Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Abraxane 5 mg/ml powder for suspension for infusion.
| Pharmaceutical Form |
|---|
|
Powder for suspension for infusion. The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg. The powder is white to yellow. |
Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Excipients with known effect: Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paclitaxel |
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. |
| List of Excipients |
|---|
|
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate) |
50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
100 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Pack size of one vial.
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
EU/1/07/428/001
EU/1/07/428/002
Date of first authorisation: 11 January 2008
Date of latest renewal: 14 January 2013
| Drug | Countries | |
|---|---|---|
| ABRAXANE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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