Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium hydroxide
Hydrochloric acid (for pH adjustment)
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

The expiry date of the product is indicated on the packaging materials.
Chemical and physical in use stability has been demonstrated for 24 hours at room temperature and 48 hours at 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.
Trisenox vial is single-dose and does not contain any preservatives.

6.4   Special precautions for storage

Store below 250C. Do not freeze.
For storage conditions after dilution of the medicinal products, see section 6.3.

6.5   Nature and contents of container

TRISENOX 2 mg/ml concentrate for solution for injection
6 ml concentrate in a clear, Type I borosilicate glass vial with a chlorobutyl rubber stopper (FluroTec coated plug) and an aluminium crimp cap with a plastic flip-top button. Each pack contains 10 vials.

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 dextrose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the vial.


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

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

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

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.


7.    LICENCE HOLDER AND MANUFACTURER
Licence holder:
Teva Pharmaceutical Industries Ltd.
P.O.B. 3190, Petah Tikva 49131
Israel

Manufacturer:
Cephalon INC, USA.
145 Brandywine Parkway,
West Chester, Pennsylvania 19380
USA