Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
None
6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life
The expiry date of the unopened vials is indicated on the packaging materials.
See also sections 6.4, 6.6.

6.4   Special precautions for storage
Unopened vials of Coliracin are stable until the date indicated when stored below       25ºC, protected from light.
For storage conditions of the reconstituted/diluted product see section 6.6.

6.5   Nature and contents of container
A white powder dispensed in 10 ml colorless glass vials with rubber stopper.
Box of 50 vials.
6.6    Special precautions for disposal and other handling
For reconstitution Coliracin should be dissolved in aseptic conditions before use in 6-8 ml of 0.9% sodium chloride or water for injection to form a clear solution.
Following reconstitution, the solution should be diluted to a suitable volume with 0.9% sodium chloride solution. The solution should be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear, colorless and free from particles. The solution is for single use and any remaining solution should be discarded.
Coliracin solution should preferably be freshly prepared and used immediately, but can be stored for no longer than 24h at 2-8 ºC. From a microbiological point of view solutions should be used immediately, unless reconstituted under controlled aseptic conditions.


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