Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium citrate, dihydrate
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

6.2     Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3     Shelf life

Unopened vials
The expiry date of the product is indicated on the packaging materials.
In-use stability after first opening and/or dilution
From a microbiological point of view, after dilution, the reconstituted medicinal product should be used immediately. However, chemical and physical in-use stability has been demonstrated for 72 hours at 15-25°C for a concentration range of 4 mg/mL to 20 mg/mL in sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be expected to exceed 24 hours at 2-8 °C.

6.4     Special precautions for storage

Store below 25 °C.
Do not freeze.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5     Nature and contents of container

2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Pack size of 10 vials.

6.6     Special precautions for disposal and other handling

Defitelio® is for single use only.
The concentrate solution for infusion has to be diluted using aseptic technique.


Defitelio® should be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion (see section 6.3 for concentration range and stability of the diluted solution) to a suitable concentration to permit 2 hour infusion time (see section 4.2).

Preparation of Defitelio® (use aseptic technique):

1. The number of vials to be diluted should be determined based on the individual patient's weight (see section 4.2).
2. Before dilution, each vial should be inspected for particles. If particles are observed and/or the liquid in the vial is not clear, the vial must not be used.
3. The total volume of infusion should be determined based on the individual patient's weight. The final concentration of Defitelio® should be in the concentration range of 4 mg/mL – 20 mg/mL (see section 6.3).
4. A volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion from the infusion bag should be withdrawn and discarded, equal to the total volume of Defitelio® solution to be added.
5. The required volume from the Defitelio® vials should be withdrawn and combined.
6. The combined volumes of Defitelio® should be added to the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
7. The solution for infusion should be mixed gently.
8. Prior to use the solution should be visually inspected for particulate matter. Only clear solutions without visible particles should be used. Depending on the type and amount of diluent the colour of the diluted solution may vary from colourless to light yellow. It is recommended that the diluted Defitelio® solution be administered to patients using an infusion set equipped with a 0.2 μm in-line filter.
9. After the infusion is complete, the intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.

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