Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Maltose.
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.
Once the infusion container has been opened the contents should be used immediately.
6.4    Special precautions for storage

Store in a refrigerator (2°C - 8°C). Keep the vial in the outer carton. Do not freeze.
Before use and within the shelf-life, the vials of 50, 100 and 200 ml can be stored at temperature not exceeding 25 °C, for a maximum of 6 consecutive months. The product can no longer be put back in the refrigerator. Discard if not used within the period of 6 months.
The starting date of the storage at temperature not exceeding 25 °C should be reported on the outer box.

6.5    Nature and contents of container

20 ml solution in a vial (type I glass) with a stopper (elastomer of halobutyl rubber); pack size of one vial.
50 ml, 100 ml and 200 ml solution in a vial (type I glass) with a stopper (elastomer of halobutyl rubber): pack size of one vial + hanger.

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, colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.
Solution should be inspected visually for particulate matter and discoloration prior to administration.

Instructions for the use of the hanger



1.   Initial status of the vial with hanger label
2.   Turn vial upside down
3.   Activate the hanger by unfolding it from the label
4.   Hang the vial on the infusion stand
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.