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)
EPOPROSTENOL SODIUM
嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)
C02KX
凍晶注射劑
EPOPROSTENOL SODIUM (2012102710) MG
盒裝
製 劑
限由醫師使用
PATHEON ITALIA S.P.A. VIALE G.B. STUCCHI, 110-20900 MONZA (MB), ITALY IT
Antihypertensives for pulmonary arterial hypertension
適用於治療結締組織疾病續發肺動脈高血壓之WHO功能分級III和IV的患者,以改善運動能力
有效日期: 2028/05/18; 英文品名: VELETRI Lyophilized Powder for Injection 1.5 mg
2018-05-18
® 0.5 VELETRI ® Lyophilized Powder for Injection 0.5 mg ® 1.5 VELETRI ® Lyophilized Powder for Injection 1.5 mg 027438 027437 ----------------------------------------------- ----------------------------------------------- VELETRI WHO IIIIV -------------------------------------------------- -------------------------------------------------- ● - VELETRI 2 ng/kg/min 15 ( ) 2 ng/kg/min [2.1] - ( 15 ) 1 2 ng/kg/min [2.2] ● - VELETRI [2.3] - [2.4) ● - 5 mL 0.9% - VELETRI 1 [2.4] - [2.4] ------------------------------------------------ ------------------------------------------------ (10 mL) 0.5 mg (500,000 ng) 1.5 mg (1,500,000 ng) VELETRI[3] ---------------------------------------------------- ---------------------------------------------------- ● [4] ● [4] ● [4] -------------------------------------------- -------------------------------------------- ● VELETRI [5.1] ● 0.9% [5.1] ● [5.3, 5.4] -------------------------------------------------- -------------------------------------------------- ● - [6.1] - / [6.1] ----------------------------------------------- ----------------------------------------------- ● [7] ● [7] ● [7] "" [16] 1. WHO IIIIV 2. VELETRI (USP) 0.9% (USP) VELETRI " " [5.1] ) 2.1 VELETRI VELETRI 2 ng/kg/min 15 2 ng/kg/min VELETRI 2 ng/kg/min 12 PAH/SSD 2.2 ng/kg/min 7 7 4.1 ng/kg/min 12 11.2 ng/kg/min 3 2 3 ng/kg/min 2.2 VELETRI 15 1 2 ng/kg/min 24 48 15 2 ng/kg/min " " [6.1 6.2] VELETRI VELETRI epoprostenol 2.3 VELETRI "" [2.4] VELETRI 0.22 (in-line filter) VELETRI (1) (2) 2 ng/ kg/min (3) (4) ± 6% (5) VELETRI 3 CADD-1 HFX 5100 (SIMS Deltec) (0.9 mL) 0.22 DEHP 60 2.4 VELETRI (USP ) 0.9% (USP) VELETRI VELETRI VELETRI (25 ° C) 5 mL (USP) 0.9% (USP) VELETRI 1 1 (25 ° C) * 2 ° 8 ° C 8 0.5 mg ≥ 3,000 ng/mL < 15,000 ng/mL 48 24 1.5 mg ≥ 15,000 ng/mL < 60,000 ng/mL 48 48 ≥ 60,000 ng/mL 72 48 * 40 ° C 2 15,000 ng/mL 4 15,000 ng/mL 60,000 ng/mL 8 60,000 ng/mL (> 25 ° 40 ° C) 25 ° C 30 ° C 60,000 ng/mL VELETRI 48 2 ° 8 ° C 8 60,000 ng/mL 24 40 ° C 60,000 ng/mL VE 阅读完整的文件