Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Disodium hydrogen phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Phosphoric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2    Incompatibilities

Sodium Valproate Wockhardt Intravenous should not be administered via the same intravenous line as other IV additives.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution according to the directions in section 6.6: Chemical and physical in-use stability has been demonstrated for seven days at 20-22°C. From a microbiological point of view, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be not 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. Do not freeze.
6.5    Nature and contents of container

Clear glass 5 ml-capacity ampoules (PhEur Type I, One Point Cut with black spot) containing 4 ml of solution and clear glass 10 ml-capacity ampoules (PhEur Type I, One Point Cut with red spot) containing 10 ml of solution.

The ampoules are packed in a PVC tray and cardboard box in packs of 1, 5 or 10 ampoules per pack.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
For infusion the product may be diluted in 0.9% saline or 5% dextrose. Tests with the recommended infusion solutions over seven days at 20-22ºC show compatibility.

Prior to use sodium valproate solution for injection and the diluted solution should be visually inspected. Only clear solutions without particles should be used.
The contents of the ampoule are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.