Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
aztreonam lysine
Gilead Sciences Ireland UC
J01DF01
aztreonam
Antibacterials for systemic use,
Cystic Fibrosis; Respiratory Tract Infections
Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 20
Authorised
2009-09-21
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER CAYSTON 75 MG POWDER AND SOLVENT FOR NEBULISER SOLUTION aztreonam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Cayston is and what it is used for 2. What you need to know before you take Cayston 3. How to take Cayston 4. Possible side effects 5. How to store Cayston 6. Contents of the pack and other information 1. WHAT CAYSTON IS AND WHAT IT IS USED FOR Cayston contains the active substance aztreonam. Caystonis an antibiotic used to suppress chronic lung infection caused by the bacteria _Pseudomonas aeruginosa_ in patients aged 6 years and older with cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system. Cystic fibrosis in the lungs leads to clogging them with thick sticky mucus. This makes it hard to breathe. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAYSTON DO NOT TAKE CAYSTON - IF YOU ARE ALLERGIC to aztreonam or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Cayston: - if you are ALLERGIC TO ANY OTHER ANTIBIOTICS (such as penicillins, cephalosporins, and/or carbapenems) - if you do not tolerate or have chest tightness from taking other inhaled medicines - if you have KIDNEY PROBLEMS - if you have ever COUGHED UP ANY BLOOD - if you have ever had LOW LUNG FUNCTION TEST Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cayston 75 mg powder and solvent for nebuliser solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains aztreonam lysine equivalent to 75 mg aztreonam. After reconstitution the nebuliser solution contains 75 mg aztreonam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for nebuliser solution. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to _Pseudomonas _ _aeruginosa_ in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients should use a bronchodilator before each dose of Cayston. Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 1. bronchodilator 2. mucolytics 3. and lastly, Cayston. _Adults and children 6 years and older _ The recommended dose for adults is 75 mg three times per 24 hours for 28 days. Doses should be taken at least 4 hours apart. Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy. The dosing in children aged 6 years and older is the same as for adults. 3 _Elderly _ _ _ Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients. If Cayston is to be prescribed to the elderly then the posology is the same as for adults. _Renal impairment _ Aztreonam is known to be excreted renally and therefore administration of Cayston in patients with renal impairment (serum creatinine > 2 times upper limit of normal) sh Les hele dokumentet