悅己膜衣錠

Pays: Taïwan

Langue: chinois

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

Télécharger Notice patient (PIL)
20-05-2020

Ingrédients actifs:

ETHINYLESTRADIOL;;DROSPIRENONE

Disponible depuis:

臺灣拜耳股份有限公司 台北市信義區信義路5段7號53樓 (23167184)

Code ATC:

G03AA12

forme pharmaceutique:

膜衣錠

Composition:

主成分 () ; DROSPIRENONE (6832003100) MG; ETHINYLESTRADIOL (Z102100625) MG

Unités en paquet:

盒裝

classe:

製 劑

Type d'ordonnance:

須由醫師處方使用

Fabriqué par:

BAYER AG (一)POSTAL ADDRESS:D-13342 BERLIN, GERMANY (二)STREET ADDRESS:MUELLERSTRASSE 178, 13353 BERLIN, GERMANY DE

Domaine thérapeutique:

drospirenone and ethinylestradiol

indications thérapeutiques:

口服避孕藥。

Descriptif du produit:

有效日期: 2026/12/24; 英文品名: YASMIN

Date de l'autorisation:

2001-12-24

Notice patient

                                1.
2.
2 1
3
d r o s p i r e n o n e
0.03
ethinylestradiol
3.
4.
4.1
4.2
4.2.1
4.2.2
(combined oral contraceptive)1%
21
2-3
●
()
(
)
2-5
7
●
(
)
(vaginal ring)
●
(minipill
)
(/IUS)
minipill
(
)7
●
(first-trimester)
●
4.6
21-28
7
12
12
1. 77
2.
7
-
-
-
●
(
2
)
7
(
)
()
●
(
2
)
7
1
●
7
1.
(
2
)
2.
7
(
)
1
3-4“”
7
()
4.2.3
“
”
“
”
“
”“”
4.3
●
/(
)
●
()
●
(“”)
●
●
●
●
ombitasvir
paritaprevir
dasabuvir
(DAA)
(4.5””)
●
●
()
●
()
●
●
●
(venous thromboembolism VTE)
VTE
1. C (APC)
III(antithrombin III deficiency)CS
)
2.
3.
(arterial thromboembolism ATE)
ATE
1.
2.
(hyperhomocysteinaemia)(antiphsopholipidantibodies)
3.
(1)
(2) (dyslipoproteinaemia)
4.4
(VTE)
0.03 mg ethinyl estradiolDRSP(COC) (
Yasmin)
(progestins)
levonorgestrel
DRSP
(VTE)
DRSP
DRSP
[
(4)]
(prospective 3-armed cohort study)
(< 50 µg ethinylestradiol)
(VTE)
8
10
/10,000
,
4.4
/10,000
2030/10,000
ethinylestradiol/
drospirenone 0.03 mg/3 mg (Yasmin)levonogestrel
3
Yasmin (
0.03 mg EE
3 mg DRSP)
levonorgestrel
1
Yasmin
023338
a) 6
b)
norgestimate
norethindrone
levonorgestrel
desogestrel
norgestrel
medroxyprogesterone
ethynodiol
diacetate
c)
levonorgestrel
desogestrel
dienogest chlormadinone acetate
gestodene
cyproterone acetate
norgestimatenorethindrone
d)
norgestimate
norethindrone
levonorgestrel
()
i3 Ingenix
(Seeger 2007)
a
EURAS
(Dinger 2007)
a
FDA
(2011)
a
(
)
(
≤ 0.04 mgEE)
b
c
Levonorgestrel/EE
d
Levonorgestrel/0.03 mg EE
d
Levonorgestrel/0.03 mg EE
(HR)
(95%[CI])
HR: 0.9
(0.5-1.6)
HR: 0.9
(0.6-1.4)
HR: 1.0
(0.6-1.8)
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)
1Yasmin
(
)
(
1)
Ingenix
[Seeger 2007]
EURAS (
[European
Active Surveillance Study]) [Dinger 2007]EURAS
(the Long-Term Active Surveillance StudyLASS)
FDA
(
1)
[Lidegaard 2009
Lidegaard
2011]
MEGA
[van Hylckama Vlieg 2009]
[Dinger 2010]
(Nested Case-Control Study)PharMetrics [Jick 2011]
GPRD [Parkin 2011]1
1YasminLNG(
#
)
< 1DRSP> 1
DRSP
* LNG
†
LASSEURAS
#
a)
b)
c)
d)
e)
f)
(BMI)
g)
h)
i)j)k)l)m)n
                                
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