MINIRIN ORAL LYOPHILISATE 240 MCG

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Desmopressin acetate 270 mcg eqv to Desmopressin

Saatavilla:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC-koodi:

H01BA02

Lääkemuoto:

TABLET, ORALLY DISINTEGRATING

Koostumus:

Desmopressin acetate 270 mcg eqv to Desmopressin 240 mcg

Antoreitti:

SUBLINGUAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Catalent UK Swindon Zydis Limited

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2019-01-22

Valmisteyhteenveto

MINIRIN
®
ORAL LYOPHILISATES 60 ΜG, 120 ΜG AND 240UG
NAME AND STRENGTH OF ACTIVE SUBSTANCE
MINIRIN
®
oral lyophilisate 60 μg:
Each unit contains 60 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
oral lyophilisate 120 μg:
Each unit contains 120 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
oral lyophilisate 240 μg:
Each unit contains 240 μg desmopressin (free base), added as
desmopressin acetate.
Excipients: Gelatin, mannitol (E421) and citric acid (anhydrous).
PHARMACEUTICAL FORM
MINIRIN
®
oral lyophilisate 60 μg: White, round, oral lyophilisate marked with
a drop shaped figure on one side.
MINIRIN
®
oral lyophilisate 120 μg: White, round, oral lyophilisate marked with
two drop shaped figures on one side.
MINIRIN
®
oral lyophilisate 240 μg: White, round, oral lyophilisate marked with
three drop shaped figures on one side.
THERAPEUTIC INDICATIONS
MINIRIN
®
oral lyophilisate is indicated for the treatment of central diabetes
insipidus.
MINIRIN
®
oral lyophilisate is indicated for the treatment of primary nocturnal
enuresis in patients (from 5 years of age) with normal ability to
concentrate urine.
POSOLOGY AND METHOD OF ADMINISTRATION
General
Method of administration: MINIRIN
®
oral lyophilisate is placed under the tongue where it dissolves
without the need for water.
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 the total daily
sublingual dose normally lies in the range of 120 μg to 720 μg. A
suitable starting dose in adu