"永信"健法凍晶注射劑

País: Taiwán

Idioma: chino

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

Ingredientes activos:

GEMCITABINE HYDROCHLORIDE;;GEMCITABINE HYDROCHLORIDE

Disponible desde:

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)

Código ATC:

L01BC05

formulario farmacéutico:

凍晶注射劑

Composición:

GEMCITABINE HYDROCHLORIDE (1010000610) (eq. to Gemcitabine.....200mg)MG; GEMCITABINE HYDROCHLORIDE (1010000610) (eq. to Gemcitabine.....1gm)MG

Unidades en paquete:

玻璃小瓶裝;;盒裝

clase:

製　劑

tipo de receta:

限由醫師使用

Fabricado por:

永信藥品工業股份有限公司台中幼獅廠 台中市大甲區工七路9號、工九路27號 TW

Área terapéutica:

gemcitabine

indicaciones terapéuticas:

非小細胞肺癌、胰臟癌、膀胱癌。GEMCITABINE與PACLITAXEL併用，可使用於曾經使用過ANTHRACYCLINE之局部復發且無法手術切除或轉移性之乳癌病人。用於曾經使用含鉑類藥物(PLATINUM-BASED)治療後復發且間隔至少6個月之卵巢癌，作為第二線治療。膽道癌。

Resumen del producto:

有效日期: 2027/10/03; 英文品名: Gemphar Lyo-Injection "Yung Shin"

Fecha de autorización:

2017-10-03

Información para el usuario

GLI, GLI5-003
059784
Lyo-Injection "Yung Shin"
R
Gemphar
Gemphar(Gemcitabine Hydrochloride)Gemcitabine
Hydrochloride
2’-deoxy-2’, 2’-difluorocytidine monohydrochloride
Gemcitabine HydrochlorideC
9
H
11
F
2
N
3
O
4
HCl299.66 g/mol
Gemcitabine Hydrochloride
2001Gemcitabine
Hydrochloride
200112.562.5
Gemcitabine Hydrochloride
.........
228mg1140mg
(eq. to Gemcitabine
......................
200mg1gm)
Mannitol
Sodium Acetate
GEMCITABINE
PACLITAXEL
ANTHRACYCLINE
(PLATINUM-BASED)
6
Gemphar
Cisplatin
IIIa
IIIb
IV
GEMCITABINE
Gemphar
II
III
IV
Gemphar
5-FU
(TCC of the urothelium)
Gemphar
Cisplatin
(TCC of the urothelium)
GEMCITABINE
PACLITAXEL
ANTHRACYCLINE
ANTHRACYCLINE
(PLATINUM-BASED)
6
GEMCITABINE
Gemphar1000mg/m
2
211
8Gemphar 30Gemphar
carboplatin AUC 4carboplatin
Gemphar
GEMPHAR
x10
6
/Lx10
6
/L
1≥ 1500
≥ 100,000100%
1500100,000
8≥ 1500
≥ 100,000100%
1000-1499
75,000-99,99950%
100075,000
GEMPHAR
500x10
6
/L51,8Gemphar800mg/m
2
100x10
6
/L3
25,000x10
6
/L
Gemphar800mg/m
2
1
Gemphar1250mg/m
2
211
8Gemphar 30paclitaxel
Gempharpaclitaxel 175mg/m
2
3
Gemphar
GEMPHAR
x10
6
/Lx10
6
/L
1≥ 1500
≥ 100,000100%
1500
100,000
8≥ 1200
≥ 75,000
100%
1000-1199
50,000-75,000
75%
700-999
≥ 50,000
50%
700
50,000
4
Gemphar1000mg/m
2
1
8
1530Gemphar
cisplatin1
Gempharcisplatin 100mg/m
2
3
Gemphar1250mg/m
2
1
830Gemphar
cisplatin1
Gempharcisplatin 100mg/m
2
Gemphar1000mg/m
2
30
187
8281815Gemphar
GempharCBCcomplete blood count
GEMPHAR
x10
6
/Lx10
6
/L
≥ 1000
≥ 100,000100%
500-99950,000-99,99975%
50050,000
(TCC OF THE UROTHELIUM)
281
8
15Gemphar 1000mg/m
2
301
cisplatin 70mg/m
2
Cisplatin
Gemcitabine1000mg/m
2
30
Gempharcisplatin211, 8cisplatin 25mg/m
2
30Gemphar 1000mg/m
2
Gemphar
(Hemolytic-
uremic syndrome)
(Capillary
leak syndrome)
(Posterior reversible encephalopathy syndrome)
3
4
Gemphar 50%
Gemphar
GempharOSHA
“OSHA Hazardous Drugs”
http://www.osha.gov/SLTC/hazardousdrugs/index.html
Gemphar0.9%5mL0.9%200mg
25mL
0.9%1
gmGemcitabine38mg/mL
200mg
1gm
Gemcitabine0.9%
0.1mg/mL
Gemphar
Gemphar30
24
Gemphar