DDAVP 100micrograms/ml intranasal solution

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Desmopressin acetate

Доступна з:

Ferring Pharmaceuticals Ltd

Код атс:

H01BA02

ІПН (Міжнародна Ім'я):

Desmopressin acetate

Дозування:

100microgram/1ml

Фармацевтична форма:

Nasal drops

Адміністрація маршрут:

Nasal

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 06050200; GTIN: 5015919400112

інформаційний буклет

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
●
Keep this leaflet, you may need to use 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.
Your
medicine
is
called
DDAVP/Desmopressin
Intranasal Solution.
It is a clear, colourless solution for
nasal use only.
●
each 1ml of the solution contains 100 micrograms of
the active ingredient, desmopressin acetate
●
other ingredients in this medicine are chlorobutanol
(preservative),
sodium
chloride
to
adjust
the
concentration, a small amount of hydrochloric acid to
adjust the acidity of the solution and purified water
●
it is presented in a brown glass vial covered with a plastic
cap. A calibrated plastic tube (rhinyle) is provided with
each pack to enable you to administer your prescribed
dose. Each vial contains 2.5ml of solution.
Marketing Authorisation Holder: Ferring Pharmaceuticals
Ltd., The Courtyard, Waterside Drive, Langley, Berkshire
SL3 6EZ (UK).
Manufacturer: Ferring AB, Soldattorpsvägen 5, SE-200 61
Limhamn, Sweden.
1.
WHAT DDAVP/DESMOPRESSIN INTRANASAL
SOLUTION IS AND WHAT IT IS USED FOR
This
medicine
is
for
nasal
use
only.
It
contains
desmopressin
acetate,
an
antidiuretic
(reduces
urine
production). It is used:
●
to diagnose and treat cranial diabetes insipidus (a
condition
which
causes
extreme
thirst
and
the
continuous production of large volumes of dilute urine).
_IMPORTANT:_
_This _
_should _
_not _
_be _
_confused _
_with_
_diabetes mellitus (sugar diabetes)_
●
to treat patients with multiple sclerosis suffering from
nocturia (the need to get up at night to pass urine)
●
as
a
test
to
check
if
the
kidneys
are
functioning
properly (renal function test).
2.
BEFORE YOU USE DDAVP/DESMOPRESSIN
INTRANASAL SOLUTION
There are general restrictions, precautions and warnings
which apply to all patients using this medicine and there
are
a

Характеристики продукта

OBJECT 1
DDAVP/DESMOPRESSIN INTRANASAL SOLUTION
Summary of Product Characteristics Updated 25-Jul-2012 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
DDAVP
®
/Desmopressin Intranasal Solution
2. Qualitative and quantitative composition
Desmopressin acetate 0.01% w/v
3. Pharmaceutical form
Aqueous solution for intranasal administration
4. Clinical particulars
4.1 Therapeutic indications
DDAVP
®
/Desmopressin Intranasal Solution is indicated for:
1) The diagnosis and treatment of vasopressin-sensitive cranial
diabetes insipidus.
2) The treatment of nocturia associated with multiple sclerosis where
other treatments have failed.
3) Establishing renal concentration capacity.
4.2 Posology and method of administration
TREATMENT OF DIABETES INSIPIDUS:
Dosage is individual but clinical experience has shown that the
average maintenance doses are as follows:
_Adults_: 10 to 20 micrograms once or twice daily.
_Elderly_: 10 to 20 micrograms once or twice daily.
_Children_: 5 to 20 micrograms daily, (a lower dose may be required
for infants).
DIAGNOSIS OF DIABETES INSIPIDUS:
The diagnostic dose in adults and children is 20 micrograms. Failure
to elaborate a concentrated urine
after water deprivation, followed by the ability to do so after the
administration of Desmopressin confirms
the diagnosis of cranial diabetes insipidus. Failure to concentrate
after the administration suggests
nephrogenic diabetes insipidus.
TREATMENT OF NOCTURIA:
For multiple sclerosis patients up to 65 years of age with normal
renal function suffering from nocturia
the dose is 10 to 20 micrograms at bed time. Not more than one dose
should be used in any 24 hour
period.
RENAL FUNCTION TESTING:
To establish renal concentration capacity, the following single doses
are recommended:
Adults: 40 micrograms
Elderly: 40 micrograms
Children (1 - 15 years): 20 micrograms
Infants (to 1 year): 10 micrograms
Adults and children with normal renal function can be expected to
achieve concentrations above
700mOsm/kg in the period of 5-9 hours following