Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium (s)-lactate solution 50%
Water for injections

6.2 Incompatibilities
There is in vitro incompatibility with fluorouracil, gentamicin, penicillin G, oxacillin, heparin (not with ready-to-use solutions), insulin, methylprednisolone and methotrexate.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Any portion of the contents remaining after use should be discarded.

Preparation
Chemical and physical in-use stability (after dilution in 0.9% sodium chloride solution or in 5% glucose solution) has been demonstrated for 10 days at room temperature (25°C) or in the refrigerator (2-8°C).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Additionally, when preparing the solution, the usual contact time of the disinfectant and the stopper of minimum 30 seconds prior pricking must be followed. Solutions for long term infusions are to be prepared immediately prior use.

6.4 Special precautions for storage

Store between 15°C and 25°C.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container
Transparent vials with rubber stopper and aluminium flip-off caps.

Original packs of 1 vial with 50 ml concentrate for solution for infusion.
6.6 Special precautions for disposal and other handling

For preparation of the solution for infusion 0.9% sodium chloride solution or 5% glucose solution can be used.

Observe the safety measures for hazardous substances during preparation and application. Observe the valid national safety measures pertaining to handling cytostatic agents when handling ARA-cell®

The solution may crystallise at temperatures below 15°C. Cloudy or precipitated solutions should be excluded from use. Use clear solutions only.

Special precautions for disposal of unused medicinal products:
Any unused medicinal product, waste material, or any materials which have come into contact with ARA-cell® should be disposed of in accordance with local requirements for cytotoxic compounds.