1 - 医薬品医療機器総合機構
Contents
1. 5 831 46 6 1 0 1 728 5 22. 10 D 1 14 pAD 8 22 3 9 41 0 31 5 48 8 72 6 36 3 94 0 40 3 25 60 32 4 18 3 57
3. fF lt GE 169 0073 3 25 1 7 vizamyl ref ge com gt 731
4. 3 eo lt _ a HPLC F UV HPLC 5 Re 105 115 18 5MBq m L 800MBq m
5. 5 F 100 689 999 999 999 95 725 5 4 959 80 12 RH in ro 7 AD H 13 flutemetamol F INN F HO S gt A N Me 18E i 109 77
6. 2 3 4 1 8F O 3 GE
7. Iom D PET PET FE PET 2 i 1
8. FH 10 11 12 OO ED ODD Or SF
9. 1 1 1 2 3 4 a b c d 409 e 100 f 9 h 2 1 0 2hm 2 90 250VAC 47 63 Hz 300W 100 240VAC 1 5A 50 60Hz 3 1 AC 4 WxDxH mm 476x392x444 kg 48 1 1F O
10. 1 1 1 3 3 1 1 1 RI 2 a b c
11. 5
12. 3 a b 4 724 5 8 6 9 2 1 PET
13. 3 180 2 X CT 1 5 0 1 1 PET 81 93 88 68 1 SoT 95 5 6 3 70 44 92 88 7 181
14. 100 68 99 99 99 95 4 95 80 RE kk I3S I 12 HI vitro lt 730 p zo AD
15. 40 12mL 5mL Fl 100 2mL C30 SPE 1 F 1mL 1 5mL C30 SPE 2 Fl 4mL 3 10 2 C30 SPE 2 3 5mL F 9 3mL 11 12 a a O Co
16. 191 8503 4 7 127 192 0033 67 4 0120 055 919 FAX 042 648 2905 0120 203 169 9 00 17 00 GE BVBA SPRL GE HEALTHCARE BVBA SPRL Global Radiopharmacy GE AS GE Healthcare AS 726 STED 4 3
17. mGy MBq 0 114 0 075 0 069 729 0 060 0 053 0 026 mSv MB 11 1 25 aMCI 20 pAD 25 70 5F PET pAD pAD SoT F 3 88 92 92 96 100 2 25 aMCI 20 pAD 27 72 SF PET pAD
18. 72 6 99 gt 56 3 94 0 2 2 40 3 25 60 SR 2 K 3 a 185MBq SB _ 120MBq 370MBq 0 114 lt gt 0 075 0 069 10mL 0 060 0 053 4 mSv MBo 0 026 1 F PET 11 1 Il 9 PET
19. HI 13 flutemetamol SF INN 18E y 14 1 AT A 109 77 51lkeV b E 1 2 F 3 Vandenbershe R et al Ann Neurol 2010 Sep 68 3 319 29 4 Curtis C et al Phase 3 Trial of Flutemetamol Labeled With Radioactive Fluorine 18 Imaging and Neuritic Plaque Density JAMA Neurol 2015 Mar 72 3 287 94 18 40
20. 929 96 100 2 25 aMCI 20 pAD 27 72 5 8F PET pAD 831 46 6 pAD SoT 1 F 5 3 0 1 92 96
21. pAD SoT E1 5 3 92 90 3 II 180 X CT PE 81 93 88 68 SoT 95 5 3 70 44 92 88 181 7 5 F
22. HE 80 T 1 F 1 OE EE
23. 1 0 1 1 6 6 7 9 1 PET 2 PET 3 90 70 110 18SMBq 20
24. 2 F WEF O O O QMA F O O 350LL QMA WF F AH111907 29mg 1mL DMSO 1mL11 4M 600uL SPE 2mL C30 SPE 1 Fl
25. 2 PET 3 PET 3 90 70 110 185MBq 20 2 1 5 1 10 F 2 6 AA i 3 9 80 4 98 m 41 0 31 5 48 89 0 014M 1mL E L E o F
26. 25 aMCI 20 pAD 25 70 F PET pAD F PET pAD SoT F 5 3 2 88 92
27. pH pH pH 6 0 8 5 3 0 2 nan 15EU ml 299 Hz O 16 5MeV 1 sO p n F SF 2 9
28. y 511keV 14 1 a F b F 1 2 F 3 Vandenberghe R et al Ann Neurol 2010 Sep 68 3 319 29 4 Curtis C et al Phase 3 Trial of Flutemetamol Labeled With Radioactive Fluorine 18 Imaging and Neuritic Plaque Density JAMA Neurol 2015 Mar 72 3 287 94 5 18 40 F gt GE 169
29. 0073 3 25 1 vizamyl ref ge com F 15 30 C 25 lt 10 C 18 24 10 1
30. 5 5 1 722 HHHHUUHHHHHHHHHH 2015 X 1 22300BZX00445000 10 JMDN 70009000 FASTlab 7 F 80
31. L 5 3 5 10 026 pn POT 9 a 2 00ug mL UV a 2 HPLC 2 6 00hg mL UV a HPLC 511keV 1 18F CA 0 93 0 HPLC 3 0 HPLC 511keV 1022keV 1
32. OE I EO ET b 3 PET Pa 727 IL 2 1 F 80 0 014M mL F 3 18SMBq 120MBq 370MBq lt gt
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