迷你寧鼻腔噴霧劑１０ＵＧ／ＤＯＳＥ

Country: Թայվան

language: չինարեն

source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

active_ingredient:

DESMOPRESSIN ACETATE

MAH:

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_code:

H01BA02

pharmaceutical_form:

鼻用噴液劑

composition:

DESMOPRESSIN ACETATE (6828000210) MG

units_in_package:

瓶裝

class:

製　劑

prescription_type:

須由醫師處方使用

manufactured_by:

ZUELLIG PHARMA SPECIALTY SOLUTIONS GROUP PTE. LTD. 15 CHANGI NORTH WAY #01-02, #02-02, #02-10, SINGAPORE 498770 SG

therapeutic_area:

desmopressin

therapeutic_indication:

中樞尿崩症、腎功能試驗。

leaflet_short:

有效日期: 2027/09/03; 英文品名: MINIRIN NASAL SPRAY 10 UG/DOSE

authorization_date:

2022-06-07

PIL

MINIRIN
®
Nasal spray 10 µg/dose
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains desmopressin acetate 0.1 mg
For full list of excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
Solution.
THERAPEUTIC INDICATIONS
-Treatment of central diabetes insipidus
The use of MINIRIN
®
nasal spray in patients with an established diagnosis will result
in a reduction in urinary output with concomitant increase in urine
osmolality and
decrease in plasma osmolality. This will result in decreased urinary
frequency and
decreased nocturia.
-Testing of renal concentrating capacity test
MINIRIN
®
nasal spray can be used to test the capacity of the kidneys to
concentrate
urine; as a diagnostic aid in the examination of the kidney function.
This is especially
useful in the differential diagnosis between level of urinary tract
infections. Cystitis will
opposite to pyelonephritis not cause a subnormal ability to
concentrate urine.
POSOLOGY AND METHOD OF ADMINISTRATION
One dose of the spray provides 0.1 ml, which corresponds to 10 µg
desmopressin
acetate.
Method of administration: see instructions in sections NATURE AND
CONTENTS OF
CONTAINER and SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER
HANDLING.
Only use MINIRIN
®
spray in patients where oral formulations are not feasible and
always start at the lowest dose (see section SPECIAL WARNING AND
PRECAUTIONS FOR USE).
In the event of signs or symptoms of water retention and/or
hyponatraemia
(headache, nausea/vomiting, weight gain, and, in severe cases,
convulsions)
treatment should be interrupted until the patient has fully recovered.
When restarting
treatment strict fluid restriction should be enforced (see section
SPECIAL WARNING
AND PRECAUTIONS FOR USE).
INDICATION SPECIFIC
_Central diabetes insipidus: _
Dosage is individual. In adults, the intranasal dose is usually 10-20
µg 1-2 times daily.
In children, it is usually 5-10 µg 1-2 times daily. In the event of
signs of water
retention, the dose should be adjusted.
_Testing of renal concentration capac