Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Purified Soybean Oil
Glycerol (Anhydrous)
Purified Egg Phospholipids
Sodium Hydroxide
Water For injection
Nitrogen

6.2. Incompatibilities
Vitalipid N Adult must not be mixed with other medicinal products except those listed in section 6.6.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4. Special precautions for storage

Store below 25°C.
Do not freeze.
Protect from light.
For storage conditions after dilution of the medicinal product, see section 6.6.

6.5. Nature and contents of container
10 ml Ampoules (Colorless glass Type 1).
Pack Size: 10 x 10 ml.


6.6 Instructions for use/handling
Vitalipid N Adult must not be administered undiluted.

Compatibility and instructions for use
All additions should be made aseptically.

10 ml (1 ampoule) of Vitalipid N Adult is added to 500 ml of Intralipid.
To ensure a homogenous admixture, the bottle should be inverted a couple of times immediately before the infusion.

Vitalipid N Adult 10 ml (1 ampoule) can also be added to Structolipid.
Vitalipid N Adult can be used to dissolve Soluvit N. The content of one vial of Soluvit N is dissolved by the addition of 10 ml of Vitalipid N Adult and added to Intralipid or Structolipid.

Vitalipid N Adult is also used as a complement in total parenteral nutrition mixing in a plastic bag.

Storage after mixing
The addition of Vitalipid N Adult to Intralipid should be made within one hour before the start of the infusion, and the infusion should be completed within 24 hours from preparation to prevent microbiological contamination.

The left- over content of opened ampoules should be discarded and not kept for later use.

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