Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Xylitol
Hydrochloric acid
Water for Injections

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.
After dilution: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 25°C. 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 2-8 °C, unless mixing has taken place in controlled and validated aseptic conditions.

6.4    Special precautions for storage

Store below 25°C. Do not freeze.
Keep ampoules in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5    Nature and contents of container

Polypropylene ampoules, 10 ml: Packs of 20
6.6    Special precautions for disposal and other handling

Addamel-N must not be given undiluted.
For single use only

Compatibility
Additions should be made aseptically.

Up to 20 ml Addamel-N can be added to 1000 ml Vamin Glucose, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free and glucose solutions 50 mg/ml-500 mg/ml.