 1993 46 6 1 22 ng kg 2 mg 1 1 49 5 68 ng kg
58. 2mg 1 1 5 4 0 3 mg kg 2 mg 1 1 1 7 3 1 3 mg kg 2mg 1 1 10 9 47 gt 1 2 2 GWCC 15 75 85 CLcr 30 80 mL min 10 ng
59. EE 9 0 12 2 0 24 0 12 43 5 26 1 0 12 6 0 73 1 0 12 3 0 37 13 1 59 6 7 0 86 1 0 12 1 0 1 012 6 0 73 0 Yi050 4 0 49 42 5 13 16 7 1 0 12 14 1 71 1 0 12 49 3 99 1 0 12 1 0 12 62 7 58 1 0 12 1 0 12 0 12 0 24 0 12 4 5 em TT ET 0 30 sw CE je 4 0 4 Q 499 e ies 2 9 0 MU 0 ET 0 1 c9 EE 6 0 CE 29 o iz we 6 1 ET 1 6 29 to J 1 1 0 12 1 0 12
60. 26 GWCK 1 59 22 3 4 3 63 18 5 4 DPP 4 on 5 21 53 7 505 508 2010 34 4 1 2
61. 10 28 100 29 TSH 1 24 uIU mL FT4 1 4 ng dL TgAb 0 3 U mL CA19 9 19U mL CEA 2 0 ng mL 5 ngx2 24 pg mL 1 10 ug PTH 49 9 pg mL 23 pg mL 46 7 ng mL FT4 1 1 ng dL FT3 2 7 pg mL TSH 10IU L TPO 0 3 U mL 29 pg mL 44 4 ng mL FT4 1 0 ng dL FT3 2 5 pg mL TgAb 0 3 U mL TPO 0 3 U mL 1 3 ClassILb Papillary Carcinoma suspec
62. 8 2 2 mg 1 26 8 50 330 pgmL 1 2 2 2 mg 1 e 1 2 2 mg 1 1
63. Caax AUC 15 45 65 CLcr gt 50 mL min 12 41 Bb 24 Linnebjerg H et al Int J Clin Pharmacol Ther 49 2 99 108 2011 gt 1 0 3 1 0 3 0 mg kg 3 1 3 0 mg kg
64. 4 gt gt GWBX GWCK ICSD BCB108 4 1 3 gt 4 DPP 4 1 GLP 1 gt 5 1
65. MI 1 0 12 emm Sm cr 1 6 I EE 0 0 _ 0 1 _0 6 EN EE 32 1 1 9 1 6 1 0 12 2 0 24 4 GWBX GWCK 818 556 818 556 ver 14 0 MAD Ver A 0 EE 0 12 EEC 0 1 Qi26 ij 0 3 0 WW Hp 6 po gt 6 2 zo ACE 2 0 3 0 oo 0 lo ieoo 2 ET 1 o EC Re MC ME emo ov 3 ezeo iemo 0 0 me 0 2 0 3 2 em TP 3 2 1 6 5 ee io meg 24 2 93
66. GWCK 9 1 31 1 2 23 7 80 RI 72 2 1 gt 12 16 gt 16 20 20 24 gt 24 i FII N 5 GWCK Intent To Treat 44 GWBX 6 5 14 12 20 6
67. GLP 1 3 12 13 14 GLP 1 C 2 13 14 1 13 4 2 12 1 0 24 Sugx2 1 2 10 ugx2 6 lt 2 0 mg TE 2
68. 155 223 204 185 mg dL 289 mg dL 223 130 mg dL 148 mg dL 85 IU L 55 UL E NR 38 lt gt 8 2008 3 CT MRI
69. 2 3 3 1 2 8C 2 4 30 32 10 1 0 3 1 0 3 0 mg kg 2 1 C C 2 mg 1 1 1C16 2 J gt 18 70 230 ug kg
70. 3 4 161 47 9 336 130 38 7 26 HbAi 15 15 26 GWBX GWCK i a 68 130 118 27 161 45 ee 16 34 8 7 19 9 23 5 28 8 29 6 5 4 11 8 20 0 0 0 0 4 10 6 Mi Ge 7 1 3 10 6 G3 6
71. 6 0 MG 1 0 1emo RE 5 0 seeo il oe iemo 4 0 4owo 6 0 RR 3 3 am 3 oo mm 0 2 EE 5 zeo ET 1 02 Geie Ge W 0 12 0 37 1 34 0 12 0 24 32 4 1 4
72. 7 GWCK Intent To Treat 45 PLG PLG GWBX GWCK 11 GWCK 1 2
73. 6 22 8 181 Ins 183 Ca 2 0 mg 359 gt Ins 1 22 181 183 3959 436 433 472 6 Ins 4 Ins 7 5x6 3x9 0mm 10 2 3
74. 6 426 32 1 4 161 9 7 104 2 7 62 7 6 5 6 7 49 6 0 43 3 ke 30 4 GWBX GWCK 818 556 818 556 1 0 12 0 1 1 O12 1 0 12 iz0 0 Qi29 Oi2 ET 9 ioi29 eo ieso WW 1 0 1 29 mm 3 0 3 2 9 CE 3 3 2e9 o iz9 oe ieso 0 6 6 023 ET 0 20 ET EEE 6 ie 3 o 3 G329 3 o 3 2
75. in 13 36 84 1 Linnebjerg H et al Br J Clin Pharmacol 64 3 317 327 2007 _ ae TTF gt gt
76. t Ws TNM pT4aN0Mx 5 mm 13 2 2 Ins 7 Ins Ins 4 1 1 Ins 6 Ins 4 jl 16 16 2 6 U 141 8 182 Ins 184 1 0 4 2 0 mg 346
Download Pdf Manuals
Related Search