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.
6.5 Nature and contents of container
Cosopt Preservative-Free is available in 0.2 ml low density polyethylene single dose containers in an aluminum sachet containing 15 single -dose containers.
30 x 0.2 ml (2 sachets with 15 single dose containers)
60 x 0.2 ml (4 sachets with 15 single dose containers)
120 x 0.2 ml (8 sachets with 15 single dose containers)
Note: Different shapes of the single-dose containers are available.
Please see section 6.6 for shape-specific diagrams and instructions for use.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
Instructions for use:
existing text & diagram replaced by new diagram AND text below
6. After putting the drop into the eye, throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution.
7. Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORIZATION
Date of first authorisation: 1 September 2006
Date of last renewal:
6 March 2008
10. DATE OF REVISION OF THE TEXT