斥消靈內服液劑１毫克/毫升

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:

SIROLIMUS

Disponível em:

美商惠氏藥廠（亞洲）股份有限公司台灣分公司 台北市信義區松仁路100號42、43樓 (23984410)

Código ATC:

L04AA10

Forma farmacêutica:

內服液劑

Composição:

SIROLIMUS (9200039600) 1MG

Unidades em pacote:

瓶裝;;盒裝

Classe:

製　劑

Tipo de prescrição:

限由醫師使用

Fabricado por:

PATHEON, INC. 2100 SYNTEX COURT MISSISSAUGA, ONTARIO, CANADA L5N 7K9 CA

Área terapêutica:

sirolimus

Indicações terapêuticas:

與CYCLOSPORINE及皮質類固醇合併使用來預防病人腎臟移殖後之器官排斥。

Resumo do produto:

註銷日期: 2022/06/22; 註銷理由: 未展延而逾期者; 有效日期: 2020/11/09; 英文品名: RAPAMUNE ORAL SOLUTION 1MG/ML

Status de autorização:

已註銷

Data de autorização:

2000-11-09

Folheto informativo - Bula

•
5.1
•
sirolimus
5.2, 5.3
•
–
Hepatic Artery
Thrombosis, HAT
tacrolimus
cyclosporine
tacrolimus
HAT
HAT
30
5.2
•
–
5.3
1
cyclosporine
2
4
cyclosporine
(
sirolimus
)
cyclosporine
cyclosporine
2-4
2
cyclosporine
Banff
(
Serum Creatinine
)
> 4.5 mg/dL
(
PRA = panel reactive antibody
)
cyclosporine
14.2
(
[
PRA
peak PRA level > 80%
])
14.3
2
13
18
8.4
14.6
2
cyclosporine
2
4
cyclosporine
cyclosporine
cyclosporine
Banff
(
Serum Creatinine
)
> 4.5 mg/dL
(
PRA = panel reactive ant
ibody
)
1
14.2
cyclosporine
6
2
15
5
2
2
5
Cyclosporine
cyclosporine
cyclosporine
2
4
cyclosporine
4
8
16-24 ng/mL
(
)
1
12-20 ng/
ml
2
/
Cyclosporine
sirolimus
Cyclosporine
sirolimus
4
(
)
cyclosporine
(
)
(
(
PRA
peak PRA level > 80%
))
1
cyclosporine
14.3
cyclosporine
1
15 mg
2
5 mg
5-7
(
)
Cyclosporine
7 mg/kg
(
)
Prednisone
5 mg
sirolimus
sirolimus
7
14
(
/
)
Sirolimus
(
loading dose
)
3
(
–
)
40 mg
40 mg
sirolimus
3
4
2
2
12.3
CYP3A4
P-gp
c y c l o s p o r i n e
(
MODIFIED
)
/
cyclosporine
(
MODIFIED
)
sirolimus
13
40
1
(
1 mg/m
2
/day
)
3
(
3 mg/m
2
)
8.6
12.3
CYP3A4
/
P-glycoprotein
/
cyclosporine
sirolimus
2
cyclosporine
(
)
12
sirolimus
2 mg/day
9 ng/mL
(
4.5-14
ng/mL
10
th
– 90
th
)
5 mg /
day
17 ng/mL
(
10-28
ng/mL 10
th
– 90
th
)
cyclosporine
(
)
4
12
sirolimus
cyclosporine
(
n = 205
)
8.6 ng/mL
(
5.0-12.7 ng
/
mL
10
th
– 90
th
)
cyclosporine
(
n = 201
)
18.6 ng/mL
(
13.6-22.4 ng/mL
10
th
– 90
th
)
3
cyclosporine
(
n =135
)
sirolimus
9.1 ng/
mL
(
5.4-13.9
ng/mL 10
th
– 90
th
)
cyclosporine
(
n =140
)
sirolimus
16.3 ng/mL
(
1
1.2-21.9 ng/mL 10
th
– 90
th
)
cyclosporine
(
)
12
sirolimus
cyc
losporine
C
min
range
(
ng/mL
)
(
)
(
10
th
– 90
th
)
sirolimus
(
cyclosporine
)
2
10 -15
15.710.0
5.4 - 27.3
2-26
10 -15
11.85.3
6.2 - 16.9
26 -52
10 -15
11.54.8
6.3 - 17.4
Cyclosporine
2
200 -300
216.9135.4
56.0 - 432.0
2-26
150 -200
173.8104.7
71.0 - 288.0
26 -52
100 -150
135.8109.5
54.5 - 217.5
Sirolimus
(
HPLC
)
cyclosporine
TDx
(
HPLC
UV
LC/ MS/ MS
)
20%
Sirolimus
Clinical Therapeutics, Volume 22, Supplement B,