骨復舒膠囊 400 毫克

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:

DISODIUM CLODRONATE (TETRAHYDRATE)

可用日期:

臺灣拜耳股份有限公司 台北市信義區信義路5段7號53樓 (23167184)

ATC代码:

M05BA02

药物剂型:

膠囊劑

组成:

DISODIUM CLODRONATE (TETRAHYDRATE) (6400091410) MG

每包单位数:

盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

BAYER OY (一)POSTAL ADDRESS：P.O. BOX 415,20101 TURKU, FINLAND(二)STREET ADDRESS：PANSIONTIE 47, 20210 TURKU, FINLAND FI

治疗领域:

clodronic acid

疗效迹象:

惡性腫瘤之蝕骨性骨頭轉栘，惡性高血鈣症。

產品總結:

註銷日期: 2022/07/21; 註銷理由: 逾期展延; 有效日期: 2021/05/24; 英文品名: BONEFOS CAPSULES 400MG

授权状态:

已註銷

授权日期:

1997-07-16

资料单张

1.
400
2.
400 mg disodium clodronate
3.
1“Bonefos”
4.
4.1
4.2
Clodronate
1600mg
1600mg
(
)
Clodronate
Clodronate


65

2400
3200mg
1600mg
1600mg
3200mg

Clodronate
1600mg
Clodronate
4.3
4.4
CLODRONATE
CLODRONATE
(4.2)
/
(
)
(EG.
)
(
/
)
)
/
(SUBTROCHANTERIC FRACTURES)
(DIAPHYSEAL FEMORAL
FRACTURES)
BONEFOS
(LESSER TROCHANTER)
(SUPRACONDYLAR FLARE)
(FEMORAL SHAFT)
4.5
Clodronate(bisphosphonates)
Clodronate(NSAIDs)
diclofenac
Clodronate
(aminoglycosides)
Estramustine phosphate
clodronate
estramustine
phosphate80%
Clodronate
Clodronate
(
)
Clodronate
/
()
4.6
4.6.1
clodronate
clodronate
4.6.2
clodronate
clodronate
4.7
4.8
ml/min
50-80 ml/min
30-50 ml/min
<30 ml/min
1600()
1200
800
(≥1/100<1/10)
**
**
**
*
**
(≥1/10,000<1/1,000)
( a l k a l i n e
phosphatase)*
2
400
0
2
1
8
0
8
●
Bonefos
Bonefos
Bonefos
()
●
Aspirin
●
(
(serum creatinine)
)
clodronate(
“” )
(NSAIDsdiclofenac)
●
amino-bisphosphonates
zoledronate
pamidronate
(
“
”)
/
Bonefos
Bonefos
Bonefos
Bonefos
()(4.4
)
MedDRA
“
”
ADR
MedDRA
Version 8.1
4.9
●
c l o d r o n a t e
(serum
creatinine)
●
5.
5.1
Clodronate
(hydroxyapatite)
clodronate
Clodronate
clodronate
3
/
clodronate
Clodronate
Clodronate
Clodronate
(osteodystrophy)
Clodronate
Clodronate
(hydroxyproline)
Clodronate
clodronate
5.2
●
c l o d r o n a t e
2%
Clodronate
30
clodronate
clodronate
2
clodronate
clodronate
(
91% 69%)
clodronate
clodronate
●
Clodronate
20
50
Clodronate
2
clodronate
Clodronate
80%
clodronate
(
20%
)
75%
●
clodronate
clodronate
clodronate
5.3
●
LD
50
240mg/kg
2-3
●
12
140
160mg/kg
1-7
80mg/kg
7-13
100-480mg/kg
800mg/kg
clodronate(
)
(
clodronate
)
(
)
(
)
()()
●
clodronate
clodronate
clodronate
●
Clodronate
6.
6.1
lactose monohydrate
talc
calcium stearate
colloidal anhydrous silica
hard gelatin capsule
titanium dioxide (E171)
red iron oxide (E172)
yellow iron oxide (E172)
6.2
6.3
CCDS Version 9.0 / 2011.08.23+(201404 TFDA request_ONJ)
Bayer OY
Pansiontie 47, 20210 Turku, Finland
754
[phone]
>3600mg/kg ()
2200 mg/kg ()