Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039, Barcelona, Spain
ZOLSKETIL pegylated liposomal 2 mg/mL concentrate for dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for dispersion for infusion. A translucent red coloured dispersion filled in a clear glass vial. When examined under suitable conditions of visibility it should be practically free from particles. |
One mL of ZOLSKETIL pegylated liposomal contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation.
ZOLSKETIL pegylated liposomal, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG). This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Excipients with known effect: Contains fully hydrogenated soy phosphatidylcholine (from soyabean) - see section 4.3.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Doxorubicin |
Doxorubicin is a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius. The exact mechanism of the antitumour activity of doxorubicin is not known. It is generally believed that inhibition of DNA, RNA and protein synthesis is responsible for the majority of the cytotoxic effects. |
| List of Excipients |
|---|
|
N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoyl- sn-glycero-3-phosphoethanolamine, sodium salt (MPEG 2000-DSPE) |
Type I glass vial with a siliconised grey bromobutyl stopper, and an aluminium seal, containing a deliverable volume of 10 mL (20 mg) or 25 mL (50 mg).
ZOLSKETIL pegylated liposomal is supplied as a single pack or packs of ten vials.
Not all pack sizes may be marketed.
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039, Barcelona, Spain
EU/1/22/1629/001
EU/1/22/1629/002
EU/1/22/1629/003
EU/1/22/1629/004
| Drug | Countries | |
|---|---|---|
| ZOLSKETIL | Austria, Estonia, Spain, France, Croatia, Italy, Lithuania, Romania |
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