MINIRIN MELT

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

DESMOPRESSIN ACETATE

Доступно од:

FERRING PHARMACEUTICALS INDUSTRY - Indonesia

INN (Међународно име):

DESMOPRESSIN ACETATE

Дозирање:

135 MCG

Фармацеутски облик:

ORAL LYOPHILISATE

Јединице у пакету:

DUS, 3 BLISTER @ 10 ORAL LYOPHILISATE

Произведен од:

CATALENT UK SWINDON ZYDIS LIMITED - United Kingdom

Датум одобрења:

2021-12-23

Карактеристике производа

PROPOSED PACKAGING MATERIAL
Code
MINMEL60,120,240-I-ID-02.02
Size
NA
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: 186724
Code of previous version
MINMEL60,120,240-I-ID-02.01
Changes
BPOM Deficiency Date 14 Sep 2021 (Revision City)
Reference
☒
CCDS version: 2010/07 Version 02
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
HINI, 30 Sep 2021
1
MINIRIN MELT
®
DESMOPRESSIN ACETATE
Oral Lyophilisates 60 μg, 120 μg, 240 μg
COMPOSITION
MINIRIN
®
Melt, 60 μg:
Each unit contains 60 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
Melt, 120 μg:
Each unit contains 120 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
Melt, 240 μg:
Each unit contains 240 μg desmopressin (free base), added as
desmopressin acetate.
Excipients: Gelatin, Mannitol, E421, Citric acid, anhydrous
PHARMACEUTICAL DOSAGE FORM
Oral lyophilisate
MINIRIN
®
Melt, 60 μg:
White, round, oral lyophilisate marked with a drop shaped figure on
one side.
MINIRIN
®
Melt, 120 μg:
White, round, oral lyophilisate marked with two drop shaped figures on
one side.
MINIRIN
®
Melt, 240 μg:
White, round, oral lyophilisate marked with three drop shaped figures
on one side.
INDICATIONS
•
Central diabetes insipidus.
•
Primary nocturnal enuresis in children aged 5 years or more.
•
Symptomatic treatment of nocturia in adult associated with nocturnal
polyuria, i.e nocturnal urine
production exceeding bladder capacity.
The use of Minirin in patient 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.
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Method of administration: MINIRIN
®
Melt is placed under the tongue where it dissolves without the need
for water.
Effect of food: Food intake may reduce the intensity and duration of
the antidiuretic effect at low doses
of desmopressin (see section Int