Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Mannitol, sodium citrate, water for injection
6.2 Incompatibilities
This medicinal product must not be allowed to come into contact with any calcium-containing solutions. Aclasta must not be mixed or given intravenously with any other medicinal products.
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
After opening, the solution is chemically and physically stable for at least 24 hours at 2 to 8°C.
From a microbiological point of view, the product 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 2⁰C to 8°C.

6.4 Special precautions for storage
The unopened bottle should be stored below 30⁰C.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container
100 ml colourless plastic vial, rubber-stopper, aluminium cap with flip-off component.
Aclasta is supplied in packs containing one, three or six vials.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

For single use only.
Only clear solution free from particles and discoloration should be used.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion.

ACL API MAY21 V13                               Page 16 of 17                 EU SmPC Mar2021, NZ DS AUG 2020 Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. REGISTRATION HOLDER AND IMPORTER:
Novartis Israel Ltd., P.O.B 7126, Tel-Aviv.