Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Sodium acetate (trihydrate)
Glacial acetic acid (for pH-adjustment)
Water for injection

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products.
6.3   Shelf life

The expiery date of the product is indicated on the packaging materials.

Following dilution, brivaracetam solution for injection/infusion was found to be physically compatible and chemically stable when mixed with the diluents listed in the section 6.6 for 24 hours and stored in PVC or polyolefin bags at temperature up to 25°C. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.

6.4   Special precautions for storage

This medicinal product does not require any special storage conditions. It is recommended to store the product at room temperature.

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

6.5   Nature and contents of container
10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap.
Each single use vial contains an extractable volume of not less than 5 ml of solution for injection/infusion.


Each carton contains 10 vials.
6.6   Special precautions for disposal and other handling

This medicinal product is for single use only, any unused solution should be discarded.
Product with particulate matter or discoloration should not be used.
Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents

Diluents
- Sodium chloride 9 mg/ml (0.9 %) solution for injection
- Glucose 50 mg/ml (5 %) solution for injection
- Lactated Ringer’s solution for injection

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