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TRISENOX Concentrate for solution for infusion (2018)

Active ingredients: Arsenic trioxide

Product Name and Form

TRISENOX 1 mg/ml concentrate for solution for infusion.

TRISENOX 2 mg/ml concentrate for solution for infusion.

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless, aqueous solution.

Qualitative and Quantitative Composition

TRISENOX 1 mg/ml concentrate for solution for infusion:

Each ml of concentrate contains 1 mg of arsenic trioxide.

Each ampoule of 10 ml contains 10 mg of arsenic trioxide.

TRISENOX 2 mg/ml concentrate for solution for infusion:

Each ml of concentrate contains 2 mg of arsenic trioxide.

Each vial of 6 ml contains 12 mg of arsenic trioxide.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Arsenic trioxide

Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.

List of excipients

Sodium hydroxide
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and Marketing

TRISENOX 1 mg/ml concentrate for solution for infusion: Type I borosilicate glass ampoule containing 10 ml of concentrate. Each pack contains 10 ampoules.

TRISENOX 2 mg/ml concentrate for solution for infusion: 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.

Marketing authorization holder
Authorization dates

Teva B.V., Swensweg 5, 2031 GA, Haarlem, Netherlands

Date of first authorisation: 05 March 2002
Date of latest renewal: 05 March 2007

Marketing authorization number:

TRISENOX 1 mg/ml concentrate for solution for infusion: EU/1/02/204/001
TRISENOX 2 mg/ml concentrate for solution for infusion: EU/1/02/204/002