MINIRIN desmopressin acetate 10 microgram/ actuation nasal spray

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desmopressin acetate, Quantity: 0.1 mg/mL (Equivalent: desmopressin, Qty 0.089 mg/mL)

Available from:

Ferring Pharmaceuticals Pty Ltd

Pharmaceutical form:

Spray, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate dihydrate; citric acid monohydrate; sodium chloride; purified water; benzalkonium chloride

Administration route:

Nasal

Units in package:

1 x 5mL, 1x 6mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Diabetes Insipidus:The treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria.,Nocturnal Enuresis: MINIRIN Nasal Spray is indicated for the symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. MINIRIN Nasal Spray should be used only in patients who are refractory to the enuresis alarm or in patients in whom enuresis alarm is contraindicated or inappropriate, and where the oral administration of desmopressin is not feasible.,Renal Concentrating Capacity: By intranasal administration to adults and children as a diagnostic test to establish renal concentrating capacity.

Product summary:

Visual Identification: Clear colouless solution; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-04-21

Patient Information leaflet

MINIRIN
®
_NASAL SPRAY_
_desmopressin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MINIRIN Nasal
Spray.
It does not contain all the available
information. It does not replace of
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MINIRIN
Nasal Spray against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINIRIN NASAL
SPRAY IS USED FOR
The active ingredient, desmopressin
acetate, in MINIRIN Nasal Spray is a
synthetic version of a naturally
occurring substance produced in the
brain called vasopressin.
It has a number of different actions
on the body including an action on
the kidney to reduce the amount of
urine produced. This means that
MINIRIN Nasal Spray can be used
for several different conditions
including:
•
primary nocturnal enuresis
(bedwetting) in patients over
6 years of age, who have a
normal ability to concentrate
urine and who have not
responded to treatment with an
enuresis alarm or in patients in
whom an enuresis alarm is
contraindicated or inappropriate
and where the oral administration
of desmopressin is not feasible..
•
cranial diabetes insipidus (large
amounts of urine being produced
day and night and constant thirst)
•
as a diagnostic test to establish if
the kidneys have the ability to
concentrate urine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU USE
MINIRIN NASAL SPRAY
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINIRIN NASAL SPRAY
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
desmopressin or any of the
ing

Summary of Product characteristics

Page 1 of 10
#152-v18A
AUSTRALIAN PRODUCT INFORMATION - MINIRIN
® (DESMOPRESSIN ACETATE)
10 MICROGRAMS/ACTUATION NASAL SPRAY
1. NAME OF THE MEDICINE
Desmopressin acetate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN Nasal Spray also contains sodium chloride, citric acid
monohydrate, dibasic sodium phosphate-
dihydrate, benzalkonium chloride solution 50% as preservative and
water-purified.
Desmopressin free base represents 89% of the desmopressin acetate
content. This is due to the difference in
molecular weight as well as the presence of acetic acid/acetate, water
and impurities.
3. PHARMACEUTICAL FORM
Nasal spray, solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diabetes Insipidus
The treatment of ADH-sensitive cranial diabetes insipidus, including
treatment of post-hypophysectomy polydipsia
and polyuria.
Nocturnal Enuresis
MINIRIN Nasal Spray is indicated for the symptomatic treatment of
primary nocturnal enuresis in patients who
have normal ability to concentrate urine. MINIRIN Nasal Spray should
be used only in patients who are refractory
to the enuresis alarm or in patients in whom enuresis alarm is
contraindicated or inappropriate, and where the oral
administration of desmopressin is not feasible.
Renal Concentrating Capacity
By intranasal administration to adults and children as a diagnostic
test to establish renal concentrating capacity.
4.2 DOSE AND METHOD OF ADMINISTRATION
Note: MINIRIN Nasal Spray is for intranasal administration only.
Administration of desmopressin acetate by
intravenous or intramuscular injection may be used when the intranasal
route is inconvenient. Caution: The
intravenous or intramuscular dose is about one tenth of the intranasal
dose.
A.
For ADH-sensitive Cranial Diabetes Insipidus
ADULT
The average daily dose is 10 to 40 micrograms intranasally.
PAEDIATRIC
2.5 to 20 micrograms daily.
The daily dose is usually given as two divided doses. The dosage must
be determined for each individual
patient and adjusted according to the diurnal pattern of response.
Respons