Desmospray, Desmopressin Nasal Spray

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

DESMOPRESSIN ACETATE

Dostopno od:

Ferring Ireland Ltd

Koda artikla:

H01BA; H01BA02

INN (mednarodno ime):

DESMOPRESSIN ACETATE

Odmerek:

10 microgram(s)

Farmacevtska oblika:

Nasal spray, solution

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Vasopressin and analogues; desmopressin

Status dovoljenje:

Marketed

Datum dovoljenje:

1987-07-09

Navodilo za uporabo



2009052533
=
No print
area
= Folding
line
=Perforation
Fiber direction

Pharmacode
75 mm from
top and
bottem.
Drawring
E-MS-3001
Size
180x370mm
Package Leaflet: Information for the User
See section 4.
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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desmospray, Desmopressin Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Desmospray contains 10 micrograms of demopressin acetate per actuation
(0.1 ml), equivalent to 8.9
micrograms desmopressin.
Excipients:
1ml Desmospray contains 0.1 mg benzalkonium chloride.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colorless 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
_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.
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