Colobreathe

colistimethate sodium

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 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

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Colobreathe : EPAR - Summary for the public (PDF/71.3 KB)

First published: 07/03/2012
Last updated: 07/03/2012
EMA/135145/2012
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Colobreathe : EPAR - Risk-management-plan-summary (PDF/66.2 KB)

First published: 18/03/2020
Last updated: 13/01/2022

This EPAR was last updated on 11/05/2023

Authorisation details

Product details
Name	Colobreathe
Agency product number	EMEA/H/C/001225
Active substance	Colistimethate sodium
International non-proprietary name (INN) or common name	colistimethate sodium
Therapeutic area (MeSH)	Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code	J01XB01

Publication details
Marketing-authorisation holder	Teva B.V.
Revision	14
Date of issue of marketing authorisation valid throughout the European Union	13/02/2012
Contact address	Swensweg 5 2031 Haarlem Netherlands

Product information

10/05/2023 Colobreathe - EMEA/H/C/001225 - IA/0055

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Colobreathe : EPAR - Product Information (PDF/451.72 KB) (updated)

First published: 07/03/2012
Last updated: 11/05/2023
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  (PDF/553.61 KB)
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  (PDF/621.38 KB)
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- Icelandic
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- Swedish
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Colobreathe : EPAR - All Authorised presentations (PDF/45.21 KB)

First published: 07/03/2012
Last updated: 27/09/2013
- Bulgarian
  (PDF/77.18 KB)
- Croatian
  (PDF/74.3 KB)
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  (PDF/46.11 KB)
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  (PDF/47.56 KB)
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  (PDF/46.62 KB)
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- Spanish
  (PDF/46.84 KB)
- Swedish
  (PDF/46.59 KB)

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Colobreathe : EPAR - Conditions imposed on member states for safe and effective use (PDF/104.37 KB)

First published: 07/03/2012
Last updated: 07/03/2012
- Bulgarian
  (PDF/150.75 KB)
- Croatian
  (PDF/109.91 KB)
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- Italian
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- Latvian
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- Lithuanian
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- Swedish
  (PDF/94.46 KB)

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

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Colobreathe : EPAR - Procedural steps taken and scientific information after authorisation (PDF/182.27 KB) (updated)

First published: 10/09/2012
Last updated: 11/05/2023
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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 (PDF/56.5 KB)

First published: 06/07/2015
Last updated: 06/07/2015
- Bulgarian
  (PDF/93.19 KB)
- Croatian
  (PDF/88.56 KB)
- Czech
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- Danish
  (PDF/56.19 KB)
- Dutch
  (PDF/59.91 KB)
- Estonian
  (PDF/56.74 KB)
- Finnish
  (PDF/56.71 KB)
- French
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- German
  (PDF/60.15 KB)
- Greek
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- Hungarian
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- Italian
  (PDF/81.31 KB)
- Latvian
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- Lithuanian
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- Maltese
  (PDF/94.38 KB)
- Polish
  (PDF/90.38 KB)
- Portuguese
  (PDF/58.39 KB)
- Romanian
  (PDF/129.95 KB)
- Slovak
  (PDF/79.74 KB)
- Slovenian
  (PDF/86.41 KB)
- Spanish
  (PDF/57.82 KB)
- Swedish
  (PDF/57.42 KB)
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Colobreathe-H-C-1225-A31-0007: EPAR - Assessment Report - Article 31 (PDF/259.83 KB)

Adopted

First published: 05/01/2015
Last updated: 05/01/2015
EMA/707128/2014

Colobreathe

Table of contents

Overview

Colobreathe : EPAR - Summary for the public (PDF/71.3 KB)

Colobreathe : EPAR - Risk-management-plan-summary (PDF/66.2 KB)

Authorisation details

Product information

Colobreathe : EPAR - Product Information (PDF/451.72 KB) (updated)

Colobreathe : EPAR - All Authorised presentations (PDF/45.21 KB)

Colobreathe : EPAR - Conditions imposed on member states for safe and effective use (PDF/104.37 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Colobreathe : EPAR - Procedural steps taken and scientific information after authorisation (PDF/182.27 KB) (updated)

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 (PDF/56.5 KB)

Colobreathe-H-C-1225-A31-0007: EPAR - Assessment Report - Article 31 (PDF/259.83 KB)

Initial marketing-authorisation documents

Colobreathe : EPAR - Public assessment report (PDF/812.23 KB)

CHMP summary of positive opinion for Colobreathe (PDF/46.53 KB)

More information on Colobreathe

Assessment report for Article-5(3) procedure: Polymyxin-based products (PDF/227.93 KB)

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