COSOPT-S OPHTHALMIC SOLUTION

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Dorzolamide Hydrochloride 22.26mg/ml eqv. Dorzolamide base; Timolol Maleate 6.83mg/ml eqv. Timolol base

Verfügbar ab:

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

ATC-Code:

S01ED51

Darreichungsform:

SOLUTION, STERILE

Zusammensetzung:

Dorzolamide Hydrochloride 22.26mg/ml eqv. Dorzolamide base 20mg/ml; Timolol Maleate 6.83mg/ml eqv. Timolol base 5mg/ml

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

Prescription Only

Hergestellt von:

Santen Pharmaceutical Co., Ltd. Noto Plant

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2018-02-26

Fachinformation

COSOPT-S
OPHTHALMIC SOLUTION
(DORZOLAMIDE 20 mg/mL, TIMOLOL 5mg/mL)
1.
NAME OF THE MEDICINAL PRODUCT
COSOPT-S Ophthalmic 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic solution, single dose container.
Clear, colourless to nearly colourless, slightly viscous solution,
with a pH between 5.5 and 5.8, and an osmolarity of 242-323 mOsM.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COSOPT-S is indicated in the treatment of elevated intraocular
pressure (IOP) in patients with ocular hypertension, open-angle
glaucoma, pseudoexfoliative glaucoma or other
secondary open-angle glaucomas when concomitant therapy is
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of COSOPT-S in the (conjunctival sac of the)
affected eye(s) two times daily.
If another topical ophthalmic agent is being used, COSOPT-S and the
other agent should be administered at least ten minutes apart.
This medicinal product is a sterile solution that does not contain a
preservative. The solution from one individual single dose container
is to be used immediately after opening
for administration to the affected eye(s). Since sterility cannot be
maintained after the individual single dose container is opened, any
remaining contents must be discarded
immediately after administration.
Patients should be instructed to wash their hands before use and avoid
allowing the container to come into contact with the eye or
surrounding structures as this could cause
injury to the eye (see instructions for use).
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.
When using nasolacrimal occ