Desmospray Desmopressin Nasal Spray 10mcg/0.1ml

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

DESMOPRESSIN ACETATE

Beschikbaar vanaf:

Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland

ATC-code:

H01BA02

INN (Algemene Internationale Benaming):

DESMOPRESSIN ACETATE 10 µg

farmaceutische vorm:

NASAL SPRAY

Samenstelling:

DESMOPRESSIN ACETATE 10 µg

Prescription-type:

POM

Therapeutisch gebied:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Autorisatie-status:

Authorised

Autorisatie datum:

2006-04-17

Bijsluiter

2009053964
Package Leaflet: Information for the User
Desmospray is a solution for nasal use only. It contains
desmopressin acetate, an antidiuretic (reduces urine
production).
•
if you are allergic to desmopressin or any of the
other ingredients of this medicine (listed in
section 6)
•
if you are over 65 years old
•
if you are taking medication for high blood
pressure or have been told that your blood
pressure is abnormal
•
if you have an illness causing fluid and/or
electrolyte imbalance e.g. vomiting, diarrhoea,
infections or fever
•
if you have a medical condition that could be
made worse by fluid and/or electrolyte
disturbance (conditions where your blood
sodium levels are too low or you are likely to
build up too much water in your body, e.g.
hyponatraemia)
•
if you have cystic fibrosis
•
if you have known hyponatraemia (serum
sodium levels below normal range)
•
if you have syndrome of inappropriate secretion
of anti-diuretic hormone, a hormone regulating
urine production (SIADH)
Do not use Desmospray:
Other medicines and Desmospray
Desmospray with food and drink
Pregnancy and breast feeding
Desmospray contains benzalkonium chloride
When used for nocturia associated with
multiple sclerosis, do not use Desmospray:
Warnings and Precautions
Talk to your doctor or pharmacist before using
Desmospray.
Take special care with Desmospray:
•
if you have difficulty or problems passing urine
•
if you suffer from bladder problems e.g.
incontinence (inability to hold in urine), hesitance in
starting urination, frequent urination and/or urgent
urination
•
if you have been warned that you are at risk of
increased intracranial pressure
•
For nocturia associated with multiple sclerosis:
STOP using Desmospray when suffering from
vomiting and diarrhoea until you are better
Desmospray should be used with caution in very
young and older patients.
If any of these apply to you, or if you are not sure,
contact your doctor or pharmacist before taking
Desmospray.
•
For nocturia associated with multiple sclero

Productkenmerken

Page 1 of 10
1. NAME OF THE MEDICINAL PRODUCT
Desmospray, Desmopressin Nasal Spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Desmospray contains 10 micrograms of desmopressin acetate per
actuation (0.1ml) equivalent to 8.9
micrograms desmopressin.
Excipients:
1 ml Desmospray contains 0.1 mg benzalkonium chloride.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Nasal Spray, Solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desmospray is indicated for:
i)
The treatment of nocturia associated with multiple sclerosis.
ii)
The diagnosis and treatment of vasopressin

sensitive cranial diabetes insipidus.
iii)
Establishing renal concentration capacity.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
GENERAL
One dose of the spray provides 0.1 ml which corresponds to 10 μg
desmopressin acetate.
Method of administration: see instructions in sections 6.5 and 6.6.
Only use Desmospray in patients where oral formulations are not
feasible and always start at the
lowest dose (see section 4.4).
Fluid restriction should be observed (see indication specific
instructions in section 4.4).
In the event of signs or symptoms of water retention and/or
hyponatraemia (headache,
nausea/vomiting, weight gain, and, in severe cases, convulsions)
treatment should be interrupted until
the patient has fully recovered. When restarting treatment strict
fluid restriction should be enforced
(see section 4.4).
INDICATION SPECIFIC
Page 2 of 10
_TREATMENT OF NOCTURIA ASSOCIATED WITH MULTIPLE SCLEROSIS _
For multiple sclerosis patients up to 65 years of age with normal
renal function suffering from
nocturia the dose is one or two sprays intranasally (10 to 20
micrograms) at bedtime. Not more than
one dose should be used in any 24 hour period. If a dose of two sprays
is required, this should be as
one spray into each nostril.
Fluid restriction should be observed, please see section _4.4 Special
Warnings and Precautions for _
_Use. _In the event of signs of fluid retention/hyponatraemia,
tre