Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy
Quofenix 300 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). Light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and colour. |
Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin.
After reconstitution each ml contains 25 mg of delafloxacin.
Excipient(s) with known effect:
Each vial contains 2480 mg of sulfobutylbetadex sodium.
Each vial contains 175 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Delafloxacin |
Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination. |
| List of Excipients |
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Meglumine |
20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.
Pack-size: 10 vials.
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy
EU/1/19/1393/001
Date of first authorisation: 16 December 2019
| Drug | Countries | |
|---|---|---|
| QUOFENIX | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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