Šalis: Taivanas
kalba: kinų
Šaltinis: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ATOSIBAN ACETATE CORRESPONDING TO ATOSIBAN
輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)
G02CX01
注射劑
ATOSIBAN ACETATE CORRESPONDING TO ATOSIBAN (7600001820) MG
小瓶
製 劑
限由醫師使用
FERRING GMBH WITTLAND 11, D-24109 KIEL, GERMANY DE
atosiban
延遲妊娠婦女迫切的早產。
有效日期: 2026/11/13; 英文品名: Tractocile concentrate for solution for infusion 7.5mg/ml
2006-11-13
2009053314 7.5atosiban 7.5atosiban atosiban 0.75 mg/ml. Mannitol, hydrochloric acid 1M and water for injections (0.9 ml)6.75 (5 ml)37.5 TRACTOCILE ® - 30304 - 1-3(0-3)50% - 18 - 24-33 - TRACTOCILE ® TRACTOCILE ® TRACTOCILE ® 7.5 mg/ml6.753 TRACTOCILE ® 7.5 mg/ml ( 300/)TRACTOCILE ® 7.5 mg/ml ( 100 / ) 45 48 TRACTOCILE ® 330 (atosiban ) TRACTOCILE ® TRACTOCILE ® TRACTOCILE ® atosiban 1-(3- )-2-(O- -D- )-4-L- -8-L- - Atosiban atosiban Atosiban Atosiban atosiban atosiban 10 12 (≤4 /) III (CAP-001) 742 23 33 atosiban ( ) β- ( 7 7 TRACTOCILE ® 59.6% (n=201) β- 47.7% (n=163, p=0.0004) CAP-001 TRACTOCILE ® (n=48, 14.2%) (p=0.0003) β- (n=20, 5.8%) CAP-001 24 28 7 atosiban β- (n=129 ) 48 atosiban β- (p=0.37) atosiban 35.9 (3.9) β-35.3 (4.2) ( 30 ) Atosiban 2491 (813) β- 2461 (831) (p=0.58) atosiban β- III 361atosiban 73 8 2 () atosiban 24 atosiban () / 5/295 (1.7)atosiban 15/288 (5.2)Atosiban Atosiban 20 24 atosiban (19 atosiban 4 ) 24 ( 1.7 atosiban 1.5 ) atosiban (10-300 /12) atosiban (10-300 / 6-12 ) ( 442±73 ng/ml298533 ng/ml ) (t α ) 0.21±0.01 (t β ) 1.7±0.3 41.8±8.2 / 18.3±6.8 atosiban 46 48 Atosiban Atosibanatosiban 300/ /atosiban 0.12 M1(des- (Orn 8 , Gly-NH 2 9 ) -[Mpa 1 ,D-Tyr (Et) 2 , Thr 4 ]-oxytocin) atosiban 1.4 2.8 M1 atosiban atosiban M1 50 atosiban M1oxytocinatosiban 10 M1() TRACTOCILE ® () Atosiban Cytochrome P450 ( ) ( ) (20 mg/kg/day ) atosiban oxytocin Atosiban 4 24 28°C 0.9 TRACTOCILE ® 7.5 / 0.9 TRACTOCILE ® 7.5/ () 7.5 / TRACTOCILE ® - 0.9% (w/v) - - 5% (w/v) 100 10 10 7.5 / TRACTOCILE ® ( 5 ) 1 0 0 7 5 TRACTOCILE ® 24 18 3 3 8 100 / TRACTOCILE ® ( ) Ferring GmbH Wittland 11, D-24109 Kiel, Germany Ferring Léčiva a.s. Ke Skále 455, 252 42 Vestec u Prahy, Czech Republic 11111 024562 TRACTOCILE ® SOLUTION FOR INJECTION 7.5 MG/ML 024561 TRACTOCILE ® CONCENTRATE FOR SOLUTION FOR INFUSION 7.5 MG/ML 1 2 3 0.9 3 1 24/ 8/ 6.75 18/ 6/ MedDRA (≥10%) (≥1- <10%) (≥0.1- <1%) (≥0.01- <0.1%) TRACTOCILE ® TRACTOCILE ® 7.5 mg/mlTRACTOCILE ® 7.5 mg/ml TRACTOCILE ® Perskaitykite visą dokumentą