Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DESMOPRESSIN ACETATE
ABBOTT INDONESIA - Indonesia
DESMOPRESSIN ACETATE
0.1 MG
NASAL SPRAY
DUS, 1 BOTOL @ 2.5 ML
FERRING GMBH - Federal Republic of Germany
2020-01-14
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 read_full_document