DESMOPRESSIN Nasal spray, solution

Active ingredients: Desmopressin

Product name and form

Desmopressin Spray 10 Micrograms/dose, nasal spray, solution.

Pharmaceutical Form

Nasal spray, solution.

Clear colourless solution.

Qualitative and quantitative composition

1 ml of nasal spray, solution contains:

100 micrograms desmopressin acetate trihydrate corresponding to 89 micrograms desmopressin.

One actuation of 0.1 ml delivers 10 micrograms of desmopressin acetate trihydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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.

List of Excipients

Citric acid, monohydrate
Disodium phosphate dihydrate
Sodium chloride
Purified water

Pack sizes and marketing

Type I amber glass bottle fitted with a metering pump composed of polypropylene, polyethylene and thermoplastic components secured with a snap on system.

Pack sizes: 6 ml.

Marketing authorization holder

Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL 35533/0145

08/04/2007