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)
DISODIUM CLODRONATE (TETRAHYDRATE)
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)
M05BA02
注射劑
DISODIUM CLODRONATE (TETRAHYDRATE) (6400091410) MG
安瓿;;盒裝
製 劑
限由醫師使用
BAYER OY (一)POSTAL ADDRESS:P.O. BOX 415,20101 TURKU, FINLAND(二)STREET ADDRESS:PANSIONTIE 47, 20210 TURKU, FINLAND FI
clodronic acid
惡性腫瘤之蝕骨性骨頭轉移,惡性高血鈣症
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
已註銷
1997-06-16
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 阅读完整的文件