MINIRIN

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

DESMOPRESSIN ACETATE

Tilgængelig fra:

ABBOTT INDONESIA - Indonesia

INN (International Name):

DESMOPRESSIN ACETATE

Dosering:

0.1 MG

Lægemiddelform:

NASAL SPRAY

Enheder i pakken:

DUS, 1 BOTOL @ 2.5 ML

Fremstillet af:

FERRING GMBH - Federal Republic of Germany

Autorisation dato:

2020-01-14

Produktets egenskaber

PROPOSED PACKAGING MATERIAL
Code
MINSPR(2.5ml)-I-ID-01.05
Size
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
MINSPR(2.5ml)-I-ID-01.04
Changes
Referring BPOM Letter date 09-Dec-2019
Reference
☒
CCDS version: 2012/08 Ver 04
☐
Core PIL version:
☒
SPC country/version/date: SE 23-Jun-2014
☒
LAC no.: 633 (SEA), 925, 939, 953 approved in
13-Dec-2019
Name & Date
INS, 20-Dec-2019
1 | P a g e
MINIRIN
®
Desmopressin acetate
Nasal Spray 10mcg/dose (0.1 mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.1 mg desmopressin acetate equivalent
to 89 µg desmopressin,
and 0.1 mg
benzalkonium chloride. Excipients: Benzalkonium chloride (solution),
sodium chloride, citric acid
monohydrate (E 330), disodium phosphate dihydrate, and purified water.
PHARMACEUTICAL FORM
Nasal spray, solution.
THERAPEUTIC INDICATIONS
Minirin Nasal Spray is indicated for the management of central
diabetes insipidus and testing of renal
concentration capacity in adults and children.
POSOLOGY AND METHOD OF ADMINISTRATION
_Central diabetes insipidus: _
Individual dosing after testing. The normal dose in adults is 10-20
mcg 1-2 times daily. in children 10
mcg 1-2 times daily.
_Testing of renal concentration capacity _
Adults : Two sprays into each nostril (a total of 40 micrograms)
Children : (1-15 years): One spray into each nostril (a total of 20
micrograms).
CONTRAINDICATIONS
MINIRIN
®
must NOT be used in:
•
habitual or psychogenic polydipsia (resulting in a urine production
exceeding 40 ml/kg/24
hours);
•
syndrome of inappropriate ADH secretion (SIADH);
•
known hyponatraemia;
•
known
or
suspected
cardiac
insufficiency
and
other
conditions
requiring
treatment
with
diuretics;
•
moderate and severe renal insufficiency (creatinine clearance below 50
ml/min);
•
hypersensitivity to the active substances or to any of the excipients.
•
Before prescribing MINIRIN, the diagnoses of alcohol abuse should be
excluded
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
MINIRIN
®
nasal
formulations
sh