OCTIM Nasal spray Ref.[27954] Active ingredients: Desmopressin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

OCTIM Nasal Spray.

Pharmaceutical Form

Nasal Spray, Solution.

Clear, colourless solution.

Qualitative and quantitative composition

Desmopressin acetate 150 micrograms per actuation.

For excipients, see 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

Sodium chloride
Citric acid monohydrate
Disodium phosphate dihydrate
Benzalkonium chloride soln 50%
Purified water

Pack sizes and marketing

Multidose container, Type I glass vial with a pre-compression pump set comprising of a spray pump with a metering valve, nasal applicator and protection cap.

Pack size: 2.5ml (25 sprays).

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

PL 03194/0056

25th October 2002

Drugs

Drug Countries
OCTIM France, United Kingdom

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