Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Glycine (Aminoacetic Acid)
Methylparaben E218
Disodium Edetate
Water for Injections

6.2   Incompatibilities

Soluvit N must only be added to or mixed with other medicinal products for which compatibility has been documented. Please refer to 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

Do not store above 25°C. Protect from light.

6.5   Nature and contents of container

Vial for injection, glass type I.
Stopper for injection vial, chlorobutyl rubber.
Pack Size: 1 x 10 vials.

6.6   Special precautions for disposal and other handling

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%,
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.