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)
DESMOPRESSIN
輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)
H01BA02
凍晶口溶錠
DESMOPRESSIN (6828000200) MG
鋁箔盒裝
製 劑
須由醫師處方使用
CATALENT U.K. SWINDON ZYDIS LTD. FRANKLAND ROAD, BLAGROVE, SWINDON, WILTSHIRE SN5 8RU, UNITED KINGDOM GB
desmopressin
成人因夜間多尿所導致之夜尿症。
有效日期: 2028/02/22; 英文品名: Nocdurna 50μg
2018-02-22
[FE992026 CS029] Nocdurna ® 10 100 25 25 50 100 5050 5(p = 0.015) 200400800desmopressin 0.25% (95% 0.21 - 0.31%) desmopressin desmopressin 60 240 (AUC) (C max ) 60 Desmopressin0.3 - 0.5 L/kg desmopressin Desmopressin P450 P450 Desmopressin P450 Desmopressin 7.6 L/hr Desmopressin 2.8 52% (44%-60%) / desmopressin AUC (50 ml/min)desmopressin 65 ( ) 1 (≥ 1/10) (≥ 1/100 < 1/10)(≥ 1/1,000< 1/100) (4 - 8) Nocdurna ® ( )3 Nocdurna ® () () Nocdurna ® Nocdurna ® desmopressin ( ) • ; • (40 ml/kg) • • (50 ml/min) • • (SIADH) ( ) Nocdurna ® desmopressin 1 8 / ( /) 65 ( 4 - 8 ) ( ) 50 ( ) Nocdurna ® Desmopressin/ / ( ) desmopressin SIADH (tricyclic antidepressants) (selective serotonin reuptake inhibitors) chlorpromazine (diuretics) carbamazepine (sulfonylurea group) ( chlorpropamide) (NSAID) (thiazide) (loop diuretics) desmopressin (nephrogenic diabetes insipidus) desmopressin desmopressin SIADH / ( chlorpromazine carbamazepine chlorpropamide) ( ) NSAID desmopressin / ( ) desmopressin loperamide desmopressin 3 / 27% desmopressin ( ) () desmopressin desmopressin (n=53) desmopressin (n=216) desmopressin / / cotyledon desmopressin desmopressin acetate (300 ) desmopressin desmopressin Nocdurna ® Nocdurna ® (50 N = 222) (25 N = 219) (13%) (3%)(3%)(2%) Desmopressin 25µg 25desmopressin (free base)desmopressin acetate 50µg 50desmopressin (free base)desmopressin acetate 25 12"25" 50 12"50" 241/3 25 50 ≥ 65 6 5 desmopressin ( ) / ( / ) () (i.e. 135 mmol/L) Nocdurna ® desmopressin 2550 25ΜG NOCDURNA ® 25ΜG 50ΜG NOCDURNA ® 50ΜG 027324 027325 MEDDRA (≥ 1/10) * (≥ 1/100< 1/10) (≥ 1/1,000< 1/100) * 1() Nocdurna ® desmopressin () ATCH01B A02 Nocdurna ® desmopressin ( arginine vasopressin (AVP) )Desmopressin V 2 ( 25 50 ) Nocdurna ® CS29 50% Nocdurna ® 2.7 (95% CI1.3 - 8.1)desmopressin ( ) 268 (CS40 desmopressin 25 ) 395 (CS41 desmopressin 50 75 ) ( ≥ 2 90% 87% ) Nocdurna ® 3 2 baseline (p=0.028) ( ) desmopressin 25 (-1.46) (-1.24) (p = 0.0003) ( ) desmopressin 50 (-1.25) (-0.88) > 33% desmop 阅读完整的文件