COMAREST Ophthalmic solution Ref.[115220] Active ingredients: Latanoprost

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: iPharma (Pty) Ltd, 124 Elevation Avenue, Randjesfontein, Midrand, 1683, South Africa

Product name and form

Comarest, 50 microgram/ml, Ophthalmic Solution.

Pharmaceutical Form

Ophthalmic solution.

Sterile, colourless or pale yellow, clear solution.

Qualitative and quantitative composition

Each millilitre contains latanoprost 50 microgram.

One drop contains approximately 1,5 microgram latanoprost.

Excipients with known effect:

Each millilitre contains benzalkonium chloride 0,02% m/v as preservative.
Sodium dihydrogen phosphate monohydrate (E339i) 7,70 mg/ml.
Disodium phosphate anhydrous (E339ii) 1,55 mg/ml.

For full list of excipients, see section 6.1.

Active Ingredient

The active substance latanoprost, a prostaglandin F analogue, is a selective prostanoid FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humour. Reduction of the IOP in man starts about three to four hours after administration and maximum effect is reached after eight to twelve hours.

List of Excipients

Benzalkonium chloride
Disodium hydrogen phosphate anhydrous (E339ii)
Sodium chloride
Sodium dihydrogen phosphate monohydrate (E339i)
Water for injection

Pack sizes and marketing

It is supplied as a 3 ml solution in a 5 ml clear low density polyethylene (LDPE) bottle with a clear LDPE dropper tip and a high density polyethylene (HDPE) screw cap.

Each bottle contains 3 ml eye drop solution corresponding to approximately 80 drops.

Marketing authorization holder

iPharma (Pty) Ltd, 124 Elevation Avenue, Randjesfontein, Midrand, 1683, South Africa

Marketing authorization dates and numbers

49/15.4/0154

12 July 2022

Drugs

Drug Countries
COMAREST South Africa

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