歐賽羅注射劑2.5微公克

Quốc gia: Đài Loan

Ngôn ngữ: Tiếng Trung

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

Thành phần hoạt chất:

Maxacalcitol

Sẵn có từ:

台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)

Mã ATC:

H05BX

Dạng dược phẩm:

注射劑

Thành phần:

Maxacalcitol (8818001100) MCG

Các đơn vị trong gói:

盒裝

Lớp học:

製　劑

Loại thuốc theo toa:

限由醫師使用

Sản xuất bởi:

Nipro Pharma Corporation Ise Plant 647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie 515-2302, Japan JP

Khu trị liệu:

Other anti-parathyroid agents

Chỉ dẫn điều trị:

接受維持性血液透析治療病人之次發性副甲狀腺機能亢進。

Tóm tắt sản phẩm:

有效日期: 2023/05/17; 英文品名: OXAROL Injection 2.5μg

Ngày ủy quyền:

2018-05-17

Tờ rơi thông tin

•
OXAROL
®
Injection
2.5 µg
5 µg
[
1 mL
]
Maxacalcitol
2.5 µg
5 µg
Dibasic sodium phosphate hydrate,
Sodium dihydrogen phosphate dihydrate,
Polysorbate 20, Sodium chloride, Anhydrous
ethanol, Water for Injection
pH
7.80
-
8.20
1
3
intact-PTH
< 500 pg/mL
HS-PTH
< 40,000 pg/mL
5 µg
intact-PTH
≥ 500 pg/mL
HS-PTH
≥ 40,000 pg/mL
10 µg
2.5 µg
10 µg
PTH
PTH
20 µg
intact-PTH
≤ 150 pg/mL
®
1.
®
1
®
2
2.
1
D
D
®
®
D
2
®
®
2
11.5 mg/dL 5.75 mEq/L
11.0 mg/dL
4.0 g/dL
mg/dL =
mg/dL
-
g/dL + 4.0
3
4
®
PTH
®
3.
®
Alfacalcidol
Calcitriol
PTH
Teriparatide
Digoxin
®
CYP3A4
Ketoconazole
®
®
CYP3A4
®
®
4.
4196
1115
26.6%
1316
933
22.2%
85
2.0%
CK CPK
64
1.5%
42
1.0%
25
0.6%
1
22.2%
®
11.5 mg/dL 5.75 mEq/
L
®
11.0 mg/dL 5.5 mEq/L
2
≥ 0.1%
< 0.1%
®
2.5
OXAROL
® INJECTION 2.5 ΜG
027425
®
5
OXAROL
® INJECTION 5 ΜG
027424
<2.0
>
(
1
)
17 Ichikawa F, et al. Nephrology. 1998; 4: 391.
18 Internal data: Pharmacological study
Effect on osteoblasts, in vitro .
19 Internal data: pharmacokinetic study
mass balance study .
20 Internal data: pharmacokinetic study
in vitro metabolizing organs .
21 Internal data: pharmacokinetic study
Investigation of metabolic
enzymes, in vitro .
22 Internal data: clinical study
drug use surveillance .
23 Internal data: clinical study
healthy subjects .
1
100
10 ºC
JPI Oct 2015
version 07
260
3
Nipro Pharma Corporation Ise Plant
647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie, Japan
(
4
)
/
AST GOT
ALT GPT
CK CPK
LDH
Al-P
X
5.
1
2
96
65
12
12.5%
®
881
64
83
9.4%
6.
®
®
®
1.1 µg/kg/day
maxacalcitol
7.
®
8.
1
®
2
®
one-point-cut
3
®
9.
1
F344/DuCrj
24
maxacalcitol
F344
18
maxacalcitol
2
977
®
34
3.5%
38
ECG
15
1
AV
T
6
3
ECG
®
ECG
1
1
1
i
6
3.3 µg
6.6 µg
AUC
0
pg
•
h/mL
354
135
795
192
min
108.1
45.9
138.7
39.9
mL/h/kg
237
70
174
50
mL/kg
259
48
362
32
maxacalcitol
0
1
2
h
pg/mL
1000
100
3.3 µg/body
0
1
2
3
4
h
pg/mL
1000
100
6.6 µg/body
ii
5
2
1
4
3.3 µg
®
1
1
2
2
14
26
10-17.5 µg
®
1
1
AUC
maxacalcitol
2
1
mass balance
200 µg
[
2
β 
-
3
H
]
maxac