“杏輝”杏止敏液

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)

资料单张 资料单张 (PIL)
26-03-2021
公众评估报告 公众评估报告 (PAR)
06-03-2021

有效成分:

CETIRIZINE DIHYDROCHLORIDE (EQ TO CETIRIZINE 2HCL )

可用日期:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84、84之4、84之6、84之7號、冬山鄉中山村新寮路95、95之1、100之7、100之13、100之15、100之16、103、136號 (42042734)

ATC代码:

R06AE07

药物剂型:

內服液劑

组成:

CETIRIZINE DIHYDROCHLORIDE (EQ TO CETIRIZINE 2HCL ) (0400005810) MG

每包单位数:

塑膠瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84號 TW

治疗领域:

cetirizine

疗效迹象:

季節性鼻炎、結膜炎、過敏性鼻炎、蕁麻疹、過敏性搔癢等過敏現象。

產品總結:

有效日期: 2028/08/28; 英文品名: Cetirizine Oral Solution“Sinphar”

授权日期:

2008-08-28

资料单张

                                PIC/S GMP
Cetirizine
Oral Solution
mL
Cetirizine dihydrochloride..................1.0mg
Sucrose
Sucralose
Methyl paraben
Propyl paraben
Sodium citrate
Cyclodextrin-beta
Alcohol
Flavor grape
Flavor banana
Water purified
3
6
10
3
6
5
2.5
hydroxyzine
piperazine
10 ml/min
Cetirizine 0.1% w/v
Cetirizine
0.5g/L
Cetirizine 0.1%
methyl Paraben
Propyl Paraben
2
cetirizine
pseudoephedrine
antipyrine
cimetidine
ketoconazole
erythromycin
azithromycin
theophylline
cetirizine
theophylline
400
16% cetirizine
theophylline
cetirizine
cimetidine
glipizide
diazepam antipyrine
pseudoephedrine
cetirizine
azithromycin
erythromycin
ketoconazole
theophylline
pseudoephedrine
cetirizine
macrolides
ketoconazole
ECG
ritonavir
cetirizine
600
ritonavir
10
cetirizine
cetirizine
40% ritonavir
-11%
cetirizine
cetirizine
Wash out period
Cetirizine
Cetirizine
Cetirizine
0.25
0.90
Cetirizine
10
Cetirizine
sleep latency
Cetirizine
Cetirizine
H
1
a)
10
Cetirizine
3200
Cetirizine
Cetirizine
1.0%
Cetirizine
Cetirizine
6
12
1%
b)
MedDRA
System Organ Class
1/10
1/100
1/10
1/1,000
1/100
1/10,000
1/1,000
1/10,000
Cetirizine
186
10
Cetirizine
Cetirizine
60
Cetirizine
QT-
(QT-interval
Cetirizine
Cetirizine
5
60
10
0.50 L/kg
10
Cetirizine
1.0 0.5
300 ng/mL
Cetirizine
93 0.3%
Cetirizine
warfarin
Cetirizine
(peak level
(AUC
Cetirizine
Cetirizine
Cetirizine
16
10
Cetirizine
50%
40%
Cetirizine
Cetirizine
6
12
6
Cetirizine
2
6
5
6
24
Cetirizine
3.1
40 mL/min
70%
7 mL/min
10
Cetirizine
70% Cetirizine
10
20
Cetirizine
50%
40%
Cetirizine
1.
2.
30
049628
G-10212
20
4000
8 4
SINPHAR PHARMACEUTICAL CO., LTD.
84, CHUNG SHAN ROAD, CHUNG SHAN VILLAGE, TUNG - SHAN SHINE, I - LAN,
TAIWAN
(0800)015151
website
h t t p
//www.sinphar.com
R
PIC/S GMP
IO-1680-03
a)
Cetirizine
Cetirizine
b)
Cetirizine
Cetirizine
Cetirizine ATC
R06A E07
hydroxyzine
H -
H
1
1
Cetirizine
Cetirizine
Cetirizine
H
1
H
Cetirizine
1
10
Cetirizine
30
Cetirizine
Cetirizine
kallikrein
adhesion molecules
ICAM-1
VCAM-1
5
10
Cetirizine
10
Cetirizine
50%
95%
24
5
12
35
Cetirizine
(
)
                                
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