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DDAVP 4 MICROGRAMS/ML INJECTION

Active substance(s): DESMOPRESSIN / DESMOPRESSIN / DESMOPRESSIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
DDAVP 4 micrograms/ml Injection.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains Desmopressin acetate 4 micrograms per ml

3.

Pharmaceutical Form
Solution for injection.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
DDAVP 4 micrograms/ml Injection is indicated as follows:
Diagnosis and treatment of cranial diabetes insipidus.
To increase Factor VIII:C and Factor VIII:Ag in patients with mild to
moderate
haemophilia or von Willebrand's disease undergoing surgery or following
trauma.
3. To establish renal concentration capacity.
4. To treat headache resulting from a lumbar puncture.
5. To test for fibrinolytic response.

4.2

Posology and method of administration
Treatment of Cranial Diabetes Insipidus:
By subcutaneous, itntramuscular or intravenous injection
Adults: The usual dose is 1 to 4 micrograms given once daily.

Children and infants: Doses from 0.4 micrograms (0. lml) 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.
Mild to moderate haemophilia and von Willebrand’s disease:
By intravenous administration.
The dose for adults, children and infants is 0.4 micrograms per kilogram body
weight administered by intravenous infusion. Further doses may be
administered at 12 hourly intervals so long as cover is required. As some
patients have shown a diminishing response to successive doses, it is
recommended that monitoring of Factor VIII levels should continue. The dose
should be diluted in SOmI of 0.9% sodium chloride for injection and given
over 20 minutes. This dose should be given immediately prior to surgery or
following trauma. During administration of intravenous Desmopressin,
vasodilation may occur resulting in decreased blood pressure and tachycardia
with facial flushing in some patients.
Increase of Factor VIII levels are dependent on basal levels and are normally
between 2 and 5 times the pretreatment levels. If results from a previous
administration of Desmopressin are not available then blood should be taken
pre-dose and 20 minutes post-dose for assay of Factor VIII levels in order to
monitor response.
Unless contraindicated, when surgery is undertaken, tranexamic acid may be
given orally at the recommended dose from 24 hours beforehand until healing
is complete.
Renal Function Testing:
By subcutaneous or intramuscular injection.
Adults and children can be expected to achieve urine concentrations above
700mOsm/kg in the period of 5 to 9
Hours following a dose of 2 micrograms
DDAVP 4 micrograms/ml Injection. It is recomended that the bladder should
be emptied at the time of administration.
In normal infants, a urine concentration of 600mOsm/kg should be achieved in
the five hour period following a dose of 0.4 micrograms DDAVP 4
micrograms/ml Injection. The fluid intake at the two meals following the
administration should be restricted to 50% of the ordinary intake to avoid
water overload.
Post Lumbar Puncture Headache:
By subcutaneous or intramuscular injection.

Where a headache is thought to be due to a lumbar puncture, an adult patient
can be given a dose of 4 micrograms DDAVP 4 micrograms/ml Injection
which may be repeated 24 hours later if necessary. Alternatively, a
prophylactic dose of 4 micrograms can be given immediately prior to the
lumbar puncture and repeated 24 hours later.
Fibrinolytic Response Testing:
By intravenous administration:
The dose for adults and children is 0.4 micrograms per kilogram body weight
adminstered by intravenous infusion.
The dose should be diluted in 50m1 of 0.9% sodium chloride for injection and
given over 20 minutes. A sample of venous blood should be taken 20 minutes
after the infusion. In patients with a normal response the sample should show
fibrinolytic activity of euglobulin clot precipitate on fibrin plates of at least
240mm2.
4.3

Contraindications
DDAVP 4 micrograms/ml Injection is contraindicated in cases of:
GENERAL:
-habitual and psychogenic polydipsia
RENAL FUNCTION TESTING, TREATMENT OF LUMBAR PUNCTURE
HEADACHE OR FIBRINOLYTIC RESPONSE TESTING:
-should not be carried out in patients with hypertension, heart disease, cardiac
insufficiency and other conditions requiring treatment with diuretic agents
FOR HAEMOSTATlC USE:
-unstable angina pectoris
-decompensated cardiac insufficiency
-von Willebrand's Disease Type IIB where the administration of Desmopressin
may result in pseudothrombocytopenia due to the release of clotting factors
which cause platelet aggregation.

4.4

Special warnings and precautions for use
Precautions:
GENERAL:
Precautions to prevent fluid overload must be taken in
-conditions characterised by fluid and/or electrolyte imbalance
-patients at risk for increased intracranial pressure
Care should be taken with patients who have reduced renal function and/or
cardiovascular disease or cystic fibrosis.

When DDAVP 4 micrograms/ml Injection is used for diagnostic purposes,
fluid intake must be limited and not exceed 0.5 litres from 1 hour before until
8 hours after administration.
Renal concentration capacity testing in children below the age of 1 year should
only be performed under carefully supervised conditions in hospital.
FOR HAEMOSTATIC USE:
When repeated doses are used to control bleeding in haemophilia or von
Willebrand's disease, care should be taken to prevent fluid overload. Fluid
should not be forced, orally or parenterally, and patients should only take as
much fluid as they require to satisfy thirst. Intravenous infusions should not be
left up as a routine after surgery. Fluid accumulation can be readily monitored
by weighing the patient or by determining plasma sodium or osmolality.
Measures to prevent fluid overload must be taken in patients with conditions
requiring treatment with diuretic agents.
Special warnings:
Special attention must be paid to the risk of water retention. The fluid intake
should be restricted to the least possible and the body weight should be
checked regularly.
If there is a gradual increase of the body weight, decrease of serum sodium to
below 130mmol/l or plasma osmolality to below 270mOsm/kg, the fluid
intake must be reduced drastically and the administration of DDAVP 4
micrograms/ml Injection interrupted.
During infusion of DDAVP 4 micrograms/ml Injection for haemostatic use, it
is recommended that the patient's blood pressure is monitored continuously.
DDAVP 4 micrograms/ml Injection does not reduce prolonged bleeding time
in thrombocytopenia.
4.5

Interactions with other Medicaments and other forms of Interaction
Substances which are known to induce SIADH e.g. tricyclic antidepressants,
selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine,
may cause an addictive antidiuretic effect leading to an increased risk of water
retention and/or hyponatremia.
NSAIDs may induce water retention and/or hyponatraemia.

4.6

Pregnancy and Lactation

Pregnancy
Data on a limited number (n = 53) of exposed pregnancies in women with
diabetes insipidus indicate rare cases of malformations in children treated
during pregnancy. To date, no other relevant epidemiological data are
available. Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryonal/foetal development, parturition or postnatal
development.
Caution should be exercised when prescribing to pregnant women. Blood
pressure monitoring is recommended due to the increased risk of preeclampsia.

Lactation
Results from analyses of milk from nursing mothers receiving high dose
Desmopressin (300 micrograms intranasally) indicate that the amounts of
Desmopressin that may be transferred to the child are considerably less than
the amounts required to influence diuresis or haemostasis.

4.7

Effects on Ability to Drive and Use Machines
None

4.8

Undesirable effects
Side-effects include headache, stomach pain and nausea. Isolated cases of allergic
skin reactions and more severe general allergic reactions have been reported. Very
rare cases of emotional disorders including aggression in children have been reported.
Treatment with Desmopressin without concomitant reduction of fluid intake may lead
to water retention/hyponatraemia with accompanying symptoms of headache, nausea,
vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

4.9

Overdose
An overdose of DDAVP 4 micrograms/ml Injection leads to a prolonged
duration of action with an increased risk of water retention and/or
hyponatraemia.
Treatment
Although the treatment of hyponatraemia should be individualised, the
following general recommendations can be given. Hyponatraemia is treated by
discontinuing the desmopressin treatment, fluid restriction and symptomatic
treatment if needed.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Desmopressin is a structural analogue of vasopressin in which the antidiuretic
activity has been enhanced by the order of 10, while the vasopressor effect has
been reduced by the order of 1500. The clinical advantage of this highly
changed ratio of antidiuretic to vasopressor effect is that clinically active
antidiuretic doses are far below the threshold for a vasopressor effect.
Like vasopressin, Desmopressin also increases concentrations of Factor
VIII:C, Factor VIII:Ag and Plasminogen Activator.

5.2

Pharmacokinetic Properties
Following intravenous injection, plasma concentrations of Desmopressin
follow a biexponential curve. The initial fast phase of a few minutes duration
and with a half life of less than 10 minutes is thought mainly to represent the
diffusion of Desmopressin from plasma to its volume of distribution. The
second phase with a half life of 51-158 minutes represents the elimination rate
of Desmopressin from the body.
As a comparison, the half life of vasopressin is less than 10 minutes.
In vitro, in human liver microsome preparations, it has been shown that no
significant amount of desmopressin is metabolised in the liver and thus human
liver metabolism in vivo is not likely to occur.
It is unlikely that desmopressin will interact with drugs affecting hepatic
metabolism, since desmopressin has been shown not to undergo significant
liver metabolism in in vitro studies with human microsomes. However, formal
in vivo interaction studies have not been performed.

5.3

Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are
additional to those already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium Chloride EP

Hydrochloric Acid EP
Water for Injection EP
6.2

Incompatibilities
None known

6.3

Shelf life

6.4

Shelf life of unopened ampoule: 48 months.
Special precautions for storage

To be stored in a refrigerator at 2°C to 8°C.
6.5

Nature and Contents of Container
Carton containing 10 x 1 ml clear Type I glass ampoules.
Each ampoule contains 1 ml of a sterile, clear, colourless solution for
injection.

6.6

Instruction for Use/Handling
As indicated under the posology and method of administration section

7

MARKETING AUTHORISATION HOLDER
Ferring Pharmaceuticals Ltd
Drayton Hall
Church Road
West Drayton
UB7 7PS
UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 03194/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/12/2008

10

DATE OF REVISION OF THE TEXT
07/09/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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