MINIRIN NOSE DROPS 0.1 mgml

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

DESMOPRESSIN ACETATE

Предлага се от:

FERRING PHARMACEUTICALS PRIVATE LIMITED

АТС код:

H01BA02

дозиране:

0.1 mg/ml

Лекарствена форма:

SOLUTION

Композиция:

DESMOPRESSIN ACETATE 0.1 mg/ml

Начин на приложение:

NASAL

Вид предписание :

Prescription Only

Произведено от:

Ferring GmbH

Статус Оторизация:

ACTIVE

Дата Оторизация:

1990-01-17

Листовка

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

Данни за продукта

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