惠妥滋持續性藥效膠囊400毫克

Država: Tajvan

Jezik: kitajščina

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

Navodilo za uporabo Navodilo za uporabo (PIL)
09-07-2020
Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-07-2020

Aktivna sestavina:

DIDANOSINE

Dostopno od:

臺灣必治妥施貴寶股份有限公司 台北市松山區健康路156號4樓、5樓 (11922609)

Koda artikla:

J05AF02

Farmacevtska oblika:

持續性藥效膠囊劑

Sestava:

DIDANOSINE (0818000900) MG

Enote v paketu:

塑膠瓶裝

Razred:

製 劑

Tip zastaranja:

須由醫師處方使用

Izdeluje:

AstraZeneca Pharmaceuticals LP 4601 HIGHWAY 62 EAST, MOUNT VERNON, INDIANA 47620 USA US

Terapevtsko območje:

didanosine

Terapevtske indikacije:

治療受HIV感染的患者。

Povzetek izdelek:

註銷日期: 2017/11/02; 註銷理由: 自請註銷; 有效日期: 2017/10/30; 英文品名: VIDEX EC DELAYED-RELEASE CAPSULES 400MG

Status dovoljenje:

已註銷

Datum dovoljenje:

2002-10-30

Navodilo za uporabo

                                ®
250400
VIDEX
®
EC Delayed-Release Capsules 250mg, 400mg
(didanosine)
Enteric-Coated Beadlets
250 023579
400 023580
DIDANOSINE
VIDEX EC
[
(5.1)
]
DIDANOSINE
(
)
DIDANOSINE
STAVUDINE
DIDANOSINESTAVUDINE
[
(5.2)
]
1
HIV
2
VIDEX ECVIDEX EC
2.1
()
1
20
(
1)20VIDEX (didanosine)
didanosine
1()
2025
200 mg
2560
250 mg
60
400 mg
2.2
VIDEX EC
VIDEX (didanosine)
VIDEX ECVIDEX EC
2
2VIDEX EC
a
(/)
(MG)
60
60
60
400
250
30-59
200
125
10-29
125
125
10
125
b
a
didanosine
b
< 60CL
cr
< 10/didanosine
didanosinedidanosine
VIDEX EC
(2)
(CAPD)
CAPD2
10/
didanosine
2.3
TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarateVIDEX EC250(
60
60/
)
200(
6060/
)
(40020%)
tenofovir disoproxil fumarate
60/VIDEX ECtenofovir disoproxil fumarate[
(7)(12.3)
]
[
(5.3)(12.3)
]
3
VIDEX EC (didanosine, USP)
•
250BMS 250 mg 6673
•
400BMS 400 mg 6674
4
4.1
Allopurinol
didanosine
allopurinoldidanosinedidanosine
[
(12.3)
]
4.2
Ribavirin
didanosine
ribavirindidanosine(dideoxyadenosine 5'-triphosphate)
didanosine
ribavirin
/
5
5.1
DIDANOSINE
VIDEX EC
VIDEX ECSTAVUDINE
VIDEX EC (didanosine)
VIDEX ECHIV-1
[
(6)
]
5.2
DIDANOSINE
didanosine
stavudine
Didanosine
stavudine
[
(8.1)
]VIDEX EC
(
)
VIDEX EC
5.3
VIDEX ECHIV
(
)
(
)
didanosine
stavudine
[
(6)
]
5.4
didanosine
didanosine
Videx EC
(
:
)(Serum bilirubin)(albumin)
international normalized ratio
INR
Videx EC
5.5
didanosine
HIV(
stavudine)
VIDEX EC [
(6)
]
5.6
didanosineVIDEX EC
[
(6)
]
5.7
(Immune Reconstitution Syndrome)
VIDEX EC
(
Mycobacterium avium
Pneumocystis jiroveci
pneumonia [PCP])
5.8
/
(
)(peripheral wasting)(facial wasting)
6
•
[
(5.1)
]
•
/[
(5.2)
]
•
[
(5.3)
]
•
[
(5.4)
]
•
[
(5.5)
]
•
[
(5.6)
]
6.1
AI454-152
48
511
VIDEX EC (
400 mg)stavudine (40 mg)nelfinavir (750 mg)zidovudine (300 mg)
lamivudine (150 mg)nelfinavir (750 mg)
3
3AI454-152
a
B,C
VIDEX EC +
STAVUDINE +
NELFINAVIR
N=258
ZIDOVUDINE/
LAMIVUDINE
D +
NELFINAVIR
N=253
57
58
/
25
11
24
36
22
17
tenofovir disoproxil
fumarate
didanosine
( 4 0 0 2 0 % )
tenofovir disoproxil fumarateVIDEX EC
a
•
250(6060/)

                                
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