QUINSAIR Nebuliser solution Ref.[7177] Active ingredients: Levofloxacin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122 Parma, Italy

Product name and form

Quinsair 240 mg nebuliser solution.

Pharmaceutical Form

Nebuliser solution.

Clear, pale yellow solution.

Qualitative and quantitative composition

Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.

Each ampoule contains 240 mg of levofloxacin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levofloxacin

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV.

List of Excipients

Magnesium chloride hexahydrate
Water for injections

Pack sizes and marketing

Ampoule: 3 ml, Low density polyethylene ampoule.

Sachet: Sealed foil laminate sachet containing 4 ampoules.

Inner box: 56 (14 sachets of 4) ampoules.

Outer box: Quinsair is supplied as a 28-day pack. This comprises an inner carton box containing 56 ampoules and a Package Leaflet. The outer carton box also contains one Zirela Nebuliser Handset packaged in its own carton box with the Manufacturer’s Instruction for Use.

Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122 Parma, Italy

Marketing authorization dates and numbers

EU/1/14/973/001

Date of first authorisation: 26/03/2015

Drugs

Drug Countries
QUINSAIR Austria, Canada, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom

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