Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glycine, water for injections.

6.2     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After first opening, an immediate use is recommended.
6.4   Special precautions for storage

Do not store above 25°C. Do not freeze.
Keep the vial in the outer carton in order to protect from light.

6.5     Nature and contents of container
10 ml, 25 ml, 50 ml, 100 ml or 200 ml of solution in a vial (Type II glass) with a stopper (bromobutyl) and a cap (aluminium) – pack size of one vial. Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

The product should be brought to room or body temperature before use.
The solution should be clear or slightly opalescent and colourless to pale yellow. Solutions that are cloudy or have deposits should not be used.
Any unused product or waste material should be disposed of in accordance with local requirements.