諾樂寧凍晶口溶錠25μg

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)

有效成分:

DESMOPRESSIN

可用日期:

輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)

ATC代码:

H01BA02

药物剂型:

凍晶口溶錠

组成:

DESMOPRESSIN (6828000200) MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

CATALENT U.K. SWINDON ZYDIS LTD. FRANKLAND ROAD, BLAGROVE, SWINDON, WILTSHIRE SN5 8RU, UNITED KINGDOM GB

治疗领域:

desmopressin

疗效迹象:

成人因夜間多尿所導致之夜尿症。

產品總結:

有效日期: 2028/02/22; 英文品名: Nocdurna 25μg

授权日期:

2018-02-22

资料单张

[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