Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol (E421)
Sodium citrate dihydrate
Water for injection

6.2   Incompatibilities
To avoid potential incompatibilities, Zoledronic Acid Fresenius concentrate is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.

This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’s solution and should be administered as a single intravenous solution in a separate infusion line.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution: Chemical and physical in -use stability has been demonstrated for 24 hours at 2°C– 8°C From a microbiological point of view, the diluted solution for infusion 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°C – 8°C. The refrigerated solution should then be equilibrated to room temperature prior to administration.

6.4   Special precautions for storage

Store below 25 ºC. Keep the vial in the outer carton in order to protect from light 
For storage conditions of the diluted solution for infusion, see section 6.3.

6.5   Nature and contents of container
5 ml concentrate in a 10ml polypropylene plastic vial, closed with a halobutyl rubber stopper covered with aluminium cap with either a tear-off tab consisting of aluminium or with a plastic lid.
Packs containing 1,4 or 10 vials.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).

Studies with glass bottles, as well as several containers types made from polyvinylchloride polyethylene and polypropylene (prefilled with 0.9% w/v sodium chloride solution or 5% w/v glucose solution ) , showed no incompatibility with Zoledronic acid.

Additional information on handling of Zoledronic Acid Fresenius, including guidance on preparation of reduced doses, is provided in section 4.2.

Aseptic techniques must be followed during the preparation of the infusion. For single use only.

Only clear solution free from particles and discolouration should be used.
Healthcare professionals are advised not to dispose of unused Zoledronic Acid Fresenius via the domestic sewage system.

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