Šalis: Indonezija
kalba: indoneziečių
Šaltinis: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DESMOPRESSIN ACETATE
FERRING PHARMACEUTICALS INDUSTRY - Indonesia
DESMOPRESSIN ACETATE
270 MCG
ORAL LYOPHILISATE
DUS, 3 BLISTER @ 10 ORAL LYOPHILISATE
CATALENT UK SWINDON ZYDIS LIMITED - United Kingdom
2021-12-23
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 Perskaitykite visą dokumentą