Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Shionogi B.V., Herengracht 464, 1017CA Amsterdam, Netherlands
Fetcroja 1 g powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder. |
Each vial contains cefiderocol sulfate tosylate equivalent to 1 g of cefiderocol.
Excipient with known effect: Each vial contains 7.64 mmol of sodium (approximately 176 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cefiderocol |
Cefiderocol is a siderophore cephalosporin. In addition to passive diffusion through outer membrane porin channels, cefiderocol is able to bind to extracellular free iron via its siderophore side chain, allowing active transport into the periplasmic space of Gram-negative bacteria through siderophore uptake systems. Cefiderocol subsequently binds to penicillin binding proteins (PBPs), inhibiting bacterial peptidoglycan cell wall synthesis which leads to cell lysis and death. |
| List of Excipients |
|---|
|
Sucrose |
14 mL vial (Type I clear glass vial), chlorobutyl elastomeric stopper, and aluminum seal with a plastic flip-off cap. The vials are packed in a cardboard carton.
Pack size of 10 vials.
Shionogi B.V., Herengracht 464, 1017CA Amsterdam, Netherlands
EU/1/20/1434/001
Date of first authorisation: 23 april 2020
| Drug | Countries | |
|---|---|---|
| FETCROJA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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