DDAVP/Desmopressin 4 micrograms/ml Solution for Injection

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

DESMOPRESSIN ACETATE

থেকে পাওয়া:

Ferring Ireland Ltd

এটিসি কোড:

H01BA; H01BA02

INN (International Name):

DESMOPRESSIN ACETATE

ডোজ:

4 microgram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

প্রেসক্রিপশন টাইপ:

Product subject to Restricted Prescription (C)

Therapeutic area:

Vasopressin and analogues; desmopressin

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1977-02-17

তথ্য লিফলেট

5009000660
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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

পণ্য বৈশিষ্ট্য

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.
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 WILLEBRAND’S DISEASE
By intrave