DDAVP/Desmopressin 4 micrograms/ml Solution for Injection

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

DESMOPRESSIN ACETATE

Disponibbli minn:

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

Kodiċi ATC:

H01BA02

INN (Isem Internazzjonali):

DESMOPRESSIN ACETATE 4 µg/ml

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

DESMOPRESSIN ACETATE 4 µg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2021-08-25

Fuljett ta 'informazzjoni

5009000992
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What is in this leaflet:
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DDAVP/Desmopressin Injection will not be given if you:
Package Leaflet: Information for the User
DDAVP
®
/Desmopressin 4 micrograms/ml Solution for Injection
Desmopressin acetate
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
pharmacist or nurse.
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See Section 4.
1. What DDAVP/Desmopressin Injection is and
what it is used for
2. Before DDAVP/Desmopressin Injection is given
3. How DDAVP/Desmopressin Injection will be given
4. Possible side effects
5. How to store DDAVP/Desmopressin Injection
6. Contents of the pack and other information
1. What DDAVP/Desmopressin Injection is
and what it is used for
DDAVP/Desmopressin Injection is a clear, colourless
solution. It contains desmopressin acetate, an
antidiuretic (reduces urine production).
It is used:
to diagnosis 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)._
during surgery or following trauma in patients with
mild to moderate haemophilia (blood condition) or von
Willebrand’s disease (blood clotting condition) to
increase blood clotting factors _(Note: _
_DDAVP/Desmopressin Injection is not suitable for _
_every patient or for the treatment of all types of _
_haemophilia or von Willebrand’s disease)._
as a test to check if the kidneys are functioning
properly (renal concentration capacity test).
2. Before DDAVP/Desmopressin Injection is
given
• are allergic to des

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DDAVP/Desmopressin 4 micrograms/ml Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml DDAVP/Desmopressin solution for injection contains 4 microgram
desmopressin acetate
equivalent to 3.56 microgram desmopressin.
Excipients with known effect:
This medicinal product contains less than 1 mmol
sodium (23 mg) per ml. For the full list of excipients,
see section 6.1.
3
PHARMACEUTICAL FORM
Solution for
injection.
(Injection)
Clear
colourless
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DDAVP/Desmopressin Injection is indicated for:
1.
For the diagnosis and treatment of cranial diabetes insipidus.
2.
In the control of bleeding in patients with mild to moderate
haemophilia and von
Willebrand’s disease type I and IIA undergoing surgery or following
trauma.
3.
To establish renal concentration capacity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
TREATMENT OF CRANIAL DIABETES INSIPIDUS:
By subcutaneous, intramuscular or intravenous injection.
The injection may be used when the intranasal or oral administration
is considered unsuitable.
Individualise dosage after testing of the effect on urine osmolality
and diuresis at different dose
levels.
Adults: The usual dose is 1 to 4
micrograms given once daily. Children:
Doses from 0.4 micrograms (0.1ml) may
be used.
DIAGNOSIS OF CRANIAL DIABETES INSIPIDUS:
The diagnostic dose in adults and children is 2 micrograms given by
subcutaneous or intramuscular
injection. Failure to elaborate a concentrated urine after water
deprivation, followed by the ability to
do so after the administration of desmopressin confirms a diagnosis of
cranial diabetes insipidus.
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Failure to concentrate after the administration suggests nephrogenic
diabetes insipidus.
When used for diagnostic purposes the fluid intake must be limited to
a maximum of 0.5 litres to
quench thirst from 1 hour before until 8 hours after administration.
MILD TO MODERATE HAEMOPHILIA AND VON WILLEBR