喬絲綾膜衣錠

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)
14-05-2020
公众评估报告 公众评估报告 (PAR)
28-03-2020

有效成分:

DROSPIRENONE;;ESTRADIOL ETHINYL (EQ TO ETHINYLOESTRADIOL)(EQ TO ETHINYLESTRADIOL)

可用日期:

培力藥品工業股份有限公司 台中市西屯區工業區六路11號 (52260152)

ATC代码:

G03AA12

药物剂型:

膜衣錠

组成:

ESTRADIOL ETHINYL (EQ TO ETHINYLOESTRADIOL)(EQ TO ETHINYLESTRADIOL) (6816000600) MG; DROSPIRENONE (6832003100) MG

每包单位数:

鋁箔盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

LABORATORIOS LEON FARMA, S.A. POLIGONO INDUSTRIAL DE NAVATEJERA, C/LA VALLINA S/N, 24008 NAVATEJERA, LEON, SPAIN ES

治疗领域:

drospirenone and ethinylestradiol

疗效迹象:

口服避孕藥。

產品總結:

有效日期: 2026/10/04; 英文品名: Jocelyn PL

授权日期:

2016-10-04

资料单张

                                喬絲綾膜衣錠
3
drospirenone
0.03
ethinylestradiol
1.
2.
combined oral contraceptive
1%
21
2-3
a.
2-5
7
b.
vaginal ring
c.
minipill
IUS
minipill
7
d.
first-trimester
e.
”
”
21-28
7
12
12
a.
7
7
b.
7
(1)
2
7
(2)
2
7
1
(3)
7
(a)
2
(b)
7
3-4
“
”
7
3.
“
“
“
“
“
“
“
“
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2.
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“
4.
5.
6.
7.
8.
9.
10.
11.
12.
104
9
3
1041407357A
1.
venous thromboembolism
;
VTE
VTE
a.
C APC
III
antithrombin III deficiency
C
S
b.
c.
2.
arterial thromboembolism
;
ATE
ATE
a.
b.
hyperhomocysteinaemia
antiphsopholipidantibodies
c.
(1)
(2)
dyslipoproteinaemia
VTE
0.03 mg ethinyl estradiol
DRSP
COC
progestins
levonorgestrel
DRSP
VTE
DRSP
DRSP
”
”
prospective 3-armed
cohort study
< 50 μg ethinylestradiol
VTE
8
10
/10,000
4.4
/10,000
20
30
/10,000
ethinylestradiol/drospirenone 0.03 mg/3 mg
levonogestrel
3
ethinylestradiol/drospirenone 0.03 mg/3 mg
levonorgestrel
1
1
ethinylestradiol/drospirenone 0.03 mg/3 mg
≤ 0.04 mg
EE
HR
95%
CI
i3Ingenix
Seeger 2007
a
b
HR: 0.9
(0.5-1.6)
EURAS(Dinger 2007)
Levonorgestrel/EE
c
HR: 0.9
(0.6-1.4)
HR: 1.0
(0.6-1.8)
FDA
2011
a
Levonorgestrel/ 0.03 mg EE
Levonorgestrel/ 0.03mg EE
d
HR: 1.8
(1.3-2.4)
HR: 1.6
(1.1-2.2)
HR: 1.7
(1.4-2.1)
HR: 1.5
(1.2-1.8)
d
026962
DET-D_01
1
Ingenix
Seeger 2007
EURAS
European Active Surveillance Study
Dinger 2007
EURAS
the Long-Term Active Surveillance Study
LASS
FDA
1
Lidegaard 2009
Lidegaard 2011
MEGA
[van Hylckama Vlieg 2009
Dinger 2010
Nested Case-Control Study
PharMetrics
Jick 2011
GPRD
Parkin 2011
1
1
ethinylestradiol/drospirenone 0.03 mg/3 mg
LNG
Ingenix (Hazard Ratio
)
EURAS
(
Hazard Ratio )
LASS
(
Hazard Ratio )
FDA-funded study
(
Hazard Ratio )
Danish
(
Rate Ratio
)
Danish re-analysis
(
Rate Ratio )
MEGA study
(
Odds Ratio )
German case-control
(
Odds Ratio )
PharMetrics
(
Odds Ratio
)
GPRD study
(
Odds Ratio
)
a, b, c, d
*
e, f, g, h
e, f, g, h
e, j, r
e, j, k, l
e, j, k
e, i
f, g,h, k, m, n, o, p
q
f
0.1
0.2
0.5
1
2
5 10
< 1
DRSP
> 1
DRSP
LNG
LASS
EURAS
a
b
c
d
e
f
BMI
g
h
i
j
k
m
n
o
p
q
r
Ingenix [Seeger 2007]
EURAS
Dinger 
                                
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