Desmospray, Desmopressin Nasal Spray Solution 10mcg

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

DESMOPRESSIN ACETATE

可用日期:

Ferring Pharmaceuticals Limited

ATC代码:

H01BA02

INN（国际名称）:

DESMOPRESSIN ACETATE

药物剂型:

NASAL SPRAY, SOLUTION

组成:

DESMOPRESSIN ACETATE 0.1 mg/ml

处方类型:

POM

治疗领域:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

授权状态:

Authorised

资料单张

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

产品特点

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.
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.
Page 1 of 8
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 doses for the renal concentration capacity test:
Adults: Two sprays into each nostril (a t