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.
If dilution to lower concentrations is required, immediate use after dilution is recommended.
The in-use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) immunoglobulin has been demonstrated for 21 days at 2°C to 8°C as well as 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspect.


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.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
Pack size: 1 vial.
Not all presentations may be marketed.
6.6   Special precautions for disposal and           other handling

The product should be brought to room or body temperature before use.

If dilution is required, 5% glucose solution is recommended. For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution. It is recommended that during dilution the risk of microbial contamination is minimised.

The product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.

KIOVIG should only be administered intravenously. Other routes of administration have not been evaluated.


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


7.    REGISTRATION HOLDER AND IMPORTER
Takeda Israel Ltd.,
25 Efal st., Petach Tikva 4951125