美偌琳膜衣錠

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)
04-09-2021
公众评估报告 公众评估报告 (PAR)
27-06-2020

有效成分:

DESOGESTREL;;ETHINYLESTRADIOL MICRONIZED

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:

G03AA09

药物剂型:

膜衣錠

组成:

ETHINYLESTRADIOL MICRONIZED (6816000610) MG; DESOGESTREL (6832001400) Desogestrel MicronizedMG

每包单位数:

PVC-PVDC/aluminium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:

desogestrel and ethinylestradiol

疗效迹象:

避孕。

產品總結:

有效日期: 2027/07/05; 英文品名: Meirolyn F.C. Tablets

授权日期:

2017-07-05

资料单张

                                美偌琳膜衣錠
Meirolyn F.C. Tablets
0.150desogestrel micronized
0.020ethinylestradiol micronized
Lactose monohydrate
, Maize Starch, Povidone K-30, α-Tocopherol, Silica colloidal
hydrated, Silica colloidal anhydrous, Stearic acid, Opadry 03B 280004
White
1.
217
2.
a.[]
()()
b.
c.IUS
IUS
d.
e.
””
21~28
VTE
”
”
3.
12
12
a.7
b.7
(1)
7
7
(2)
7
7
(3)
7
(a)
(b)
7
4.
34””
5.
7
(combined hormonal contraceptives; CHCs)
CHCs
1.(venous thromboembolism
VTE)VTE
a.(deep vein thrombosis
DVT)(pulmonary embolism
PE)
b.
C (APC)III
(antithrombin III deficiency)
CS)
c.””
d.
2.(arterial thromboembolism
ATE)ATE
a.
b.(stroke)(transient ischemic attack
TIA)
c.(hyperhomocysteinaemia)
(antiphospholipid antibodies)
d.(””)
e.(””)
(1)
(2)
(3)(dyslipoproteinaemia)
1.
2.
3.
4.
5.
6.
7.
C(HCV)ombitasvir/paritaprevir/ritonavir
/dasabuvir
(””)
1.
/CHCs
CHCs
CHCs(combined oral contraceptives; COCs)
a.
CHCs
CHCs
levonorgestrel
norgestimate
norethisterone
()COCs
levonorgestrelCOCsVTE2
12VTE2
(
0.05
ethinylestradiol)
VTE312CHCs15CHCs
VTEVTE(520)1~2%VTE
CHCsCHCsVTEVTE
CHCs
15VTE
VTE
*CHC=
**910000 WY 7-27
(venous thromboembolism
VTE)
CHCsVTEVTECHCs
4CHCs
CHCs()
VTE
027194
DST-D_01
CHCs
VTE
VTE
CHCs
CHCs
VTE
””
VTE
CHCs
(1)
2)
(Arterial thromboembolism
ATE)
CHCs()()
ATE
CHCsATE
CHCs
CHCs
C (APC)antithrombin-III
C
S
(
)
/
ATE
CHCs
1)
2)
b.
1)
(HPV)COCs
2)54
meta-analysis
COCs(RR=1.24)
COC
COC
COCsCOCs
COC
3)
COCs
COCs
c.C
C
ombitasvir/paritaprevir/ritonavir
(/dasabuvir)
ethinylestradiol
Alanine Aminotransferase (ALT)(ULN)5
ombitasvir/paritaprevir/ritonavir
/dasabuvir
(”””
”)
2
d.
1)COCs
2)
COCs
C
OCs
COCs
COCsCOCs
3)
COCs
COCs
4)COCsCOCs
5)
COCs
COCs(0.05ethinylestradiol)
COCs
6)COCs
7)COCs
8)80
2.
a.
1
2CHCs
3
4
b.
3.
””
”
”
etonogestreldesogestrel
””
4.
COCs
””COCsCOCs
COCs
1.
(
P450
(CYP))(
)
phenytoin
phenobarbital
primidone
bosentan
carbamazepine
rifampicin
oxcarbazepintopiramate
felbamate
griseofulvin
HIV
(
ritonavir)
(efavirenz)
28
HIV(nelfinavir)(nevirapine)/C(HCV)(boceprevirtelaprevi
                                
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