Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Teva B.V., Swensweg 5, 2031 GA, Haarlem, Netherlands
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. |
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.
| Active Ingredient | 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 |
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.
Teva B.V., Swensweg 5, 2031 GA, Haarlem, Netherlands
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
Date of first authorisation: 05 March 2002
Date of latest renewal: 05 March 2007
| Drug | Countries | |
|---|---|---|
| TRISENOX | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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