Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Water for injections,
sodium hydroxide (to adjust the pH)

6.2   Incompatibilities
Admixture of medicinal products containing carbonates, phosphates, sulphates or tartrates may lead to precipitation.

6.3   Shelf life

- of the medicinal product in the unopened container:The expiry date of the product is indicated on the packaging materials

- of the medicinal product after opening of the container:
From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage
Do not store above 250C
Do not freeze.

6.5   Nature and contents of container
The solution for infusion is packed in polyethylene plastic bottles.
Polyethylene plastic bottles:      1 x / 10 x    500 mL

6.6   Special precautions for disposal and other handling
For intravenous use only.
For single use only. Discard any unused solution.
Do not reconnect partially used containers.
Do not use if container or closure is damaged. Use only clear solutions free from visible particles.
Use sterile equipment for the infusion and an aseptic technique when connecting the infusion.
Prime the infusion equipment with the solution prior to the infusion in order to prevent air entering the system.
For further information, please refer to section 4.2.