Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium hydroxide
Hydrochloric acid (as pH adjuster)
Water for injections

6.2   Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

4 years.
After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15°C-30°C and 48 hours at refrigerated (2°C-8°C) temperatures. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Store Below 25
Do not freeze.

6.5   Nature and contents of container
Type I borosilicate glass ampoule containing10 ml of concentrate. Each pack contains 10 ampoules.

6.6   Special precautions for disposal and other handling

Preparation of TRISENOX
Aseptic technique must be strictly observed throughout handling of TRISENOX since no preservative is present.

TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection immediately after withdrawal from the 

ampoule. It is for single use only, and any unused portions of each ampoule must be discarded properly. Do not save any unused portions for later administration.

TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.

TRISENOX must be administered intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if vasomotor reactions are observed. A central venous catheter is not required.

The diluted solution must be clear and colourless. All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if foreign particulate matter is present.

Procedure for proper disposal

Any unused medicinal product, any items that come into contact with the product, or waste material must be disposed of in accordance with local requirements.