康立解靜脈輸注液1.5克/1.5毫升

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)

资料单张 资料单张 (PIL)
26-03-2021
公众评估报告 公众评估报告 (PAR)
14-04-2020

有效成分:

Fomepizole

可用日期:

華宇藥品股份有限公司 台北市中山北路二段115巷43號8樓 (70680851)

ATC代码:

V03AB34

药物剂型:

注射劑

组成:

Fomepizole (9200082000) MG

每包单位数:

安瓿瓶裝;;盒裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

健亞生物科技股份有限公司 新竹縣湖口鄉中興村工業一路1號 TW

治疗领域:

fomepizole

疗效迹象:

甲醇(methanol)或乙二醇(ethylene glycol, 例如抗凍劑)中毒的解毒劑,或用於懷疑攝入甲醇或乙二醇,無論是否與血液透析合併治療。

產品總結:

有效日期: 2026/06/30; 英文品名: Fomeject Injection 1.5g/1.5ml

授权日期:

2016-06-30

资料单张

                                TWUPFOMEJECT PI1.2; 05/2016
1.5
/1.5
FOMEJECT (FOMEPIZOLE) INJECTION 1.5G/1.5ML
000016
1.
Fomeject (fomepizole)
(alcohol dehydrogenase)
(inhibitor)Fomepizole
4-methylpyrazole
C4H6N2
82.1
25
(77
)
Fomepizole
(chloroform)
fomepizole 1.5 mL(1 g/mL)
2.
2.1 FOMEPIZOLE
15 mg/kg
12
10 mg/kg
4
12
15 mg/kg
20mg/dL
pH
30
2.2
(RENAL DIALYSIS)
Fomepizole
4
(Hemodialysis)
Fomepizole
fomepizole
6
fomepizole
6
4
1
1-3
1/2
3
12
3.
3.1
(alcohol dehydrogenase)
(inhibitor)
(methanol)
(ethylene glycol)
(methanol)
(alcohol dehydrogenase)
(formaldehyde)
(formaldehyde dehydrogenase)
(formic acid)
(metabolic acidosis)
(visual disturbances)
1-2 mL/kg
(ethylene glycol)
(glycoaldehyde)
(glycolate),
(glyoxylate)
(oxalate)
(glycolate)
(oxalate)
(metabolic acidosis)
(ethylene glycol toxicosis)
1.4 mL/kg
fomepizole
(alcohol dehydrogenase)
(alcohol dehydrogenase) 50% fomepizole
0.1 mol/L
(ethylene glycol)
fomepizole
(obtunded)
(moribund)
fomepizole
(metabolic acidosis)
(plasma)
fomepizole
10mol/L(0.82 mg/L)
(formate)
(alcohol dehydrogenase)
fomepizole
100
300mol/L(8.6-24.6 mg/L)
(alcohol
dehydrogenase)
fomepizole (10-20 mg/kg)
(alcohol
dehydrogenase)
3.2
0.6 L/kg
1.02 L/kg
7-20 mg/kg
1-3.5%
(unchanged)
4-carboxypyrazole
80-85%
4-hydroxymethylpyrazoleN-glucuronide conjugates of
4-carboxypyrazole and 4-hydroxymethylpyrazole
Michaelis-Menten
[100-300mol/L, 8.2-24.6 mg/L]
cytochrome P450
(mixed-function oxidase system)
30-40
first-order kinetics
3.3
3.4
(methanol)
(ethylene glycol)
11
16
7
14
(hemodialysis)
(alcohol dehydrogenase)
(methanol)
(ethylene glycol)
(post-dialysis periods)
20 mg/dL
(glycolate)
(formate)
5
(ethylene glycol)
46.5-345 mg/dL
fomepizole
4.
(methanol)
(ethylene glycol,
)
5.
fomepizole
pyrazoles
6.
6.1
(BOLUS INJECTION)
(5
)
25 mg/mL
(venous irritation)
(phlebosclerosis)
6.2
(methanol)
(ethylene glycol)
(
)
(
)
(sodium
bicarbonate)
PH
(BUN)
(creatinine)
(urinalysis)
(ethylene glycol)
(oxalate crystals)
(methanol)
(electrocardiography)
(acidosis)
( transaminase)
(eosinophilia)
6.3
10-20 mg/kg
(alcohol dehydrogenase)
40%
50%
cytoc
                                
                                阅读完整的文件