Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride
Sodium citrate dihydrate

Citric acid monohydrate

Water for injections
6.2 Incompatibilities
Ondansetron-Fresenius should not be administered in the same syringe or infusion as any other medication.

Ondansetron-Fresenius should only be mixed with those infusion solutions that are recommended in section 6.6.


6.3 Shelf life

Unopened:

The expiry date of the product is indicated on the packaging materials.
After first opening:

After first opening the medicinal product should be used immediately.

Infusion:
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with the solutions given in section 6.6.

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 normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

The diluted solutions should be stored protected from light.


6.4 Special precautions for storage

Store below 300C. Keep the ampoules in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.


6.5 Nature and contents of container

Type I clear glass ampoules

2 ml: Pack sizes: 1, 5,10 and 50 ampoules.
4 ml: Pack sizes: 1, 5,10 and 50 ampoules.

Not all pack sizes may be marketed.


6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.
Ondansetron-Fresenius may be diluted with the following solutions for infusion: 
Sodium chloride 9 mg/ml (0.9 % w/v)
 solution Glucose 50 mg/ml (5 % w/v) solution
Mannitol 100 mg/ml (10 % w/v) solution

Ri ge s la tate solutio


The diluted solutions should be stored protected from light.

Note: Ondansetron-Fresenius ampoules should not be autoclaved.