Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gentium S.r.l, Piazza XX Settembre, 2, 22079 Villa Guardia (Como), Italy
Defitelio 80 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The solution is clear light yellow to brown, free from particulate matter or turbidity. |
One mL of concentrate contains defibrotide* 80 mg corresponding to a quantity of 200 mg in 2.5 mL in a vial, and corresponding to a concentration in the range of 4 mg/mL to 20 mg/mL after dilution.
* produced from porcine intestinal mucosa.
Excipient with known effect:
Each vial contains 0.89 mmol (equivalent to 20.4 mg) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Defibrotide |
Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions. The mechanism of action is multifactorial. It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance. However, the exact mechanism of action of defibrotide is not fully elucidated. |
| List of Excipients |
|---|
|
Sodium citrate, dihydrate |
2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Pack size of 10 vials.
Gentium S.r.l, Piazza XX Settembre, 2, 22079 Villa Guardia (Como), Italy
EU/1/13/878/001
Date of first authorisation: 18 October 2013
Date of latest renewal: 26 May 2023
| Drug | Countries | |
|---|---|---|
| DEFITELIO | Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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