Country: Taiwan
Bahasa: Cina
Sumber: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ILOPROST
台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)
B01AC11
吸入用液劑
ILOPROST (6832002300) MG
盒裝
製 劑
須由醫師處方使用
BERLIMED S.A. C/FRANCISCO ALONSO, 7 POLIGONO INDUSTRIAL SANTA ROSA 28806 ALCALA DE HENARES (MADRID), SPAIN ES
iloprost
原發性肺動脈高血壓。
有效日期: 2028/05/07; 英文品名: Ventavis Nebuliser Solution 20 μg/ml
2018-05-07
1. 20 /Ventavis Nebuliser Solution 20 µg/ml 2. 120iloprost (iloprost trometamol) (6.1“”) 3. 4. 4.1 4.2 “ / ” (4.5) ● Breelib Ventavis 10 microgram/ml 2.5 iloprost ventavis 20 microgram/ml5.0iloprost Ventavis 2.5 iloprost ( ) 5.0 5.0 2.5 69 4-10 ● ● (18 ) ● (5.2) 2.5 3-4 ( 6 ) 5.0 3-4 ● (creatinine) >30 ml/min (Cockroft-Gault ) 30 ml/min iloprost 4.4.5 3-4(4.2“”) 4.4.6 Ventavis Ventavis (4.6“”) iloprost Ventavis(4.6“”) 4.4.7 BREELIB Breelib Breelib 3 Ventavis Breelib Ventavis 10 / 2.5 iloprost 2.5 5.0 Ventavis 10/Ventavis 20 / 5.0 iloprost Ventavis 20 / Ventavis 10 / (“”) 4.5 Iloprost ( 4.4“ ”) Ventavis iloprost ( heparin, coumarin ) ( ( theophylline pentoxifylline dipyridamole trapidil ibudilast) 3 (PDE3) ( amrinone enoximone milrinonecilostazol anagrelide) ) iloprost ( 4.8“ ”) 8 300 (acetylsalicylic acid) iloprost iloprost digoxin t-PA iloprost cytochrome P450 iloprost 4.6 4.6.1 (PH) / ( ) Ventavis Ventavis ( 4.4“ ”) 4.6.2 / iloprost ( 1 iloprost ) Ventavis ( 4.4“ ”) 4.7 4.8 4.8.1 iloprost (≥20%) 4.8.2 Ventavis (MedDRA SOCs)MedDRA (ADR) 131 ≥1/10≥1/100< 1/10 “” 20 / VENTAVIS NEBULISER SOLUTION 20 ΜG/ML 000053 4.3 - ( ) - - - - - - () - - - 4.4 4.4.1 ( 4.5“ ”) (1 2 ) (therapeutic gaps) / / (4.8“”) 4.4.2 Ventavis 85 mm Hg 4.4.3 ( 4.8“ ”) (COPD) 4.4.4 (PVOD) (MEDDRA) * § / § * § * / * / § 4.8.3 ” 4.8.3 (4.4“”) ( ) ( 4.5“ ”) 12.2% iloprost 16.2% 4.9 4.9.1 4.9.2 8 iloprost 10 ml/min/kg iloprost 5.3 • prostacyclin ( ) apathy ()14 ng/kg/min () 14 47 ( ) 26 26 48.7 / / (NOAEL) 10(13)(AUC) • iloprost • iloprost iloprost ( iloprost 1%) • 20 iloprost 26 () 6. 6.1 Trometamol Ethanol Sodium chloride Hydrochloric acid Water for injections 6.2 6.3 6.4 30 6.5 1 ML 100 6.6 / 6.6.1 BreelibVentavis 20/ 5iloprost(MMAD; Mass Median Aerodynamic Diameter)1-5 Ventavis 6.6.2 BREELIB Breelib Ventavis CCDS version 13 / Mar 2017 Berlimed S.A. C / Francisco Alonso 7, Poligono Industrial Santa Rosa, 28806 Alcala de Henares (Madrid), Spain 57101535 Baca dokumen lengkap