薩溫珂®凍晶注射劑100毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

Siltuximab

可用日期:

臺灣百濟神州有限公司 臺北市信義區松仁路97號4樓 (82911456)

ATC代码:

L04AC11

药物剂型:

凍晶注射劑

组成:

Siltuximab (9200081300) (Nominal amount 100mg/vial)MG

每包单位数:

玻璃小瓶裝;;盒裝

类:

菌　疫

处方类型:

限由醫師使用

厂商:

JANSSEN BIOLOGICS B.V. EINSTEINWEG 101, 2333 CB LEIDEN, THE NETHERLANDS NL

治疗领域:

siltuximab

疗效迹象:

適用於治療人類免疫不全病毒(HIV)陰性及人類皰疹病毒-8(HHV-8)陰性的多發性Castleman氏病(Multicentric Castleman's Disease(MCD))患者。

產品總結:

有效日期: 2025/09/10; 英文品名: Sylvant® Powder for Concentrate for Solution for Infusion 100mg

授权日期:

2015-09-10

资料单张

PLEASE NOTE:
WHILST ARK PHARMA GRAPHICS WILL MAKE EVERY EFFORT
TO ENSURE THE ACCURACY OF TEXT AND BARCODES ARE
CAPTURED, IT IS THE ULTIMATE RESPONSIBILITY OF THE
CUSTOMER’S REGULATORY DEPARTMENT AND PRODUCTION
SITES TO ENSURE THAT TEXT (INCLUDING BRAILLE) AND
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EUSAPHARMA
JOB NO.:
PROOF NO.:
ARTWORK APPROVAL SIGNATURE BOX
PROOFREADER
SITE PACKAGING
REGULATORY
MARKET AFFILIATE
TEXT SIZES
Smallest Text
7 pt
Line Spacing
7.2 pt
Product Name
Market
Component
No. of Colours
Profile
Dimensions
Barcode
Pharmacode
SAP Code
Job No.
Asset No.
Packaging
Supplier
Originated on
Originated by
Originated at
Amended by
Date completed
Reason for Update
& CCR Number
ARK
PHARMA GRAPHICS
LEA/SYL/TW/
1216
P3/M3
Sylvant
Taiwan
Leaflet
2 (Two)
TBC
808 x 297 mm
N/A
TBC
N/A
LEA/SYL/TW/1216/01
285
TBC
20/05/2021
Operator 001/004
ARK
Operator 001/004
25/08/2021
Updates to Text
Bar prints 100mm @ 100%
FONTS USED
Helvetica
PMS 485
®
SYLVANT
® POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
100
000984
400
000985
1
SYLVANT
®
(HIV)
-8
(HHV-8)
Castleman
(Multicentric Castleman’s
disease(MCD))
HIV
HHV-8
MCD
SYLVANT
®
SYLVANT
®
IL-6
2
2.1
3
1
SYLVANT
®
11
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12
SYLVANT
®
3
1
SYLVANT
®
®
值
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LEA/SYL/TW/1216/01
LEA/SYL/TW/1216/01
a
≥
≥
≥
≥
SYLVANT
®
+BSC
A
N=53
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≥
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值
15 (28%)
15 (28%)
2 (4%)
2 (4%)
2 (4%)
2 (4%)
4 (8%)
14 (26%)
5 (9%)
14 (26%)
4 (8%)
4 (8%)
2 (4%)
6 (11%)
4 (8%)
4 (8%)
4 (8%)
10 (19%)
2 (4%)
1 (2%)
0
0
0
0
0
2 (4%)
1 (2%)
2 (4%)
4 (8%)
0
0
0
1 (2%)
0
0
0
1 (2%)
1 (2%)
b
3 (12%)
2 (8%)
0
0
0
0
1 (4%)
4 (15%)
1 (4%)
7 (2