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Iopidine 0.5% Ophthalmic solution (2011)

Active ingredients: Apraclonidine

Product Name and Form

IOPIDINE 5mg/ml Eye Drops, Solution.

Pharmaceutical form

Eye drops, solution.

A colourless to pale yellow solution.

Qualitative and Quantitative Composition

1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).

Excipients: 1 ml of solution contains 0.1 mg benzalkonium chloride

For a full list of excipients, see section 6.1.

Chemical substance
Description
Apraclonidine

Apraclonidine is an α2-adrenergic receptor agonist and a weak α1-adrenergic receptor agonist. It is used for the prevention and treatment of postsurgical intraocular pressure elevation.

List of excipients

Benzalkonium chloride
Sodium acetate (trihydrate)
Sodium chloride
Hydrochloric acid and/or Sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and Marketing

5 ml and/or 10 ml white LDPE DROP-TAINER dispensers with a natural LDPE dispensing plug and white polypropylene closure.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

29 December 1994/Renewed 20 October 2010

Marketing authorization number:

PL 00649/0132