ランタス XR 注ソロスターに係る 医薬品リスク管理計画書
Contents
1. MR2. 5 5 1 Pn 5 000
3. 1 IGF 1 E jA 6
4. 6 Sin acta 58 EN YA
5. RMP De 3 3 EFC13799
6. 300 m FY 100 AZ mL amp OU 0 FZ 1 2 1
7. NA ga ce Caan RG ec erica NR rary
8. 100 mL HbAlc HE
9. 300 ImnL 100 mL 100 mL 300 mL 100 mL 100 mL 100 mL MIER
10. 2 4 1 1 RE PR 3 000 gt 0 19 95 3 000 A NE CN A NN
11. FAS EFC12449 EFC12312 12 EFC12456 EFC12347 R 6
12. 1 EFC12449 EFC12436 Basal Bolus 14 4 21 146 Pil 2 EFC12512 EFC12347 11 0 16 145 Bil AAA 1 34 5 146 Bil 2 2 1 3 145 Sil 1 1 4 2 146 Bil 2 1 4 2 145 Bil BERAS T Wale Be TG
13. ih ea ca re i EE i eM A
14. 10 1 2 3 4 5 6 7 Currie CJ Poole CD Gale EAM The influence of glucose lowering therapies on cancer risk in type 2 diabetes Diabetologia 2009 52 9 1766 77 Colhoun HM Scottish Diabetes Research Network Epidemiology Group Use of insulin glargine and cancer incidence in Scotland a study from the Scottish Diabetes Research Network Epidemiology Group Diabetologia 2009 52 9 1755 65 Jonasson JM Ljung R Talback M Haglund B Gudbjornsdottir S Steineck G Insulin glargine use and short term incidence of malignancies a population based follow up study in Sweden Diabetologia 2009 52 9 1745 54 Hemkens LG Grouven U Bender R Gunster C Gutsc h midt S Selke GW et al Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues a cohort study Diabetologia 2009 52 9 1732 44 Stiirmer T et al Cancer incidence among those initiating insulin therapy with glargine versus human NPH insulin Diabetes Care 2013 Nov 36 11 3517 25 Habel LA et al Cohort study of insulin glargine and risk of breast prostate and colorectal cancer among patients with diabetes Diabetes Care 2013 Dec 36 12 3953 60 Grimal
15. ae EK ut Vaio
16. af
17. 26 HbAlc HOE901 U300 XR HOE901 U300 22 00 8 59 70mg dL 26 3 9mmolL 1 26 0 00 5 59 70mg dL 3 9mmolL 1 26 70mg dL 3 9mmol L LA 1 26 HbAlc
18. 6 ele eagles lt INS amen
19. 6 EMR 7 Fe Ly
20. 1 EFC12449 EFC12456 Basal Bolus 2 EFC12312 EFC12347 07 1 145 Bil 0 7 1 145 Bil 0 7 1 145 NA E Ay E HJ 6 SIE Sn E
21. JE 16 4 6 2 IRIE F 300 mnL 100 mL amp OY 0 HZ MR
22. HOE901 U300 26 HbAlc 7 5 7 0 26 70mg dL 3 9mmolL 26 HbAlc 7 5 7 0 26 FPG 26 PRO 26 2015 9 2017 1 4 HOE901 U300 26 2
23. 1 2 1 E 3 100 mL
24. E E HJ 6
25. E 1 4 80 1 1 1 1 ee ee ee 1 98
26. 5 2 5 000 50 EFC13799 5 3 6
27. XR 27 7 31 20 2 2000 4 21 87249 22700AMX00700000 XR 1 1 5SmL 450 1 1 4 20
28. 920 460 50 15 30 2 4 26 2 a4 0 RMP
29. 6 144 146 H 2 EFC12512 EFC12347 2 80 0 116 145 E 1 3 4 5 146 Be OM BEERS 0 7 1 146 Bil 2 0 7 1 145 Bil Heel 6
30. di Bensouda L et al ISICA group Risk of breast cancer by individual insulin use an international multicenter study Diabetes Care 2014 Jan 37 1 134 43 11 1 2 HR MEAS RE OU 6
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