Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
TRUSOPT 20 mg/ml eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous, solution. |
Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide.
Excipient with known effect: One ml of eye drops solution contains 0.075 mg benzalkonium chloride and one drop contains about 0.002 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dorzolamide |
Dorzolamide is a potent inhibitor of human carbonic anhydrase II. Following topical ocular administration, dorzolamide reduces elevated intra-ocular pressure, whether or not associated with glaucoma. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
TRUSOPT container contains 5 ml of solution. Two alternate containers may be marketed.
White translucent low-density polyethylene (LDPE) container with a transparent linear LDPE dropper tip and a white polypropylene (PP) cap or OCUMETER Plus Ophthalmic Dispenser consists of a translucent, high-density polyethylene container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2-piece cap assembly. The 2-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label.
TRUSOPT is available in the following packaging configurations:
1 × 5 ml (single 5-ml container)
3 × 5 ml (three 5-ml containers)
6 × 5 ml (six 5-ml containers)
Not all pack sizes may be marketed.
Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
PL 16058/0014
Date of first authorisation: 09 January 1995
Date of latest renewal: 11 November 2009
| Drug | Countries | |
|---|---|---|
| TRUSOPT | Austria, Australia, Brazil, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa |
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