Emadine 0.05% w/v, Eye drops, Solution (2011)

Active ingredients: Emadine

Product Name and Form

EMADINE 0.5 mg/ml, Eye Drops, solution.

Eye drops, (solution).

Clear, colourless solution.

Qualitative and Quantitative Composition

1 ml of solution contains emedastine 0.5 mg (as difumarate)

Excipients: Benzalkonium chloride 0.1 mg/ml

For a full list of excipients, see section 6.1

Emadine

Emedastine is a potent selective and topically effective histamine H₁ antagonist. In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.

Benzalkonium chloride 0.1 mg/ml
Trometamol
Sodium chloride
Hypromellose
Hydrochloric acid/sodium hydroxide (to adjust pH)
Purified water

Pack sizes and Marketing

EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.

Not all pack sizes may be marketed.

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

Date of first authorisation: 27th January 1999

Date of last renewal: 29th January 2004

Marketing authorization number:

EU/1/98/095/001-2

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