QUOFENIX Powder for concentrate for solution for infusion Ref.[28025] Active ingredients: Delafloxacin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy

Product name and form

Quofenix 300 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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

Meglumine
Sulfobutylbetadex sodium
Disodium edetate
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid, concentrated (for pH-adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy

Marketing authorization dates and numbers

EU/1/19/1393/001

Date of first authorisation: 16 December 2019

Drugs

Drug Countries
QUOFENIX Austria, Estonia, Finland, Ireland, Lithuania, Poland, United Kingdom

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