DEXAMETHASONE Solution for injection

Active ingredients: Dexamethasone

Product name and form

Dexamethasone 3.8 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Colourless aqueous solution.

Qualitative and quantitative composition

Each one ml contains 3.8 mg dexamethasone (as sodium phosphate) which is equivalent to 5.0 mg dexamethasone sodium phosphate.

Excipient with known effect:

Sodium: <1 mmol sodium (23 mg) per dose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Glycerol (E422)
Disodium edetate
Water for injections
Sodium hydroxide (E524) or
Phosphoric acid (E338)

Pack sizes and marketing

2 ml colourless glass vial containing 1 ml of solution. Available in cartons of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0060

Date of first authorisation: 31 March 1989

Date of latest renewal: 18 June 2010