迷你寧錠０．２公絲

Land: Taiwan

Taal: Chinees

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

Werkstoffen:

DESMOPRESSIN ACETATE

Beschikbaar vanaf:

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

farmaceutische vorm:

錠劑

Samenstelling:

DESMOPRESSIN ACETATE (6828000210) MG

Eenheden in pakket:

盒裝;;塑膠瓶裝

klasse:

製　劑

Prescription-type:

須由醫師處方使用

Geproduceerd door:

FERRING INTERNATIONAL CENTER SA CHEMIN DE LA VERGOGNAUSAZ 50, CH-1162 SAINT-PREX, SWITZERLAND CH

Therapeutisch gebied:

desmopressin

therapeutische indicaties:

中樞尿崩症，原發性夜尿症（限用於７歲以上病患），成人因夜間多尿所導致之夜尿症。

Product samenvatting:

註銷日期: 2023/07/11; 註銷理由: 自請註銷; 有效日期: 2023/09/11; 英文品名: MINIRIN TABLETS 0.2MG

Autorisatie-status:

已註銷

Autorisatie datum:

2018-05-22

Bijsluiter

QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN
®
Tablets 0.1 mg:
Each tablet contains desmopressin acetate 0.1 mg equivalent to
desmopressin (free base) 0.089 mg.
MINIRIN
®
Tablets 0.2 mg:
Each tablet contains desmopressin acetate 0.2 mg equivalent to
desmopressin (free base) 0.178 mg.
For a full list of excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
Oral Tablet
Minirin
®
0.1 mg: White, oval and convex tablets with a single score and marked
"0.1" on one side.
Minirin
®
0.2 mg: White, round and convex tablets with a single score and marked
"0.2" on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
THERAPEUTIC INDICATIONS
- Central diabetes insipidus. The use of MINIRIN
®
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.
- Primary nocturnal enuresis in children aged 7 years or more.
- Symptomatic treatment of nocturia in adults associated with
nocturnal polyuria, i.e. nocturnal urine production exceeding
bladder capacity.
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Effect of food: Food intake may reduce the intensity and duration of
the antidiuretic effect at low doses of desmopressin (see
section INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION)
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
WARNINGS AND PRECAUTIONS FOR USE).
If adequate clinical effect is not achieved within 4 weeks following
appropriate dose titration the medication should be
discontinued.
INDICATION SPECIFIC
_Central diabetes insipidus:_
Dosage is individual in diabetes insipidus but c