Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical Particulars

6.1 List of excipients
L-proline
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

Stability after first opening:
Privigen is intended for single use. Once the vial has been broached, its contents should be used promptly. Because the solution contains no preservative, Privigen should be infused immediately.

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 first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container
Packs
Solution in vials:
• 2.5 g/25 ml
• 5 g/50 ml
• 10 g/100 ml
6.6 Special precautions for disposal and other handling
Privigen comes as a ready-to-use solution in single-use vials. The product should be brought to room temperature (25°C) before use. A vented infusion line should be used for the administration of Privigen. Flushing of the infusion tubes with physiological saline or 5% glucose solution is permitted. Always pierce the stopper at its center, within the marked area.
The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.

If dilution is desired, 5% glucose solution should be used. For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the 5% glucose solution. Aseptic technique must be strictly observed during the dilution of Privigen.

Any unused medical product and waste material should be disposed of in accordance with local requirements.