Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
levofloxacin
Chiesi Farmaceutici S.p.A
J01MA12
levofloxacin
Antibacterials for systemic use,
Cystic Fibrosis; Respiratory Tract Infections
Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 15
Authorised
2015-03-25
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT QUINSAIR 240 MG NEBULISER SOLUTION levofloxacin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Quinsair is and what it is used for 2. What you need to know before you use Quinsair 3. How to use Quinsair 4. Possible side effects 5. How to store Quinsair 6. Contents of the pack and other information 1. WHAT QUINSAIR IS AND WHAT IT IS USED FOR Quinsair contains an antibiotic medicine called levofloxacin. It belongs to the group of antibiotics called fluoroquinolones. Quinsair is used to treat LUNG INFECTIONS caused by _Pseudomonas_ _aeruginosa _in adults with CYSTIC FIBROSIS. It is an antibiotic medicine that is breathed (inhaled) directly into the lungs where it kills the bacteria causing the infection. This helps to improve breathing in people with cystic fibrosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE QUINSAIR DO NOT USE QUINSAIR: - if you are ALLERGIC to LEVOFLOXACIN, to any other QUINOLONE ANTIBIOTICS, such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6) - if you have ever had a problem with your tendons (INFLAMMATION of a TENDON or a RUPTURED TENDON) during treatment with a QUINOLONE OR FLUOROQUINOLONE ANTIBIOTIC - if you suffer Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. Each ampoule contains 240 mg of levofloxacin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution. Clear, pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quinsair is indicated for the management of chronic pulmonary infections due to _Pseudomonas _ _aeruginosa_ in adult patients with cystic fibrosis (CF, see section 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 240 mg (one ampoule) administered by inhalation twice daily (see section 5.2). The doses should be inhaled as close as possible to 12 hours apart. Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment. Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit. If a dose is missed, it should be taken as soon as the patient remembers providing that at least an 8- hour interval is allowed before inhaling the next dose. Patients should not inhale the contents of more than one ampoule to compensate for the missed dose. If acute symptomatic bronchospasm occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator at least 15 minutes to 4 hours prior to subsequent doses (see sections 4.4 and 4.8). _Elderly patients_ _(≥_ _ 65 years old)_ The safety and efficacy of Quinsair in elderly patients wi Lesen Sie das vollständige Dokument