詠葆玖靜脈輸注濃縮液 2毫克/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)

有效成分:

Patisiran sodium

可用日期:

艾拉倫股份有限公司 臺北市信義區松智路1號11樓 (1146/1147室) (82802416)

ATC代码:

N07XX12

药物剂型:

注射液劑

组成:

主成分 (每ml含:) ; Patisiran sodium (9200040000) (equivalent to patisiran......2.0MG)MG

每包单位数:

玻璃小瓶裝;;盒裝

类:

製　劑

处方类型:

限由醫師使用

厂商:

Ajinomoto Althea, Inc. 11040 Roselle Street, San Diego, CA92121 USA US

治疗领域:

patisiran

疗效迹象:

適用於治療成人TTR(transthyretin)家族性澱粉樣多發性神經病變(Familial Amyloidotic polyeuropathy)。神經病變的疾病嚴重度限於第一、二期的病人。

產品總結:

有效日期: 2030/12/10; 英文品名: Onpattro 2mg/mL concentrate for solution for infusion

授权日期:

2020-12-10

资料单张

2 毫克/毫升
®
詠葆玖
靜脈輸注濃縮液
patisiran
2 毫克/毫升
®
詠葆玖
靜脈輸注濃縮液
patisiran
Cholesterol
Disodium hydrogen phosphate, heptahydrate
Potassium dihydrogen phosphate, anhydrous
Sodium chloride
Water for injections
6.2
6.6
6.3
36()
(
30
°
C)(in-use)16
2-8
°
C(30
°
C)16()
6.4
(2-8
°
C)
Onpattro(25
°
C)14
6.3
6.5
5 mLI
(chlorobutyl)
1
6.6
9 mg/mL (0.9%)
• Onpattro
•
• Onpattro
• Onpattro(4.2)
•
• 0.45
(PES)Onpattro
• Onpattro
• Onpattro9 mg/mL (0.9%)
200 mL(2-)(DEHP)
•
• Onpattro 2 /
PATISIRAN
•
•
•
4
1. Onpattro
2. Onpattro
3. Onpattro
4.
5. Onpattro
6.
1. ONPATTRO
Onpattropatisiran
OnpattroATTR(hATTR)
hATTR
“
” (
TTR)
• A
• TTR
“
”
•
OnpattroTTR
• TTR
•
Onpattro
2. ONPATTRO
ONPATTRO
• patisiran(6)
Onpattro
Onpattro
(
“
”)
Onpattro
(
3
“Onpattro
”
)
4
A
OnpattroA
A
A
Onpattro
A
•
Onpattro
OnpattroA
A
Onpattro
(
“
”
)
OnpattromNIS+7
Norfolk QoL-DN
NISV30M
tafamidis meglumine
diclunisal
TTR
Onpattro
hATTR
(4.2)
5.2
OnpattropatisiranDLin-MC3-DMA
PEG
2000
-C-
DMG
95%patisiran
3300
μ
g/kg
24
patisiran(C
max
)(C
trough
)(AUC
τ
)
(
±
)
7.15
±
2.14
μ
g/mL
0.021
±
0.044
μ
g/mL
184
±
159
μ
g·h/
mLAUC
τ
3.2
DLin-MC3-DMA
C
max
C
trough
AUC
τ
(
±
)
40.2
±
11.5
μ
g/mL
1.75
±
0.698
μ
g/mL
1403
±
105
μ
g·h/mLAUC
τ
1.76
PEG
2000
-C-DMGC
max
C
trough
AUC
τ
(
±
)
4.22
±
1.22
μ
g/mL
0.0236
±
0.0093
μ
g/mL
145
±
64.7
μ
g·h/mL
AUC
τ
Onpattro
α
1-
≤2.1%3300
μ
g/kgpatisiran
DLin-MC3-DMAPEG
2000
-
C-DMG(V
ss
)0.26
±
0.20 L/kg
0.47
±
0.24 L/kg
0.13
±
0.05 L/kg
(
±
)
PatisiranDLin-MC3-DMA
4-dimethylaminobutyric acid (DMBA)PEG
2000
-C-DMG
3
300
μ
g/kgpatisiran(CL
ss
)
±
3.0
±
2.5 mL/h/kg
Patisiran(t
1/2
β
)
±
3.2
±
1.8
patisiran
1%
DLin-MC3-DMA
(CL
s s
)
±
2 . 1
±
0.8
mL/h/kg
965.5%
DLin-MC3-DMA(DMBA)
PEG
2 0 0 0
-C-DMG(CL
s s
)
±
2 . 1
±
0.6
mL/h/kgPEG
2000
-C-DMG
PEG
2000
-C-DMG
/
(10
500
μ
g/kg)
patisiran(DLin-MC3-DMA
PEG
2000
-C-DMG)3
300
μ
g/kg
patisiran
/
PatisiranTTR3
300
μ
g/kg
p