脂黴素微脂粒凍晶乾粉注射劑

Țară: Taiwan

Limbă: chineză

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

Ingredient activ:

AMPHOTERICIN B

Disponibil de la:

香港商吉立亞醫藥有限公司台灣分公司 臺北市信義區松仁路32號10樓之1、36號10樓之1 (54376860)

Codul ATC:

J02AA01

Forma farmaceutică:

凍晶乾粉注射劑

Compoziție:

主成分 () ; AMPHOTERICIN B (0812200102) MG

Unități în pachet:

小瓶

Clasă:

製　劑

Tip de prescriptie medicala:

限由醫師使用

Produs de:

Gilead sciences, Inc. 1800 Wheeler Avenue, La Verne, California, 91750 USA US

Zonă Terapeutică:

amphotericin B

Indicații terapeutice:

• 治療感染囊球菌腦膜炎的HIV患者• 治療嚴重全身性及/ 或深部黴菌感染• 治療臟器的利時曼氏病。在免疫不全且患有臟器的利時曼氏病之患者使用AmBisome治療，在初期寄生蟲清除後仍有高復發率。• 對發燒的重度嗜中性白血球缺乏症患者可能罹患黴菌感染症之經驗療法。

Rezumat produs:

有效日期: 2027/03/01; 英文品名: AMBISOME FOR INJECTION

Data de autorizare:

2002-03-01

Prospect

AmBisome
Amphotericin B, USP 50 mg
hydrogenated soy
phosphatidylcholine 213 mg
cholesterol NF 52 mg
distearoylphosphatidylglycerol
84 mg
alpha tocopherol USP 0.64 mg
sucrose NF 900 mg
disodium succinate hexahydrate 27 mg
pH
5.0 – 6.0
AmBisome
Liposomal
amphophilic
AmBisome
Amphotericin B
amphophilic
Amphotericin B
AmBisome
AmBisome
100 nm
Amphotericin B
Streptomyces nodosus
Amphotericin B
[
1R-
1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E,
31E, 33R*,35S*,36R*,37S*
]
-33-
[
3-Amino-3,6-dideoxy-
β
-D-mannopyranosyl
oxy
]
-
1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-di
oxabicyclo
[
33.3.1
]
nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid
CAS
No.
1397-89-3 .
Amphotericin B
C
47
H
73
NO
17
924.09
AmBisome
Amphotericin B
s t e ro l
ergosterol
NA
+
, K
+
, H
+
, and Cl
-
Amphotericin B
ergosterol
cholesterol
AmBisome
Amphotericin B
Liposomal
intracellular
extracellular
AmBisome
Amphotericin B
Aspergillus fumigatus
Aspergillus flavus
Candida
albic
ans
,
Candida krusei
,
Candida lusitaniae
Candida parapsilosis
,
Candida tropicalis
Cryptococcus neoformans
Blastomyces dermatitidis
2
3
AmBisome
amphotericin B
Sporothrix schenckii
Candida glabrata
Candida krusei
Candida tropicalis
Candida lusitaniae
Candida parapsilosis
Aspergillus terreus
amphotericin B
AFST-
EUCAST
1
2
1
AmBisome
[
µg/mL
]
C. albicans
59
0.015-0.12
C. glabrata
18
0.5-1
C. parapsilosis
18
0.5-1
C. krusei
19
0.5-2
C. lusitaniae
9
0.06-0.125
C. tropicalis
10
0.25-1
C. guilliermondii
4
0.06-0.12
Saccharomyces cerevisiae
3
0.03-0.06
Cryptococcus neoformans var. neoformans
10
0.06-0.12
Cryptococcus neoformans var. gattii
3
0.03-0.06
Trichosporon inkin
3
0.03-0.06
Trichosporon asahii
4
0.01-0.03
Geotrichum candidum
4
0.06-0.25
2
AmBisome
[
µg/mL
]
A. fumigatus
29
0.5-2
A. terreus
34
2-4
A. flavus
21
1-4
A. niger
13
1-2
*
Rhizomucor species
17
0.3-0.125
Absidia corymbifera
4
0.125-1
Absidia species
17
0.5-2
Rhizopus microsporus var. oligosporus
3
0.03-0.25
Rhizopus oryzae
6
1-4
Rhizopus species
12
1-4