Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Water for Injection
Sodium chloride
Ethanol
Hydrochloric acid
Trometamol

6.2 Incompatibilities

No data available for other than those medicinal products described under section "Instructions for use/handling", therefore, this medicinal product should not be mixed with other than those mentioned in section 6.6 Instructions for use and handling".


6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage

Store below 30ºC.
6.5 Nature and contents of container

- Ampoule 1 ml containing 0.5 ml concentrate for solution for infusion; Colourless, glass type I ,Ph.Eur


6.6 Instructions for use/handling
Ilomedin should be used only after dilution.
Because of the possibility of interactions, no other drug should be added to the ready- to-use infusion solution.
The ready- to-use infusion solution must be freshly prepared each day in order to guarantee the sterility.

• Instructions for dilution
The contents of the ampoule and the diluent should be mixed thoroughly.
Dilution of Ilomedin for use with an infusion pump:
For this purpose, the contents of an ampoule of 0.5 ml Ilomedin (i.e. 50 µg) are diluted with 250 ml of a sterile physiological saline solution or a 5% glucose solution.

Dilution of Ilomedin for use with a syringe driver:
In this case, the contents of one ampoule Ilomedin of 0.5ml (i.e. 50 µg) are diluted with 25 ml of sterile physiological saline solution or 5% glucose solution.