捷立復錠劑320毫克

País: Taiwan

Língua: chinês

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

Ingredientes ativos:

GEMIFLOXACIN MESYLATE

Disponível em:

和聯生技藥業股份有限公司 台北市敦化北路３１１號５樓 (04270075)

Código ATC:

J01MA15

Forma farmacêutica:

膜衣錠

Composição:

GEMIFLOXACIN MESYLATE (0812701210) (320)MG

Unidades em pacote:

塑膠瓶裝;;鋁箔盒裝

Classe:

製　劑

Tipo de prescrição:

須由醫師處方使用

Fabricado por:

歐帕生技醫藥股份有限公司 新竹縣湖口鄉光復路1號 TW

Área terapêutica:

gemifloxacin

Indicações terapêuticas:

慢性支氣管炎之急性惡化、社區型肺炎。

Resumo do produto:

註銷日期: 2023/07/07; 註銷理由: 未展延而逾期者; 有效日期: 2021/09/28; 英文品名: Factive Tablets 320mg

Status de autorização:

已註銷

Data de autorização:

2006-09-28

Folheto informativo - Bula

O
F
CO
2
H
CH
3
O
N
N
N
N
.
CH
3
SO
3
H
H
2
N
FACTIVEFACTIVE
Gemifloxacin4
65%<
10%N-acetyl
gemifloxacin
gemifloxacin
E-gemifloxa-
cincarbamyl glucuronide
P450cytochrome P450 enzyme
gemifloxa-
cingemifloxacin
Gemifloxacin4
0 mg
640 mg
gemifloxacin640
mg7
< 20%gemifloxacin 320 mg
Moraxella
catarrhalis
MDRSPMoraxella
catarrhalisKlebsiella pneumoniae
MDRSP multi-drug resistant Streptococcus pneumoniae
penicillin-resistant
Streptococcus
pneumoniae
PRSPpenicillincephalosporin
cefuroximemacrolidetetracyclinetrimethoprim / sulfamethoxazole
13
102
1
FACTIVE
FACTIVE
Gemifloxacin0.5
2gemifloxacin71%
95%60% - 84% 320 mg gemifloxacin
Cmax [AUC]
0-24
1.61
0.51 μg/mL
0.70-2.62 μg/mL9.93
3.07 μg
hr/mL4.71-20.1 μg
hr/mL1423
AUC(0-24)
8.36μg/mL
3.2-47.7 μghr/mL
gemifloxacin 320mg
FACTIVE
gemifloxacin
60% 70%
55% 73%gemifloxacin
Gemifloxacin1.2:1
Vdss / F
4.18 L / kg1.66 - 12.12 L / kg
GemifloxacinGemifloxacin
Gemifloxacin1
gemifloxacin
320 mg
2
FACTIVELG320
gemifloxacin mesylate320 mg gemifloxacincrospovidone
hydroxypropyl methylcellulose
magnesium stearate
microcrystalline cellulose
polyethylene glycol
povidone
titanium dioxide
gemifloxacin mesylate Gemifloxa-
c i n
fluoroquinolonesesquihydrate
Gemifloxacin(R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-
pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic
acid
Gemifloxacin Mesylate485.49
GemifloxacinpH
350μg/mL
pH7.0
37C
18
H
20
FN
5
O
4
CH
4
O
3
S
40
minimum
erythematous doseMEDgemifloxacin 160 mggemifloxacin 320 mg
ciprofloxacin
500 mgGemifloxacin
6
295-430nm5
365
nm
Agemifloxacin
ciprofloxacin
500 mg
gemifloxa-
cin0.039%
Fluoroquinolones
FACTIVE
60
FluoroquinolonesFACTIVE
FACTIVE
Fluoroquinolone
f
MM
23
20-22
19
S
I
R
2
5 μg gemifloxacingemifloxacin
5
μg gemifloxacin
Enterobacteriaceae
MIC(ΜG/ML)
20
16-19
15
S
I
R
e
MM
18
S
eHTM
2
【禁忌症】
Gemifloxacin
禁忌症是有對
gemifloxacin
fluoroquinolone
抗生素、或產品的任
一種成分過敏病史的病患。
【警告事項】
過去使用
quinolone
或
fluoroquinolone