국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
DESMOPRESSIN ACETATE
FERRING PHARMACEUTICALS PRIVATE LIMITED
H01BA02
0.1 mg/ml
SOLUTION
DESMOPRESSIN ACETATE 0.1 mg/ml
NASAL
Prescription Only
Ferring GmbH
ACTIVE
1990-01-17
MINIRIN ® Intranasal Solution 0.1mg/ml DECLARATION Each ml of solution contains desmopressin acetate 0.1mg, chlorobutanol (preservative) 5mg, sodium chloride, hydrochloric acid (to adjust pH to 4) and purified water to 1ml. PRESENTATION MINIRIN ® intranasal solution is supplied in a bottle with two rhinyle tubes marked with volumes from 0.025ml to 0.2ml. PROPERTIES MINIRIN ® contains desmopressin, a structural analogue of the natural hormone arginine vasopressin. Two chemical changes have been made to the natural hormone, namely desamination of 1-cysteine and substitution of 8-L-arginine by 8-D-arginine. These structural changes result in a compound with significantly increased antidiuretic potency, very little activity on smooth muscle, hence the avoidance of undesirable pressor side effects. Intranasal administration of 10-20 ȝg desmopressin provides an antidiuretic effect, lasting in most patients for 8-12 hours. INDICATIONS _Central diabetes insipidus _ The use of MINIRIN ® in patients 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. _Renal concentrating capacity test _ MINIRIN ® can be used to test the capacity of the kidneys to concentrate urine; as a diagnostic aid in the examination of the kidney function. This is especially useful in the differential diagnosis between level of urinary tract infections. Cystitis will opposite to pyelonephritis not cause a subnormal ability to concentrate urine. CONTRAINDICATIONS MINIRIN ® intranasal solution is contraindicated in cases of: - habitual and psychogenic polydipsia (urine production exceeding 40ml/kg/24 hours) - syndrome of inappropriate ADH secretion (SIADH) - known hyponatra 전체 문서 읽기
04-I-SG-03.04; Modified by MELM, 18-Oct-2016; CCDS Update (DES-13-001), response to IR dated 6-Sep-2016 MINIRIN ® Intranasal Solution 0.1 mg/ml QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 0.1 mg desmopressin acetate equivalent to 89 µg desmopressin. Excipients: Chlorobutanol, sodium chloride, hydrochloric acid (for pH adjustment), purified water. PHARMACEUTICAL FORM Nasal drops, solution. THERAPEUTIC INDICATIONS _Central diabetes insipidus _ The use of MINIRIN ® in patients 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. _Renal concentrating capacity test _ MINIRIN ® can be used to test the capacity of the kidneys to concentrate urine; as a diagnostic aid in the examination of the kidney function. This is especially useful in the differential diagnosis between level of urinary tract infections. Cystitis will opposite to pyelonephritis not cause a subnormal ability to concentrate urine. POSOLOGY AND METHOD OF ADMINISTRATION General The rhinyle tube has a graduated scale corresponding to 2.5 µg, 5 µg, 10 µg, 15 µg and 20 µg desmopressin acetate. MINIRIN ® nasal formulations should be used only when treatment with oral formulations is inappropriate and always start at the lowest dose (see section Special warnings and precautions for use). Fluid restriction should be observed (see indication specific instructions in section Special warnings and precautions for use). If signs of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in serious cases convulsions) develop, treatment should be discontinued until the patient has recovered completely. Fluid intake should be strictly limited when treatment is reinstated (see section Special warnings and precautions for use). Indication specific _Central diabetes insipidus:_ Dosage is individual but clinical experience has shown that the normal daily d 전체 문서 읽기