Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sodium chloride, sodium-(S)-lactate-solution (50%) and hydrochloric acid 36% for buffering, water for injections

6.2     Incompatibilities

Due to chemical incompatibilities EPI-cell® should not be mixed with heparin. If EPI-cell® is administered concomitantly with other cytostatic drugs, they should not be directly mixed with each other. EPI-cell® should neither be brought into contact with any solution of alkaline pH (hydrolysis).
6.3   Shelf life
The expiry date is indicated on the packaging materials.
Chemical and physical in-use stability after dilution in 5% glucose solution or 0.9% sodium chloride solution has been demonstrated for 2 weeks at 2°C to 8°C and at 25°C.

6.4    Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Keep the vial in the outer carton in order to protect the content from light.
6.5    Nature and contents of container

Clear vials (glass type I) with chlorobutyl stopper and aluminium cap with plastic flip-off top.

Pack of 1vial containing 25 ml solution for injection.
6.6    Special precautions for disposal and other handling

Discard any remaining contents after use.

Instructions for use and handling
EPI-cell® is a ready-to-use solution and has a pH of 2.5 – 3.5. Prior to administration, the solution should be brought up to room temperature. EPI-cell® contains no preservatives and is therefore not intended for multiple-dose usage.

Prior use the solution for injection must be free of particles. Solutions for injection, which contain particles, must not be used and must be disposed in accordance to the current guidelines for cytostatic agents.

When handling EPI-cell®, appropriate precautionary measures should be taken, as with all similar cytotoxic substances (contact with skin and mucosae should be avoided).

Personnel handling EPI-cell® must wear protective clothing. Should EPI-cell® come into contact with skin or mucosae, careful cleaning with water and soap is recommended. Contact with the skin or eyes should be treated immediately by copious lavage with water or water and soap or sodium bicarbonate solution, and medical attention should be sought.

Instructions for the removal of any unused solution
Any unused EPI-cell® and all materials which have come into contact with EPI-cell® must be correctly disposed in accordance to the current guidelines for cytostatic substances.