DESMOSPRAY Nasal spray, solution Ref.[49934] Active ingredients: Desmopressin

General

One dose of the spray provides 0.1 ml which corresponds to 10 µg desmopressin acetate.

Method of administration: see instructions in sections 6.5 and 6.6.

Only use Desmospray in patients where oral formulations are not feasible and always start at the lowest dose (see section 4.4).

Fluid restriction should be observed (see indication specific instructions in section 4.4).

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see section 4.4).

Indication specific

Treatment of Nocturia associated with multiple sclerosis

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.

Fluid restriction should be observed, please see section 4.4 Special Warnings and Precautions for Use. In the event of signs of fluid retention/hyponatraemia, treatment should be interrupted.

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 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.

Fluid restriction should be observed, please see section 4.4 Special Warnings and Precautions for Use.

Renal Function Testin

To establish renal concentration capacity, the following single doses are recommended.

Adults: Two sprays into each nostril (a total of 40 micrograms).

Children (1-15 years): One spray into each nostril (a total of 20 micrograms).

Infants (to 1 year): One spray (10 micrograms).

Adults and children with normal renal function can be expected to achieve concentrations above 700mOsm/kg in the period of 59 hours following administration of Desmospray. It is recommended that the bladder should be emptied at the time of administration. After administration of Desmospray, any urine collected within one hour is discarded. During the next 8 hours two portions of urine are collected for osmolality testing. Fluid restriction should be observed, please see section 4.4 Special Warnings and Precautions for Use.

In normal infants a urine concentration of 600mOsm/kg should be achieved in the 5 hour period following the administration of Desmospray. The fluid intake at the two meals following the administration should be restricted to 50% of the ordinary intake in order to avoid water overload.

Special Populations

Older people

The initiation of treatment in older patients (over 65 years) is contraindicated in patients being treated for nocturia associated with multiple sclerosis.

Dosage recommendation for older patients suffering from central diabetes insipidus is the same as for other age groups.

Renal Impairment

Desmospray is contraindicated in case of moderate and severe renal insufficiency (creatinine clearance below 50 ml/min) (see section 4.3)

Hepatic Impairment

In vitro human liver microsome metabolism studies of desmopressin have shown that no significant amount is metabolised in the liver by the cytochrome P450 system. Thus human liver metabolism in vivo by the cytochrome P450 system is unlikely to occur. The effect of desmopressin on the pharmacokinetics of other drugs is likely to be minimal due to its lack of inhibition of the cytochrome P450 drug metabolising system (see section 4.5).

Paediatric Population

Desmospray is indicated for use in the paediatric population (see section 4.1). Dose recommendations are outlined in section 4.2.

Overdose of Desmospray leads to a prolonged duration of action with an increased risk of water retention and hyponatraemia.

Treatment

Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given: Interruption of the desmopressin treatment, restriction of fluid intake and symptomatic treatment as necessary.

3 years.

Do not store above 25°C. Store in the original carton. Store in an upright position.

The spray pack comprises of a 10ml amber glass injection vial fitted with a snap-on tamper-proof pre-compression spray pump, to which a 20 mm nasal applicator is attached. The fill volume is 7.1ml including overage to allow delivery of 60 doses of 0.1ml.

Before Desmospray is used for the first time, prime the pump by pressing downward 4 times or until an even spray is obtained. If the spray has not been used for a week it will be necessary to prime the pump again by pressing it downwards once or until an even spray is obtained.

Instructions for use

The patient should blow his/her nose before using the spray

1. Remove the protection cap.
2. Control that the end of the tube inside the bottle is submerged in the liquid.
3. Re-prime the pump if the spray has not been used within the last week.
4. Once it has been primed, the pump delivers one dose each time pressure is applied.
5. The head must be tipped back slightly while inserting the applicator straight into the nostril.
6. When a higher dose is needed, spray alternatively into each nostril.
7. Replace cap after use and store the bottle in an upright position.

The spray bottle should always be stored in an upright position.

If there is any doubt concerning the correct intake of the dose, the spray should not be re-administered until the next scheduled dose.

In young children, administration should be under strict adult supervision to ensure the correct dosage.