Quinsair

levofloxacin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Quinsair. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Quinsair.

For practical information about using Quinsair, patients should read the package leaflet or contact their doctor or pharmacist.

: Quinsair is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in adults who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Quinsair contains the active substance levofloxacin. Before using Quinsair, doctors should consider official guidance on the appropriate use of antibiotics.

: Quinsair is available as a nebuliser solution in single-dose containers called ‘ampoules’. It can only be obtained with a prescription.
Quinsair is inhaled using a device called Zirela nebuliser system, which converts the solution in the ampoule into a fine mist. The medicine is not to be inhaled with any other device. The recommended dose is one ampoule twice a day, ideally 12 hours apart. After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment. Treatment cycles may be repeated for as long as the patient benefits.

: The active substance in Quinsair, levofloxacin, belongs to the group of antibiotics known as ‘fluoroquinolones’. It works by blocking enzymes that P. aeruginosa bacteria use to make copies of their DNA during cell multiplication. By doing this, it stops the bacteria that are causing the infection from growing and multiplying.
Levofloxacin is a well-known antibiotic. Systemic formulations of levofloxacin (such as tablets and solutions for infusion) have been authorised in the EU since the 1990s.

: Quinsair has been investigated in two main studies in patients who had cystic fibrosis with P. aeruginosa lung infection. The first study, which involved 330 patients, compared Quinsair with placebo (a dummy treatment), while the second, involving 282 patients, compared it with another inhaled antibiotic (tobramycin). In both studies, the majority of patients were adults.
In the first study, Quinsair was shown to be better than placebo at improving the patients’ forced expiratory volume in one second (FEV1), adjusted for the patient’s age, height and sex. FEV1 is the most air a person can breathe out in one second. Following 28 days of treatment, the patients taking Quinsair had an improvement in FEV1 of 1.73%, while for patients taking placebo the improvement in FEV1 was of around 0.43%. However, the study failed to show that Quinsair is more effective than placebo at increasing the time it took before the patients had an exacerbation (flare-up) of their disease.
The second study showed that Quinsair was at least as good as tobramycin at improving FEV1 following 1 to 3 treatment cycles.

: The most common side effects with Quinsair are cough (seen in 54% of patients), dysgeusia (taste disturbances, 30%) and tiredness/weakness (25%). For the full list of all side effects reported with Quinsair, see the package leaflet.
Quinsair must not be used in patients with epilepsy and those with a history of tendon disorders related to the use of fluoroquinolone antibiotics. It must not be used in pregnant or breastfeeding women. For the full list of restrictions, see the package leaflet.

: The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Quinsair’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the modest improvement in FEV1 seen with Quinsair meant that it could help to meet the need for additional inhaled antibiotics to treat long-term P. aeruginosa infections in cystic fibrosis.
Regarding safety, Quinsair was well tolerated with side effects similar to those of levofloxacin given systemically (throughout the body). Because levofloxacin has a potential risk on cartilage, the use of the product was not considered justified in adolescents.

: A risk management plan has been developed to ensure that Quinsair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Quinsair, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Quinsair will carry out a study to investigate the long-term safety of Quinsair when used in clinical practice in the European Union.
Further information can be found in the summary of the risk management plan .

: The European Commission granted a marketing authorisation valid throughout the European Union for Quinsair on 26 March 2015.
For more information about treatment with Quinsair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Quinsair : EPAR - Summary for the public (PDF/77.5 KB)

First published: 12/06/2015
Last updated: 12/06/2015
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Quinsair : EPAR - Risk-management-plan summary (PDF/138.54 KB)

First published: 12/06/2015
Last updated: 12/06/2015

More detail is available in the summary of product characteristics

This EPAR was last updated on 29/03/2019

Authorisation details

Product details
Name	Quinsair
Agency product number	EMEA/H/C/002789
Active substance	levofloxacin
International non-proprietary name (INN) or common name	levofloxacin
Therapeutic area (MeSH)	Cystic Fibrosis Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code	J01MA12
Additional monitoring	This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder	Horizon Pharma Europe BV
Revision	9
Date of issue of marketing authorisation valid throughout the European Union	25/03/2015
Contact address	Chiesi Orphan B.V. Graadt van Roggenweg 340 3531 AH Utrecht The Netherlands

Product information

22/02/2019 Quinsair - EMEA/H/C/002789 - N/0020

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Quinsair : EPAR - Product Information (PDF/346.83 KB) (updated)

First published: 12/06/2015
Last updated: 29/03/2019
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Annex I - Summary of product characteristics
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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Quinsair : EPAR - All Authorised presentations (PDF/19.24 KB)

First published: 12/06/2015
Last updated: 12/06/2015
- Bulgarian
  (PDF/66.21 KB)
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  (PDF/52.79 KB)
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  (PDF/58.92 KB)
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  (PDF/20.11 KB)
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  (PDF/19.85 KB)
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  (PDF/19.65 KB)

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

Changes since initial authorisation of medicine

List item

Quinsair : EPAR - Procedural steps taken and scientific information after authorisation (PDF/88.77 KB) (updated)

First published: 13/10/2015
Last updated: 29/03/2019
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Quinsair : EPAR - Scientific conclusion - Article 31 referral (PDF/139.14 KB)

First published: 29/03/2019
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  (PDF/197.31 KB)
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  (PDF/176.66 KB)
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  (PDF/194.62 KB)
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  (PDF/110.63 KB)
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  (PDF/106.24 KB)
- French
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- Greek
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- Hungarian
  (PDF/174.08 KB)
- Italian
  (PDF/119.54 KB)
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  (PDF/168.56 KB)
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  (PDF/192.77 KB)
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  (PDF/167.23 KB)
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  (PDF/111.74 KB)
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  (PDF/118.53 KB)
List item

Quinsair-H-A-31-1452 : EPAR - Assessment report (PDF/1.06 MB)

Adopted

First published: 29/03/2019
EMA/818158/2018

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014

19/12/2014

Quinsair

Table of contents

Overview

Quinsair : EPAR - Summary for the public (PDF/77.5 KB)

Quinsair : EPAR - Risk-management-plan summary (PDF/138.54 KB)

Authorisation details

Product information

Quinsair : EPAR - Product Information (PDF/346.83 KB) (updated)

Contents

Quinsair : EPAR - All Authorised presentations (PDF/19.24 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Quinsair : EPAR - Procedural steps taken and scientific information after authorisation (PDF/88.77 KB) (updated)

Quinsair : EPAR - Scientific conclusion - Article 31 referral (PDF/139.14 KB)

Quinsair-H-A-31-1452 : EPAR - Assessment report (PDF/1.06 MB)

Initial marketing-authorisation documents

Quinsair : EPAR - Public assessment report (PDF/2.88 MB)

CHMP summary of positive opinion for Quinsair (PDF/89.84 KB)

News

More information on Quinsair

How useful was this page?

Quinsair

Table of contents

Overview

Quinsair : EPAR - Summary for the public (PDF/77.5 KB)

Quinsair : EPAR - Risk-management-plan summary (PDF/138.54 KB)

Authorisation details

Product information

Quinsair : EPAR - Product Information (PDF/346.83 KB) (updated)

Contents

Quinsair : EPAR - All Authorised presentations (PDF/19.24 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Quinsair : EPAR - Procedural steps taken and scientific information after authorisation (PDF/88.77 KB) (updated)

Quinsair : EPAR - Scientific conclusion - Article 31 referral (PDF/139.14 KB)

Quinsair-H-A-31-1452 : EPAR - Assessment report (PDF/1.06 MB)

Initial marketing-authorisation documents

Quinsair : EPAR - Public assessment report (PDF/2.88 MB)

CHMP summary of positive opinion for Quinsair (PDF/89.84 KB)

News

More information on Quinsair

Related content

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