布洛坦乾粉注射劑

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)

下载 资料单张 (PIL)
02-03-2022
下载 公众评估报告 (PAR)
02-03-2022

有效成分:

CEFOPERAZONE SODIUM;;SULBACTAM(AS SODIUM)STERILE;;CEFOPERAZONE SODIUM;;SULBACTAM(AS SODIUM)STERILE;;CEFOPERAZONE SODIUM;;SULBACTAM(AS SODIUM)STERILE

可用日期:

永信藥品工業股份有限公司 台中市大甲區頂店里中山路一段1191號 (56065601)

ATC代码:

J01DD62

药物剂型:

乾粉注射劑

组成:

CEFOPERAZONE SODIUM (0812302010) (eq. to Cefoperazone.....500mg) (potency)MG; SULBACTAM(AS SODIUM)STERILE (4410009511) (eq. to Sulbactam.....500mg)MG; CEFOPERAZONE SODIUM (0812302010) (eq. to Cefoperazone.....1gm) (potency)GM; SULBACTAM(AS SODIUM)STERILE (4410009511) (eq. to Sulbactam.....1gm)GM; CEFOPERAZONE SODIUM (0812302010) (eq. to Cefoperazone.....2gm) (potency)GM; SULBACTAM(AS SODIUM)STERILE (4410009511) (eq. to Sulbactam.....2gm) (potency)GM

每包单位数:

紙盒裝;;玻璃小瓶裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

永信藥品工業股份有限公司台中幼獅三廠 台中市大甲區工六路26號,工十路12之1號 TW

治疗领域:

cefoperazone and beta-lactamase inhibitor

疗效迹象:

適用於治療由感受性細菌所引起的下列感染:上、下呼吸道感染、上、下泌尿道感染、腹膜炎、膽囊炎、膽管炎及其他腹腔內感染、骨盆發炎、子宮內膜炎及其他生殖道感染、以及創傷燙傷、手術後之二次感染。

產品總結:

有效日期: 2026/12/07; 英文品名: Burotam Powder for Injection

授权日期:

2021-12-07

资料单张

                                Cefoperazone
Sulbactam
1
Cefoperazone 1g
62 ug/mL
2g
105 ug/mL
Sulbactam1g
20 ug/mL
2g
55
ug/mL
65
5
2gCefoperazone
250 ug/mL
Sulbactam
100 ug/mL
30~408
22g3
2.
5
1g2~3
Sulbactam 1,704.5 ug/mL
Cefoperazone 559.7 ug/mL
12Sulbactam 72%
Cefoperazone
25.3%
3.
i. 6
1g252
Sulbactam 2.5~20.8 ug/mL
Cefoperazone 170.8~2087.5 ug/mL
ii.
4.
Sulbactam
Cefoperazone
CefoperazoneSulbactam
1. Cefoperazone/Sulbactam
(4g,
q12h)(Healthcare-associated pneumonia)
cefepime (2g, q12h)
Cefoperazone/Sulbactam
79cefepime
87Evaluable population147
Cefoperazone/
Sulbactam
66cefepime
81
test-of-cure
Cefoperazone/Sulbactam54
cefepime64
Cefoperazone/Sulbactam7
cefepime
2
2. 1,837
11~2g70%1~2
81.8 % (81/99)
83% (531/640)
72.8% (614/843)
91.9% (34/37)Douglas91.4%
(53/58)95.4% (124/
130)
Cefoperazone/Sulbactam
1g2g6~10mL
5%
0.9%
5%
0.9%
Cefoperazone/Sulbactam
6
48
1.
2. 25
3.
1220100
1.
(*1)
(*2)
1.
2. K
1. BENEDICT’S TEST, FEHLING’S TEST,
CLINITEST
2. DIRECT COOMBS
Β-LACTAM
1.
i. GramCitrobactor
KlebsiellaEnterobactorSerratia
Proteus
Haemophilus influenza
AcinetobacerGram
Bacteroides
ii. Sulbactam
β-lactamaseCefoperazone
Cefoperazoneβ-lactamase
2.
Sulbactamβ-lactamase
Ic
II
III
IV
IaVCefoperazone
CefoperazoneCefoperazone
1.
51g42g
YUNG SHIN PHARMACEUTICAL IND. CO., LTD.
11191
( 0 4 )2 6 8 7 5 1 0
0
26
1%
(*1)
AST(GOT)ALT
(GPT)ALP
(*1)
K
PROTHROMBIN
(*1)
B
(*1)
(*1)
(*1)
(*1)
(*1)
(*2)
0.1 ~ 1%
BILIRUBIN
(*2)
0.1%
2140122
®
BII, BII2-001
061039
4.
5.
K
6.
1.
2.
6
12,8081,023
(7.99%)
(0.75%)(0.45%)(0.21%)
AST(GOT)
(3.18%)ALT(GPT)(3.41%)
ALP(1.05%)
(HEALTHCARE-ASSOCIATED
PNEUMONIA, HCAP)166
CEFOPERAZONE/SULBACTAM 79
CEFEPIME
87
58
(73%) CEFOPERAZONE/SULBACTAM
58
(67%) CEFEPIME
I.
II.
III.
IV. (PIE)
X
PIE
V. STEVENS-JOHNSON
(TEN)(AGEP)
VI.
VII.
VIII.CEFOPERAZONE
CEFOPERAZONE
CEFOPERAZONE
IX. K
CEFOPERAZONE
K
K
K
Cefoperazone Sodium
...................................
500mg, 1gm (potency)
(eq. to Cefoperazone
.....................................................
500mg, 1gm)
Sulbactam (as Sodium) Sterile
.......................................
                                
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