Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sodium dihydrogen phosphate dihydrate
Phosphoric acid (85%) (for pH adjustment)
Water for injections

6.2    Incompatibilities
Grafalon concentrate for solution for infusion must not be mixed with glucose, blood, blood-derivatives, solutions containing lipids, and sodium heparin.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at room temperature. However, from a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are at the responsibility of the user.

6.4    Special precautions for storage

Store in a refrigerator (2 °C - 8 °C). Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.

For instruction on preparation and administration of the ready-to-use diluted infusion solution, see section 4.2.
6.5    Nature and contents of container

Pack with 1 or 10 vials                  containing 5 ml solution
Pack with 1 or 10 vials                  containing 10 ml solution

6.6    Special precaution for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.