Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Pixuvri 29 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. Dark blue lyophilised powder. |
One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Excipient with known effect:
One vial contains 39 mg sodium.
Upon reconstitution and dilution, this medicinal product contains approximately 1g (43 mmol) sodium per dose, equivalent to 50% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pixantrone |
Pixantrone is a cytotoxic aza-anthracenedione. Unlike approved anthracyclines (doxorubicin and others) and anthracenediones (mitoxantrone), pixantrone is only a weak inhibitor of topoisomerase II. Pixantrone is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell lymphomas (NHL). |
| List of Excipients |
|---|
|
Sodium chloride |
Type I glass vial with grey butyl rubber stopper with aluminium seal and red plastic cap containing 50 mg pixantrone dimaleate equivalent to 29 mg pixantrone.
Pack size of 1 vial.
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
EU/1/12/764/001
Date of first authorisation: 10 May 2012
Date of latest renewal: 06 June 2019
| Drug | Countries | |
|---|---|---|
| PIXUVRI | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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