Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Glycine, water for injections.

6.2   Incompatibilities
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.

The medicinal product should be used immediately after first opening.
6.4   Special precautions for storage
Store in a refrigerator (2°C - 8°C).

Keep the vial in the outer carton in order to protect from light.

Do not freeze.
6.5   Nature and contents of container
10 ml or 50 ml of ready-for-use solution for intravenous infusion in a vial (type II glass) with a stopper (bromobutyl) and a cap (aluminium).

One box containing:

1 vial with 10 ml (1,000 U) solution for infusion or
1 vial with 50 ml (5,000 U) solution for infusion
Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling
The medicinal product should be brought to room or body temperature before use.

Products should be inspected visually for particular matter and discoloration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Do not use solutions which are cloudy or which have deposits.

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