アボネックス筋注30μgペン（PDF File 3400KB）
Contents
1. In2. 63 2 IF IF 10 9 3 IF 10 20 9 TIF 2008 IF 2008
3. y 12 18 IV AVX JAP 07_21 VI 2 VE VE B PA Th1 12 19 18 TET Th1 IE Thl 1b 1 1 x as ER
4. 3 V 4 IV ip re 5 1 BE 2 T 3 cr eee ee
5. L ji Y E DIAS Fal LEA Es BRO VAR ALES 38 Er m ia ESE FISD
6. BS gt V 1 lt gt lt gt 25 Bil 2 la 1 30zg
7. 51 2 IFNp 1a 30ug 6 MIU RRA AT 3 ww TEN 8 1a 0 59 59 0 9 52 X 1 All 30g 1a
8. 37 3
9. 2 FAR 1 2 1 OKERREI Stevens Johnson
10. 1 2 la tt E 2
11. E 12 2 30 g 1 1 1 30g PC PE ABS
12. EAE TIERA ERRERA 383 18 50 14 MRI 3 3 IFN 8 1a 30wg 1 3 CDMS
13. 2013 4 1 1 1 2 2 Il 1 3 2 RZ 3 3 rororo ee 3 A 4 5 BR cr ee 4 6 EAZ HZ KE PBB cocooan e 4 7 GAS GRRE ee 4 Il 1 8 ee ee ee a ee ee 5 2 5 3 oo 5 ma 5 IV 1 BURG ee 6 2 6 3 e e e o a 7 4
14. AST GOT ALT GPT y GTP 1 3 1 1 2 REA
15. 28 1 2 RZ 3 EEO 9 OR MILA REO D DREIZ ORTE 6 BS 4 5 6 7 8
16. 3 1 OS 5 5 ERIS TEN MB AD EER ZENA A fi BA ake roe PER IEE FAI NOM NN 3 aS
17. Bis 10 1 2 11 12 13 5 1 1 60 g 46 a OK EDS amp Al LE 14 1
18. 45 gt 30 EX 1 HE BL KCL T CA 15 D CHB amp ALE 3m gt 1 Fe SAN 5 cm DAHA tHE PFO 2 DE
19. 30 7 g 1b 2011 4 12 2013 12 4 22500AMX01909000 2014 5 30 54 10 2006 7 H 26 2016 7 25 SS z KOROA HOT 13
20. 10 1 15 210 nena pee NE ON came Nts
21. 1 1 EE 30 7 8 9 10 12 La FIN E 1 2 3 4 5 6 er er Ww F nk
22. 11 12 6 1 gt BSE 8 TSE REDQM
23. SHA Ball GF taj EERS KUT meer 1 ee Lita OFFA A 1
24. 30 u g 25 25 100 20 80 11 44 a 4 4 4 ALT GPT 4 7 28 4 4 2 8 2 8 2 8 Eit 1 4 1 4 1 4 3 12 2 8 2 8 1 4 ARTE 4 2 8 ex 1 4 252 1 4 1 4 Re 4 4 1 4 H 4 earns 3 12 a ENE 4 1 2 1 2
25. 2 IFNg la 30u g XIF 60 u g 1 3 4 IFNg la 30ug 60g ao 802 Poser 18 55 ink 3 2 EDSS 2 0 5 5 3 3 IFN
26. 7 _ orn _ OIFNB la 30g 1 ae 2 EDSS 1 0 6 AM MRI Gd Gd Kaplan Meier ai un A 2 MO ix ZTR Y A Ek
27. TSE TSE 237 2
28. 3 6 9 12 124 BOWPRTERUR T hb ae ve 25 2C 6 a 60 5 RH D ORAM soe cee Lie het Ate 25 2 en ame lemme sie Lahr hh ede 18 seaman TO a 204W hr m 1 2 x3 x4 x5 2006 7 PETG PE 400 750 nm UV 320 400 nm CPE
29. IFNB la 30u g XI 60 ug 1 3 4 EDSS SE 1 0 EDSS 5 0 0 5 MRI Gd CN Sm cece V IFNB la 30ug 60ug ny Z ae 5 Clanet M et al siey 2 1a 1 Neurology 59 1507 2002
30. mae R C Fa SBE SIVA FE F 749 F 2 12 12 TV AVX JAP 07_21 2
31. 100 100 100 100 169 16 100 7 7 100 13 13 100 10 10 100 E DA F H FED 92 46 50 90 H 2
32. IFN8 la 30ug SH 1 8 TL R01 NS26321 01A1 10 E E a 1 IFN8 la 7 5 90 ug 30u g pie ety tg l Ronen 5 CDMS we 18 45 ink bere 1 3
33. 9 INF8 1a U mL 40 5 n 87 PRE 30 204 EDN SAS 0 T ji T T T T 0 12 24 36 48 60 72 84 96 108 120 132 144 156 168 wg Trah Cmax IU mL AUCor6a IU hr mL 60 87 13 0 71 4 2 006 9 2 MG ug L 2 500 7 n 92 2 000 1 500 5 Be M G 1000 500 4 0 T T T T T T T 0 24 48 72 96 120 144 168 9 Tmax hr Emax ug L EAucoegy 2 ug hr L 60 92 47 61 860 72 230 1 2z MG 2 ANOVA 1a 1 30pg
34. EDI ALT GPT 2 24 1 43 OH LEGER MIRRA 30 g 351 9 347 98 9 1 452 172 49 0 84 23 9 80 22 8 69 19 7 RR 65 18 5 26 74 16 46 204 58 1 63 17 9 48 13 7 30 8 5 16 4 6 49 14 0 48 13 7 28 8 0 15 4 3 82 23 4
35. 42 30 u g 2 24 8 4 25 16 3 25 12 2 25 8 1 24 4 3 25 12 1 25 4 BUN 2 25 8 1 25 4 K 1 24 4 2 22 9 re ALT GPT 2 24 8 LDH 1 24 4 1 25 4 5 19 26 BEHET 2 22 9 2 24 8 1 1
36. FA Th TARR E GAX
37. 50 EXE T IFNB la IFNB la 30g 6 MIU IFNB la 30ug 6 MIU ERUF Fy PEIRA Clr 196 196 g kg 70 90ug kg 2 6 10 14 2 9 7 50g kg 10 MIU kg 1 6 50 g kg DEM 6 lt THE HEK 2 BEED CD40 CD154 20mg kg 5mg kg 20mg kg
38. 3 IF TF 2013 PDF ITF TIF IF MR IF IF
39. la RAOR Tu 47 16 48 K JERRARD AE 1 1 V 2 3 1 IFN 8 1a 33 3 u g kg 10 MIU kg
40. yz E 100 100 w z4 ait Xe F 50 HEE 50 H aul lt BR Mm wo EDSS 2 0 371 12 1 540 75 9 EDSS 2 12 1 531 24 48 72 104 EDSS 0 11 0 935 0 27 0 889 0 28 0 991 0 34 0 958 TV RF 2 ERO Kaplan Meier 0 04
41. 33g g kg 100 3 4 1a natalizumab a4 1477 FERK 2 PML 2 natalizumab 1a 30zg 2 PML 30 1 32 1 33 5 la 1 4 1 4 30g W
42. 2 2 MHC 1 7 vitro IFN8 la IFN8 1b A549 MHC 1 A549 ED IFN 2 MHC I FACS 6 IFN 8 1a IFNg 1b MHC 1 IFNg A549 MHC 1 250 5 om IFNB la o o IFN B 1b 200 4 150 1007 50 0 T T T T 1 10 100 1 000 5 000 pg mL IFN8 CPE jn vitro IFNB la IFNB lb CPE A549 IFN8 15 20 30
43. gt 1 2 DROE lt gt 1 2 la 3 1 2009 4 2 25 IFN8 1a30rg 1 24 12 8 4 0 12 16 20 24 4 MR
44. 2 MRI D 7 Lies 3 D D 4 30 g 5 25 25 100 20 80 11 44 7 28 30 u g 2 351 347 99 204 58 Tv 7 VEU PA 172 49 103 29 84 24
45. WHO 2009 5 10 11 12 13 14 1 8 la 0 la 30p g
46. zU Ax AE 4 RE 7 8 9 ne a LC MERI 1 BRO 2 a 10
47. pl 7 3 8 5 1a n a NR 70 10C eee 36 5 3C 6 3 SDS PAGE 4 A A I CPE 278nm 320nm 380nm 10 OOOIU IV 1 1 1 2 307g 0 5mL 1 3 WEH
48. gt 1 2 23 4 5 6 25 IFN 8 la 30ug 6 MIU 1 T 34 53h 12 hr L ry Eraz 24 24 24 48 8 64nmol L Ewe je 593 O9nmol nmol L 1479 n 25 13 124 To tid Fo 2 a 84
49. IP IF O 2013 IF 2013 IF PDF IF IF 2013 25 10 TIF 2013 i OO ND i ey i
50. OSN 5 6 EHH ners LA hy 8 B
51. Fria UMH 1 11 Bl j a x S DS E D
52. 2 er 3 rl 1 ITV aAUA FFE HEROS 4 chs an aes hese eat ss 5 6 34 7
53. 2006 2006 9 VT ARTE 30ug Jz o 30gg 1 30gg 2012 7 2013 12 2 1 INB la IFN 1 7
54. 2 8 2012 3 W JE 96 5 7 996 5 MS i A 2003 5 28 2003 8 14 ea a at HRS MS MS ee ee MS 2000 6 6 5 x 3 MR
55. 2 1 2 16mm 3 4 3 15 1 1 la 5 1
56. orooro 30 4 rororo 30 5 BBRSARLZOMH e 30 6 32 7 35 8 37 9 46 10 46 11 46 12 ee 46 13 46 14 47 15 47 16 48 IX 1 49 2 eooo 50 X 1 53 2 53 3 RRS RPP a a a a a e A a a B i e eoi a a 53 4 53 5 FERRE 53 6 54 7 BEBO An RE wa e e a a e a D a a G o T 54 8 n ia E E e EE E a a E EN E e e A 54 QO 54 10
57. 48 MRI Gd Gd T T Kaplan Meier CDMS IFNg la 0 56 2 38 6 IFN8 1a 21 1 MRI Gd Gd IFN la T T RLU IFNg la 15 C
58. fF AVONEX Jacobs 1988 F IFN 8 la E 1996 5 EU Hi 2002 4 IFN 8 1b Biogen Idec 1997 3 L E5 EU 2003 2003 6 7 2005 7 30g Biogen Idec 1999
59. 1 2 3 A 29
60. 196 u g kg 39 15 MIU kg u g kg 10 30 50 18 MIU kg 90 u g kg 1 4 4 2 6 wa BERERE 4 IFN B la30ug 6MIU IFNB la 60ug 12 MIU 1 6 BED MEMES 2 13 2 1
61. 2 2 3 4 1 2 8 2 2 8 5 1 3 E 53 7
62. 33 3 u g kg 6 4 2 21 49 a 0 25 10 MIU kg 1 5 HSA 33 3 g kg 1 2 4 1
63. CAS ROXRE LT KAIORE IC EV RI KEIR 5 zU 1 JEL CHIME ob 1 HOA VRAD x J E EX 31
64. 2 1 1la JAN 2 Interferon Beta 1a Genetical Recombination JAN 3 AFA 3 166 31 141 80 N 1a N Met Ser Tyr Asn Leu Leu Gly Phe Leu GIn Arg Ser Ser Asn Phe GIn Cys GIn Lys Leu Leu Trp Gln Leu Asn Gly Arg Leu Glu Tyr Cys Leu Lys Asp Arg Met Asn Phe Asp Ile Pro Glu Glu Ie Lys Gln Leu GlIn GIn Phe Gln Lys Glu Asp Ala Ala Leu Thr Ile Tyr Glu Met Leu GIn Asn Ile Phe A la Ile Phe Arg Gln Asp Ser Ser Ser Thr Gly Trp Asn Glu Thr Ile Val Glu Asn Leu Leu Ala Asn Val Tyr His Gln Ie Asn His Leu Lys Thr Val Leu Glu Glu Lys Leu Glu Lys Glu Asp Phe Thr Arg Gly Lys Leu Met Ser Ser Leu His Leu Lys Arg Tyr Tyr Gly Arg Ile Leu His Tyr Leu Lys Ala Lys Glu Tyr Ser His Cys Ala Trp Thr Ile Val Arg Val Glu Ie Leu Arg Asn Phe Tyr Phe Ile Asn Arg Leu 60 Thr
65. CPE IFN 8 1a IFNB 1b 217 OMIU mg 9 7MIU mg TIEFN 8 la IFN 8 1b 22 IFNB MIU mD zg mL MIU mg IFN8 1a 6 5 30 217 IFNB 1b 29 300 97 X 9 mL IFN IFNg 1a ELISA 20 Daudi in vitro IFNB la IFNB 1b Daudi B Daudi IFN 8 2 UF LV 1Ci 6 IFN 8 1a IFN 8 1b IC 35 4pg mL 7 08IU mL 357 4pg mL 71 48IU mL GH IFNB la IFNB 1b 10 Daudi
66. 7 1 2 2 P450 2C9 2C19 35 PITEN
67. 2008 4 TF IF 2013 2 IF IF H
68. 20mg kg TFN 8 la 26 52 CTR SAVES Enis 163 A kh pie 7 Te 0 0 60wg 12 MIU 3 T1FN la 0 825 33 3 u g kg 0 25 10 MIU kg 1 5 HSA PBS 3 8 15 6
69. ZIE BOE y C TE 1 44 40 5 5
70. 1981 Jacobs IFN 8 F IFN 1993 IFN 8 1a TI 1990 4 IFN 8 la 1 1998 2000 4 L
71. 54 11 54 12 54 13 55 14 rororo 55 15 55 16 55 17 55 XI X 1 56 2 57 XI 1 e a a a a a O O O O O O E O O E O O 58 2 r O O O 0 61 XM 63 I 1 la IFN B IFNB
72. IF IF IF D A4 9 IF IF 2 IF IF IF
73. Sey 15 1 2 3 we 4 5 5 1 2 CYP450 gt IFN B 1a 1 25 u g kg 0 25 MIU kg 50 u g kg 10 MIU kg 13 CYP450 CYP1A1 CYP1A2 CYP2B CYP2E CYP3A CYP4A CYP450 B TFN 8 1a 26 3 4 5 6 1 2
74. Ten ZS y JE GEIR fii SRG TLE KE 8 RER KELK R TF OR a HD SB dS k U it B HE Ath BANK AE K 3 MEJE RO bee a FG 2 41 1 2 4 4 2
75. 8 9 22 1 12 10 22 1 12 M 5 E
76. Th1 metalloproteinase 9 MMP 9 4 Thi 9 oO 4 Th1 E IFNy MHC II ICS IF TNF LASHER 19 VCAM 1 Thl 1 0 HIR B TIF 8 IL 10 BBB matrix E Th1 BBB IFNy TF Thl Th1 16 22 23 IFN 8
77. j IFNB OF CD4TT helper type 1 Th1 blood brain barrier BBB E Thl MHC A Il IL 12 Th1 B MEC II IL 12 Th1 BBB 19 19 20 Th1 antigen 4 VLA 4 Thl 1 vascular cell adhesion TIFN Thi very late molecule 1 VCAM 1 IFN VLA 4
78. 2015 6 2 876399 IF 2013 1a ss3oue AVONEX IM Injection 1a UE RFE ERS 1 0 5mL 1a H a E 30g 1a JAN o Interferon Beta 1a Genetical Recombination JAN 2013 12 4 2014 5 30 Tt 2014 6
79. OMERRE 39 HUS Wr Y po TIED
80. ena 1230857010101 6399422G2023 622308501 30ug XI X 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 Jacobs L D et al N Engl J Med 343 898 2000 Sorensen P S et al Lancet 362 1184 2003 Rudick R A et al Neurology 50 1266 1998 Durelli L et al Lancet 359 1453 2002 Clanet M et al Neurology 59 1507 2002 Saida T et al Mult Scler 18 1782 2012 Jacobs L D et al Ann Neurol 39 285 1996 R01 NS26321 01A1 Rudick R A et al Neurology 49 358 1997 ESKER IPA AR NS26321 a a iat I C95 812 IV AVX JAP 07_21 64 1297 2006 Martinez A et al BMC Neurology 5 19 2005 Sospedra M et al Annu Rev Immunol 23 683 2005 A ASHIK 61 1367 2003 Barna B P et al J Neuroimmunol 23 45 1989 McRae B L et al J Immunol 160 4298 1998 Calabresi P A et al Neurology 49 1111 1997 Stuve
81. ug 1 2 gt D _ ja REPEAL TEAR HS RRL 301 Poser EZR 18 55 3 2 EDSS 1 0 3 5 2 LL IFN 8 2
82. 0 90 1a 0 61 MRI Gd O Gd IFNg BL IFNB la al n 158 n 143 0 5 044 He po a 0 34 1T R 02 g 0 1 p 0 05 Mantel Cox Log rank 0 0 T T T T T T T 0 3 6 9 12 15 18 21 24 Gd 1 2 132 141 123 134 82 83 2 32 3 17 1 59 1 04 1 65 080 037 062 031 028 048 022 pie 0 821 0 024 0 051 ee 1 0 23 1 0 56 oro 22 olo zg olo 34 olo is Mann Whitney IFN la
83. P450 1A2 P450 y HFFR gt P450 2C9 2C19 lt fe gt E Hfi lt 7IL7IF Y ONE gt
84. 1996 5 1997 3 EU 1a 2012 7 39 gt 1la 1 30g gt 1
85. P450 1A2 1 P450 1A2 1 1 8 1 gt 25 25 100 20 Bil 80 11 44 7 Pil 28 30u g Bill gt lt 2 351 347 99 204 58 172 Bil 49 103 29 84 24 IE 80 23 30 u g 1 2
86. lt gt 36 E yu E AMAA Hy E P450 H P450 1A2 LE AF 1 H H
87. 158 158 100 143 141 99 TIFNp la 106 67 96 61 87 55 53 34 HE 49 31 6 49 31 p lt 0 001 p lt 0 001 37 2396 p 0 017 BE 33 219 p 0 001 Fisher 7 Jacobs L D et al Ann Neurol 39 285 1996 as 9 Rud ick R A et al Neurology 49 358 1997 10 1 NS26321
88. 2 1 Od AR 82 23 69 Bil 20 O RARE REINA BML BERS V 10 000 uL
89. IF IF IF T Ee r IF
90. Ea 28 8 0 9 2 6 SERR 103 29 3 31 8 8 55 15 7 9 26 13 3 7 14 4 0 15 4 3 28 8 0 Seal 22 6 3 18 5 1 12 3 4 296 44 5 6 oe AIS IDD DR OBEE DEED b 5 BE
91. IFNg 100 5 90 4 804 704 604 50 40 4 Kakaa oO 304 204 104 0 om IFNB la o o IFNB 1b 10 100 1 000 pg mL FNC RE ICso pg mL IFN 1a 35 4 IFNB 1b 357 4 IFNg 1a 5g 1 0MIU 5pg 1 0IU ICso 50 3 2 VI 1 IFNB la 3 CPE YE Lr IFN 8 MG Ha IX xa 1 2 gt
92. 50 Bl 26 REIER 48 25 I 42 22 p lt 0 001 32 179 p 0 001 32 Bil 17 p 0 001 39 Pil 20 p 0 024 Fisher 1 Jacobs L D et al N Engl J Med 343 898 2000 11 C95 812 3 4 16 6 1 lt gt 2 Tu MS 2
93. IFN 8 la 4 2 IFN8 1a 5g kg 1 MIU 13 5 g kg HCA IFN8 1a 50 u g kg 10 MIU kg 1 50r g kg 4 A 1 j 4 49 2 SHERR 1 2 196 u g kg E
94. 3 7 8 e VWI 1 TSE 1 6 1
95. 4 Tel 0120 560 086 9 00 5 00 www biogen co j IF 2015 6 http www pmda go jp act TW 3 IF 1
96. 80 23 82 23 69 20 30 u g TSI uy 2 IT 1 1 30zg 2 Avonex IM Injection Pen 3
97. 2 eee ee Sap 4 IFNB la 7 5 15 30 47 5 bie 1 ete Ys 14 2 16 SNARARE EO 30ug 75 1 meen L 8 MG 15 g MG 15 g 30gg 30 g 8 MG 4 3 8 TL R01 NS26321 01A1 11
98. 92 IFNB la 60ug 12 MIU XO Ty tk 18hr TE 30 u g 60 g 3 gt 92 IFNB 1a 60ug 12 MIU MG T 13 0hr C 71 4IU mL AUC jaa 2 006 9IU hr mL 8 MG T 47 61hr E 860 u g L Epe 0i 72 230 ugthr L 1a 1 30g H gt I lt 1 2
99. E 7 64 5 T T T T T T T 24 48 96 168 Tmax hr Emax nmol L EAucoes nmol hr L 34 53 11 71 8 64 3 15 593 09 401 90 615 86 26 75 8 80 625 98 21 00 53 75 0 40 16 40 996 11 1 251 50 1 Emax Eauc 2 1 Eauc Eauc 996 11 ch ast VI UE E n 25 7 24 J 2 1 2 3 4 5 lt B gt 26 0 17 L kg hr 3 Bil 5ug kg 1 0 MIU
100. 7 5 7 6 r ororau anaa 7 7 7 8 ooa aaae 7 9 o e 8 10 a kee Sek s ace eae ee ns 8 11 Hiie e 8 12 e e o a 8 13 8 V 3 1 2 3 PHBE MILA E e e 9 roro 9 BERRA t oroo 9 VI 1 2 ooo 19 19 VI 1 oon 22 2 25 3 25 4 DHr ooo 26 5 HB a a a 26 6 PER e rosorna 27 7 27 8 AMZ See a ee DE A lt 27 Vi 1 0 e 28 2 ro 29 3
101. IF PDF e IF e IF De IF http www pmda go jp e IF e IF IF
102. kg ook 6 lt B gt 26 0 16 L kg 3 Bil 5ug kg 1 0 MIU kg 7 3 lt gt n 6 IFNB la 30zg 6 MIU IFN 8 la T 1 9hr C 1 950 IU mL AUC 14 398 IU hr mL 25 10 MI HERI En 2 IFNg 1a 1 25g kg 0 25 MIU kg 50k g kg U kg 13 4 IFN 8 1a 1 25 g kg 20 160 IU mL 50 u g kg 3 200 6 400 IU mL 15 IFN B 1a IFN 1a 29 42 4
103. vitro 33 9 Ele WE
104. 0 et al Ann Neurol 40 853 1996 Byrnes A A et al Ann Neurol 51 165 2002 Jacobs L et al Arch Neurol 44 589 1987 Panitch H S et al Drugs 44 946 1992 CAB IC 15 1 C 852 P9317 94 03 P9418 01 01 P9418 94 02 P9318 94 08 88 1992 Rudick R A et al N Engl J Med 354 911 2006 Kleinschmidt DeMasters B K et al N Engl J Med 353 369 2005 Langer Gould A et al N Engl J Med 353 375 2005 Matson M A et al Curr Med Res Opin 27 2271 2011 P9216 93 03 py pt rr LT rT ic H F gt TH 56 36 P9015 91 08 2 37 Xl 1 la 1988 12
105. DMS 1 05 09 n 193 n 190 98 4 056 0 7 Cox C D 06 M S 054 _ 2 044 2 03 7 0 2 4 o1 00 1 1 1 3 0 3 6 9 2 15 18 21 24 27 30 33 36 Gd wae 6 12 18 179 183 152 165 124 147 114 134 06 07 1 49 0 87 1 63 073 1 36 0 45 1 39 1 29 0 25 0 18 0 34 0 17 0 34 0 13 pig NS 0 034 0 019 lt 0 001 0 0 0 0 0 0 0 0 0 12 0 7 o 23 o 16 0 27 0 20 o 33 0 13 1 2 Mann Whitney IFN8 la 193 189 98 190 182 96 TIFN8 la 98 51 76 39 51 269 50 26
106. Gly Tyr Leu Arg Asn166 C Asn Cys 4 CoogH1408N246025257 25 300 5 Glycoprotein containing 166 amino acid residues produced from Chinese Hamster Ovary CHO cells by expressing the gene for human interferon beta derived from human leukocyte strain K 562 HAY 6 IFNB la 7 CAS 145258 61 3 K 562 CHO 166 JED BTR OER VNTR I 1 1 pH 7 1 7 4 2 3 4 5 6 7 X A 2
107. I ae MS CDMS MS B E E MS H MRI CD SPMS H 12 SPMS C 1998 4 6 1998 5 pea ue eee NY MS cutee SOMBER amp MS RI CD NG SPMS 1 12 RN SPMS D 1998 9 28 1999 2 we S
108. I Gd 23 Bil 5 9 2 8 p 0 0012 EK IFNB 1a 23 23 5 9470 28472 2 5 0 5 278 0 3 0 0 32 3 70 3 0 0012 4 83 3 100 63 1 lt 0 0001 1 2 12 8 4 0 4 3 12 16 20 24 4 4 Wilcoxon 5 6 Saida T et al Mult Scler 18 1782 2012 3 gt 5 Pil IFN 1a 7 5 15 30 47 5 90 u g 1 14 2 16 30 g 75 1
109. ZR HRA 4 30ug ONY AY TE Aa 2 pH pH 1 pH 4 5 5 1 2 1 3 HE EE RER pH 3 2 1 1 0 5mL 1la 30g 2 1 0 5mL 0 79mg 0 25mg L 15 8mg 20 0 025mg 3 4 5
110. ies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans but potential benefits may warrant use of the drug in pregnant women despite potential risks An Australian categorisation of risk of drug use in pregnancy D Drugs which have caused are suspected to have caused or may be expected to cause an increased incidence of human fetal malformations or irreversible damage These drugs may also have adverse pharmacological effects Accompanying texts should be consulted for further details 61 2 SPC LE lt Safety and effectiveness in pediatric patients 2013 3 A have not been established Paediatric population The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established Currently available data are described in secti
111. on 4 8 and 5 1 but no SPC g recommendation on a posology can be made 2012 8 H The safety and efficacy of AVONEX in children below 12 years of age have not yet been established No data are available 62 Xl 63 eres 6t9 0120 560 086 9 00 5 00 i www biogen co jp 7103 0027 4 1 AVP004MD1506
112. pre filled pen 2011 9 14 Avonex 30mcg 0 5ml solution for injection in pre filled pen 60 2 1 FDA FDA 1 2 FDA Pregnancy Category C 2013 3 A An Australian categorisation of D 2012 4 risk of drug use in pregnancy FDA Pregnancy Category C Animal reproduction stud
113. wv 2004 4 21 Ax 9 Y NN ERG MS MS MRI CDMS 1997 10 24 SR CG 2005 5 19 Ax 69 A 2 B 64 C 1 D 1 1 59 2012 3 2012 2 27 Avonex Pen EU 2011 6 Avonex 30mcg 0 5ml solution for injection in pre filled pen 2011 4 12 Avonex Pen 2011 11 18 Avonex Pen 2011 11 9 Avonex Pen 2011 11 15 Avonex Pen 2011 9 26 Avonex 30mcg 0 5ml solution for injection in
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