Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Torisel 30 mg concentrate and solvent for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear, colourless to light-yellow solution, free from visible particulates. The solvent is a clear to slightly turbid, light-yellow to yellow solution, free from visible particulates. |
Each vial of concentrate for solution for infusion contains 30 mg temsirolimus.
After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section 4.2).
Excipient with known effect:
1 vial of concentrate contains 474 mg of anhydrous ethanol.
1.8 ml of the solvent provided contains 358 mg anhydrous ethanol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Temsirolimus |
Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein (FKBP-12), and the protein/temsirolimus complex binds and inhibits the activity of mTOR that controls cell division. In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12. When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked. |
| List of Excipients |
|---|
|
Concentrate: Anhydrous ethanol Solvent: Polysorbate 80 (E433) |
Concentrate: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 1.2 ml of concentrate.
Solvent: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 2.2 ml of solvent.
Pack size: 1 vial of concentrate and 1 vial of solvent.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
EU/1/07/424/001
Date of first authorisation: 19 November 2007
Date of the latest renewal: 13 July 2017
| Drug | Countries | |
|---|---|---|
| TORISEL | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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