Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, Spain
Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. Clear, colourless solution. |
Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion.
Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in Escherichia coli (BL21) by recombinant DNA technology.
Excipient with known effect: Each ml of solution contains 50 mg of 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 |
|---|
|
Acetic acid glacial |
Pre-filled syringe with injection needle, with or without a needle safety guard. Package containing one, three, five, seven or ten pre-filled syringe (s), with or without blister and alcohol swabs. The packs without blister are without needle safety guard. The blister packs are for individual syringes with prefixed needle safety guard. The pre-filled syringes are made from Type I glass with a permanently attached stainless steel needle in the tip and have 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel. The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4). Each pre-filled syringe contains 0.5 ml solution.
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/1/14/946/001
EU/1/14/946/002
EU/1/14/946/005
EU/1/14/946/006
EU/1/14/946/007
EU/1/14/946/008
EU/1/14/946/009
EU/1/14/946/010
EU/1/14/946/017
Date of first authorization: 18.09.2014
| Drug | Countries | |
|---|---|---|
| ACCOFIL | Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom |
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