Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Colistimethate sodium
Teva B.V.
J01XB01
colistimethate sodium
Antibacterials for systemic use,
Cystic Fibrosis
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.
Revision: 16
Authorised
2012-02-13
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER COLOBREATHE 1,662,500 IU INHALATION POWDER, HARD CAPSULES colistimethate sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Colobreathe is and what it is used for 2. What you need to know before you use Colobreathe 3. How to use Colobreathe 4. Possible side effects 5. How to store Colobreathe 6. Contents of the pack and other information 1. WHAT COLOBREATHE IS AND WHAT IT IS USED FOR Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin. Colobreathe is used to control persistent lung infections caused by the bacterium _Pseudomonas _ _aeruginosa_ in adult patients and children aged 6 years and older with cystic fibrosis. _Pseudomonas _ _aeruginosa_ is a very common bacterium that infects nearly all cystic fibrosis patients at some time during their lives. Some people will get this infection whilst very young but for others it will be much later. If this infection is not properly controlled it will cause damage to the lungs. How it works Colobreathe works by destroying the bacterial cell membrane, having a lethal effect on them. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLOBREATHE DO NOT USE COLOBREATHE • if you/your child are allergic to colistimethate sodium, colistin sulphate or polymyxins. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Colobreathe. TELL YOUR DOCTOR IF YOU/YOUR CHILD HAS EVER HAD ANY OF THE FOLLOWING CONDITIONS • have reacted badly to inhaled dry powde Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Colobreathe 1,662,500 IU inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder) Hard transparent PEG-gelatin capsules containing a fine white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colobreathe is indicated for the management of chronic pulmonary infections due to _Pseudomonas _ _aeruginosa_ in patients with cystic fibrosis (CF) aged 6 years and older (see section 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial active substances. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _ _ _Adults and children of 6 years of age and older _ One capsule to be inhaled twice daily. The dose interval should be as close as possible to 12 hours. _ _ The efficacy of Colobreathe has been demonstrated in a study of 24-weeks duration. Treatment may be continued for as long as the physician considers that the patient is obtaining clinical benefit. _Renal impairment_ No dose adjustment is considered to be necessary (see section 5.2). _Hepatic impairment_ No dose adjustment is considered to be necessary (see section 5.2). _Paediatric population_ The safety and efficacy of Colobreathe in children under 6 years of age have not been established. No data are available. Method of administration For inhalation use only. Colobreathe capsules are to be used only with the Turbospin powder inhaler. The capsules must not be swallowed. 3 To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professional, with the first dose being given under medical supervision. If other treatments are being taken, they should be taken in the following order: Inhaled bronchodilators Chest physiotherapy Other inhaled medicinal produc Read the complete document