"杏輝"杏節挺錠

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)

资料单张 资料单张 (PIL)
04-06-2021
公众评估报告 公众评估报告 (PAR)
11-04-2020

有效成分:

ALENDRONATE SODIUM

可用日期:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84、84之4、84之6、84之7號、冬山鄉中山村新寮路95、95之1、100之7、100之13、100之15、100之16、103、136號 (42042734)

ATC代码:

M05BA04

药物剂型:

錠劑

组成:

ALENDRONATE SODIUM (9200036510) (eq. to Alendronate acid 70mg)MG

每包单位数:

鋁箔盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84號 TW

治疗领域:

alendronic acid

疗效迹象:

停經婦女骨質疏鬆症之治療。男性骨質疏鬆症之治療,以增加骨密度。

產品總結:

有效日期: 2027/09/20; 英文品名: PlusDmax Tablets "Sinphar"

授权日期:

2012-09-20

资料单张

                                PlusDmax
Tablets
2800IU
D
3
(alendronate sodium)
PlusDmax
alendronate sodium
Alendronate sodium
Alendronate sodium
bisphosphonate
Bisphosphonates
pyrophosphate
hydroxyapatite
Cholecalciferol
D
Secosterol
25 hydroxyvitamin D
3
3
1,25-dihydroxyvitamin D (calcitriol
3
)
(parathyroid hormone
hypophosphatemia
1 25 dihydroxyvitamin D
3
D
3
D
D
D
D
PlusDmax
91.37
alendronate monosodium salt
trihydrate
70
alendronic acid
Microcrystalline cellulose
Vitamin-D3
(Cholecalciferol)
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate
Alendronate Sodium
(IV)
2
alendronate
5
70
0.64%
0.6%
Alendronate
2800IU
D
3
Alendronate
alendronate
1
alendronate
(
40%
Alendronate
30
2
Alendronate
Alendronate
60%
prednisone 20
)
Alendronate
20
44%
Cholecalciferol
2
Alendronate
2800IU
D
D
D
3
3
3
AUC
296 4ng-hr/mL
0-120 hrs
D
Cmax
5.9ng/mL
(Tmax
12
Alendronate
2800IU
D
3
D
D
3
3
Alendronate Sodium
1 mg/kg
Alendronate
(
)
28
(
5 ng/mL
78%
Cholecalciferol
D
3
D
25-hydroxyvitamin
3
D
D
3
3
D
vitamin D-binding
3
protein
Alendronate Sodium
Alendronate
Cholecalciferol
D
25-hydroxyvitamin D
3
3
1 25-dihydroxyvitamin D
3
D
(glucuronidation)
3
Alendronate Sodium
14
[
C] Alendronate
72
50%
10
Alendronate
71 mL/min
200 mL/min
6
95%
(terminal half-life
10
Alendronate
Cholecalciferol
D
48
3
2.4% 4
4.9%
Alendronate 70
2800IU
D
D
3
3
24
alendronate
Alendronate
alendronate
Alendronate Sodium
Alendronate
(
)
alendronate
(
)
Cholecalciferol
D
3
Alendronate Sodium
35 mg/kg
3
alendronate
alendronate
(
35
60 mL/min
Alendronate
(
<35 mL/min
alendronate
Cholecalciferol
1 25-dihydroxyvitamin D
3
Alendronate Sodium
alendronate
Cholecalciferol
D
3
(
)
717
(
25-
hydroxyvitamin D
22.2ng/mL[56 nmol/L]
9-90ng/mL[22.5-225 nmol/L])
15
alendronate 70
/
D 2800
D
3
alendronate 70
/
D 2800IU n
350
3
10
)
alendronate70
(n
332
25
)
D
25-hydroxyvitamin D
15 ng/mL(37.5nmol/L)
alendronate 70
/
D 2800IU
alendronate
(
89%
3
68%
25-hydroxyvitamin D
9 ng/mL (22.5nmol/L)
alendronate 70
/
D 2800IU
3
alendronate
(
99% 87%
24
652
24
alendronate 70
/
D 2800
3
2800
D
5600
)
3
D 2800
(n=
                                
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