替告盼定"山德士"凍晶注射劑200毫克

Riik: Taiwan

keel: hiina

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

Laadi alla Infovoldik (PIL)
14-06-2021
Laadi alla Avaliku hindamisaruande (PAR)
28-03-2020

Toimeaine:

TEICOPLANIN

Saadav alates:

台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)

Ravimvorm:

凍晶注射劑

Koostis:

TEICOPLANIN (0812010000) (Potency: Teicoplanin activity equal to 200,000IU)MG

Ühikuid pakis:

瓶裝;;盒裝

Klass:

製 劑

Retsepti tüüp:

限由醫師使用

Valmistatud:

LEK PHARMACEUTICALS D.D., SLOVENIA VEROVSKOVA 57, SI-1526 LJUBLJANA, SLOVENIA SI

Näidustused:

葡萄球菌感染所致之心內膜炎、骨髓炎、肺炎、敗血病、軟組織感染、腸炎、梭狀桿菌感染所致之假膜性結腸炎。

Toote kokkuvõte:

註銷日期: 2021/09/11; 註銷理由: 自請註銷; 有效日期: 2023/06/08; 英文品名: Teicoplanin Sandoz Powder for Injection 200mg

Volitamisolek:

已註銷

Loa andmise kuupäev:

2018-06-08

Infovoldik

                                Teicoplanin 200
sodium chloride, water for injection
- “” 200
TEICOPLANIN SANDOZ POWDER FOR INJECTION 200MG
027449
>15 mg/L
1
11
>20 mg/L
1
>30 mg/L
1
6 mg/kg
11
12 mg/kg
11
12 mg/kg
11
3
5
>15 mg/L
1
>20 mg/L
1
30-40 mg/L
1
12
6 mg/kg3
12
12 mg/kg35
12
12 mg/kg35
-
-
-
()
-
/
-
-
1
(FPIA)
21()
teicoplanin
●
(HPLC)
teicoplanin
10 mg/L
(FPIA)15 mg/L
● HPLCteicoplanin
15-30 mg/L
FPIA
30-40 mg/L
teicoplanin
-
(Surgical Prophylaxis)
400 mg (
85
6 mg/kg)
- 100-200 mg714
216
12
10 mg/kg
6 mg/kg
12
10 mg/kg
10 mg/kg
2
16 mg/kg
8 mg/kg
30
()
10 mg/L (HPLC
)15 mg/L (FPIA)
(
40-60 ml/min)
(
40 ml/min)
Teicoplanin
400 mg20 mg/L
20 mg/L
20 mg/L
Teicoplanin
3
5
30
()
()
teicoplanin
vancomycin
vancomycin
(Red Man Syndrome)
(Red Man Syndrome)()
30
teicoplanin
Stevens-Johnson
(SJS)(Toxic Epidermal Necrolysis, TEN)SJSTEN
teicoplanin
teicoplanin
teicoplanin
12 mg/kg
teicoplanin
()
()
teicoplanin
aminoglycosides,
amphotericin B, ciclosporin, and furosemide, ethacrynic acid,
cisplatin, colistin
()
teicoplanin
teicoplanin
()
Teicoplanin
()
DRESS
(
)
Stevens-Johnson
“
(Red Man Syndrome)”
transaminase
/alkaline phosphatase
//
()
()
29 400
(95 mg/kg)
teicoplanin
()
glycopeptide
Actinoplanes teichomyceticus
((MIC)16 mg/L)
(
m e t h i c i l l i n
)
(Listeria
Lek Pharmaceuticals d.d.
Verovškova 57, SI-1526 Ljubljana, Slovenia
9911
TWI-200718
0.9%
Ringer
Hartmanns
1.36%3.86% Dextrose
5%
0.18%4%
2-8 7
2524
2-8
24
monocytogenes)(micrococci)Eikenella corrodensJK(group JK
corynebacteria)
Clostridium difficilepeptococci
(
16 mg/L)
(Nocardia asteroides)
(Lactobacillus spp)(Leuconostoc)
aminoglycosides
D
rifampicin
fluorinated quinolones
11-14
(sensidisc)30 mcg teicoplanin(inhibition zone)
14 mm10 mm
()
(
0.3
3
)
(
150
)
6 mg/Kg
0
12
24
24
30
4
10 mg/L
(trough serum concentration)
3-6
mg/Kg
0.94-1.4 L/Kg
90-95% teicoplanin
Teicoplanin
97%
(terminal half-life)150
()
aminoglycosides
252
[]
Teicoplaninaluminium/propylene
100
15
2-8
7
25
24
200200 mg/3 ml
                                
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