波賽特口服懸液劑

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)

有效成分:

POSACONAZOLE, MICRONIZED

可用日期:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC代码:

J02AC04

药物剂型:

口服懸液劑

组成:

POSACONAZOLE, MICRONIZED (0812204720) MG

每包单位数:

玻璃瓶裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

Cenexi HSC 2, RUE LOUIS PASTEUR, 14200 HEROUVILLE SAINT CLAIR, FRANCE FR

治疗领域:

posaconazole

疗效迹象:

1.對amphotericin B或itraconazole或voriconazole治療無效或不能忍受之成人侵入性麴菌病（invasive aspergillosis）的第二線用藥。（無效的定義是先前用有效抗黴菌劑的治療劑量至少7天，感染惡化或未改善）2.對itraconazole或fluconazole治療無效或不能忍受之成人口咽念珠菌感染（oropharyngeal candidiasis）的第二線用藥。（無效的定義是先前用有效抗黴菌劑的治療劑量至少治療一段時間：持續性黴菌血症3天，非黴菌血症型感染7天，食道念珠菌病14天，感染惡化或未改善）3.適用於13歲以上高危險病人，用來預防侵入性黴菌感染，包括造血幹細胞移植接受者因為植體宿主反應，而接受高劑量免疫抑制劑治療，及acute myelogenous leukemia或高危險myelodysplastic syndrome病人接受誘導化學治療，而引起長期嗜中性白血球減少症。

產品總結:

註銷日期: 2018/09/12; 註銷理由: 自請註銷; 有效日期: 2020/10/06; 英文品名: Posanol 40 mg/ml oral suspension

授权状态:

已註銷

授权日期:

2010-10-06

资料单张

1
POSANOL
S-CCDS-MK5592-OS-T-112016
MK5592-TWN-2016-013980
1.
NAME OF THE MEDICINAL PRODUCT
Posanol 40 mg/ml oral suspension
2.
DESCRIPTION AND Q UALITATIVE COMPOSITION Posanol
®
(posaconazole) is a triazole antifungal agent available as a
suspension for oral
administration.
Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3_R_,5_R_)-5-
(2,4-difluorophenyl)tetrahydro-5-
(1_H_-1,2,4-triazol-1-y lm ethy
l)-3-furanyl]methoxy]phenyl]-1-piperaziny l]phenyl]-2-[(1S,2S)-
1-ethyl-2-hydroxypropyl]-2,4-dihydro-3_H_-1,2,4-triazol-3-one with an
empirical formula of
C
37
H
42
F
2
N
8
O
4
and a molecular weight of 700.8. The structural formula is:
Posaconazole is a white powder and is insoluble in water.
POSANOL Oral Suspension is a white, cherry -flavored immediate-release
suspension
containing 40 mg of posaconazole per mL and the following inactive
ingredients:
polysorbate 80, simethicone, sodium benzoate, sodium citrate
dihydrate, citric acid
monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide,
artificial cherry flavor,
and purified water.
3.
PHARMACEUTICAL FORM
ORAL SUSPENSION
WHITE SUSPENSION
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. Second-line treatment for invasive aspergillosis in adults with
disease that is refractory to
amphotericin B, itraconazole or voriconazole, or in adults who are
intolerant of these
medicinal products. (Refractoriness is defined as progression of
infection or failure to
improve after a minimum of 7 days of prior therapeutic doses of
effective antifungal
therapy.)_ _
2.
Second-line
treatment
for
oropharyngeal
candidiasis
in
adults
with
disease
that
is
refractory to itraconazole and fluconazole. (Refractoriness is defined
as progression of
infection or failure to improve after a minimum treatment period:
persistent fungemia:
3 days; non-fungemic infections: 7 days; esophageal candidiasis: 14
days of prior
therapeutic doses of effective antifungal therapy.)
3. Posanol is also indicated for prophylaxis of invasive fungal
infections in the following
patient pop