Desmospray 10micrograms/dose nasal spray

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Desmopressin acetate

Доступно од:

Ferring Pharmaceuticals Ltd

АТЦ код:

H01BA02

INN (Међународно име):

Desmopressin acetate

Дозирање:

10microgram/1dose

Фармацеутски облик:

Spray

Пут администрације:

Nasal

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 06050200; GTIN: 5015919411521

Информативни летак

Desmospray
®
desmopressin acetate
PATIENT INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
• Keep this leaflet, you may need to read it again
• If you have further questions, please ask your doctor
or pharmacist
• This medicine has been prescribed for you personally
and you should not pass it on to others. It may harm
them even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IMPORTANT THINGS THAT YOU NEED TO KNOW:
• Desmospray is used
- to treat patients with multiple sclerosis suffering
from nocturia (the need to get up at night to pass
urine), when other treatments have failed
- to diagnose and treat cranial diabetes insipidus (a
condition that causes extreme thirst and the
continuous production of large volumes of dilute
urine)
- as a test to check if the kidneys are functioning
properly (renal function test)
• You should avoid drinking large amounts of fluid while
you are being treated with Desmospray, as this could
lead to a build up of water which dilutes the salt in the
body. This is a serious problem and may lead to
convulsions.
• If you experience unusually bad or prolonged headache,
confusion, unexplained weight gain, ankle swelling,
nausea or vomiting STOP USING DESMOSPRAY. You
should tell your doctor immediately or go to the
casualty department at your nearest hospital.
Now read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine
that might be especially important for you.
In this leaflet:
1. What Desmospray is and what it is used for
2. Before you use Desmospray
3. How to use Desmospray
4. Possible side effects
5. How to store Desmospray
6. Further information
1. WHAT DESMOSPRAY IS AND WHAT IT IS USED FOR
Desmospray is a solution for nasal use only. It contains
Desmopressin acetate, an antidiuretic (reduces urine
production). It is used:
• to treat patie

Карактеристике производа

OBJECT 1
DESMOSPRAY, DESMOPRESSIN NASAL SPRAY
Summary of Product Characteristics Updated 25-Jul-2012 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
DESMOSPRAY
®
, Desmopressin Nasal Spray.
2. Qualitative and quantitative composition
DESMOSPRAY contains 10 micrograms of Demopressin acetate per
actuation.
3. Pharmaceutical form
Nasal spray.
4. Clinical particulars
4.1 Therapeutic indications
DESMOSPRAY is indicated for:
i) The treatment of nocturia associated with multiple sclerosis where
other treatments have failed.
ii) The diagnosis and treatment of vasopressin-sensitive cranial
diabetes insipidus.
iii) Establishing renal concentration capacity.
4.2 Posology and method of administration
TREATMENT OF NOCTURIA:
When DESMOSPRAY is used for the treatment of nocturia associated with
multiple sclerosis, fluid
intake must be limited to a minimum from 1 hour before using the spray
at bedtime until the next morning
and in any case for a minimum of 8 hours after administration.
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.
TREATMENT OF DIABETES INSIPIDUS:
Dosage is individual but clinical experience has shown that the
average maintenance dose in adults and
children is one or two sprays (10 to 20 micrograms) once or twice
daily. If a dose of two sprays is
required, this should be as one spray into each nostril.
DIAGNOSIS OF DIABETES INSIPIDUS:
The diagnostic dose in adults and children is two sprays (20
micrograms). Failure to elaborate a
concentrated urine after water deprivation, followed by the ability to
do so after the administration of
DESMOSPRAY confirms the diagnosis of cranial diabetes insipidus.
Failure to concentrate after the
administration suggests nephrogenic diabetes insipidus.
RENAL FUNCTION TESTING:
Recommended do