MINIRIN NASAL SPRAY 10 mcgdose

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DESMOPRESSIN 0.089 mg/ml EQV DESMOPRESSIN ACETATE

Available from:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC code:

H01BA02

Dosage:

0.1 mg/ml

Pharmaceutical form:

SPRAY

Composition:

DESMOPRESSIN 0.089 mg/ml EQV DESMOPRESSIN ACETATE 0.1 mg/ml

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Ferring GmbH

Authorization status:

ACTIVE

Authorization date:

1990-01-17

Patient Information leaflet

MINIRIN
®   

Nasal spray 10 microg/dose 

DECLARATION 
Each  ml  of  solution  contains  desmopressin  acetate  0,1  mg,  benzalkonium  chloride  (preservative)  0.1  mg,  constituents,  and 
purified water to 1 ml. 

PRESENTATION 
MINIRIN
®
 nasal spray is 
supplied in bottles provided with precompression spray pumps designed to deliver 100 μl solution (=10 
μg desmopressin acetate) per actuation. 

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  μg 
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 uri

Summary of Product characteristics

05,36-I-SG-02.04; Modified by MELM, 18-Oct-2016; CCDS Update
(DES-13-001), response to IR dated 6-Sep-2016
MINIRIN
®
Nasal spray 10 microg/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
_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
1 dose of the spray provides 0.1 ml, which corresponds to 10 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 indi