COSOPT 20 + 5 Mg/Ml Eye Drops Solution
Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Svojstava lijeka
(SPC)
22-05-2024
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Aktivni sastojci:
DORZOLAMIDE, TIMOLOL
Dostupno od:
Clear Pharmacy
ATC koda:
S01ED51
INN (International ime):
DORZOLAMIDE, TIMOLOL
Doziranje:
20 + 5 Mg/Ml
Farmaceutski oblik:
Eye Drops Solution
Tip recepta:
Product subject to prescription which may be renewed (B)
Područje terapije:
Beta blocking agents
Status autorizacije:
Authorised
Datum autorizacije:
2012-01-13
Svojstava lijeka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to
20 mg dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol.
Excipients: Benzalkonium chloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
_Product imported from ITALY:_
Clear, colourless to nearly colourless, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or
pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose is one drop of COSOPT in the (conjunctival sac of the) affected eye(s) two times daily.
If another topical ophthalmic agent is being used, COSOPT and the other agent should be administered at least ten
minutes apart.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into
contact with the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common
bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from
using contaminated solutions.
Patients should be informed of the correct handling of the OCUMETER PLUS bottles.
_Usage Instructions_
1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap
between the bottle and the cap is normal for an unopened bottle.
2. Tear off the Safety Strip to break the
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