Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
IFO-cell 2g
Disodium phosphate dihydrate, sodium chloride, hydrochloric acid, water for injections 
IFO-cell 5g
Urea, disodium phosphate dihydrate sodium chloride, hydrochloric acid, water for injections 
6.2 Incompatibilities
Benzyl alcohol-containing solutions can reduce the stability of ifosfamide.

6.3 Shelf life
The expiry date is indicated on the printing materials.

Chemical and physical stability of IFO-cell, prepared for use with 5% glucose solution or 0.9% sodium chloride solution has been demonstrated for both 2 days at 25 °C and for 2 days at 2 °C to 8 °C, each followed by one additional day at 25°C.From a microbiological point of view, the ready-to-use preparation should be used immediately. If the ready-to-use preparation is not used immediately, the user is responsible for the duration and conditions of storage, unless dilution has taken place under controlled and validated aseptic conditions.

6.4 Special precautions for storage
Store in a refrigerator (2-8°C).

Keep container in outer carton.
6.5 Nature and contents of container
Colourless glass vial with a rubber stopper and a flip-off aluminium cap with a plastic cap.
IFO- cell 2g

Packs of 1 vial with 50 ml solution for infusion

IFO- cell 5 g
Pack of 1 vial with 25 ml concentrate for solution for infusion

6.6 Special precautions for disposal and other handling
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The following protective recommendations are advised during handling due to the toxic nature of the substance: dilution and administration must be undertaken only by trained personnel. Pregnant staff and breastfeeding mothers should be excluded.
Protective clothing, goggles, masks and disposable PVC or latex gloves should be worn.
A designated area should be defined for dilution (preferably under a laminar-airflow system).
The work surface should be protected by a disposable, plastic backed absorbent paper.
IFO-cell® and all materials having come into contact with IFO-cell® must be discarded correctly in accordance with the applicable guidelines for cytostatic substances.
Accidental contact with the skin or eyes should be treated immediately by copious lavage with water. Soap and water should then be used on non-mucous membranes. Spillage should be removed by dry or moist disposable towels.
Care must be taken in the disposal of all waste material (syringes, needles and disposable towels etc.) Used items should be placed in appropriate secure containers in readiness for destruction in an appropriate high-temperature incinerator with an after-burner.