INSTRUCTIONS FOR USE SECTION

Instructions for use/handling, and disposal

Adults and children age 11 years and above:

The contents of one vial of Soluvit N are dissolved by adding 10 ml of:

1. Vitalipid N Adult

or 2. Intralipid 10%, Intralipid 20%, Intralipid 30%, Structolipid

or 3. Water for Injections

or 4. Glucose solution for infusion (5%-50%)

Soluvit N may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes and trace elements provided that compatibility and stability have been confirmed.

Children below 11 years of age:

The contents of one vial are dissolved by adding 10 ml of:

1. Vitalipid N Infant (for children above 10 kg/bw)

or 2. Intralipid 10%, Intralipid 20%

or 3. Water for Injections

or 4. Glucose solution for infusion (5%-50%)

Children weighing less than 10 kg should be given 1 ml of the dissolved mixture per kg body weight per day. Children weighing 10 kg or more should be given 10 ml (one vial) per day.

Due to differences in the dosage regimes for Soluvit N and Vitalipid N Infant, the mixture 1 is not recommended for children weighing less than 10 kg.

Soluvit N may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes and trace elements provided that compatibility and stability have been confirmed.

Disposal

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

Manufacturer:

Fresenius Kabi AB, Uppsala, Sweden

March 2019

---