Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Water for injections
Sodium chloride
Hydrochloric acid, dilute 10% (for pH adjustment)

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store below 25°C.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer.
Packs of 1x20 ml and 5x20 ml.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Product with particulate matter or discolouration should not be used.
This medicinal product is for single use only, any unused solution should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Vimpat solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
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.