Država: Evropska unija
Jezik: angleščina
Source: myHealthbox
colistimethate sodium
Forest Laboratories UK Ltd
J01XB01
colistimethate sodium
Each capsule contains 1662500IU (approximately equal to 125mg) of colistimethate sodium
Inhalation powder, hard capsule
To inhale from the capsule through the inhaler
8,56 capsules + 1 Turbospin inhaler
Medicinal product subject to medical prescription
Penn Pharmaceutical Services Ltd, Forest-Tosara Ltd
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 6 years and older
Authorized
2012-02-13
20 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. WHAT IS IN THIS LEAFLET 1. What Colobreathe is and what it is used for 2. What you need to know before you take 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLOBREATHE DO NOT USE COLOBREATHE: if you/your child are allergic to colistimethate sodium (sometimes known as colistin), colistin sulphate or polymyxins: WARNINGS AND PRECAUTIONS TELL YOUR DOCTOR IF YOU/ Preberite celoten dokument
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. For the list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder) Hard transparent 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 agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology To ensure proper administration of the drug, 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. 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. _Adults _ One capsule to be inhaled twice daily. The dose interval should be as close as possible to 12 hours. _ _ _Paediatric population_ _ _ _Children of 6 years of age and older _ The same dose recommendations as for adults apply to children of 6 years of age and older. _Children below 6 years of age _ The safety and efficacy of Colobreathe in children under 6 years of age has not been established. No data are available. Preberite celoten dokument