Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol
Sodium citrate
Water for injections

6.2   Incompatibilities
To avoid potential incompatibilities, Zoledronic Acid Taro 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: 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.
For storage conditions of the reconstituted solution for infusion, see section 6.3.

6.5   Nature and contents of container

5 ml concentrate in a clear glass vial, closed with bromobutyl rubber stopper sealed with 'baby-blue' aluminum seal.
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Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).

Additional information on handling of Zoledronic Acid Taro, 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 Taro via the domestic sewage system.

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