ALCAINE Eye drops, solution Ref.[8266] Active ingredients: Proparacaine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mount Wellington, Auckland 1060, New Zealand. PO Box 4079, Auckland 1140, New Zealand. Free Phone: 0800 804 079.

Product name and form

ALCAINE TM proxymetacaine hydrochloride Eye Drops 0.5%.

Pharmaceutical Form

Sterile preserved eye drops, solution.

Qualitative and quantitative composition

Alcaine Eye Drops contain the active ingredient proxymetacaine hydrochloride 0.5% (5 mg/mL).

Excipient with known effect: Benzalkonium chloride 0.1 mg in 1 mL as a preservative.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Proparacaine

Proxymetacaine is a potent topical anaesthetic of the ester type. The main site of anaesthetic action is the nerve cell membrane where proxymetacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarisation of the membrane.

List of Excipients

Benzalkonium chloride 0.1 mg in 1 mL as a preservative
Glycerol
Hydrochloric acid and/or sodium hydroxide to adjust pH
Purified water

Pack sizes and marketing

Alcaine Eye Drops come in a 15 mL, dropper bottle consisting of a low density polyethylene.

Marketing authorization holder

Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mount Wellington, Auckland 1060, New Zealand.

PO Box 4079, Auckland 1140, New Zealand.

Free Phone: 0800 804 079.

Marketing authorization dates and numbers

12 July 2018

Drugs

Drug Countries
ALCAINE Canada, Cyprus, Ecuador, Estonia, Hong Kong, Lithuania, New Zealand, Poland, Singapore, Turkey, United States

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