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

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Ferring Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Product name and form

Desmospray, Desmopressin Nasal Spray.

Pharmaceutical Form

Nasal spray, solution.

Clear, colorless solution.

Qualitative and quantitative composition

Desmospray contains 10 micrograms of demopressin acetate per actuation (0.1 ml), equivalent to 8.9 micrograms desmopressin.

Excipients: 1ml Desmospray contains 0.1 mg benzalkonium chloride.

For the full list of excipients see section 6.1.

Active Ingredient Description
Desmopressin

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

Benzalkonium chloride solution
Sodium chloride
Citric acid monohydrate
Disodium phosphate dihydrate
Purified water

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA1009/005/001

Date of first authorisation: 09 July 1987
Date of last renewal: 09 July 2007

Drugs

Drug Countries
DESMOSPRAY Ireland, United Kingdom

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