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 Infant may only be added to or mixed with other medicinal products for which compatibility has been documented. See 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. Special precautions for disposal
Vitalipid N Infant must not be administered undiluted.

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

Up to 10 ml (1 ampoule) of Vitalipid N Infant is added to Intralipid 10% or 20%. To ensure
a homogenous admixture, the container should be inverted a couple of times immediately before the infusion.

Vitalipid N Infant can be used to dissolve Soluvit Infant. The contents of one vial of Soluvit Infant is dissolved by the addition of 10 ml of Vitalipid N Infant and added to Intralipid 10% or 20%.

For children weighing more than 10 kg Vitalipid N Infant can also be used to dissolve Soluvit N. For children less than 10 kg body weight the dissolution with Soluvit N is not recommended due to differences in dosage regimens.

Storage after mixing
The addition of Vitalipid N Infant to Intralipid 10% or 20% 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 contents 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.