Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Monobasic Sodium Phosphate
Dibasic Sodium Phosphate
Sodium hydroxide
Benzalkonium chloride
Water for injections


6.2   Incompatibilities
None known.


6.3   Shelf life
24 months
Discard ‘Tiloptic’ Eye Drops Solution 30 days after first opening the bottle.


6.4   Special precautions for storage
Store below 25°C. Do not Freeze. Protect from light.


6.5   Nature and contents of container
The 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 two-piece cap assembly. The two-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 two perforated tabs on the container label extending on to the cap. The dispenser contains 5 ml of solution.


6.6   Special precautions for disposal and other handling


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.   REGISTRATION HOLDER
Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 9100301.

8.   REGISTRATION NUMBER(S)
113 20 22175