Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Water for injections.

6.2 Incompatibilities

MultiHance should not be admixed with any other drug.
6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
From a microbiological point of view, the product should be used immediately after drawing into the syringe.

6.4 Special precautions for storage

Do not freeze.
Store below 25°C.
6.5 Nature and contents of container

5 mL, 10 mL, 15 mL and 20 mL of a clear aqueous solution filled into single dose colourless type I glass vials with elastomeric closures, aluminium sealing crimps and polypropylene caps.
5 ml, 10 ml, 15 ml: package containing 1 vial. 20 ml: package containing 1 or 5 vials Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
MultiHance should be drawn up into the syringe immediately before use and should not be diluted.

Before use, examine the product to assure that the container and closure have not been damaged, the solution is not discoloured and no particulate matter is present.

When MultiHance is used in conjunction with an injector system, the connecting tubes to the patient and the relevant disposable parts should be disposed after each patient examination. Any additional instructions from the respective equipment manufacturer must also be adhered to.

For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Revised in March 2018 according to MoH guidelines.

MARKETING AUTHORIZATION HOLDER:
Dexcel Ltd.,
1 Dexcel Street, Or-Akiva 3060000, Israel