骨復舒注射劑

Land: Taiwan

Språk: kinesisk

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

Aktiv ingrediens:

DISODIUM CLODRONATE (TETRAHYDRATE)

Tilgjengelig fra:

臺灣拜耳股份有限公司 台北市信義區信義路五段7號台北101大樓之53至54樓 (23167184)

ATC-kode:

M05BA02

Legemiddelform:

注射劑

Sammensetning:

DISODIUM CLODRONATE (TETRAHYDRATE) (6400091410) MG

Enheter i pakken:

安瓿;;盒裝

Klasse:

製　劑

Resept typen:

限由醫師使用

Produsert av:

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

Terapeutisk område:

clodronic acid

Indikasjoner:

惡性腫瘤之蝕骨性骨頭轉移，惡性高血鈣症

Produkt oppsummering:

註銷日期: 2017/04/10; 註銷理由: 自請註銷; 有效日期: 2016/05/07; 英文品名: BONEFOS 60MG/ML CONCENTRATE FOR PARENTERAL INFUSION

Autorisasjon status:

已註銷

Autorisasjon dato:

1997-06-16

Informasjon til brukeren

1.
®
(Bonefos 60mg/ml Concentrate for Parenteral
Infusion)
2.
1ml
60mg disodium clodronate
5ml
300mg disodium clodronate
3.
4.
4.1
4.2
Clodronate


65
4.2.1 ()
clodronate

Clodronate 300mg (5ml)500ml
(
9mg/ml)
5%
(50mg/ml)
Clodronate
1500mg
500ml

Clodronate
clodronate 300
50%
5
clodronate
4.3
4.4
CLODRONATE
CLODRONATE
(4.2)
/
(
)
(EG.
)
(
/
)
)
/
BONEFOS
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
Creatinineml/min
50-80
12-50
<12
%
25
25-50
50
(≥1/100<1/10)
**
**
**
*
**
(≥1/10,000<1/1,000)
( a l k a l i n e
phosphatase)*
2
®
021809
Bonefos 60mg/ml Concentrate
for Parenteral Infusion
●
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
C l o d r o n a t e
(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
sodium hydroxide
water for injections
6.2
6.3“/”
6.3 /
5ml
500ml
(9mg/ml
)
5%
(50mg/ml)
1500mg
5ml
5
(
25ml)
500ml
(9mg/ml)5%(50mg/ml)
6.4
CCDS Version 9.0 / 2011.08.23+(201404 TFDA request_ONJ)
Ever Pharma Jena GmbH
D-07745 Jena, Otto Schott-Strasse 15, Germany
754
(02)8101-1