新医薬品の「使用上の注意」の解説
Contents
1. MAO gt gt2. 1 NT i 9 AA UE 13 11 2012 12 3 4
3. 25 Soon D et al J Clin Pharmacol 46 10 1179 1187 2006 24 3 HMG CoA AUC 40 Cmax 28 tx 4 25 gt AUC 40 Ca 28 4 HMG CoA 26 Kothare P A et al Int J Clin Pharmacol Ther 45 2 114 120 2007 26 4
4. RF gt gt gt 1 2 C 0 5 ng mL 24
5. FF 1 gt 2 19 8 1 14 22 2001 20 Weber G et al SOUTH AFR
6. 3 3 4 Hb Hct INR 1 1 Hb 12 9 g dl 3 4 INR
7. a 4 gt SU SU SU SU 4 DPP 4 1 GLP 1 SU Recommendation 13 4 1 1 14
8. MAO MAO 15 9 2 176 179 1990 16 68 81 1994 17 1 6 11 1996 18 2 778 779 1998 20 3 IN
9. 4 1 1 3 eg
10. 4 1 2 8 2 25 3 4 30 J gt 1 1 2 3 4 JIS T 3226 2 A A BD
11. 7 8 1 100 pg 10 2 NSY 1 gt 1 29o gt LCW gt 1 100 ug
12. 43 gt CCDS Company Core Data Sheet gt 4 DPP 4 1 GLPE 1 44 4
13. 35 gt 7 7 a 2 5 ugx2 5 uugx2 HbA 9 10 ugx2 1 3
14. CT CT CT HE 12 mm 3 mm 8500 mm CE OE CRP2 2 40 U L 78 U L CT
15. 1t 2 TINR 23 gt tx 2 INR INR 2 2 Suwgx2 60 1 22 10ugx2 30
16. Heloderma suspectum 39 Exendin 4 1 GLP 1 glucagon like peptide 1 GLP 1 7 36 amide 53 GLP 1 2 B 2 2002 2005 4
17. 11 2008 3 CT MRI 3 2 12 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
18. A 6 1 2 lt gt 2 25 3 10 ng AUC 95 1 21 0 96 1 53 1 13 0 89 1 43 1 18 0 93 1 49 AUC
19. LL ERCP ES Fine needle aspiration Se 42 4 UR 4 PT
20. 5 ug 8 1 10 ug 35 1 5 ug 25 0 10 ug 36 1 14 10 ug 5 ug 4 10 pg 4 14 24 N 72 N 72 n n n 6 n n 18 25 0 26 36 1 17 23 6 20 27 8 1 1 4 5 6 9 0 0 0 1 1 4 17 23 6 24 33 3 10ng 5S pg 1 2 4 10 ng 2 20 2 1 3 sw kesl es 46
21. 61 UL BP 22 UL 6 UL CT EST 41U L 39 10 2 5 ugx2 5 ugx2 1 10ugx2 1 2 10 ngx2 3
22. ET gt HbAi 3 4 VK 2 179 10 ng 1 2 24 CE HbA 12 16 32 2 100 _ A 4A 90 1 0 0 5 g 10 ug 20 1 _ 80 NN lt e 3 75 70 65 60 5 5 EE 50 2 HbA
23. 28 Lopez Ruiz A et al Pharm World Sci 32 5 559 561 2010 2 36 4 1 3 0 7 37 gt 0 7 1 2
24. 146 50 7 52 SU 4 5 6 lt gt 4 N 37 N 37 N 37 n n n n n n n n 1 4 10 0 10 27 0 15 40 5 20 54 1 0 0 0 0 0 0 1 2 7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I 4 10 0 10 27 0 16 43 2 20 34 1 ER ron mewl ses roo 10ug Snug 1 2 4 10 ng 2 8
25. 3 1 CRP 8 8 mg dL 114007mm 327 IU L BP 223 U L 1330 IU L AST 20 IU L ALT 41 IU L Vital CT
26. 10 mg 2 mL 20 msg 20 mgx2 200 mL 2 9 11 AST 1330 IU L ALT 1177 IU L ALP 372 IU L 1410 U L 4 6 0 5g 1 5 g 5 20 20 mg 20 mg 300 mL CT density
27. 4 1 3 gt gt 4 DPP 4 iR 0 gt
28. AUC 1 30 Calara F et al Clin Ther 27 2 210 213 2005 3 4 1 2 8C 2 2 C 30 3 4 30 4 2 250 ng kg 1 10mg 1 2 143 C C
29. 70 mg dL SU 70 mg dL SU 50 8 4 3 pg 10 ug 3 1 tH 35 5pg DKE73 Es 10gg HhF72 4 5ug 9 3 27 53 7 505 508 2010 34 4 1 0
30. 3 30 Calara F et al Clin Ther 27 2 210 213 2005 D 9 1 1 2 3 4 JIST3226 2 A A BD 5 A 6 1
31. PH CE NO 0 ee 6 653 1991 7 955 956 1995 gt mk Pt 9 8 84 9 1683 1686 1996 9 139 143 2000 gt 10 451 4S8 199 11
32. AST 353 IU L ALT 743 IU L ALP 523 IUL 817 UL MRCP 109 UL 263 UL 38 9 2 0 2 5 uugx2 1 10ugx2 74 5 ugx2 28 10 ugx2
33. 4 31 gt SU IL SU 288 224 77 8
34. 25 49 gt 2 15 75 85 CLcr 30 80 mL min 5 10 ng Cx AUCo 15 45 65 CLcn gt 50 mL min 12 41 29 Linnebjere H et al Int J Clin Pharmacol Ther 49 2 99 108 2011 gt
35. 288 224 77 8 146 0 7 75 26 0 41 14 2 32 1 1 31 10 8 26 9 0 27 gt TL 1 2 2 10 ug 288 224 77 8 3 146 30 7 75 26 0 41 14 2 32 11 1 31 10 8 26 9 0 23 18 41 288 14 2 26 3 Ei N 37 N 126 N 288 0 0 0 1 0 8 1 0 8 0 7 0 0 0 0 0 0
36. 1 1 10 ng 1 2 gt 2 18 10 us 60 13 1 mg dL nD 150 100 nl Placebo 15min min b50min Omin 6Omin 0 BU 120 180 240 30DU 35U dD min 1 2 1 Linnebjerg H et al Diabet Med 23 3 240 243 2006 gt IT 5 ng 10 ug
37. 2006 11 EU 2012 3 90 2 2010 10 2 2013 4 IE Ui GE Ai 1 lt kk 1 HE ci 1 lt
38. 10 ug HbA 3 ug S3 ug 10ug 6 ug 1 10 ug 4 5 ug 10 ug 1 10 ug EL C 4 1 1 4 2 2 Kadowaki T et al Endocrine J 56 3 415 424 2009 3 Kadowaki T et al J Diabetes investig 2 3 210 217 2011 4 Inagaki N et al J Diabetes investig 2 6 448 456 2011
39. ES5 5 gL 7Z EE 10ag HL EE 5hug b dd d 8 8 um tm to to to te P P 34 P PF P P L 7g L mm L HB L L L H 5 4 Full Analysis Set L S pg 13 5 10 ug 8 1 S ug 4 2 10 ug 16 7 15 8 5 47 15 24 N 72 ea od
40. n n n 1 0 9 12 5 3 4 2 0 0 0 10 13 9 a 1 en eeww aar S ug 1 2 4 10 ng 2 20 2 1 3 tPF 5 dd Tr Lh FE 10 HL FTE Fu oe 4 3 E 2 5 Full Analysis Set 48 6 1 22 pg kg 1 10ug 1 2 229 68 hg kg 1 10ug 1 2
41. GLP 1 DPP 4 http www 1ds or 1p uploads photos 797 pdft gt 14 1 3 gt
42. 2 1 3 32 5 24 N 35 5 Hg 10 ug N 72 N 72 n n n n n n 31 2 20 3 37 51 4 6 42 58 3 1 8 22 9 37 51 4 41 56 9 0 0 0 0 0 0 1 1 4 0 0 0 0 0 0 0 0 0 PE 8 22 9 36 50 0 42 58 3 1 10ug Susg 1 2 4 2 1 3 10 ug 1 2 20 6 SU 24 5 pg 10ng N 72 N 72 n n N n n N n 1 10ug Ssug 1 2 4 2 3
43. 70 mmHg PCA 28 000 CT 2 40 lt gt
44. kk 3 9 1 2 Ne cd AANA 5 EE 7 1 kk 7 2 i 11 oo 19 dR lt lt lt 27 5 PE 49 6 i 49 51 SSS 51 UE a i 53 IO GASDSDODRASSjASSAAASS SSS SSSA SAS SA SRA SR CSS SSR OS SSS SS SS SS SS SS SRO SA SS 55 2 ET TT ee
45. 0 1 4 5 0 2 3 5 0 2 2 4 0 0 3 3 0 1 2 3 0 0 1 1 1 0 0 1 0 0 1 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 0 1 1 1 0 0 MedDRA ver 12 0 Sug 1 2 1 29 3 No N 37 N 126 N 125 N 288 1 2 7 0 0 0 1 6 3 1 0 0 0 0 1 0 8 0 0 0 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 3 8 1 26 20 6 36 28 8 65 22 6 a 2 5 4 1 0 8 0 0 0 3 1 0 0 0 0 0 0 0 3 2 4 3 1 0 1 2 7 0 0 0 1 0 8 0 7 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 0 0 0 1 0 8 1 0
46. 1 4 11 weey m 10 ug 1 2 20 lt SU 2mg 40 mg 2 5 mg 2mg 4mg 40meg 80 meg 2 5mg 5 mg 4mg 80mg 5 mg 33 4 DPP 4 SU SU SU lt SU gt TI
47. 1 gt gt 1 gt
48. 8 9 10 2 9 27288 0 7 mi 8 1 2 2 5 ugx2 175 176 0
49. 10 ug 1 Sug 4 1 10 wg ug 10 ug S pg 1 10 ug 10 ug HbAi 3 pug ng 10 ug 10 ug Sug 10 ug RN gt 1 60 2 1 ug 1 2 1 5 ug 10 mg
50. JDS gt diy 7 8
51. Pe EE FDA Pregnancy Category C 2012 1 An Australian categorisation of risk of drug use in pregnancy C 2012 11 N 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 owng to their pharmacological effects have caused or may be suspected of causing harmful effects on the human fetus or neonate without causing malformations These effects may be reversible Accompanying texts should be consulted for further details 0 6
52. 13 36 84 Linnebjerg H et al Br J Clin Pharmacol 64 3 317 327 2007 _ 0 NINE 70 FRR TTF gt gt 4
53. a i a a MG LT 45 gt L CCDS Company Core Data Sheet CCDS 1 30 3
54. C 20 ng C 1 1 ww 2 Sugx2 EE 2N Weed 3 7 5 ugx2 0 6 4 mmolL Na 132 K 5 7 Cl 86 9 16 8 231 a 5 1 mmolL pH 7 10 SL 6
55. 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 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 13 2010 2009
56. gt gt 14 1 3 gt 4 DPP 4 1 GLP 1 gt 5 1 1 ae gt
57. 1 Sug 1 2 1 1 10 uig 1 2 gt 2 2 gt 1 2 60
58. 10 2 3 3 1 36 mg dL 2 1 68 mg dL 88 mg dL 10 12 9 13 1
59. 89 93 1997 gt 12 2 208 211 2001 _ Tms ee J FFP TTF
60. HbA 7 2 10ugx2 0 80 mg dL 4 13 5 mg dL 38 9mmolL K 2 mmolL pH7 3 150 mg dL 5 12 Na 140 mmolL Na 84 mmol L 21 mmolL EFNA 4 2 ATN 24 10 9 mg dL 44 6 mmolL K 5 5 mmolL 0 4 mgdL HbA 5 5 2 3 0m g dL 3 2 6 mg dL 7 1 5 mg dL PD
61. 1 0 8 1 0 3 0 0 0 1 0 8 1 0 8 2 0 7 0 0 0 0 0 0 1 6 2 0 7 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 0 0 0 1 0 8 1 0 3 4 10 8 25 19 8 46 36 8 7 26 0 3 8 1 13 10 3 16 12 8 32 11 1 4 10 8 13 10 3 14 11 2 31 10 8 5 4 5 4 0 19 15 2 26 9 0 0 0 0 8 6 3 8 6 4 16 5 6 0 0 0 9 7 1 6 4 8 15 2 0 0 0 2 1 6 6 9 3 1 0 0 0 4 0 3 2 4 8 2 8 0 0 0 2 1 6 4 0 7 2 4 0 0 0 2 1 6 2 1 6 4 1 4 0 0 0 1 6 2 1 6 4 1 4 1 2 7 0 0 0 2 1 6 3 1 0 1 2 7 0 0 0 1 0 8 0 7 0 0 0 1 0 8 1 0 8 2 0 7 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 0 8 0 0 0 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 1 2 7 0 0 0 0 0 0 1 0 3 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 0 0 0 0 1 0 8 1 0 3 0 1 0 1 0 1 0 1 0 1 0 1 0 0 5 5
62. 32 5 ugx2 Ee 1 10 ugx2 44 130 140 2 INR 6 7 Hb 7 1 g dl K 1 INR 3 1 9 3 gdl 2 137 199 66 mmHg
63. C 29 gt 18 70 230 ug kg 14 31 105 5 6 25 27 142 143 2 1 1 230 ng kg C C 2350 ug kg C 6 BE 13 03 0013 15 02 PFU400 4
64. gt CLcr gt 80 mL min 8 CLcr 50 80 mL min 8 CLcs 30 30 mL min 6 CLck lt 30 mL min 8 5 10 ug ti 1 45 2 12 3 16 5 95 t 2 CLck gt 50 mL min
65. 2013 4 i 2 gszg 300 kT 10ug 300 Bety 1
66. 3 0 0 0 0 0 0 1 0 8 1 0 3 0 0 0 1 0 8 0 0 0 1 0 3 y 6 EEE MedDRA ver 12 0 1 Sung 1 2 1 1 10 ug 1 2 30 4 9
67. ICAN MEDICAL JOURNAL 474 475 1967 21 DIABETES NUTRITION AND METABOLISM 2 1 75 93 1989 22 659 1991 gt 38 30 ug 150 ug 10 ng 1 30 3 4 tax AUC 23 Blase E et al J Clin Pharmacol 45 5 570 577 2005 24 Kothare P A et al BMC Clin Pharmacol 12 8 2012 22 3
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