Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria
Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe.
Zarzio 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion in pre-filled syringe (injection or infusion). Clear, colourless to slightly yellowish solution. |
Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe: Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*. Each pre-filled syringe contains 30 MU (equivalent to 300 μg) filgrastim in 0.5 mL.
Zarzio 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe: Each mL of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*. Each pre-filled syringe contains 48 MU (equivalent to 480 μg) filgrastim in 0.5 mL.
* recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in E. coli by recombinant DNA technology.
Excipient with known effect: Each mL of solution contains 50 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Filgrastim |
Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. |
| List of Excipients |
|---|
|
Glutamic acid |
Pre-filled syringe (type I glass) with injection needle (stainless steel) and needle safety guard, containing 0.5 mL solution.
Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Not all pack sizes may be marketed.
Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria
Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe:
EU/1/08/495/001
EU/1/08/495/002
EU/1/08/495/003
EU/1/08/495/004
Zarzio 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe:
EU/1/08/495/005
EU/1/08/495/006
EU/1/08/495/007
EU/1/08/495/008
Date of first authorisation: 06 February 2009
Date of latest renewal: 13 November 2013
| Drug | Countries | |
|---|---|---|
| ZARZIO | Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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