Example: marketing

BS KHK - pmda.go.jp

BS 100mg KHK BS 500mg KHK BS 100mg KHK BS 500mg KHK RMP BS 100mg KHK BS 500mg KHK 874291 30 1 Infusion reaction 4 12 13 B 4 13 5 Stevens-Johnson SJS Toxic Epidermal Necrolysis TEN 6 6 7 PML 7 8 8 9 10 10 RPLS 11 TLS 11 13 2.

(別紙様式) リツキシマブ. BS. 点滴静注100mg「KHK」 リツキシマブ. BS. 点滴静注500mg「KHK」 に係る医薬品リスク管理計画書(

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Advertisement

Transcription of BS KHK - pmda.go.jp

1 BS 100mg KHK BS 500mg KHK BS 100mg KHK BS 500mg KHK RMP BS 100mg KHK BS 500mg KHK 874291 30 1 Infusion reaction 4 12 13 B 4 13 5 Stevens-Johnson SJS Toxic Epidermal Necrolysis TEN 6 6 7 PML 7 8 8 9 10 10 RPLS 11 TLS 11 13 2.

2 14 CD20 B 14 3. CD20 B 15 4. 15 15 RMP 1 30 1 12 1 23 1 2017 9 27 2017 9 27 874291 22900 AMX00970000 22900 AMX00971000 2017 6 15 BS 100mg KHK BS 500mg KHK 1 10mL 100mg 1 50mL 500mg 1 CD20 B 1 375mg m2 1 8 1 1 1

3 375mg m2 8 12 CD20 B 1 375mg m2 1 8 2 1 375mg m2 1 4 2 5% 10 1 CD20 B 2 CD20 B 3 1 2 CD20 B 3 29 12 6 4 Infusion reaction Infusion reaction 24 III GP13-301 infusion reaction infusion reaction B HBs B HBV HBV HBV HBs HBs HBc HBV HBV de novo B de novo B HBs HBV de novo B CD20 B non-Hodgkin s lymphoma NHL

4 HBV HBs HBs HBc B HBV 5 B CD20 B I GP13-101 AST ALT 6 Stevens-Johnson SJS Toxic Epidermal Necrolysis TEN NHL SJS TEN

5 7 B PML NHL PML PML 8 PML 9

6 10 NHL 11 RPLS NHL RPLS RPLS

7 RPLS TLS TLS NHL CD20 B NHL TLS TLS TLS 12 TLS B 13

8 14 CD20 B infusion reaction B Stevens-Johnson SJS Toxic Epidermal Necrolysis TEN PML RPLS TLS CD20 B 5 2 300 infusion reaction 1% 95% 1 300 8 24 12 52 1 52 1.

9 Infusion reaction B Stevens-Johnson SJS Toxic Epidermal Necrolysis TEN 15 PML RPLS TLS 2 1 16.

10