Colobreathe

colistimethate sodium

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This is a summary of the European public assessment report (EPAR) for Colobreathe. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Colobreathe.

What is Colobreathe?

Colobreathe is a medicine that contains the active substance colistimethate sodium. It is available as capsules containing a powder for inhalation using an inhaler device.

What is Colobreathe used for?

Colobreathe is used to manage long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and over who have cystic fibrosis.

Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas which secrete fluids such as mucus and digestive juices. In cystic fibrosis, these fluids become thick and viscous, blocking the airways and the flow of digestive juices. The accumulation of mucus in the lungs allows bacteria to grow more easily causing infections, lung damage and breathing problems. Bacterial lung infection with P. aeruginosa is frequent in cystic-fibrosis patients.

The medicine can only be obtained with a prescription.

How is Colobreathe used?

The contents of Colobreathe capsules are inhaled using a powder inhaler called Turbospin. They are not to be inhaled using any other device.

The recommended dose is one capsule twice daily, taken as close as possible to 12 hours apart. The very first dose at the start of the treatment should be taken under medical supervision. Treatment may continue for as long as the doctor considers that the patient is benefiting from it.

If the patient is also receiving other treatments for cystic fibrosis, they should be taken in the following order: inhaled bronchodilator, chest physiotherapy, other inhaled medicines and then Colobreathe.

How does Colobreathe work?

The active substance in Colobreathe, colistimethate sodium, is an antibiotic in the polymyxin group. Polymyxins work by disrupting the cell membrane of bacteria by interacting with certain components of the membrane called phospholipids. Polymyxins target a group of bacteria called Gram-negative bacteria, which includes P. aeruginosa, because their cell membranes contain a high level of phospholipids.

Colistimethate sodium is a well known antibiotic that has been used for several years to treat lung infection in cystic-fibrosis patients and is available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in). Colobreathe, as a powder for inhalation, is expected to be more convenient for patients than nebulisers.

How has Colobreathe been studied?

The effects of Colobreathe were first tested in experimental models before being studied in humans.

Colobreathe was compared with another medicine, tobramycin nebuliser solution, in 380 cystic-fibrosis patients aged six years and above with P. aeruginosa lung infection. The patients’ condition had been stabilised by treatment with tobramycin before the study. The main measure of effectiveness was based on the improvement in FEV1, adjusted for the patients’ age and height, after 24 weeks. FEV1 is the most air a person can breathe out in one second.

What benefit has Colobreathe shown during the studies?

Colobreathe compared well with the tobramycin treatment, considering the fact that the patients were already stabilised on tobramycin nebuliser. Among patients that completed the study, the improvement in FEV1 adjusted for age and height was 0.39% with Colobreathe compared with 0.78% with tobramycin. The improvements in FEV1 seen with Colobreathe were considered sufficient proof of effectiveness, considering the fact that the patients in the study were already stabilised on tobramycin nebuliser.

What is the risk associated with Colobreathe?

The most common side effects seen with Colobreathe in studies were: unpleasant taste, cough, throat irritation, difficulty breathing and dysphonia (difficulty speaking). Inhalation may also lead to coughing or bronchospasm (tightening of the muscles in the airway), which may be controlled by first treating the patients with inhaled beta-2-agonist medicines. For the full list of all side effects reported with Colobreathe, see the package leaflet.

Colobreathe must not be used in people who are hypersensitive (allergic) to colistimethate sodium or to colistin sulphate or polymyxin B.

Why has Colobreathe been approved?

The CHMP concluded that the modest improvement in FEV1 seen with Colobreathe was sufficient evidence of the medicine’s effectiveness, given that larger improvements would not be expected in patients whose condition was already stabilised on tobramycin nebuliser. In addition, the Committee noted that patients generally prefer inhaling powder to using a nebuliser.

The side effects seen with Colobreathe were considered acceptable. No more serious side effects were seen with Colobreathe than with tobramycin.

The Committee therefore decided that the benefits of Colobreathe are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Colobreathe?

The company that makes Colobreathe will supply education packs to patients and healthcare professionals. The packs will contain information on the need to comply with treatment, instructions on how to use the medicine and information on side effects.

Other information about Colobreathe

The European Commission granted a marketing authorisation valid throughout the European Union for Colobreathe on 13 February 2012.

For more information about treatment with Colobreathe, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Colobreathe : EPAR - Summary for the public BG = bălgarski 07/03/2012  
Colobreathe : EPAR - Summary for the public ES = español 07/03/2012  
Colobreathe : EPAR - Summary for the public CS = čeština 07/03/2012  
Colobreathe : EPAR - Summary for the public DA = dansk 07/03/2012  
Colobreathe : EPAR - Summary for the public DE = Deutsch 07/03/2012  
Colobreathe : EPAR - Summary for the public ET = eesti keel 07/03/2012  
Colobreathe : EPAR - Summary for the public EL = elliniká 07/03/2012  
Colobreathe : EPAR - Summary for the public EN = English 07/03/2012  
Colobreathe : EPAR - Summary for the public FR = français 07/03/2012  
Colobreathe : EPAR - Summary for the public IT = italiano 07/03/2012  
Colobreathe : EPAR - Summary for the public LV = latviešu valoda 07/03/2012  
Colobreathe : EPAR - Summary for the public LT = lietuvių kalba 07/03/2012  
Colobreathe : EPAR - Summary for the public HU = magyar 07/03/2012  
Colobreathe : EPAR - Summary for the public MT = Malti 07/03/2012  
Colobreathe : EPAR - Summary for the public NL = Nederlands 07/03/2012  
Colobreathe : EPAR - Summary for the public PL = polski 07/03/2012  
Colobreathe : EPAR - Summary for the public PT = português 07/03/2012  
Colobreathe : EPAR - Summary for the public RO = română 07/03/2012  
Colobreathe : EPAR - Summary for the public SK = slovenčina 07/03/2012  
Colobreathe : EPAR - Summary for the public SL = slovenščina 07/03/2012  
Colobreathe : EPAR - Summary for the public FI = suomi 07/03/2012  
Colobreathe : EPAR - Summary for the public SV = svenska 07/03/2012  

This EPAR was last updated on 06/07/2015 .

Authorisation details

Product details

Product details for Colobreathe
NameColobreathe
Agency product numberEMEA/H/C/001225
Active substance

colistimethate sodium

International non-proprietary name (INN) or common name

colistimethate sodium

Therapeutic area Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code J01XB01

Publication details

Publication details for Colobreathe
Marketing-authorisation holder

Forest Laboratories UK Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union13/02/2012

Contact address:

Forest Laboratories UK Limited
Whiddon Valley Barnstaple
Devon
EX32 8NS
United Kingdom

Product information

Product information

12/06/2015  Colobreathe -EMEA/H/C/001225 -IAIN/0020

Name Language First published Last updated
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015
Colobreathe : EPAR - Product Information SV = svenska 07/03/2012 30/06/2015

Contents

  • 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.


Name Language First published Last updated
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013
Colobreathe : EPAR - All Authorised presentations SV = svenska 07/03/2012 27/09/2013

Name Language First published Last updated
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  
Colobreathe : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 07/03/2012  

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Colobreathe : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 10/09/2012 30/06/2015
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007 : EPAR - Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations SV = svenska 06/07/2015  
Colobreathe-H-C-1225-A31-0007: EPAR - Assessment Report - Article 31 SV = svenska 05/01/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Colobreathe : EPAR - Public assessment report SV = svenska 07/03/2012  
CHMP summary of positive opinion for Colobreathe SV = svenska 29/09/2011  

Authorised

This medicine is approved for use in the European Union