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353 - pmda.go.jp

353.. 3. 6. 1 . 6. 294 .. 8. 10. pmda .. pmda .. 30 2018 .. 03 3595 2435 . 100 8916 1 2 2 03 5253 1111 2755 2754 2756. Fax 03 3508 4364. 353.. No.. 1 3.. 30 19 .. 2 6.. 3 294 8.. 4 30 10.. 1.. 60-70% .. 24 .. 3 2018 .. 30 11 37 25 . 3 .. 30 .. 29 .. 1.. 2018 4 .. 4 .. 10 .. 30 .. 29 .. _ 29 .. kg 30 50mg . kg mg .. 5 2018 . 2.. 30 19 .. 20mg 100mg MSD .. PD-L1 .. AST. GOT ALT. GPT -GTP A1-P .. AST. GOT ALT. GPT -GTP A1-P .. 11 26 30 .. 7,700 . 29 . 2018 6 .. No.. 200mg . 80 .. 14 ALP GTP .. 17 AST ALT ALP GTP .. 19 ERCP . endoscopic retrograde cholangiopancreatography . smooth . 20 . 24 .. 26 ALP GTP ERCP .. Class . ENBD . endoscopic nasobiliary drainage .. 31 IgE IgG4 . 35 500mg/ . 36 . CO2 . NPPV: noninvasive positive pressure ventilation .. COPD . Grade4 .. 14 17 20 24 26 31 35 . ALP U/L 1,693 2,545 1,640 3,712 3,880 4,716 3,619. -GTP U/L 603 934 672 1,370 1,378 1,099. AST U/L 17 201 405 53 313 112 149. ALT U/L 6 230 374 121 241 130 89.

医薬品・医療機器等安全性情報 No.353 -3- 2018年5月 厚生労働省医薬・生活衛生局 【情報の概要】 厚生労働大臣への副作用等報告は,医薬関係者の業務です。

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Transcription of 353 - pmda.go.jp

1 353.. 3. 6. 1 . 6. 294 .. 8. 10. pmda .. pmda .. 30 2018 .. 03 3595 2435 . 100 8916 1 2 2 03 5253 1111 2755 2754 2756. Fax 03 3508 4364. 353.. No.. 1 3.. 30 19 .. 2 6.. 3 294 8.. 4 30 10.. 1.. 60-70% .. 24 .. 3 2018 .. 30 11 37 25 . 3 .. 30 .. 29 .. 1.. 2018 4 .. 4 .. 10 .. 30 .. 29 .. _ 29 .. kg 30 50mg . kg mg .. 5 2018 . 2.. 30 19 .. 20mg 100mg MSD .. PD-L1 .. AST. GOT ALT. GPT -GTP A1-P .. AST. GOT ALT. GPT -GTP A1-P .. 11 26 30 .. 7,700 . 29 . 2018 6 .. No.. 200mg . 80 .. 14 ALP GTP .. 17 AST ALT ALP GTP .. 19 ERCP . endoscopic retrograde cholangiopancreatography . smooth . 20 . 24 .. 26 ALP GTP ERCP .. Class . ENBD . endoscopic nasobiliary drainage .. 31 IgE IgG4 . 35 500mg/ . 36 . CO2 . NPPV: noninvasive positive pressure ventilation .. COPD . Grade4 .. 14 17 20 24 26 31 35 . ALP U/L 1,693 2,545 1,640 3,712 3,880 4,716 3,619. -GTP U/L 603 934 672 1,370 1,378 1,099. AST U/L 17 201 405 53 313 112 149. ALT U/L 6 230 374 121 241 130 89.

2 T-Bil mg/dL D-Bil mg/dL WBC / L CRP mg/dL 31 . IgG4(TIA) mg/dl IgE (RIST) 22 IU/mL ANA 40 . PR3-ANCA U/ml MPO-ANCA U/ml M2 .. 7 2018 . 3.. 294 . 30 19 .. 25mg MSD . mg . 50mg 100mg .. mg . PML PML .. MRI .. 20mg 100mg MSD . AST. GOT ALT. GPT -GTP A1-P .. AST. GOT ALT. GPT -GTP A1-P .. 2018 8 .. 75 150 15% . 75mg 150mg EPD .. 9 2018 . 4.. 30 . 30 .. / . 30 23 .. 30 23 . 300mg .. 30 19 . mg . 30 18 . 100mg 150mg . 30 18 . mg . 30 18 . 30mg .. 30 18 . mg mg . 30 18 . 1,200mg . 30 18 . 10mg . 30 14 . 10mg 20mg . 30 23 . 250mg 1 .. 30 . 150mg 200mg .. 10mg 20mg 30 19 . 10mg 20mg 2 . 29 12 25 . 300mg . 2018 10 3. SBI 29 12 19 .. 29 12 15 . 25mg 125mg . 120mg 400mg . 29 12 13 . 200mg . 200mg .. MSD 29 12 . 625mg . EA 29 12 . mg 14 .. 250 500 1000 CSL 29 12 . 1500 2000 2500 . 3000.. 29 11 27 .. 29 11 27 . 10mg . 29 11 22 . 200mg . 29 11 22 . 100mg 400mg 18F . 29 11 10 .. 11 2018.


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