華利希納注射劑

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:

THESIT(POLIDOCANOL)

可用日期:

台灣大昌華嘉股份有限公司 台北市內湖區堤頂大道二段407巷20弄1、3、5、7號10樓及22、24、26號10樓及22號10樓之1 (70824858)

药物剂型:

無菌注射加壓組合產品(最終滅菌)

组成:

主成分 () ; THESIT(POLIDOCANOL) (8408000800) MG/ML

每包单位数:

雙罐組合包與投藥套組以1:1及1:3包裝

类:

製　劑

处方类型:

限由醫師使用

厂商:

BIOCOMPATIBLES UK LIMITED CHAPMAN HOUSE, FARNHAM BUSINESS PARK, WEYDON LANE, FARNHAM, SURREY, GU9 8QL, UNITED KINGDOM. GB

疗效迹象:

治療大隱靜脈、副隱靜脈的閉鎖不全，以及在膝蓋上下方大穩靜脈系統肉眼可見之靜脈曲張。VARITHENA可改善淺靜脈閉鎖不全的症狀以及改善靜脈曲張的外觀。

產品總結:

註銷日期: 2021/12/17; 註銷理由: 自請註銷; 有效日期: 2023/08/23; 英文品名: Varithena (Polidocanol injectable foam)

授权状态:

已註銷

授权日期:

2018-08-23

资料单张

PAGE 1 OF 2
027413
1 (polidocanol
)
(GSV)
2
(varicosities)
5 mL
15 mL 1% GSV
氧
氧 polidocanol (
)
75
(tumescent anesthesia) (GSV 1 mL/sec
0.5 mL/sec
)
(SFJ) 3-5 cm
10
2
15 mL
2
15 ml
5
(
)
䗻
3
Polidocanol 180 mg/18 mL (10 mg/mL) 1%
polidocanol mL 1.3 mg polidocanol
4
•
polidocanol [
(5.1)]
•
•
5
5.1 (ANAPHYLAXIS) polidocanol
10
5.2
TIA
VARITHENA
·
氧
氧 䲘
patent foramen
ovale ; PFO
PFO
VARITHENA
VARITHENA
5.3 [
(6)]
(3
)
6
6.1
12
1333 GSVI
0.125% 0.5% 1.0% 2.0%
437 1%
3%
8 ( 1%
3% ) (
588
)
A 0.125% 0.5% 1.0% 2.0%
B
C (
) 80%
1333 (2.9%) (
DVT) (1.7%)
DVT (1.1%)
(isolated) (1.4%) <1%
(49%) D-dimer
值
值
D-dimer
值值
1333
4.0%
2.7%
䗻
1.1%
0.7%
7
8
8.1 C
8.2
8.3
8.4
8.5
㱢
8.6
9
均值
12
12.1
12.2
䗻
基
值
13
䗻
值
氧
氧
夠
矽
®
(POLIDOCANOL INJECTABLE FOAM)
(151
)
1.0%
(149
)
a
(437
)
14 (9.3)
0
9 (6.0)
5 (3.3)
5 (3.3)
0
2 (1.3)
0
25 (16.8)
24 (16.1)
23 (15.4)
18 (12.1)
16 (10.7)
12 (8.1)
8 (5.4)
7 (4.7)
65 (14.9)
46 (10.5)
38 (8.7)
32 (7.3)
30 (6.9)
24 (5.5)
40 (9.2)
10 (2.3)
10
O
O
O
O
O
O
O
O
O
OH
氫氫 ䷋
氫
氫
氫氧
氫氧 ䷋
氫氯
氫氯
值值
夠夠
䷒ 的氧
氧氧
氧氧 䲘
氮
氮
11
11.1
11.2
11.3
䆋
值
值
PMS 7467
Warm Gray
PMS 2955
Die Line
100% 95% 50%
5%
Product Name
Market
Component
No. of Colours
Profile
Dimensions
Point of Sale Code
Pharmacode
Change Control No.
Production Site No.
Production Site
Printer
Originated on
Originated by
Originated at
Proof Status
Amended by
Date Completed
TEXT SIZES
Main Body Text
12 pt
Line Spacing
14 pt
FONTS USED
Pro
Varithena
Taiwan
IFU
5 (Five)
N/A
472 x 900 mm
118 x 300 mm Folded
N/A
N/A
N/A
CN01200.1
BTG Farnham
CCL Ashford
28/09/2018
Operator 001/004
ARK
P8 / M8
Operator 001/004
19/11/2018
BTG Version 3 - November 2017
ARK PHARMA GRAPHICS LTD.
Crown House Business Centre,
Home Gardens,
Dartford, Kent, DA1 1DZ.
Tel [phone]
JOB NO.:
BAR PRINTS 100MM @ 100%
ARTWORK APPROVAL SIGNATURE BOX
PROOFREADER
BTG REGULATORY
BTG QUALITY ASSURANCE
CHANGE CONTROL NUMBER
BTG
CN01200.1
Black
PMS 032
PAGE 2 OF 2
值
值
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