利憶靈持續性藥效膠囊24毫克

국가: 대만

언어: 중국어

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

환자 정보 전단 환자 정보 전단 (PIL)
07-12-2021
공공 평가 보고서 공공 평가 보고서 (PAR)
20-04-2020

유효 성분:

GALANTAMINE HYDROBROMIDE

제공처:

嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)

ATC 코드:

N06DA04

약제 형태:

持續性藥效膠囊劑

구성:

GALANTAMINE HYDROBROMIDE (9200042310) MG

패키지 단위:

鋁箔盒裝;;塑膠瓶裝

수업:

製 劑

처방전 유형:

須由醫師處方使用

Manufactured by:

JANSSEN-CILAG S.P.A. VIA C. JANSSEN 04100 BORGO S. MICHELE-LATINA, ITALY IT

치료 영역:

galantamine

치료 징후:

治療ALZHEIMER症輕度至中度嚴重失智症

제품 요약:

有效日期: 2025/07/27; 英文品名: REMINYL PROLONGED RELEASE CAPSULES 24MG

승인 날짜:

2005-07-27

환자 정보 전단

                                ®
REMINYL
® PROLONGED RELEASE CAPSULES
24 24mg 024276
R E M I N Y L
®
g a l a n t a m i n e
hydrobromidegalantamine base 24
24 mg1
G24
galantamine hydrobromide
galantamine base
24
Alzheimer
REMINYL
®
8
- 16
16
- (
)
24
REMINYL
®
()
REMINYL
®
(
= 52-104 mL/min)(
= 9-51 mL/min)
galantamine
≥ 9 mL/min
(
–
)
9mL/min
REMINYL
®
galantamine
(Child-Pugh
score 7-9)4
8
4
8
16
(Child-Pugh score > 9)
REMINYL
®
CYP2D6
CYP3A4
REMINYL
®
(
–
galantamine
)
galantamine hydrobromide
REMINYL
®
(
–
)
ALZHEIM
ER’
S
Alzh
eimer’s
(
Alzheim
er’s
)
REMINYL
®
(
)
REMINYL
®
REMINYL
®
(Stevens-
Johnson Syndrome)(
)
REMINYL
®
Alzheime
r ’s
(galantamine)
REMINYL
®
(
)
(
digoxin
beta
)
REMINYL
®
(
(NSAIDS)
)
REMINYL
®
REMINYL
®
REMINYL
®
REMINYL
®
(
–
)
Alzheime
r’
s
(
–
)
REMINYL
®
(MCI)
REMINYL
®
Alzheimer
’
s
(
)
galantamine
REMINYL
®
galantamine
MCIAlzheime
r’
s
Alzheime
r’s
(n=4614)
REMINYL
®
Galantamine
CYP2D6
CYP3A4
galantamine
galantamine
GALANTAMINE
CYP2D6
CYP3A4
galantamine
AUCgalantamine
ketoconazole
paroxetine
galantamine
AUC30%
40%erythromycin(
CYP3A4)
galantamine
AUC
10% Alzheime
r ’
s
galantamine
amitriptyline
fluoxetine
fluvoxamine
paroxetine
quinidine (CYP2D6)
galantamine25~33%
CYP2D6
CYP3A4
(
)
galantamine(
–
)
MemantineN-methyl-D-aspartate
(NMDA)10 mg
12
(2
10 mg)16 mg/day
galantamine
GALANTAMINE
Galantamine(
12 mg)
digoxin
warfarinGalantamine
warfarin
galataminecytochrome
P450
galantamine
Galantamine
(
digoxin
beta)
galantamine
succinylcholine
16 mg/kg (25
)
40 mg/kg (63
)
16 mg/kg
REMINYL
®
REMINYL
®
REMINYL
®
REMINYL
®
Alzheime
r’
s
REMINYL
®
(
)
(
)
galantamine
hydrobromide
galantamine hydrobromide – ≥1%
6502
Alzheime
r’
s
8REMINYL
®
REMINYL
®
≥1%1
1.
8
REMINYL
®
≥1%
REMINYL
®
(N=3956)
%
(N=2546)
%
7.4
2.1
3.8
1.0
3.6
2.3
6.8
2.9
7.1
5.5
1.6
0.7
1.4
0.6
1.3
0.4
1.5
0.8
1.0
0.3
20.7
5.5
10.5
2.3
7.4
4.9
2.0
0.6
1.9
1.4
1.5
1.0
2.1
0.7
1.2
0.5
3.5
1.8
2.0
1.5
(Malaise)
1.1
0.5
4.7
1.5
3.9
3.0
1.1
0.5
REMINYL
®
(
) – <1%
1 4 5 4
Alzheime
r ’
s5
                                
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