本剤調製時及び投与時の注意事項
Contents
1. PVC PVC PVC2. PVC PVC PVC DEHHP 2
3. 50mg m 1 2 70mg m 60mg m 50mg m2 60mg7m 50mem 20mg 2mL 80mg 8mL a g 32 0mg 300 1296 0mg 300 5184 0mg AN 80 80 640 0mg 551 8mg 2207 2mg 3 0 40 10Vv
4. A CYP3A4 i 2 DE
5. CRP 0
6. 9 10 K Na CI Ca BUN A G CK CPK
7. 1 2 ST 1 1
8. PVC PVC 2 2 5 PVC 2 4 e PVC 4 4
9. 1 2 3 4 80 80 5 16 80 SG SANDOZ a Novartis company CONTENTS WW
10. 2 5 1 1 J 2 CRP 70mg m2 70mg m2 2
11. e 530 8mg body 1 4mg body 12 24 36 48 4mg body 1 2 3 4mg body 12 24 36 48 P12
12. 3kg EE 2 EE 100mg m2 3 2 5 1 5 En ms a EE Grade4 8
13. PVC 4 250mL 500mL 5 0 3 0 74mg mL 250mL 5 0 3 lt 0 74mg mL 200mg 0 74mg mL
14. PVC 4 0 0 a 1 250mL 500mL 5 0 3 0 74mg mL 250mL 5 0 3 0 74mg mL 200mg 0 74mg mL
15. 20mg 2mL 80mg 8mL Docetaxel Intravenous Infusion 20mg 2mL 80mg 8mL SANDOZI Dose Limiting Factor DLF 1 2 3
16. Onco Safe SV Onco Safe SV Onco Safe SV Onco Safe SV lt 2c 250mL 500mL 5 0 3 0 74mg mL
17. i 4 1 2 1 1 20mg 1m
18. 1 2 3 BL 7 1 ca 2 3 1 4 80 80 5 6
19. 2 3 IM 6 3 CYP3A4
20. 1 2 000 mm3 2 2 1 4 1 1 3 250 500mL 5 1 9 10 2
21. 3808 8 Drug Information 2 4 1 G CSF 2 EE OO EA I 3 i AST GOT ALT GPT Al P EE
22. 4 4 PVC 5 DEHP 5 5 4 56 2 25C 4 4 25C 1
23. 4 0 15C 30C 1 Hart M Acott S Physical and chemical stability of Taxotere docetaxel one vial 20 mg ml infusion solution following refrigerated storage Ecancermedicalscience 2010 4 202 2 Thiesen J Kramer 1 Physico chemical stability of docetaxel premix solution and docetaxel infusion solutions in PVC bags and polyolefine containers Pharm World Sci 1999 Jun 21 3 137 41 87424 6 20mg 2mL bp
24. 551mg 2207mg 95 191 1mg 95 2 764 4mg 80 a 1 1 1 60mg m 1 75mg m 3 4 1 75mg m 1 1 70mg m 1 3 4
25. 827 7 ms 6 0120 982 001 OZ00 URL http www sandoz jp IDTX1408D 2 1 SA 2014 8
26. 15 30 1 Hart M Acott S Physical and chemical stability of Taxotere docetaxel one vial 20 mg ml infusion solution following refrigerated storage Ecancermedicalscience 2010 4 202 2 Thiesen J Kramer 1 Physico chemical stability of docetaxel premix solution and docetaxel infusion solutions in PVC bags and polyolefine containers Pharm World Scl 1999 Jun 21 3 137 41 0120 982 001 FAX 03 5469 0366 827 7 2014 8 URL http 7 Www Sandoz jp DTX1408E 2 1 DA
27. 9 180mg 720mg I 335mg 1580mg 5 10mg mL 20mg mL 10mg mL 2 8mg 32m8 80 80 2 300 1296mg 300 5184mg 80 054g 80 2168 80 160mg 80 640mg 0 395g 1 58g
28. EE 2 0 10 1 10 14 Il 1 15 1 100mg m2 2 1 16 SIADH 16mg 8mg1 2 SIAD
29. 3 100mg m 3 818 9mg m 489 7mg m 3kg 10 1 N W 7 4 ONCO SAFE sv 5 Onco Safe SV
30. 75mg m 1 75mg m 1 1 70mg m 1 3 4 70mg m2 5mg m2 lt 1 1 75mg m 1 5 3 HHHI 2 000 mm3 0 80 80
31. 56mazsmL Drug Informationn 2 2mL 8mL 2 2mL 4 0mg 2mL 80mg 8mL Omg 2m 2012 12 Docetaxel Intravenous Infusion 20mg 2mL 80mg 8mL SANDOZ gt 80mg 8mL 2012 12 Docetaxel 2 22400AMX01189000 Dose Limiting Factor DLF
32. _ a oo ee ee ee ee lt Z2 ONCO SAFE 20mg 2mL 80mg 8mL 20mg 80mg 20mg 1mL 80mg 4mL
33. 20mg 1mL 80mg 4mL 11 2 5 3 12 Stevens Johnson Lyell Stevens Johnson Lyell Se A NA A a 2 1 1
34. DEHP 2 PVC PVC 2 5 PVC 2 4 PVC
35. 4 a 5 10 5 3 6 7 DIC DIC FDP 8
36. PVC DEHP 59 59 4 5 2 25 4 4 25 C 1 4
37. 3 2 1 4 1 10 1 4 ey 5 1
38. 350 400mg m 4 000 mm 2 000 mm 100 000 mm 8 0g dL 5 1 5 1 5mg dL 1 5 1 5mg dL 60mL min PO gt 60Torr 0 2 000 mm
39. 80 pH 1 8 0mg 5 oe a 300 1296 0mg 1 3 7 7 ale 20mg 2mL 20mg 80 160 0mg 2mL a ON 3 0 4 0 2 A 32 Omg 10y v 5 300 5184 0mg 2 2 80mg 8mL 80mg 80 640 0mg 8mL 2207 2mg 1 20mg 2mL 2650mL 2 80mg 8mL 250mL 1 1 60mg m2 1 3
40. EE NE RO AST GOT ALT GPT Al P LDH y GTP 1 2 25 2 60 5 2 20mg 2mL 80mg 8mL 2 3 I 20mg 2mL a 5 PR 0120 982 001 80mg 8mLI 9 00 17 00 lt URL http www sandoz jp SG SANDOZ a Novartis company 2014 5 4 2014 1
41. 2014 8 2 SANDOZ 2014 3 a Novartis company 20mg 2mL 80mg 8mL Docetaxel Intravenous Infusion 20mg 2mL 80mg 8mL SANDOZ gt 250mL 500mL 5 0 3 0 74mg mL
42. 4 1 75mg m 1 1 70mg m lt 1 3 4 1 75mg m 1 1 70mg m2 1 3 4 oo 0 2 1 1 75mg m lt 2 1 3
43. NM i UN 3 MDS FN 4 CHO K1 5 35mg m2 1 1 1 35mg m2 1 8 15 4 TI 48
44. H 3 17 Radiation Recall 100mg m2 3 2 818 9mg m2 489 7mg m2
45. L 80mg 4mL 2 5 3 4 2 1 1 2 1 100mg m 16mg 8mg 1 2
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